The Vaccine Adverse Event Reporting Syst

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The Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System - 601 Total Events - 01 Feb 2021
Vaccine Event
Row # Symptoms Age VAERS ID
Manufacturer Category
One week after the shot (1-14-2021) Patient (19 y.o.)reported side pain and appeared constipated, Laxatives given along with
Tylenol, on further assessment Patient was noted to have left leg redness and abdominal fullness. Dr. was updated and we had
orders for close monitoring, the next day when she got up, her leg appeared better, and she had passed a small BM, but by lunch
she had developed significant pain and edema in her left leg, and the color of her leg was reddened again. She was sent to the
18-29 Life emergency room with her symptoms. She was admitted back to our facility yesterday, her diagnoses included Acute provoked
1 ABDOMINAL DISTENSION MODERNA 955565-1
years Threatening left external illiac, femoral, popliteal, and peroneal DVT. Elevated Factor II levels, Elevated APC resistant, May-Thurner Syndrome,
history of developmental disabilities, fecal impaction and urinary retention - suspected related to her fecal impaction. Vascular
surgery was consulted, and pt. was started on a heparin drip, and mechanical thrombectomy was needed for both legs due to
multiple clots. She was started on Eliquis and Plavix, and thigh high compression stockings were ordered, ace wraps being used
until these are supplied. Her Fecal impaction was addressed also and the urinary retention resolved.
"Narrative: Patient seen in ED 1-17-21 with c/c of ""bloated with epigastric pain"". Patient with complicated medical history
including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker
implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac
history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and
patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day,
and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable
65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
2 ABDOMINAL DISTENSION PFIZER\BIONTECH Death 959929-1
years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR
unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting
inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly
declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and
resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and
family is considering autopsy at time of this report."
65+
3 ABDOMINAL PAIN MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
years
The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10. The pain gradually
increased, became more intense, and more constant. Mild fever and chills started happening, and I took Ibuprofen. By about 4
40-49 Life days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night.
4 ABDOMINAL PAIN PFIZER\BIONTECH 951817-1
years Threatening Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery
and it was found to be perforated. It was removed. I am currently recovering in the hospital. I received the vaccine as a health
care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat
which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and
my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or
collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while
to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse
came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart
rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour .
40-49 Life My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my
years Threatening heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for
help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and
oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the
collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was
swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly
blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to
the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies
and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis, and angina BIBA as a Medical Alert for cardiac arrest
50-59 noted PTA. Per EMS, the patient called because he was having constant, diffuse abdominal pain x 1 day that radiated to his
6 ABDOMINAL PAIN PFIZER\BIONTECH Death 942106-1
years chest. On scene, the patient had a witnessed arrest with EMS starting CPR. He was given 3 rounds of epi without ROSC. Pt had
no associated shockable rhythm. Of note, pt's wife, had noted pt had received covid vaccine the prior day.
I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began with severe abdominal pain,
low grade fever, nausea and loss of appetite. My abdominal pain persisted and worsened over the next 24-36hours. I presented
to the ER on Sunday, January 10, 2021 at 8am with severe right lower quadrant pain, pelvic pain, nausea and low grade fever. I
50-59 Life was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix
years Threatening was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was
removed as well as part of the omentum. I remained in the hospital on IV Metronidazole and Ciprofloxacin for 2 days and was
discharged on 1/13/21 at 9pm. I am continuing to recvoer at home on the same 2 antibiotics in oral form. I have a JP drain that
is still in place. Of note I had two negative COVID 19 tests on 1/9/21 and 1/10/21. Both were PCR tests.
6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she started to have abdominal pain
60-64 Life which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a
years Threatening perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening
of 1/3/2021.
presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely
65+ due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP;
9 ABDOMINAL PAIN PFIZER\BIONTECH Death 963057-1
years progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening
clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21
12/23- began to experience intermittent right lower quadrant pain in the morning, fever of 100.4 F in the evening which subsided
40-49 Life
10 ABDOMINAL PAIN LOWER PFIZER\BIONTECH 909720-1 with ibuprofen. 12/24- no fever noted but intermittent right lower quadrant pain continued, seen at the Health Clinic, sent to
years Threatening
Hospital ER for CT scan, diagnosed with appendicitis, appendectomy performed.
Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab results showed elevated WBC
50-59 Life
11 ABDOMINAL PAIN LOWER PFIZER\BIONTECH 923000-1 and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from
years Threatening
12/26/20-12/28/20.
12 ABDOMINAL PAIN LOWER PFIZER\BIONTECH 947687-1
Received vaccine around 10:40 am, by 10:50 started to feel dizzy, eyes felt full, dry, tingly, swollen, voice became raspy and throat
itched. Received 25 mg Benadryl PO at around 10:55. Face, arms, chest and abdomen developed a fine red itchy rash, tongue
40-49 Life swollen and itchy, lips tingling, wheezing, blood pressure elevated, pulse thready given 25 mg PO Benadryl, taken to the
13 ABDOMINAL PAIN UPPER PFIZER\BIONTECH 907042-1
years Threatening Emergency Room, symptoms persisted, stomach hurt became nauseated, received IV solumedrol, Pepcid, IV fluids, nebulized
albuterol. Sent home once stable after 3 hours, with instruction to take Benadryl every 4-6 hours fir the next 2 days, albuterol as
needed, and prednisone for the next 5 days.
PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN
ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING
~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM,
50-59 Life EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED
14 ABDOMINAL PAIN UPPER PFIZER\BIONTECH 920994-1
years Threatening 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED
BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO
PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE
ACHES, SORE THROAT.
Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19
vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021
Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary
65+
15 ABDOMINAL PAIN UPPER PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing
issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and
sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.
She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms
or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16, she
65+ awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of headache,
16 ABDOMINAL PAIN UPPER PFIZER\BIONTECH Death 954812-1
years nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently. Per her
niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile.
(continue on page 2)
17 ABDOMINAL PAIN UPPER PFIZER\BIONTECH Death 959929-1
50-59
18 ABDOMINAL X-RAY PFIZER\BIONTECH Death 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years
50-59 Life
19 ABDOMINAL X-RAY PFIZER\BIONTECH 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years Threatening
"Patient was found ""acting abnormal"" on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found
65+
20 ABNORMAL BEHAVIOUR MODERNA Death 940866-1 pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on
years
1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest."
Vaccine Event
"The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at
therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to
65+ his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and
21 ABNORMAL BEHAVIOUR PFIZER\BIONTECH Death 920545-1
years found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was ""abnormal"" how he
was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was
found without a pulse, respirations, or blood pressure at 1:54 pm. He was a DNR."
PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN
SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO
65+ CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A
22 ABNORMAL BEHAVIOUR PFIZER\BIONTECH Death 951101-1
years STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE
TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT
THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS.
65+
23 ABNORMAL BEHAVIOUR PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
ABSENCE OF IMMEDIATE 65+
24 PFIZER\BIONTECH Death 926462-1 Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021
TREATMENT RESPONSE years
ABSENCE OF IMMEDIATE 65+
25 PFIZER\BIONTECH Death 926568-1 patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020
TREATMENT RESPONSE years
ACTIVATED PARTIAL 50-59 Life was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix
26 PFIZER\BIONTECH 947687-1
THROMBOPLASTIN TIME years Threatening was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was
Severe Right sided chest pain, right sided muscle spasms and difficulty breathing two weeks after vaccine was administered
ACTIVATED PARTIAL
30-39 Life Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or
27 THROMBOPLASTIN TIME PFIZER\BIONTECH 951560-1
years Threatening deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively
PROLONGED
improved over days. Was discharged after 6 days on admission. Was discharged on oral anticoagulant (Rivaroxaban aka xarelto)
"Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was given .. Vaccine NDC #
59267-1000-1. 0.3 ml given by RN. Patient called his PCP: ""... I had very bad chest and shoulder pains, neck pains and slight
fever from 9 pm until early this morning (Jan 8). My blood pressure was 155/95 mmHg. Should I see you today? Still feel sore all
ACTIVATED PARTIAL upper body. Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8): patient was told
60-64 Life
28 THROMBOPLASTIN TIME PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
PROLONGED patient go to the emergency room. Patient understood the importance to seek medical attention..... Emergency Room notes:
seen by MD on Jan 9. Note at 0749: patient complained of chest pain on/off since received COVID vaccine on Jan 7. Pain was
substernal and radiated to the left shoulder, assoc with some SOB. EKG obtained and revealed ST segment elevation and a
""cardiac alert"" was called."
About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.
ACTIVATED PARTIAL
30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
SHORTENED
after the injection.
The patient was well prior to vaccination (12/17). The day after, he felt mildly unwell and had a low grade fever. The following day,
he had a fever of 102. He received 1L of fluid at Urgent Care and had a BP ion the 80s. Shortly thereafter, he felt palpitations and
ACTIVATED PARTIAL
40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
SHORTENED
increased, and AF spontaneously converted to sinus. He had no dysuria. Curtures so far have not shown growth at our hospital.
Urinary culture from urgent care has reportedly shows 20k gram positive cocci.
ACTIVATED PROTEIN C
31 RESISTANCE TEST MODERNA 955565-1
POSITIVE
Patient tolerated the vaccine well with no apparent side effects. Ten days later awoke 12:30 AM with severe chest and upper
ACUTE CORONARY 65+ Life
32 MODERNA 924201-1 back pain, presented to Med Center where he was found to have an Acute Coronary Syndrome. Transferred to Medical Center
SYNDROME years Threatening
where he underwent successful PCI with two drug eluting stents for a 99% mid-LAD stenosis
50-59 Life Pt found unresponsive at home, respiratory distress. Had reported nausea and vointing for two days prior to admit which started
33 ACUTE KIDNEY INJURY MODERNA 958235-1
years Threatening 1/15. Acute metabolic encephalopathy and acute renal failure Currently at time of this report still in critical care
65+ Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital
34 ACUTE KIDNEY INJURY MODERNA Death 959591-1
years and treated for worsening AKI and hypotension.
65+ Life Patient had slow progression of kidney disease but since vaccine had unexpected acute kidney failure. He had to have dialysis
35 ACUTE KIDNEY INJURY MODERNA 950787-1
years Threatening and may need biopsy of kidney to confirm if he needs lifelong dialysis. He is still being hospitalized.
50-59 Life
36 ACUTE KIDNEY INJURY PFIZER\BIONTECH 955096-1 Acute liver injury requiring transplant evaluation and acute kidney injury
years Threatening
37 ACUTE KIDNEY INJURY PFIZER\BIONTECH Death 951101-1
Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac
arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient
65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
38 ACUTE KIDNEY INJURY PFIZER\BIONTECH Death 959179-1
years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure
reporting was made available.
The patient received her first Moderna COVID-19 vaccination on 12/29/2020. However the patient was diagnosed with a positive
COVID-19 test on January 4, 2021. Patient complained of nausea, vomiting, back pain, and sharp chest pain. On January 13, the
patient presented to the emergency department again with shortness of breath and sharp, stabbing left-sided chest pain
radiating to her back and right side. Initial work up ruled out cardiac etiologies. CTA chest demonstrated COVID-19 pneumonia.
The patient complained of bilateral lower extremity weakness which had been progressing since her COVID-19 vaccination, per
ACUTE MYOCARDIAL 50-59 Life
39 MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
INFARCTION years Threatening
13th, the patient was able to ambulate to and from the bathroom herself. Then on January 14 the patient required maximum
assistance. Neurology was consulted and work up initiated for suspected possible Guillain-BarrT syndrome (GBS) secondary to
recent COVID-19 infection. On January 15, 2021, the patient became obtunded and unable to protect airway. She was emergently
intubated for acute hypercapnic respiratory failure secondary to GBS. Neurology started GBS treatment with IVIG. Patient also
developed NSTEMI and Takotsubo cardiomyopathy. Patient remains critically ill requiring mechanical ventilation.
40 PFIZER\BIONTECH 909130-1 Acute NSTEMI with symptom onset 4 days after vaccination
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I
41 PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
I had complete occlusion of the right coronary artery
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness
of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the
42 PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal
of the thrombosis.
ACUTE MYOCARDIAL 65+
43 PFIZER\BIONTECH Death 934059-1 Acute anterior MI with death
INFARCTION years
At night they found him lifeless. Probably following acute MI; pain in the arm and swelling in the arm of vaccination; pain in the
arm and swelling in the arm of vaccination; This is a spontaneous report from a contactable other healthcare professional via
Division of Health. The other healthcare professional reported similar events for three patients. This is the second of three
reports. A male patient of an unspecified age received BNT162B2 (lot# EK4175), via an unspecified route of administration on
25Dec2020 at single dose for Covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD)
with smoking background, atrial fibrillation, aortic stenosis, diabetes with damage to all target organs (nephropathy, retinopathy,
neuropathy), carotid stenosis, deep vein thrombosis (DVT) history, history of alcohol use with hepatitis, history of Hodgkin's
lymphoma after successful chemotherapy treatment, got around on a scooter. The patient's concomitant medications were not
reported. The patient was vaccinated on 25Dec2020 and passed away at home on 28Dec2020. Before his death, according to
ACUTE MYOCARDIAL
44 PFIZER\BIONTECH Unknown Death 929027-1 his daughter, he complained about pain in the arm and swelling in the arm of vaccination on an unspecified date of Dec2020. At
INFARCTION
night they found him lifeless. Probably following acute myocardial infarction (MI). The outcome of pain in the arm and swelling
in the arm of vaccination was unknown, acute MI was fatal. It was not reported if an autopsy was performed. Follow-up attempts
are completed. No further information is expected.; Sender's Comments: Fatal acute myocardial infarction is more likely
attributed to the patient underlying medical conditions including vascular stenosis and diabetes with complications. The impact
of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and
Investigators, as appropriate,Linked Report(s) : IL-PFIZER INC-2020519349 same reporter/product, similar event, different
patient;IL-PFIZER INC-2021009752 same reporter/product, similar event, different patient; Reported Cause(s) of Death: acute MI
Vaccine Event
1/6/21 Pt received vaccine and complained of difficulty swallowing and rapid heart rate. Pt received methylprednisolone 125mg
IVP, diphenhydramine 25mg IVP, & famotidine 20mg IVP. Pt reported improvement and was discharged. Sent home on
diphenhydramine and oral prednisone. 1/7/21 Pt unable to swallow her own secretions and experienced eyelid swelling. Pt
ACUTE RESPIRATORY 30-39 Life
45 MODERNA 929391-1 vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for
FAILURE years Threatening
admission - acute respiratory failure secondary to anaphylactic reaction. Decision was made to emergently intubate the patient
for airway protection despite aggressive intervention. Pt successfully extubated 1/8/21. Plan to discharge home and start
Medrol Dose Pack 1/9/21.
51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours
ACUTE RESPIRATORY 50-59 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated
46 MODERNA Death 946293-1
FAILURE years further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at
medical center.
Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory
ACUTE RESPIRATORY 6-17 Life
47 PFIZER\BIONTECH 921641-1 decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without
FAILURE years Threatening
improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.
loss of consciousness Narrative: Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21
nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no
n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per
65+
48 ADENOVIRUS TEST PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU
emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing.
Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm.
Pt had witnessed arrest by wife. Pt wife started CPR and called EMS. CPR started at 15:12. Continued by EMS. Pt arrived to
65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
49 ADJUSTED CALCIUM PFIZER\BIONTECH Death 950441-1
years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
was unresponsive to verbal and tactile stimulus and had fixed unreactive pupils. He was pronounced at 16:13.
he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit
but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer
(brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization.
Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER
UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER
UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much,
kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind
just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as:
around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he
started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale.
50-59 The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services
50 AGITATION PFIZER\BIONTECH Death 934968-1
years were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to
the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication
for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient
continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes.
When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient
calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The
patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not
responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the
patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome
of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was
unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2,
was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away
50-59 Life
51 AGITATION PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
65+
52 AGITATION PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
ALANINE
53 AMINOTRANSFERASE PFIZER\BIONTECH Death 950441-1
INCREASED
ALANINE
INCREASED
ALANINE
INCREASED
"Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing
factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis
congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP,
Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any
occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine ""administered
ALANINE
65+ without complications."" Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS
years increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation
INCREASED
period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized
prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization
attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted
above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI
Bleed in the death note from 01/10/2021"
Presented to the ED after developing chest tightness, cough, lightheadedness, and throat closing sensation. She received the
Moderna COVID-19 vaccine on the morning of presentation. Within 15 minutes of receiving the vaccine she developed pain and
ALANINE numbness, starting at the injection site traveling down the ulnar aspect of her arm, and nausea. Over the next several hours she
30-39 Life
57 AMINOTRANSFERASE MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
NORMAL took PO Benadryl 25mg; however, her symptoms were not alleviated. She was subsequently evaluated in the ED. á Received PO
Benadryl 25mg, IV Benadryl 25mg, Epinephrine 0.3mg x 2, IV Famotidine 20mg, IV Solumedrol 125mg & 60mg, DuoNebs x 3,
Racepinephrine x 1.
ALANINE
60-64 Life Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of
58 AMINOTRANSFERASE MODERNA 958913-1
years Threatening 105.2F
NORMAL
Resident was seen by MD on 1/11/2021 due to increasing in edema and shortness of breath. Lasix 40 mg STAT given. New
ALANINE
65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
59 AMINOTRANSFERASE MODERNA Death 952881-1
years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
NORMAL
oxygen. He was assisted to the toilet on 1/15/2021 in the morning where he subsequently passed away.
Patient has end stage renal disease and rapidly worsening dementia, family could no longer care for him at home, and he was
ALANINE
65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
years reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138
NORMAL
CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm.
ALANINE
61 AMINOTRANSFERASE PFIZER\BIONTECH 903123-1
NORMAL
ALANINE
NORMAL
Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent
Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was
afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a
slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates
consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64.
He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler,
guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after
ALANINE his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes,
60-64
63 AMINOTRANSFERASE PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
NORMAL phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit
was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient
could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police
Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the
patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-
suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's
Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further
testing.
64 ALBUMIN GLOBULIN RATIO PFIZER\BIONTECH Death 950441-1
Vaccine Event
Resident began having fever on 1/11/21 @0600. VS= T-102 B/P- 100/57 P- 112 RR- 24 O2 Sat 92% on RA. MD called. Rapid
COVID Test was negative. CBC,CMP, U/A were ordered as well as CXR. Resident's condition declined. At 3:00pm resident started
50-59
65 ALBUMIN URINE PRESENT MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
Condition worsened. Resident sent to nearest ER for evaluation. Later in the evening the staff AT Medical Center called to inform
staff that resident had expired @ 2230 as a result of Respiratory Failure and Sepsis.
1) Skin rash over 80% of my body including, face and lips; started to change my voice sound and started to compromise my
40-49 Life
66 ALLERGY TO VACCINE MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
years Threatening
blood stream, within minutes the shakes stopped and within 2 hours the rash was gone.
Pain at site of injection, eyes, throat, face swelling. Unclear thinking, hoarse speech, headache, hives, swelling. Intervention taken
40-49 Life
67 ALOPECIA MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the
vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling. Patient was treated in an emergency
department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and
famotidine. The next day, patient again developed shortness of breath and her husband administered the EpiPen. EMS arrived
ALTERED STATE OF 30-39 Life and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was
CONSCIOUSNESS years Threatening altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on
epinephrine drip. Stridor continued and was unresponsive to nebulized albuterol. Patient was then intubated and placed on
mechanical ventilation. Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids.
admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day. Patient was monitored on hospital
floor for one additional day and was then discharged with no residual symptoms.
The patient passed away today, 1/13/2021. She was a hospice patient. She showed no adverse effects after receiving the
65+
69 ANAL INCONTINENCE MODERNA Death 941607-1 vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went
years
limp and was non-responsive. The patient passed away at 7:45 am.
65+ Life patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was
70 ANAL INCONTINENCE PFIZER\BIONTECH 953333-1
years Threatening hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.
18-29 Life Pt developed anaphylaxis, was given IM Benadryl, and was sent to the ED. Pt spent 1 night in the hospital, went home, and has
71 ANAPHYLACTIC REACTION MODERNA 913445-1
years Threatening come back and is in the ICU. Pt had hives, itching, chest tightness, swollen lips.
18-29 Life
72 ANAPHYLACTIC REACTION MODERNA 930079-1 Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
years Threatening
18-29 Life
73 ANAPHYLACTIC REACTION MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
years Threatening
30-39 Life
74 ANAPHYLACTIC REACTION MODERNA 929391-1 vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for
years Threatening
30-39 Life
75 ANAPHYLACTIC REACTION MODERNA 931772-1 Anaphylaxis
years Threatening
Day 1-3 after the dose flu like symptoms Day 3-7 swelling in lymph nodes on left side of body (baseball sized) took ibuprofen and
30-39 Life
76 ANAPHYLACTIC REACTION MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
rash all over body and face still going on Day 16- present: severe joint pain and fever, unable to obtain any relief
Anaphylaxis (urticaria, tongue swelling, subjective difficulty breathing) starting approx. 24hrs first moderna dose. No prior
30-39 Life
77 ANAPHYLACTIC REACTION MODERNA 952707-1 episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV,
years Threatening
Epinepherine 0.3mg IM. Monitored in ED, complete resolution of symptoms, discharged home.
Anaphylaxis/Angioedema Patient was given EpiPen 0.3 mg IM; Methylprednisolone 125 mg once; Diphenhydramine 25 mg IV
40-49 Life
78 ANAPHYLACTIC REACTION MODERNA 907022-1 push once; Famotidine 20 mg IV push once; Dexamethasone 10 mg IV push once Patient was intubated and put on propofol and
years Threatening
midazolam drips for sedation
Anaphylaxis. Immediately experienced shortness of breath, rapid heart rate, and rash. I am a Nurse Practitioner in the emergency
department. Had went down to the temporary vaccine station to receive my vaccine, immediately returned to the ER and began
40-49 Life to experience symptoms of anaphylaxis. Was immediately placed in a treatment room and received treatment by the ER
years Threatening physician, which included oxygen, intravenous Benadryl, Solumedrol, and Normal Saline. Was observed for several hours and
then eventually sent home with prescription for Prednisone and Pepcid. I do have a allergy to shellfish, was never asked about
my allergies and nothing on the paperwork I was given prior to the injection noted a concern for shellfish allergies.
40-49 Life
80 ANAPHYLACTIC REACTION MODERNA 943272-1 Systemic: Anaphylaxis-Medium; symptoms lasted 1 day
years Threatening
40-49 Life Anaphylaxis- throat tightness , nausea , rash , pruritis , chest tightness, wheezing . 9-11 called epinephrine x 2 , decade on , IV
years Threatening Benadryl , duo-nebs, famotidine, admission to icu high dose prednisone , nebulizers , zofran , duo-neb nebulizers
40-49 Life
82 ANAPHYLACTIC REACTION MODERNA 955491-1 Systemic: Anaphylaxis-Severe, Systemic: Seizure-Severe
years Threatening
50-59 Life
83 ANAPHYLACTIC REACTION MODERNA 924050-1 anaphylaxis, dyspnea
years Threatening
Anaphylactic reaction, Severe edema and raised red rash entire body, Severe itching ,Soft tissue edema of throat. Swelling of,
65+ Life
84 ANAPHYLACTIC REACTION MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
STEROIDS, MULTIPLE MEDS
65+ Life
85 ANAPHYLACTIC REACTION MODERNA 955478-1 Systemic: Anaphylaxis-Severe; symptoms lasted 1 day
years Threatening
Within 15 minutes of receiving the vaccine I began to get very itchy and blotchy with a hoarse voice. The paramedic downstairs
walked me up to the emergency room. I was treated with medications to help calm the itching and burning feeling. By 940 I went
18-29 Life
86 ANAPHYLACTIC REACTION PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
closing. I was transferred by ambulance to medical center in the ICU. I am still here and have had two toner anaphylactic
episodes since. I have been on a epi drip, steroids, famotidine, Ativan and Benadryl. I also had a picc like placed.
Anaphylaxis. The COVID shot was given, no reaction then. After 7 minutes, congestion, severe cough, vomiting phlegm, feeling
like throat closing started happening. Code was called, Benadryl was immediately given intramuscular in the left arm, blood
pressure, pulse ox was taken, and then was taken to the Emergency Department. In the ED, I was given prednisone, one EPI, anti-
18-29 Life
87 ANAPHYLACTIC REACTION PFIZER\BIONTECH 917712-1 nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under
years Threatening
observation for 4 hours. I was discharged after all symptoms dissipated and was given Prednisone 20 MG (3 tabs a day) to take
to help my lungs. Management followed up almost immediately, everyone from the moment I had the anaphylactic reaction was
quick and prepared.
Not all or limited to: anaphylactic reaction: Feeling lump in throat, tongue feeling funny with numbness, feeling of hard to
30-39 Life
88 ANAPHYLACTIC REACTION PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
dizziness/lightheartedness, cough, voice changes.
30-39 Life
89 ANAPHYLACTIC REACTION PFIZER\BIONTECH 914596-1 Anaphalaxis reaction, stridor an unable to breathe. Happened in 30 seconds
years Threatening
Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth
swelling; This is a spontaneous report from a contactable physician, the patient. A 34-year-old non-pregnant female patient
received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified
route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19
immunization. Medical history included severe dust mite allergy (based on skin test). Prior to the vaccination, the patient was not
diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN),
hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for
unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four
weeks prior to the vaccination. On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction,
severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening.
The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and
30-39 Life diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after
90 ANAPHYLACTIC REACTION PFIZER\BIONTECH 929526-1
years Threatening she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone
bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first
time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the
anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were
recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath,
throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen,
hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with
BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use. The impact of this
report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the
review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any
appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as
appropriate.
30-39 Life Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy,
years Threatening ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
Vaccine Event
-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy.
-0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood
pressure and it was 141/86 in right arm. Normal is 110s/60s-70s. No anxiety feelings. -0740 throat started to have increased
mucous production. Had the tickle and tightness in throat. Asked and received 25mg Benadryl with cup of water. -0742 started
clearing throat frequently and slight cough. Knew it was anaphylaxis and told the team I need to go to the ER. Asked for
additional 25mg Benadryl. Also took 20mg Famotidine and 2 puffs Albuterol inhaler--this is my prescribed anaphylaxis routine.
Had Epipens on standby. -0743 put on O2 saturation monitor and watched O2 drop into 90-92 range. Asked for epipen on
standby as I know when I need to start it. Didn't want to take that when I knew I was about to get it in the ER and knowing self
hadn't progressed that far. Felt chest tightness and shortness of breath. Voice started becoming hoarse. -0800 EMS arrived
(delay as team didn't know if they were supposed to call 911 or a Code--they chose EMS even though in hospital). Then staff at
30-39 Life COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker
years Threatening route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice
completely hoarse by this time. -About 0817 arrived to ER bay. At this time, frequently coughing and cough started to sound
stridorous. Difficulty getting breaths in. Had chest pain near heart. Greeted by MD, 2 RNS, and technician. -0819 received IM
epinephrine. Attached to 5 lead EKG monitoring and O2 monitoring. Blood pressure done again. Higher than previous. -About
0821 had working IV (previous two attempts failed as veins were constricting). Given IV Solumderol. Started bolus of 1L Normal
Saline. -Not sure how long after by cough subsided, increased mucous production subsided, as well as hoarseness decreased. -
Held for observation for 2hours (would be longer if not resolved). - Discharged around 1015. At this time, hoarseness almost all
gone. Minimal throat clearing. Cough resolved. -Prescribed epipen inhalers (mine expired) and Prednisone. Prednisone is PRN
for mild breathing difficulties if it starts again tomorrow 1/13/21. -At 1400 took 50mg Benadryl and 20mg Famotidine as
previously prescribed for anaphylaxis maintenance. Will continue this as previously prescribed every 6hours until symptoms stay
resolved. -Made follow up appointment with Primary Care Physician per protocol
30-39 Life Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to
years Threatening the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.
Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop
symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching,
30-39 Life
94 ANAPHYLACTIC REACTION PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one
hour after treatment in ED.
Anaphylaxis; throat closing; tongue swelling; Peripheral shutdown; This is a spontaneous report from a contactable physician
and pharmacist received from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20201209083957
and ADR 24541453-001 and ADR 24541453-002. A 49-year-old female patient (healthcare worker) received BNT162b2 vaccine
(Batch/lot: EJ0553) on 08Dec2020, via an unspecified route of administration route at single dose for COVID-19
immunization.The patient had a pertinent medical history of food allergy (Lemon/lime, egg and meringue cheesecake) with no
known previous reaction to vaccines. Concomitant medications included progestogen orally and an unspecified medication
topically, both for menopause and Vitamin B12 orally for vitamin B12 deficiency. On 08Dec2020 during post-vaccination
observation the patient developed within minutes throat closing, tongue swelling, peripheral shutdown, no wheeze, chest clear.
These events were reported as anaphylaxis, and required hospitalization. Vaccinated at hospital and received vaccine as she is
patient facing employee. Otherwise fit and healthy, no cardiovascular, respiratory, gastrointestinal or neurological disease. No
history of allergy to medicines. History of a similar allergic reaction to lemon/lime and meringue cheesecake. After 3 mouthfuls
of cheesecake, onset of reaction. Required adrenaline, ambulance and treatment as inpatient. Allergy blood tests and skin tests
inconclusive (unknown what tested for). Carries Epi Pen but never used. Has remained on a gluten and dairy free diet since the
reaction. On the day of vaccination, her presenting anxiety was possible allergy to eggs. Within approximately 8 minutes of
vaccination, she started to cough and became hypertensive (peak 175mmHg systolic), with a heart rate (HR) of 110 beats per
40-49 Life minute (bpm) - pulse oximetry, no trace. No wheeze, no erythema of oral mucosa, no swelling. Started clawing at her neck and
years Threatening described feeling of itching internally. It was reported the patient carried an adrenalin autoinjector (EPIPEN). The patient was
treated with IM adrenaline, IM chlorphenamine maleate (PIRITON), IM hydrocortisone given with minimal improvement and given
two nebulised adrenaline (adrenaline nebulizers) which resulted in rapid resolution of symptoms (15 minutes elapsed between
administration of IM adrenaline and nebulised adrenaline). Around 20 minutes later her symptoms returned. Given nebulised
adrenaline with rapid recovery. Admitted to short stay unit (emergency department (ED)) for observation and discharged around
19:30 on 08Dec2020. No tryptase testing performed, no other blood tests. There was no reaction at the injection site. On
09Dec2020 the patient was at home and reported feeling tired, with heavy limbs. She is apyrexial with no ongoing signs of
allergy. Lab tests on 08Dec2020 includes: Blood pressure systolic: 175mmHg, Heart rate: 110bpm and Pulse oximetry: No trace.
The patient had recovered from the events in Dec2020. The events were considered serious medically significant, for
hospitalization and for being life threatening. The patient has not had symptoms associated with COVID-19. Patient has not been
tested or has had an inconclusive test for COVID-19 (as reported). Patient is not enrolled in clinical trial. The vaccine was given
by hospital staff member. Follow up (10Dec2020): New information received from GB-MHRA-WEBCOVID-20201209083957 and
ADR 24541453-002 includes: patient history, concomitant medications, lab tests, clinical course and the only event reported was
anaphylaxis.; Sender's Comments: The reported information is limited. Based on the close temporal relationship, the subject's
signs and symptoms, being, at least in part, suggestive of anaphylaxis and the past medical history of allergy, there is a
reasonable possibility that the events are related to BNT162 vaccine.
40-49 Life
96 ANAPHYLACTIC REACTION PFIZER\BIONTECH 908003-1 ANAPHLACTIC REACTION, SOB, CHEST PRESSURE, TIGHTNESS IN THROAT, TACHYCARDIA
years Threatening
right after the vaccine she felt light headed felt better in observation after about 7 minutes employee c/o heart racing,Chest
pressure, feeling light headed, throat scratchy and tight. allergy to MRI contrast dye only - Gadolinium. Has had lots of vaccines
40-49 Life
97 ANAPHYLACTIC REACTION PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
admitted to the hospital overnight for anaphalaxis on a second trip to ED. She will not be able to get her second dose of the
vaccine. this should be entered into the VAERS reporting system. She is till using the benedryl.
40-49 Life Pt. began to feel weak with palpitations about 8-10 minutes after vaccination, her pulse was extremely fast, she then began to
years Threatening complain of lower mid-esophageal burning
40-49 Life
99 ANAPHYLACTIC REACTION PFIZER\BIONTECH 915765-1 Patient had an anaphylactic reaction to the vaccine the day after it was given and went to the nearest ER.
years Threatening
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart
palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 .
Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was
taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face
40-49 Life
100 ANAPHYLACTIC REACTION PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right
side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was
ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more
meds naproxen
40-49 Life
101 ANAPHYLACTIC REACTION PFIZER\BIONTECH 921989-1 Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
years Threatening
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness;
Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received
the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of
administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no
known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020
(Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10
minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on
chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events
occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with
40-49 Life methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine
years Threatening (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on
08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen
(MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on
chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness
and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported
information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable
possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer
product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for
adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be
promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere,
40-49 Life
103 ANAPHYLACTIC REACTION PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
fluids were influsing and epi drip started, went to ICU
About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I
waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it
40-49 Life
104 ANAPHYLACTIC REACTION PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen,
benadryl and called ambulance where they took me to medial emergency department.
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking
out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP
was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath
and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a
40-49 Life prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home
years Threatening but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen
was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after
three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day
still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in
case I have another bad reaction to anything.
PT WAS OBSRVED IN HOLDING AREA LEANING FORWARD IN HER CHAIR ABOUT 7 MINUTES AFTER RECIEVING THE VACINE.
RN ASSESSED AND NOTED: AUDIBLE WHEEZE, RESP 40/MIN, LIP SWELLING AND PT COMPLAINED OF NAUSEA. PT WAS
50-59 Life ESCORTED TO ER IN WHEELCHAIR ACCOMPANIED BY 2 RN'S (2 MINUTE WALK) ONE HOUR LATER - AS REPORTED BY DR (ER)
years Threatening WORKING DIAGNOSIS - ANAPHYLAXIS / STATUS ASTHMATICUS MEDS RECIEVED: SOLUMEDROL 125, DIPHENHYDRAMINE
50MG, FAMOTIDINE 20MG --ALL IV EPINEPHERINE 0.3MG IM X1 FOLLOWED BY 0.3MG IV X 1 FOLLOWED BY 0.1MG IV X1 PT IS
RECIEVING O2 - AND PROGRESSING TO BIPAP
50-59 Life
107 ANAPHYLACTIC REACTION PFIZER\BIONTECH 933369-1 Anaphylactic reaction
years Threatening
Vaccine Event
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness;
dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable
Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,
lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-
19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit
hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone,
levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin,
morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry
wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021
11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed
50-59 Life
108 ANAPHYLACTIC REACTION PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021.
The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A
possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat
tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and
chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of
the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic
reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for
safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part
of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics
Committees and Investigators, as appropriate.
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in
for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling
fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside
to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be
experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl
instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after
50-59 Life vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was
years Threatening decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient
and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call
911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again
to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing
then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the
vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed
to leave with a friend/coworker driving her home.
60-64 Life Throat closure (angioedema/anaphylaxis) requiring ambulance transport to Hospital emergency room and stay IV infusion of
years Threatening Benedryl, solumedrol, and Pepcid with excellent results. Observed twelve hours, then discharged.
Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency
60-64 Life
111 ANAPHYLACTIC REACTION PFIZER\BIONTECH 950759-1 Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed
years Threatening
prednisone and Benadryl. I was diagnosed with Anaphylaxis.
anaphylaxis; This is a spontaneous report from a contactable physician reporting on behalf of patient. A patient of unspecified
age and gender received single dose of BNT162B2 (batch/lot number and exp date not reported), via an unspecified route of
administration on an unspecified date for immunisation. The patient's medical history and concomitant medications were not
reported. On an unspecified date, the patient experienced anaphylaxis with a very protracted course requiring an epi dose for 4.5
days and was still in the ICU (date/s unspecified) following administration of the COVID vaccine. The physician would like to use
a drop of leftover vaccine from one of the vials to do a future skin test after the patient is stable. They were unsure if they needed
Life
112 ANAPHYLACTIC REACTION PFIZER\BIONTECH Unknown 911511-1 permission as this was standard practice in allergy to test afterwards but wanted to check in with the company. The outcome of
Threatening
event was unknown. Information about batch/lot number has been requested.; Sender's Comments: A possible causal
association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible
temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk
profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
anaphylactic reaction/anaphylaxis; This is a spontaneous report from a Pfizer Sponsored Program from a contactable
pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number:
EK4176), via an unspecified route of administration on 09Jan2021 at 0.3 mL, single (standard like 0.3ml by injection once to
deltoid, side unknown) to prevent from getting COVID. The patient's medical history and concomitant medications were not
reported. The patient experienced anaphylactic reaction/anaphylaxis on 09Jan2021. Clinical course: The patient got the vaccine
while waiting to go into the watch room, to be watched for a few minutes, and she experienced anaphylactic
reaction/anaphylaxis, she went down, they gave her an Epinephrine, she didn't respond to the first dose, a second dose was
given in the arm where the vaccine was given, then she was picked up by an ambulance. Agent stated the caller has been on
hold for almost an hour. Caller clarifies dose was given in the arm, it occurred on Saturday with the same lot. Saturday and it
Life went away on Saturday, the patient was worried about it coming back, thus why she asked about Epinephrine pen, the patient
113 ANAPHYLACTIC REACTION PFIZER\BIONTECH Unknown 951992-1
Threatening was taken to the hospital, and given Epinephrine a couple more times, and it resolved eventually, the patient was not admitted,
she went to the Emergency Department. It could have required hospitalization but would most likely say life threatening had she
not been treated. Reporter seriousness for anaphylaxis is life threatening. The outcome of event was recovered on 09Jan2021.
Relatedness of bnt162b2 to reaction anaphylaxis is related for primary source.; Sender's Comments: A possible causal
association between administration of BNT162B2 and the onset anaphylactic reaction/anaphylaxis cannot be excluded,
considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this
appropriate.
Anaphylaxis Allergic reaction COVID-19 vaccine: dizziness, vomiting and shortness of breath. Received vaccine and about 5/10
Life
114 ANAPHYLACTIC REACTION PFIZER\BIONTECH Unknown 959417-1 minutes later developed symptoms of chest tightness shortness of breath wheezing. Arrived to ED at 1156 and discharged at
Threatening
1507. Given epi IM Solu-Medrol, Pepcid, Benadryl, albuterol.
30-39 Life Nausea, hives, anaphylactic shock, throat swelling, hypotension, headache, dizziness, weakness . The symptoms returned at
115 ANAPHYLACTIC SHOCK MODERNA 927223-1
years Threatening 1:25pm the best day as well. I?ve now had two anaphylactic reactions
anaphalactic shock reaction, epi injection by hospital emergency staff at vaccine site, emergency room admission . We were
50-59 Life
116 ANAPHYLACTIC SHOCK PFIZER\BIONTECH 950111-1 very lucky vaccine site was Hospital was concerned that this might happen as patient had a previous anaphalactic shock by
years Threatening
antibiotic injection few years ago
50-59
117 ANEURYSM PFIZER\BIONTECH Death 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years
50-59 Life
118 ANEURYSM PFIZER\BIONTECH 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years Threatening
Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm.
She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the
vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per
CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of
65+
119 ANEURYSM RUPTURED MODERNA Death 959568-1 Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by
years
Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was
transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She
was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to
treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter.
30-39 Life
120 ANGIOEDEMA MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
40-49 Life
121 ANGIOEDEMA MODERNA 907022-1 push once; Famotidine 20 mg IV push once; Dexamethasone 10 mg IV push once Patient was intubated and put on propofol and
years Threatening
50-59 Life 12/30 9:30 am developed angioedema. Swelling of face, lips, tight throat. Also had bright red rash over body trunk and arms.
122 ANGIOEDEMA MODERNA 914392-1
years Threatening Both palms were red, hot and painful.
2 minutes after vaccine was administered, noticed swelling back of tongue, progressed to posterior 2/3 of tongue, tachycardia,
elevated BP. Progressive angioedema involving larynx, cough, shortness of breath. No wheezing. Physical exam did do show any
50-59 Life
123 ANGIOEDEMA MODERNA 920787-1 obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered.
years Threatening
some improvement in symptoms. In 30mins, reoccurrence of angioedema and second epinephrine vaccine administered.
Monitored for 2 hours without reoccurrence of symptoms and discharged from ER.
18-29 Life
124 ANGIOEDEMA PFIZER\BIONTECH 902946-1 Swelling of hands follwed by angioedema
years Threatening
18-29 Life
125 ANGIOEDEMA PFIZER\BIONTECH 904334-1 Angioedema, hives, tachycardia, shortness of breath
years Threatening
within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours post-vaccine I developed
nausea, fever (100.4) and chills and secondary to this had poor sleep. The next day I took scheduled alternating Tylenol &
ibuprofen during the day and then overnight 1 episode of chills that woke me up. no events Saturday or Sunday. Then Monday
1/11 in the early morning I started to develop a rash on my b/l elbow and right foot 3rd toe. I applied mometasone topical cream
to these locations. while at work the rash extended down both forearms then by 5pm it was on both hips and extending along
30-39 Life
126 ANGIOEDEMA PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
itching woke me up. I repeated Benadryl 25mg at 8am. The rash seems to be getting better on the arms but then by noon I had a
new breakout on my neck and face. I took Benadryl 50mg at 1pm. The rash continued to have a rapid progression over the next
hour and resulted in angioedema with my throat swelling, lips puffed and numb and eye swelling. I was injected with an epi pen
and sent to the ED where I received PO prednisone, famotidine, and Benadryl. The face/neck rash then greatly improved and I
was sent home on prednisone 40mg daily for 3 days.
Vaccine Event
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema,
hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia,
hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus,
chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and
shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath;
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous
report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of
BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the
first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a
single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no
known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER
UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not
40-49 Life
127 ANGIOEDEMA PFIZER\BIONTECH 942808-1 receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with
years Threatening
COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were
reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken
as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine
(MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe
angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's
Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives,
tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible
128 ANGIOEDEMA PFIZER\BIONTECH 904504-1
Patient received vaccine in afternoon of 12/28. She works in ER as housekeeper 7pm-7am. The day she received the vaccine she
40-49 Life became ill with fever chills and nausea and left work at 2am. On 12/31 she developed hemianopia. She went to ER and they did
129 ANGIOGRAM MODERNA 941476-1
years Threatening CT scan. She was told it was complex migraine. She left and came Home. On 1/1/21 her vision was back to normal. On 1/3 she
suffered bilateral cerebellum ischemic stroke. She is currently in medical center. In Trauma.
65+ Life
130 ANGIOGRAM MODERNA 957091-1 COVID-19 Vaccine
years Threatening
65+ Life
131 ANGIOGRAM PFIZER\BIONTECH 932623-1 Acute ischemic stroke, basilar occlusion
years Threatening
50-59 Life
132 ANGIOGRAM CEREBRAL MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
30-39 Life The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and
133 ANGIOGRAM CEREBRAL PFIZER\BIONTECH 932366-1
years Threatening weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
50-59
134 ANGIOGRAM CEREBRAL PFIZER\BIONTECH Death 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years
50-59 Life
135 ANGIOGRAM CEREBRAL PFIZER\BIONTECH 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years Threatening
Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA.
65+ Life She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her
136 ANGIOGRAM CEREBRAL PFIZER\BIONTECH 932145-1
years Threatening body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at
10:31am.
She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness. She did recover
ANGIOGRAM CEREBRAL 60-64 Life fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an
ABNORMAL years Threatening indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this
inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later.
I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwise, I am a very healthy
physician, normal BMI, I have also been tested 5-6 times negative for COVID. I do get exposed in my job, but wear proper PPE.
Viral infection in FEB that was like COVID-19 sx, I did AB test as soon as it was available, and negative. ---The Event: Monday
ANGIOGRAM CEREBRAL 40-49 Life
138 PFIZER\BIONTECH 932420-1 morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx
NORMAL years Threatening
(could not get words out coherently), then fell into bed and started right wrist and right foot posturing. This lasted 10 min. I have
non-memory of it, but my MD husband witnessed it. After 10 minutes, I was back to normal, except shaky and some word finding
difficulties. After 30 min, totally back to normal.
ANGIOGRAM PULMONARY 40-49 Life Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found
139 MODERNA 954442-1
ABNORMAL years Threatening to have a right lower lobe pulmonary embolism. Treated with Xarelto and sent home with outpatient follow up.
I am a registered nurse at hospital. On 12/25, seven days after receiving the shot I started to get right lower leg pain and I kept
complaining about it till New Years Day. I had no symptoms of a DVT. I triaged on 1/1/21 and the doctors ordered labs/imaging
and the results were as followed: D-Dimer biomarker (+) , Ultrasound of the Rt lower leg ( - ) , CTA showed a PE (segmental right
ANGIOGRAM PULMONARY 30-39 Life
140 PFIZER\BIONTECH 957555-1 upper lobe pulmonary artery consistent with pulmonary embolus). I was discharged on Xarelto and advised to follow up with a
ABNORMAL years Threatening
hematologist. On 1/5/2021, I went to hematology and they did a whole bunch of labs. I was sent to get a ultrasound of the leg
because the pain persist and they found a clot hidden by my soleus. The plan is to continue on the Xarelto for 6 months. Come
back in 3 weeks to scan my leg again and get my lab results. On 1/12/2021, I received the 2nd shot of the Pfizer vaccination.
40-49 Life I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not
141 ANGIOPLASTY PFIZER\BIONTECH 930889-1
years Threatening sure if these are related but I felt I should report it.
142 ANION GAP MODERNA Death 958228-1
143 ANION GAP PFIZER\BIONTECH 903123-1
144 ANION GAP PFIZER\BIONTECH Death 950441-1
numbness, starting at the injection site traveling down the ulnar aspect of her arm, and nausea. Over the next several hours she
30-39 Life
145 ANION GAP DECREASED MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
took PO Benadryl 25mg; however, her symptoms were not alleviated. She was subsequently evaluated in the ED. á Received PO
Racepinephrine x 1.
"Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day
was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient
ANTI-NMDA ANTIBODY 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
NEGATIVE years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for
encephalopathy."
Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pneumonia without fever was
made, patient started azithromycin on 1/5 and albuterol treatments every 4-6 hrs. Initially he improved, but then worsened. chest
xray on 1/6 was negative for pneumonia, PCR covid test was negative, albuterol treatment did not bring much relief. He started
40-49 Life respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed
147 ANTICOAGULANT THERAPY MODERNA 946978-1
years Threatening multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered
thrombolysis and was discharged home from the ICU on 1/12 on oral anticoagulants. He is gradually improving, but very weak.
He tires easily and gets a drop in oxygen to 90- 93%, as well as an increase in the heart rate to 120 when walking less than half a
mile. He runs out of breath with exertion.
ANTINUCLEAR ANTIBODY 50-59 Life Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute
NEGATIVE years Threatening pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).
ANTINUCLEAR ANTIBODY 50-59 Life thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now
149 MODERNA 919546-1
POSITIVE years Threatening extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)
ANTIPHOSPHOLIPID 50-59 Life thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now
150 MODERNA 919546-1
ANTIBODIES years Threatening extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)
ANTIPHOSPHOLIPID 30-39 Life Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or
ANTIBODIES POSITIVE years Threatening deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively
right after vaccine was given i got a head to toe hot flush. i thought it was just anxiety. within 2 minutes i had expolsive diarrhea,
30-39 Life felt dizzy. looked in the mirror and saw my neck and chest covered in red rash and hives. felt hot flush again. dr came in noticed
152 ANXIETY MODERNA 935478-1
years Threatening hives all over both my arms as well. felt sob and if someone was holding my neck with their hand. given benadryl and epi taken
to local er.
"Client received vaccine at approximately 3:50pm, waited in observational area x30min. Left with husband, stated that she got a
few miles down the road and starting experiencing tightness in her chest and flushing. She took 50 mg of Benadryl, 30mg of
prednisone and two puffs on her inhaler. She returned to the clinic, upon assessment from nursing she looked extremely flushed
and anxious, she stated that she still felt tightness and that she had a history of anaphylaxis once before and had used an epi
60-64 Life
153 ANXIETY MODERNA 924078-1 pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse
years Threatening
was normal, respirations normal, she continued to experience tightness and ""not able to catch my breath"", encouraged to use
epi pen. She administered epi pen to right thigh at approximately 4:45PM, 911 called. Within a few minutes, she stated she was
feeling better, less tightness in the chest, flushing was subsiding. BP at 190/70 at 4:52. EMS on scene at 5:03pm. Vitals normal ,
EKG normal. Client decided not to transport with EMS."
Vaccine Event
Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial
paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of
my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my
18-29 Life
154 ANXIETY PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone
cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and
was diagnosed with likely allergic reaction to the covid-19 vaccine.
"Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine
made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and
prickly sensation on her chest and feeling ""off"". Felt dizzy, developed small hives on her chest. She was attended to
immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably.
Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking.
30-39 Life Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably,
155 ANXIETY PFIZER\BIONTECH 952478-1
years Threatening speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her
site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About
16:30 patient reported her tingling, prickly sensation In her chest is getting worse, developed sensation of lump in her throat, able
to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she
feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole
time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition."
"Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was having a hard time swallowing
which progressed to tongue swelling, all taste buds popped up and sore, hives on face & neck, reddened face. Itchy neck and
30-39 Life
156 ANXIETY PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
all over body. Woke up feeling heaviness as if she had ""sumo wrestler"" on her body. 24 hours post vaccine heaviness started to
lift but felt as if she had a vise on her lungs. Continuing to take Atarax every 6 hours per MD order."
40-49 Life
158 ANXIETY PFIZER\BIONTECH 913854-1 anxiety, tachycardia, flushing, diaphoresis, HTN, SOB
years Threatening
40-49 Life
159 ANXIETY PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty
breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took
50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of
throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged,
Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB
milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a
40-49 Life few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and
years Threatening told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-
Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I
already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it
mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone
was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg
again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this
morning as well, only mild tightness in the throat currently with mild body aches this whole time.
40-49 Life
161 ANXIETY PFIZER\BIONTECH 953402-1 Was feeling anxious right after vaccine given. Laid in cot for a short time, then stated her throat felt like it was closing.
years Threatening
65+ Within 24 hours of receiving the vaccine, fever and respiratory distress, and anxiety developed requiring oxygen, morphine and
162 ANXIETY PFIZER\BIONTECH Death 914690-1
years ativan. My Mom passed away on the evening of 12/26/2020.
65+
163 ANXIETY PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
The day following the vaccine, the patient complained of throat issues and anxiety. This was not new... however . That evening
65+ he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative. On 12/30/2020,
years patient complained of sternal pressure and was transferred to the hospital. The patient died 12/31/2020 and records obtained
from the hospital indicated the patient died from a massive myocardial infarction.
"Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer
COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per
wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which
65+ ""dissipated after a few minutes"" followed by a headache which ""dissipated after a few minutes"" as well. Then patient
years complained of nausea, no vomiting and ""couldn't relax."" Per wife, from around 1400/1500, patient stayed on his recliner while
still having a conversation with her--""he didn't get up to eat."" Last conversation they had was around 2000/2100. Per wife, at
around 2100/2200, patient was quiet and when she checked on him, ""he wasn't responding anymore."" Wife then called 911,
""but they couldn't revive him."""
Vaccine Event
Hypoxic respiratory failure; Dyspnea exacerbated; This is a spontaneous report downloaded from the Medicines Agency (MA)
WEB DK-DKMA-WBS-0028232. The report was received from a contactable physician via The Medicines Agency (MA). A 45-year-
old male patient received BNT162B2 (COMIRNATY) (Lot #: EJ6797, Expiration Date: 30Apr2021), via intramuscular on
30Dec2020 at single dose for Covid-19 vaccination. Medical history included ongoing treatment noncompliance, ongoing
alcohol abuse chronic, ongoing psychosis, dyspnoea from 20Dec2020 and ongoing, ongoing hallucination, ongoing tobacco
abuse, ongoing paranoid schizophrenia, chronic obstructive airways disease exacerbated from Aug2020 and ongoing, chronic
obstructive airways disease exacerbated from Nov2020 to an unknown date (not ongoing), hypoxic down to 60 % from
20Dec2020 and ongoing, Amphetamine abuse (not ongoing), ongoing pain, ongoing opioid abuse, ongoing anxiety, and ongoing
insomnia. There is no information regarding past medication. Concomitant medication included prednisolone (PREDNISOLON
ACTAVIS) from 20Nov2020 for Chronic obstructive airways disease, ipratropium bromide, salbutamol sulfate (IPRAMOL) from
20Nov2020 for Chronic obstructive airways disease exacerbated, orphenadrine hydrochloride (LYSANTIN) from 02Dec2019 to
03Jan2021 for Anxiety aggravated, quetiapine fumarate (QUETIAPIN ACCORD) from 16Dec2020 to 03Jan2021 for Psychiatric
symptom, salbutamol sulfate (VENTOLINE) from 03Nov2018 for Chronic obstruct airways disease, paracetamol
(PARACETAMOL ORIFARM) from 30Nov2020 to 03Jan2021 for Pain, quetiapine fumarate (QUETIAPIN ARROW) from 15Aug2020
to 03Jan2021 for Psychiatric symptom, buprenorphine hydrochloride, naloxone hydrochloride (BUPRENORPHINE/NALOXONE
MYLAN) from 29Jun2020 to 03Jan2021 for Opioid abuse, paliperidone palmitate (XEPLION) from 19Dec2019 to 03Jan2021 for
Psychiatric disorder prophylaxis, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) from
04Jul2019 to Jul2019 for Chronic obstruct airways disease, promethazine hydrochloride (PHENERGAN) from 24Sep2020 to
03Jan2021 for Insomnia. The patient experienced hypoxic respiratory failure on 31Dec2020, dyspnea exacerbated on
166 ANXIETY PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
arrest or respiratory treatment in the event of respiratory failure. Initially the patient did not want to transfer to somatic
treatment. But because of anxiety after dyspnoea the patient got treatment with oxygen. On 01Jan2021 the patient denied again
treatment despite clear indication for oxygen therapy and COPD exacerbations treatment with ipratropium bromide and
salbutamol sulfate (IPRAMOL) and inhalations. On 02Jan2021 the patient received oxygen-treatment, but the patient did not
want further somatic treatment. It was stated in the patient journal that the patient did not want treatment and that in the given
situation there was nothing more to do. Therefore the patient was returned to department with palliative treatment in the form of
oxygen, midazolam subcutaneous (S.C.) and morphine S.C. On the 03Jan2021 the patient's respiration was calm. The patient
was unreachable. At 14:00 he was restless and got palliative treatment with midazolam and morphine. The patient underwent
lab tests and procedures which included c-reactive protein: normal on an unspecified date, 16 on 27Dec2020, fibrin D dimer:
normal on 31Dec2020, fluid balance assessment: normal on 27Dec2020, forced expiratory volume (FEV 1): 37 % on 2018,
hepatic enzyme: normal on 27Dec2020, oxygen saturation: 64 % on an unspecified date, 60 % on 20Dec2020, 58 % on
27Dec2020, 62 % on 31Dec2020, 35 % (in the ambulance) on 31Dec2020, 100 % (on oxygen-treatment) on 31Dec2020, 40-60%
on 02Jan2021 12:47 pm, 58 % (in the ambulance) on 02Jan2021 09:00 am, 30 % on 02Jan2021 04:24 am, 99 % (on oxygen-
treatment) on 02Jan2021, PCO2 up to 12.8 (Unit not specified) on an unspecified date, PO2 Down to 4.8 (Unit not specified) on
an unspecified date. The patient died on 03Jan2021. An autopsy was not performed. The outcome of the events was fatal.
Causality: The reporter assessed that even though the patient's symptoms have occurred long before the vaccination, it can not
be ruled out that the patient's dyspnoea and hypoxia due to COPD have been aggravated by the vaccine. If the Medicines Agency
receives supplemental significant information regarding this case the case will be re-submitted.; Reported Cause(s) of Death:
Dyspnea exacerbated; Hypoxic respiratory failure
anaphylactic reaction/anaphylaxis; This is a spontaneous report from a Pfizer Sponsored Program from a contactable
pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number:
EK4176), via an unspecified route of administration on 09Jan2021 at 0.3 mL, single (standard like 0.3ml by injection once to
deltoid, side unknown) to prevent from getting COVID. The patient's medical history and concomitant medications were not
reported. The patient experienced anaphylactic reaction/anaphylaxis on 09Jan2021. Clinical course: The patient got the vaccine
while waiting to go into the watch room, to be watched for a few minutes, and she experienced anaphylactic
reaction/anaphylaxis, she went down, they gave her an Epinephrine, she didn't respond to the first dose, a second dose was
given in the arm where the vaccine was given, then she was picked up by an ambulance. Agent stated the caller has been on
hold for almost an hour. Caller clarifies dose was given in the arm, it occurred on Saturday with the same lot. Saturday and it
Life went away on Saturday, the patient was worried about it coming back, thus why she asked about Epinephrine pen, the patient
167 ANXIETY PFIZER\BIONTECH Unknown 951992-1
Threatening was taken to the hospital, and given Epinephrine a couple more times, and it resolved eventually, the patient was not admitted,
she went to the Emergency Department. It could have required hospitalization but would most likely say life threatening had she
not been treated. Reporter seriousness for anaphylaxis is life threatening. The outcome of event was recovered on 09Jan2021.
Relatedness of bnt162b2 to reaction anaphylaxis is related for primary source.; Sender's Comments: A possible causal
association between administration of BNT162B2 and the onset anaphylactic reaction/anaphylaxis cannot be excluded,
considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this
appropriate.
Patient vaccinated on 12/28. Approximately one day later, develops cough and on azithromycin x 1 week. On 1/3, patient
30-39
168 APHASIA MODERNA Death 939050-1 develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory
years
failure secondary to COVID - on H&P. Patient died on 1/4/21 at 7:20am.
50-59 Life thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now
169 APHASIA MODERNA 919546-1
years Threatening extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)
40-49 Life
170 APHASIA PFIZER\BIONTECH 932420-1 morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx
years Threatening
1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer on an empty stomach) Minute
40-49 Life 10: Nausea Minutes 23-25: Neck tightness (like doing unsupported crunches and holding my head up) Minute 27: Inability to
171 APHASIA PFIZER\BIONTECH 954720-1
years Threatening swallow and inability to speak EMS on site administered EpiPen auto-injection to left thigh, immediate improvement in
symptoms Transport to hospital via ambulance Hospital monitored me for several hours and discharged same day
172 APHASIA PFIZER\BIONTECH 932145-1
10:31am.
65+
173 APNOEIC ATTACK PFIZER\BIONTECH Death 952799-1 On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed
years
Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating.
Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Sunday had emergency appendectomy for
actuate appendicitis.; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the
patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand,
lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had
numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and
throat; Post surgery had allergic reaction unknown reason with head to toe rash; Post surgery had allergic reaction unknown
reason with head to toe rash; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient
(pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number:
EL1283) on left arm on 08Jan2021 at 6:30 AM at single dose for covid-19 immunisation. The relevant medical history included
celiac, anemia, known allergies: Sulfa and Gluten. Concomitant medications were not reported. The patient received first dose of
BNT162B2 via intramuscular (lot number: Ek5730) on left leg on 18Dec2020 at 11:00 AM at single dose for covid-19
30-39 Life
174 APPENDICECTOMY PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
and tingling to left hand, lips and throat. On Saturday the patient had sweating, chills, headache, nausea. On Sunday had
emergency appendectomy for actuate appendicitis. Post surgery had allergic reaction unknown reason with head to toe rash. It
was also reported that the adverse event started on 08Jan2021 at 03: 15 PM (as reported). The patient had 1-day
hospitalization. The patient received treatment for the events. The adverse events resulted in Emergency room/department or
urgent care. The events were reported as serious due to life threatening and hospitalization. The most recent COVID-19 vaccine
was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The
outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events
cannot be excluded based on a compatible temporal relation between vaccination and onset of events. Medications
administered during appendectomy may confound reactions experienced post-surgery. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and
analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate
action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
40-49 Life
175 APPENDICECTOMY PFIZER\BIONTECH 909720-1 with ibuprofen. 12/24- no fever noted but intermittent right lower quadrant pain continued, seen at the Health Clinic, sent to
years Threatening
176 APPENDICECTOMY PFIZER\BIONTECH 951817-1
50-59 Life
177 APPENDICECTOMY PFIZER\BIONTECH 923000-1 and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from
years Threatening
12/26/20-12/28/20.
178 APPENDICECTOMY PFIZER\BIONTECH 947687-1
18-29 Life Acute appendicitis, onset morning of 1/1/2021 (Reporting this because Pfizer covid vaccine had 3-4x higher risk of appendicitis,
179 APPENDICITIS MODERNA 916710-1
years Threatening although data not reported for Moderna covid vaccine)
Vaccine Event
30-39 Life
180 APPENDICITIS PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
40-49 Life
181 APPENDICITIS PFIZER\BIONTECH 909720-1 with ibuprofen. 12/24- no fever noted but intermittent right lower quadrant pain continued, seen at the Health Clinic, sent to
years Threatening
50-59 Life
182 APPENDICITIS PFIZER\BIONTECH 923000-1 and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from
years Threatening
12/26/20-12/28/20.
60-64 Life
183 APPENDICITIS PFIZER\BIONTECH 957282-1 Appendicitis
years Threatening
APPENDICITIS 40-49 Life days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night.
PERFORATED years Threatening Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery
30-39 Life Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by neurology and diagnosed
185 AREFLEXIA PFIZER\BIONTECH 930777-1
years Threatening with Guillain- Barre Syndrome thought to be secondary to the Pfizer Covid Vaccine
50-59 Life
186 ARTERIOGRAM CAROTID MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
187 ARTERIOGRAM CAROTID PFIZER\BIONTECH 932366-1
50-59
188 ARTERIOGRAM CAROTID PFIZER\BIONTECH Death 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years
50-59 Life
189 ARTERIOGRAM CAROTID PFIZER\BIONTECH 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years Threatening
190 ARTERIOGRAM CAROTID PFIZER\BIONTECH 932145-1
10:31am.
ARTERIOGRAM CAROTID 40-49 Life
At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of chest pain and shortness of
breath prompting a trip to the Emergency Department. A chest CT Angio to rule out pulmonary embolus was done and negative
for pulmonary embolus. My EKG showed some mild ST changes and a troponin I level was elevated at 0.08 (normal 0.04).
ARTERIOGRAM CORONARY 40-49 Life
192 PFIZER\BIONTECH 949611-1 Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed
which showed regional wall motion abnormalities consistent with Takotsubo cardiomyopathy and an ejection fraction of 45%. I
was then taken to cardiac catheterization lab for coronary angiograms which were normal. My LV angiogram was consistent
with Takotsubo cardiomyopathy and my LVEDP was elevated. I was started on a beta blocker and sent home the following day.
ARTERIOVENOUS FISTULA 65+ Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock; Aneurysm of arteriovenous
193 PFIZER\BIONTECH Death 962390-1
ANEURYSM years dialysis fistula; expired 1/16/2021
30-39 Life
194 ARTHRALGIA MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of
COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours ,
60-64 Life
195 ARTHRALGIA MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the
experienced COVID symptoms )
Patient presented to our Emergency Department via EMS in full code status; asystole. Patient expired. Per nursing, husband
65+
196 ARTHRALGIA MODERNA Death 953129-1 stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went
years
unresponsive and husband called EMS.
40-49 Life
197 ARTHRALGIA PFIZER\BIONTECH 930897-1 Shortness of breath, cough, rash on face and neck, arthralgia
years Threatening
50-59 Life
198 ARTHRALGIA PFIZER\BIONTECH 934676-1 Chills Hip pain
years Threatening
upper body. Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8): patient was told
60-64 Life
199 ARTHRALGIA PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
patient go to the emergency room. Patient understood the importance to seek medical attention..... Emergency Room notes:
60-64 Life Patient developed a septic knee (history of arthroplasty) need for immediate surgery, hospitalization and months to years of
200 ARTHRITIS BACTERIAL MODERNA 919593-1
years Threatening antibiotics in his future now.
201 ASCITES PFIZER\BIONTECH 947687-1
ASPARTATE his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes,
60-64
202 AMINOTRANSFERASE PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
INCREASED phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit
testing.
ASPARTATE
INCREASED
Vaccine Event
ASPARTATE
INCREASED
ASPARTATE
INCREASED
ASPARTATE
INCREASED
ASPARTATE numbness, starting at the injection site traveling down the ulnar aspect of her arm, and nausea. Over the next several hours she
30-39 Life
207 AMINOTRANSFERASE MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
ASPARTATE
208 AMINOTRANSFERASE MODERNA 958913-1
NORMAL
ASPARTATE
NORMAL
ASPARTATE
NORMAL
ASPARTATE
NORMAL
65+ Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age
212 ASPIRATION PFIZER\BIONTECH Death 942072-1
years 87. No evidence of acute vaccine reaction.
50-59 Life
213 ASPIRATION JOINT PFIZER\BIONTECH 934676-1 Chills Hip pain
years Threatening
214 ASTHENIA MODERNA 927223-1
40-49 Life
216 ASTHENIA MODERNA 958509-1 Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
years Threatening
Resident had the COVID vaccine 12/30/2020. 12/31/20, resident has been in bed all shift. Staff became concerned when
resident was not easily aroused. Resident displayed signs of tremors, twitching, confusion, in and out of consciousness, low O2
sats, elevated pulse and fever, fatigue and weakness. Writer called NP. NP stated this is most likely a reaction d/t the COVID
vaccine. She gave orders for Benadryl 25mg IM x1 now and Tylenol 1000 mg now. NP also stated resident will not be getting the
second dose of vaccine. Will continue to monitor and update NP if worsening symptoms. After receiving Benadryl and Tylenol at
145pm, resident began to appear as though she was feeling better and was talking to talk, fever had gone down. Tonight resident
is not easily aroused, lethargic, continues to have tremors and twitches, almost appearing as convulsions. When asked if she
knows where she is or what day it is, resident can properly answer. Resident denies SOB but staff has noted loud squeals while
breathing. NP was updated and gave new orders to give Benadryl 25 mg IM x1 if needed and Ok to send resident to ED. Resident
50-59 Life currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am
years Threatening was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident.
Writer and NAR attempted to reposition resident and resident's breathing became more labored. Resident turned back to
previous position and writer called on call MD at approx. 1220am. MD returned call approx. 1235am with orders to send resident
to ED. 911 called and ambulance arrived about 1245am. History of present condition given to EMTs and they stated resident
would be going to Hospital. Writer has attempted to contact Hospital ED x3 but have been unable to get through. An EMT did just
call to clarify when vaccine was given, what symptoms have been present and when they started. She said she has everything
she should need and she will let Hospital ED staff know to call if they need anything else. Writer will again attempt to contact
them though. Resident's temp was 97.5 and BG 128. When EMTs arrived they got an O2 reading of 60%. Resident did open her
eyes a couple times during transfer from bed to stretcher and while stretcher was going outside but no responses from resident
were made.
60-64
218 ASTHENIA MODERNA Death 952713-1 Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21
years
60-64 Life
219 ASTHENIA MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
65+ Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be
221 ASTHENIA MODERNA Death 957799-1
years resuscitated
Resident was noted to have increase weakness on 1/15/2021. Resident was warm to touch with low grade fever of 99.3 F.
65+
222 ASTHENIA MODERNA Death 958745-1 Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found
years
slumped over in his w/c not responding and vital signs absent.
223 ASTHENIA MODERNA Death 959591-1
5 minutes after injection, my feet and palms itched and I was lightheaded but I tried to shake it off and it faded over the next 10
minutes. I did report it and stayed longer and was ok. Then i went straight home and layed down because i did not sleep well
night before (was on call ) i awoke 1 hour post injection dry heaving, very nauseated, mild headache, achy, itchy over different
parts of my body and weak. Sat up and my face was getting itchier, lips started to swell, tongue started to swell and itch, throat
felt like someone was strangling me, had trouble swallowing and trouble breathing. took 2 benadryls immediately and went out
into cold air, thought about calling 911 but got better in 10-15 minutes. never have had a reaction like this in my life. have had
65+ Life
224 ASTHENIA MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
benadryl worked and I slept due to the benadryl for 5 hours, when I woke up the benadryl wore off and it started again. took more
benadryl, and it improved. before bedtime, the benadryl wore off and I had a hard time swallowing my night time meds like my
throat was swollen. Took 2 more benadryls, today I am weak and nauseated and ate very little and feel like my face is still red
and itchy. I told my sister and she said she is allergic to PEG which i later noted was in the vaccine. i am very disappointed that I
had this reaction- I have desparately wanted this vaccine as a medical worker with a lot of covid patients- I onlu hopr this one
shot will protect me enough because it is clear to me that i cannot take this vaccine again.
65+ Life Throbbing head ache, difficulty breathing, lips numbness, chest discomfort, upper back, lower legs, fingers tingling/numbness,
years Threatening high blood pressure 148/83, underarm sweating, feels weak
226 ASTHENIA PFIZER\BIONTECH 939190-1
Vaccine Event
40-49 Life
229 ASTHENIA PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
Pt. developed tachycardia, hypertension and felt weak with decreased verbal responsiveness, alert but lethargic. She complained
50-59 Life
231 ASTHENIA PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
difficulty breathing, there were no cutaneous signs of edema, tongue enlargement, etc.
50-59 Life
232 ASTHENIA PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
encephalopathy."
Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th
resident sustained a fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results. Evening of 8th
65+
234 ASTHENIA PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice. Continued with fever, crackles and N/V and loss of
appetite from the 9th and 10th of January. Resident expired at 820am on 1/11/2021.
increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to
65+
235 ASTHENIA PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
diminished, loss consciousness and passed away. 01-12-2021
12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain
65+
236 ASTHENIA PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away
Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF, P
80, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3, has been complaining of generalized weakness, fatigue, decreased
65+
237 ASTHENIA PFIZER\BIONTECH Death 962827-1 appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the
years
hospital, condition clinically deteriorated. Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30
p.m. earlier today. Preliminary cause of death: Hypoglycemia induced lactic acidosis.
238 ASTHENIA PFIZER\BIONTECH Death 963057-1
Patient is a 99yr old female who got a covid vaccine in the afternoon of 1/10/21 and woke up in the morning of 1/11/21 with
65+ Life altered mental status, weakness, and dysarthria. She was taken from her assisted living facility to the hospital and MRI showed a
years Threatening small stroke in the right medial thalamus. She was also found to have new onset atrial fibrillation. She was treated appropriately
for both conditions and discharged to a skilled nursing facility on 1/13/21.
hemolytic anemia; reduced air entrance; passed away; low blood pressure; jaundice appeared on the whole body with
lymphocytosis; jaundice appeared on the whole body with lymphocytosis; shortness of breath in mild efforts; weakness which
expressed by shortness of breath in mild efforts; hands tremor; shortness of breath; This is a spontaneous report from a
contactable consumer received via regulatory authority. This consumer reported different fatal events for four patients. This is
the third of four reports. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;
lot number was not specified) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19
immunisation. Medical history included Kerattis, prostatectomy other, blood pressure problems (treated with nifedipine and
hydrochlorothiazide/ramipril (TRITACE COMP)), hyperlipidemia (treated with statins), oncological patient-underwent radical
restriction of the prostate, and sensitivity to phenylephrin. Concomitant medications were not reported. Three days after the
240 ASTHENIA PFIZER\BIONTECH Unknown Death 944155-1
vaccine (on 24Dec2020) he started to feel shortness of breath, arrived for hospitalization 10 days after vaccination. Five days
after vaccination (on 26Dec2020) he experienced weakness which expressed by shortness of breath in mild efforts, hands
tremor. 6 days after vaccination (on 27Dec2020) jaundice appeared on the whole body with lymphocytosis. On the day after, he
referred to the physician and blood tests were sent. He was hospitalized following diagnosis of hemolytic anemia. He received
two blood doses and steroids. Two hours before he passed away, low blood pressure was measured and reduced air entrance,
CPR was performed without success and the patient passed away. The date of death was unknown. The cause of death was
unknown. It was unknow if an autopsy was performed. The outcome of event unknown cause of death was fatal, and of other
events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : IL-
PFIZER INC-2021019507 Same reporter, same product, different patient/events; Reported Cause(s) of Death: passed away
241 ASYMPTOMATIC COVID-19 MODERNA 914392-1
65+
242 ASYMPTOMATIC COVID-19 MODERNA Death 956903-1 mi Narrative: patient with asymptomatic covid 19, covid positive 12/10/2020.
years
Woke up on 1/6/2021 with hot flashes, palpitations, dizziness and heart racing. Went to urgent care and they did an EKG which
40-49 Life
243 ATRIAL FIBRILLATION MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
years Threatening
No cause was found and no history of A-Fib or family history.
50-59 Life Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History
244 ATRIAL FIBRILLATION MODERNA 947648-1
years Threatening provided by S.O and daughter
a couple hours after the vaccine, I experienced a bit of rapid heart rate, which resolved after a few minutes. The following day
around 3 pm I began to have chills and felt like I had the raid heart rate again. By 5 pm I was beginning to feel really bad, I was
50-59 Life freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove
245 ATRIAL FIBRILLATION MODERNA 955945-1
years Threatening me to the emergency department. I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday
afternoon. The diagnosis was pneumonia, I don't really believe this, as I felt fine and had no symptoms prior to the onset of the
fever.
246 ATRIAL FIBRILLATION PFIZER\BIONTECH 904436-1
40-49 Life Palpitations, shortness of breath, chest tightness, presyncope, which led to New onset atrial fibrillation with rapid ventricular
years Threatening response and required synchronized cardioversion and hospitalization. Discharged on anticoagulation and beta-blocker.
248 ATRIAL FIBRILLATION PFIZER\BIONTECH Death 963057-1
Atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The
regulatory authority report number is GB-MHRA-EYC 00236011. An 87-year-old female patient received BNT162B2 (PFIZER-
BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0553), intramuscular on 18Dec2020 at 0.3 mL, single for covid-19
immunization. Medical history included ongoing hypothyroidism, ongoing diabetes, ongoing atrial fibrillation, ongoing frailty and,
ongoing osteoporosis, all from unknown dates. Concomitant medication included prednisolone (MANUFACTURER UNKNOWN),
levothyroxine (MANUFACTURER UNKNOWN), salbutamol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER
UNKNOWN), doxycycline (MANUFACTURER UNKNOWN). The patient experienced atrial fibrillation on an unspecified date, which
250 ATRIAL FIBRILLATION PFIZER\BIONTECH Unknown Death 928992-1 was serious as it was medically significant, involved hospitalization and lead to death. Clinical course was as follows: the patient
was vaccinated. Consent was obtained and a pre immunization checklist was completed. She was observed following the
administration of the vaccine, and no adverse effects were noted. She returned home. She became unwell and was admitted to
hospital approximately 24 hours later. The patient was admitted to the hospital 24 hours following the vaccination, and
subsequently died later, while in the hospital. The full clinical details were unknown, but the diagnosis from Accident &
Emergency was atrial fibrillation. It is not clear if this had any relation to the vaccine that was administered, but could not be
excluded, per the reporter. The patient died on 20Dec2020. It was not reported if an autopsy was performed. No follow-up
activities are possible. No further information is expected.; Reported Cause(s) of Death: Atrial fibrillation
50-59
251 AUTOPSY MODERNA Death 918518-1 syncopal episode - arrested - CPR - death
years
Patient received COVID-19 (Moderna) vaccine from the Health Department on afternoon of January 8, 2021 and went to sleep
65+
252 AUTOPSY MODERNA Death 934539-1 approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January
years
9, 2021
65+
253 AUTOPSY MODERNA Death 943362-1 Pt collapsed at home approx 5:30 pm and died
years
Vaccine Event
65+
254 AUTOPSY MODERNA Death 953785-1 Death
years
30-39 LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased
255 AUTOPSY PFIZER\BIONTECH Death 921667-1
years somewhere between 1/3/2021 and 1/4/2021. Cause of death is unknown, and an autopsy is being performed.
his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes,
60-64
256 AUTOPSY PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit
testing.
"Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found
pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable
other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second
dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021
12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity,
epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient
received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR),
ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide
(LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina
leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other
vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal
and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on
21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19
65+ (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20
257 AUTOPSY PFIZER\BIONTECH Death 940955-1
years minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on
11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was
unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It
was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating
nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple
underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19
diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However,
based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of
BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely
excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for
Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of
Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"
65+
258 AUTOPSY PFIZER\BIONTECH Death 946959-1 Sudden death 18 hours post vaccine .
years
65+
259 AUTOPSY PFIZER\BIONTECH Death 952204-1 Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep.
years
Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in connection with the vaccination and/or
COVID-19 disease/positivity; This is a spontaneous report from a contactable physician. This physician reported similar events
for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose for COVID-19
immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, there was
death in connection with the vaccination and/or COVID-19 disease/positivity. It was reported that: two deceased were autopsied,
whose death was in connection with the vaccination or COVID-19 disease/positivity. The clinical outcome of death in connection
with the vaccination and/or COVID-19 disease/positivity was fatal. The patient died on an unspecified date. The cause of death
260 AUTOPSY PFIZER\BIONTECH Unknown Death 937724-1 was reported as: death in connection with the vaccination and/or COVID-19 disease/positivity. An autopsy was performed, and
the results were not reported.; Sender's Comments: The association between the event lack of effect (death was in connection
with the vaccination or COVID-19 disease positivity) with BNT162b2 can not be fully excluded given the limited information. The
impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety
evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and
Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021006905 same reporter, same product, same event, different
patient; Reported Cause(s) of Death: Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in
connection with the vaccination and/or COVID-19 disease/positivity
platelets dropped so low/thrombocytopenia; Hemorrhagic stroke/brain hemorrhage; This is a spontaneous report from a
contactable nurse. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified
route of administration on 18Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications
were unknown. The reporter read about the doctor that died that developed thrombocytopenia after taking the vaccine, stated it
was in the news yesterday. The patient received the Pfizer Covid vaccine on 18Dec2020, and he died 16 days later from a brain
hemorrhage. Autopsy stated that said he had a hemorrhagic stroke on 03Jan2021. His platelets dropped so low that he had
specialists that tried to get his platelet count back up again and they could not get his platelets back up again and he ended up
having the hemorrhagic stroke. The reporter already had thrombocytopenia and she was debating what she should do about
261 AUTOPSY PFIZER\BIONTECH Unknown Death 960437-1
getting vaccine. Outcome of the events was fatal. Information on the lot/batch number has been requested.; Sender's
Comments: Very limited information is currently available. Lacking patient's underlying medical conditions, clinical course,
relevant lab data, the Company cannot make a meaningful causality assessment. The reported hemorrhagic stroke following low
platelet count are managed as related to the suspect, BNT162B2, for reporting purpose only. The impact of this report on the
action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: Hemorrhagic stroke/brain
hemorrhage; platelets dropped so low/thrombocytopenia
262 AZOTAEMIA PFIZER\BIONTECH Death 963057-1
50-59 Life
263 BACK PAIN MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
"1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt
65+
264 BACK PAIN MODERNA Death 933846-1 better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death
years
certificate."
65+
265 BACK PAIN MODERNA Death 953129-1 stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went
years
65+ Life
266 BACK PAIN MODERNA 924201-1 back pain, presented to Med Center where he was found to have an Acute Coronary Syndrome. Transferred to Medical Center
years Threatening
started with left sided lower back pain; This is a spontaneous report from a contactable Nurse (patient). A 22-year-old female
patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration at left arm on
16Dec2020 13:45 at single dose for covid-19 immunization. Medical history included allergies for All fish. The patient's
concomitant medications were not reported. The patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started
with left sided lower back pain. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency
18-29 Life
267 BACK PAIN PFIZER\BIONTECH 946096-1 room/department or urgent care, Hospitalization (2 days), Life threatening illness (immediate risk of death from the event). The
years Threatening
patient received the Heparin drip and xarelto at home for the event. The patient was not pregnant. The patient received the covid
test post vaccination on 09Jan2021. Test type was Nasal Swab. The result was negative. The outcome of the event was
recovered with sequel on unspecified date.; Sender's Comments: From the information provided it is unclear what is the nature of
the reported event and what are the reasons that have put the subject at immediate risk of death. The event is considered
possibly related to the suspect product based on the positive temporal association.
At the time of the injection sharp pain across my back , then at about 5 mins after feelings of light headedness, progressing pain
30-39 Life across my back, trouble feeling like I could get enough air in with breathing and dizziness and I tried to get to the floor to sit or
268 BACK PAIN PFIZER\BIONTECH 909165-1
years Threatening lay down but passed out. Then the next event I recall was a sharp pain in my thigh(apparently administered Eli pen) . I regained
consciousness and was gasping andI was told I had been given a shot of epi.
Fever to 103.7F, respiratory rate 36. Was transferred from facility to hospital. Since then has been found to have gram-negative
60-64 Life rod bacteremia, although urinalysis was negative, urine culture pending. Patient has since defervesced after receiving 1 dose of
269 BACTERAEMIA PFIZER\BIONTECH 929689-1
years Threatening cefepime. Overall the most likely cause of fever seems to be urosepsis w/ bacteremia, pending confirmation with urine & blood
cultures.
Vaccine Event
270 BACTERIAL TEST NEGATIVE PFIZER\BIONTECH Death 959929-1
50-59
271 BACTERIAL TEST POSITIVE MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
Acute allergic reaction; Unsteadiness; Confused; Dizziness; Exhaustion; Feeling drunk; This is a spontaneous report from a
contactable physician manually downloaded from the database: GB-MHRA-WEBCOVID-20201211215403, Safety Report Unique
Identifier GB-MHRA-ADR 24542614. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration on 11Dec2020 at single dose for covid-19 immunisation. The patient medical history was
reported without any specified term but with precise dates from 16Mar2020 to 28Mar2020, other history included depression,
Life
272 BALANCE DISORDER PFIZER\BIONTECH Unknown 907573-1 gastrooesophageal reflux disease and anxiety. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) in
Threatening
Oct2020 for influenza immunisation, lofepramine hydrochloride for depression, omeprazole for gastrooesophageal reflux
disease, propranolol for anxiety. The patient experienced unsteadiness, confused, dizziness, exhaustion, feeling drunk, acute
allergic reaction on 11Dec2020. All events were reported as serious (medically significant, life threatening). Outcome of
dizziness was recovered in Dec2020, outcome of exhaustion was not recovered, and outcome of other events were recovering.
Information on the lot/batch number has been requested.
BAND NEUTROPHIL 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
PERCENTAGE DECREASED years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
BAND NEUTROPHIL 18-29 Life Acute appendicitis, onset morning of 1/1/2021 (Reporting this because Pfizer covid vaccine had 3-4x higher risk of appendicitis,
274 MODERNA 916710-1
PERCENTAGE INCREASED years Threatening although data not reported for Moderna covid vaccine)
BAND NEUTROPHIL 50-59 Life
275 PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
PERCENTAGE INCREASED years Threatening
He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia
hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe
fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2
(Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history
included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included
hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a
Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work
due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am.
Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had
suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema
and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date.
BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with
BASAL GANGLIA 50-59 Life
276 PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
HAEMORRHAGE years Threatening
unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization
(22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage.
Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020,
Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the
COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not
tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided
hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening
of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety
review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and
Investigators, as appropriate.
65+
277 BASAL GANGLIA STROKE MODERNA Death 958971-1 Hemorrhagic Stroke, Right Basal Ganglion
years
"15-20 mins after receiving the vaccine she reported she had difficulty swallowing and difficulty breathing and was ?shaking."" a
PA wrote in her note that when she ran in to help, she found the patient to be tachypneic, diaphoretic, warm with some red
blotchy patches on face, chest & neck. Able to speak easily c/o trouble breathing & sensation of throat swelling & extremities
feeling abnormal. No stridor. No facial edema noted by that clinician. Administered epi-pen 0.3mg - IV started , Benadryl 50mg
IVP and solumedrol 125mg IVP. Patient reports she subsequently arched her back and had rigidity of her arms/legs and tremors.
Clinic PA reports that while she was there, pt was never hypotensive. Initially hypertensive after epi as expected with some
favorable response after 10-15 min Staff there gave her IM epinephrine, IV Solu-Medrol and 50 mg IV Benadryl. EMS was
30-39 Life
278 BASE EXCESS MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
benadryl and discharged from the ER. She had a diffuse itchy rash. The following day she again developed recurrence of throat
swelling. Went back to a different ER. Developed dyspnea immediately prior to arrival at ER. There was again given solumedrol
and benadryl and pepcid and developed muscle rigidity and arched back for 10 minutes. Symptoms of SOB and dyspnea
resolved with epinephrine. Was discharged from the ER with prednisone after being monitored for 5 hours. Is continuing to take
prednisone and benadryl. Rash is still present but improving with scheduled benadryl. Has new redness at injection site today.
Continues to feel some throat swelling but no tightness today. This information was gathered from talking with pt today for a
phone appt and also from her medical chart regarding her vaccination visit and two ER visits."
BASILAR ARTERY 65+ Life
279 PFIZER\BIONTECH 932623-1 Acute ischemic stroke, basilar occlusion
OCCLUSION years Threatening
BASOPHIL COUNT 30-39 Life
280 MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
DECREASED years Threatening
30-39 Life
281 BASOPHIL COUNT NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
282 BASOPHIL COUNT NORMAL PFIZER\BIONTECH 903123-1
283 BASOPHIL COUNT NORMAL PFIZER\BIONTECH Death 950441-1
284 BASOPHIL PERCENTAGE PFIZER\BIONTECH Death 950441-1
BASOPHIL PERCENTAGE 30-39 Life
BASOPHIL PERCENTAGE 30-39 Life
286 MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
Racepinephrine x 1.
Vaccine Event
BASOPHIL PERCENTAGE 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
DECREASED years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
BETA-2 GLYCOPROTEIN 30-39 Life Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or
ANTIBODY NEGATIVE years Threatening deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively
BILEVEL POSITIVE AIRWAY 65+ Life
289 MODERNA 930611-1 Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP
PRESSURE years Threatening
BILEVEL POSITIVE AIRWAY 50-59 Life ESCORTED TO ER IN WHEELCHAIR ACCOMPANIED BY 2 RN'S (2 MINUTE WALK) ONE HOUR LATER - AS REPORTED BY DR (ER)
PRESSURE years Threatening WORKING DIAGNOSIS - ANAPHYLAXIS / STATUS ASTHMATICUS MEDS RECIEVED: SOLUMEDROL 125, DIPHENHYDRAMINE
BILEVEL POSITIVE AIRWAY 65+
291 PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
PRESSURE years
BILEVEL POSITIVE AIRWAY 65+ due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP;
PRESSURE years progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening
293 BILIRUBIN CONJUGATED MODERNA 958913-1
BILIRUBIN CONJUGATED 60-64
294 PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
INCREASED years
testing.
Life 1day after vaccine,developed severe headache & later blister in head officially Shingle . Then decreased platelet count fatally to
295 BLISTER MODERNA Unknown 953397-1
Threatening 29(ITP).now hospitalized getting treatment.
BLOOD ALBUMIN 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
DECREASED years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
BLOOD ALBUMIN 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
DECREASED years reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138
BLOOD ALBUMIN 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
DECREASED years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
30-39 Life
299 BLOOD ALBUMIN NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
300 BLOOD ALBUMIN NORMAL MODERNA 958913-1
301 BLOOD ALBUMIN NORMAL PFIZER\BIONTECH 903123-1
302 BLOOD ALBUMIN NORMAL PFIZER\BIONTECH 904436-1
303 BLOOD ALBUMIN NORMAL PFIZER\BIONTECH Death 950441-1
BLOOD ALKALINE 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
PHOSPHATASE INCREASED years reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138
BLOOD ALKALINE 60-64
PHOSPHATASE INCREASED years
testing.
BLOOD ALKALINE 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
PHOSPHATASE INCREASED years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
BLOOD ALKALINE 30-39 Life
PHOSPHATASE NORMAL years Threatening
Racepinephrine x 1.
BLOOD ALKALINE 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
PHOSPHATASE NORMAL years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
BLOOD ALKALINE 40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
PHOSPHATASE NORMAL years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
Vaccine Event
BLOOD BICARBONATE 30-39 Life
BLOOD BILIRUBIN 60-64
INCREASED years
testing.
12/18/2020: COVID19 vaccine received. 12/19/2020: Patient noticed petechiae/bruising on arms, legs and face. Worsened over
next 48 hours. 12/21/2020: Patient had blood drawn (CMP, PT/INR, CBC) at lab. 12/22/2020: Labs resulted; CMP and PT/INR
BLOOD BILIRUBIN 65+ Life
312 PFIZER\BIONTECH 908869-1 WNL (exceptions: SCr 1.24, TBil 1.7); CBC with platelet count of 1,000 resulting in patient admission to Hospital. At admission he
INCREASED years Threatening
received 80 mg of prednisone, 40 g of IV Ig and a unit of platelets. 12/23/2020: Continued hospitalization. Patient's platelets
improved to 20,000 and he received another 35g of IV Ig. 12/24/2020: Patient discharged with platelets of 38,000.
BLOOD BILIRUBIN 65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
INCREASED years Threatening and confused (beyond baseline)
30-39 Life
314 BLOOD BILIRUBIN NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
315 BLOOD BILIRUBIN NORMAL MODERNA 958913-1
316 BLOOD BILIRUBIN NORMAL MODERNA Death 958228-1
317 BLOOD BILIRUBIN NORMAL PFIZER\BIONTECH 903123-1
318 BLOOD BILIRUBIN NORMAL PFIZER\BIONTECH Death 950441-1
319 BLOOD BILIRUBIN NORMAL PFIZER\BIONTECH Death 959179-1
BLOOD CALCIUM 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
30-39 Life
321 BLOOD CALCIUM NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
322 BLOOD CALCIUM NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
323 BLOOD CALCIUM NORMAL MODERNA 958913-1
324 BLOOD CALCIUM NORMAL MODERNA Death 958228-1
325 BLOOD CALCIUM NORMAL PFIZER\BIONTECH 903123-1
326 BLOOD CALCIUM NORMAL PFIZER\BIONTECH Death 950441-1
BLOOD CHLORIDE 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
BLOOD CHLORIDE 65+ Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital
DECREASED years and treated for worsening AKI and hypotension.
BLOOD CHLORIDE 60-64 Life
329 PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
BLOOD CHLORIDE 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
DECREASED years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
BLOOD CHLORIDE 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
Vaccine Event
BLOOD CHLORIDE 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
INCREASED years reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138
30-39 Life
333 BLOOD CHLORIDE NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
334 BLOOD CHLORIDE NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
335 BLOOD CHLORIDE NORMAL MODERNA 958913-1
336 BLOOD CHLORIDE NORMAL PFIZER\BIONTECH 903123-1
BLOOD CHOLESTEROL 50-59 Life thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now
337 MODERNA 919546-1
INCREASED years Threatening extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)
BLOOD CREATINE 50-59 Life 12/30 9:30 am developed angioedema. Swelling of face, lips, tight throat. Also had bright red rash over body trunk and arms.
338 MODERNA 914392-1
PHOSPHOKINASE NORMAL years Threatening Both palms were red, hot and painful.
12/30/2020 07:02 AM Resident noted to have some redness in face and respiration were fast. Resident vital signs were
abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times.
Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also
made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been
poor for few days. 12/30/2020 07:32 AM Received order from agency to administer Acetaminophen 650mg suppos rectally due
to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP
BLOOD CREATININE 65+
339 MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
INCREASED years
swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital
signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident
sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by
nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate
resident family to be able to be at bedside when time comes to do so. NP ordered IVF and IV Levaquin on 12/31/20. Family
chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics
BLOOD CREATININE 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
BLOOD CREATININE 50-59 Life
BLOOD CREATININE 60-64
INCREASED years
testing.
BLOOD CREATININE 65+ CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A
INCREASED years STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE
BLOOD CREATININE 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
INCREASED years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
BLOOD CREATININE 65+ Life
BLOOD CREATININE 65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
Racepinephrine x 1.
BLOOD CREATININE 60-64 Life Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of
349 MODERNA 958913-1
NORMAL years Threatening 105.2F
BLOOD CREATININE 40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
NORMAL years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
BLOOD CREATININE 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
NORMAL years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
50-59 Life
352 BLOOD CULTURE PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
353 BLOOD CULTURE PFIZER\BIONTECH 929689-1
cultures.
65+
354 BLOOD CULTURE PFIZER\BIONTECH Death 919108-1 Fever, Malaise
years
355 BLOOD CULTURE PFIZER\BIONTECH 953333-1
Vaccine Event
356 BLOOD CULTURE NEGATIVE PFIZER\BIONTECH 904436-1
Patient 101 years old, nursing home resident, received vaccine 1/11, on 1/13 found on floor without obvious trauma,
unresponsive. Brought to ED and was bradycardic, hypotensive, hypothermic and refractory to aggressive medical management.
65+
357 BLOOD CULTURE NEGATIVE PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as
soon as discovered.
358 BLOOD CULTURE NEGATIVE PFIZER\BIONTECH Death 959179-1
359 BLOOD CULTURE NEGATIVE PFIZER\BIONTECH Death 959929-1
50-59 Life
360 BLOOD GASES MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
361 BLOOD GLUCOSE PFIZER\BIONTECH 939190-1
BLOOD GLUCOSE 40-49 Life
362 MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
dizziness.
BLOOD GLUCOSE 60-64 Life Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of
363 MODERNA 958913-1
INCREASED years Threatening 105.2F
BLOOD GLUCOSE 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
BLOOD GLUCOSE 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
30-39 Life
366 BLOOD GLUCOSE NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
367 BLOOD GLUCOSE NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
368 BLOOD GLUCOSE NORMAL MODERNA 926787-1
were made.
369 BLOOD GLUCOSE NORMAL MODERNA 958913-1
370 BLOOD GLUCOSE NORMAL MODERNA Death 959591-1
371 BLOOD GLUCOSE NORMAL PFIZER\BIONTECH 903123-1
30-39 Life
372 BLOOD GLUCOSE NORMAL PFIZER\BIONTECH 909278-1 Rapid onset of hoarseness, throat tingling and tightness
years Threatening
50-59 Life
373 BLOOD GLUCOSE NORMAL PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
60-64 Life
374 BLOOD GLUCOSE NORMAL PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
375 BLOOD GLUCOSE NORMAL PFIZER\BIONTECH Death 950441-1
376 BLOOD HOMOCYSTEINE MODERNA 919546-1
30YO F ICU nurse obesity (BMI 35) COVID 19 on Dec 2 symptoms, Dec 3 tested positive for COVID-19. never hospitalized,
outpatient only. 12/12 completed isolation 12/21 received vaccine 12/7 developed Fever chills diarrhea SOB cough Urgent care
BLOOD LACTATE
30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
377 DEHYDROGENASE PFIZER\BIONTECH 917210-1
years Threatening WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense
INCREASED
infiltrate DDimer 7.8 LDH 599 CRP 41 procal 0.67 ferritin 500 Viral respiratory PCR negative Sputum cx with oral flora (pending)
COVID ag testing neg COVID PCR 1/3 targets positive (called as indeterminate).
Vaccine Event
378 BLOOD LACTIC ACID PFIZER\BIONTECH 929689-1
cultures.
379 BLOOD LACTIC ACID PFIZER\BIONTECH Death 959179-1
BLOOD LACTIC ACID 40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
DECREASED years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
BLOOD LACTIC ACID 65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
DECREASED years Threatening and confused (beyond baseline)
No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal
BLOOD LACTIC ACID 65+ breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse
INCREASED years was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple
cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.
BLOOD LACTIC ACID 65+ vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated,
INCREASED years cardiac arrest, died 01/07/21.
BLOOD MAGNESIUM 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
INCREASED years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
BLOOD MAGNESIUM 30-39 Life
Racepinephrine x 1.
BLOOD MAGNESIUM 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
NORMAL years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
BLOOD MAGNESIUM 40-49 Life
387 PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
BLOOD MAGNESIUM 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
NORMAL years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
BLOOD OSMOLARITY 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
30-39 Life
390 BLOOD PH INCREASED MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
50-59 Life
391 BLOOD PH INCREASED PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
BLOOD PHOSPHORUS 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
BLOOD POTASSIUM 30-39 Life
Racepinephrine x 1.
BLOOD POTASSIUM 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
BLOOD POTASSIUM 30-39 Life Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy,
DECREASED years Threatening ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
BLOOD POTASSIUM 40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
DECREASED years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
BLOOD POTASSIUM 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
BLOOD POTASSIUM 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
BLOOD POTASSIUM 60-64 Life Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of
402 MODERNA 958913-1
Vaccine Event
BLOOD POTASSIUM 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
NORMAL years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
BLOOD POTASSIUM 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
NORMAL years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
BLOOD PRESSURE 65+ his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and
ABNORMAL years found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was ""abnormal"" how he
This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight
loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination
campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm, she was noted on vital sign checks (done every 4 hours for
first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am,
BLOOD PRESSURE 65+
406 MODERNA Death 949630-1 pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5
DECREASED years
mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had
persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort
measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen, became
hypotensive, and died peacefully on 1/8/2021 at 7:45 pm.
BLOOD PRESSURE 65+
407 PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
DECREASED years
she was dying as her blood pressure dropped to 70/40 and to come for a last visit; This is a spontaneous report from a
contactable consumer. A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. Medical history included COVID in
Dec2020, urinary tract infection (UTI), dehydration and Covid sickness (vomiting) (was treated earlier in month for UTI and
dehydration from the Covid sickness (vomiting)). Known allergies: no. The patient's concomitant medications were not reported.
After testing positive in mid December to COVID and being declared Covid free on 30Dec by the nursing staff and in good health,
with normal vitals and oxygen levels, the patient was given a vaccination on 02Jan2021. In the early evening the patient's blood
pressure dropped to 70/40 and the reporter was told to come for a last visit. The patient was sleeping comfortably. She did not
BLOOD PRESSURE 65+ Life wake up when spoke with her. No one expected her to make it through the night. The next morning she work up, ate breakfast,
DECREASED years Threatening watched TV, got IVs and oxygen and her vitals improved significantly. Lab tests and procedures included blood pressure: 70/40
on 02Jan2021, oxygen levels: normal, COVID test: positive in Dec2020 (testing positive in mid December to COVID and being
declare Covid free on 30Dec), vitals: normal; improved significantly. Facility where the most recent COVID-19 vaccine was
administered: Nursing Home/Senior Living Facility. If the patient received any other vaccines within 4 weeks prior to the COVID
vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been
tested for COVID-19: No. AE resulted in: Life threatening illness (immediate risk of death from the event). Serious: Yes.
Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged
hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Information about lot/batch number has been requested.
At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I was admitted to ICU at the
BLOOD PRESSURE 65+ Life
409 PFIZER\BIONTECH 956578-1 Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was
caused by the vaccine.
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER.
BLOOD PRESSURE 50-59 Life
410 PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
DIASTOLIC INCREASED years Threatening
and feeling very unwell.
BLOOD PRESSURE 65+
411 PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
IMMEASURABLE years
The vaccine was received at 1:12 PM, and I felt fairly fine, aside from injection site pain and some tingling in my left arm until I
had sudden significant elevation of heart rate, with shortness of breath, and throat swelling/tightening at approximately 1:26PM.
I cold compress was applied to my forehead and I was put in a reclining position & then received Epinephrine at 1:28PM. EMS
(present onsite) arrived for transport at 1:31PM. 4L of oxygen was applied after O2 sat of 89% noted by EMS. Blood pressure
BLOOD PRESSURE 30-39 Life was elevated to >200/100 initially by EMS. Symptoms improved quickly following epinephrine, with some residual feelings of
412 MODERNA 916859-1
INCREASED years Threatening very mild throat fullness, and I developed chills which improved over time. I was transported to emergency department where I
was evaluated (symptoms mostly resolved at that time, but ED physician noted a little swelling remaining in my uvula), then IV
Benadryl and Decadron were given. Later acetaminophen was also given for headache that developed during my ED stay. My
vitals were monitored throughout and observation occurred until I was discharged at approximately 5:00PM, as symptoms had
not recurred.
"Patient called this nurse stating she had an allergic reaction to COVID vaccination given on Friday 1/15/21. States she felt fine
for the 15 minutes post immunization, was on her way home and started feeling dizzy, short of breath, chest heavy, throat felt full
""like a ball in it"". She came back to clinic which was closed but sat in the parking lot for a while. While in parking lot trying to
figure out what to do, her symptoms lessened. She got home safely but started to feel jittery/shaky and her BP was very high
(couldnt remember exact number). She then went to urgent care where they told her she was having an allergic reaction and
given a pill of something and steroid for 6 days. Went home from urgent care and BP still high but got better at bedtime.
BLOOD PRESSURE 30-39 Life Saturday she had a ""really bad headache and just layed around all day. I was not able to function at all."" Sunday she still had a
413 MODERNA 956527-1
INCREASED years Threatening headache and added muscle aches. Monday she started feeling ""a lot better"" until 8 PM when she was walking around doing
her nightly routine and started to feel a wave of dizziness, throat felt funny so she sat down and took her BP with result of
207/131. Says this reaction felt worse than Friday's reaction so she went to ER where she was again told she was having an
allergic reaction and the steroid given to her at Urgent Care was not helping and to stop taking them. Given Benadryl in the
waiting room, had labs and EKG which came back ""normal"", and given a different med Vistaril to take with any future
symptoms. Was also told to NOT take the second dose of COVID vaccination. Says she has not had to take the Vistaril yet and
has not had any sign of reaction today so far. Said she did report the initial headache on the V-safe app."
Patient presented to receive COVID-19 vaccine, received vaccine at approximately 10 am. Patient waited 15 minutes for
observation and left observation area without complaining of any sx. Patient returned a few minutes after reporting tongue
414 MODERNA 922279-1 tingling which eventually got to her lips. . No difficulty breathing or any other sx. No history of allergies. NP/RN administered PO
Benadryl 25 mg. As of report of this iReport no additional symptoms or intervention needed. Last vitals: 131/83 75spo2. BP
higher than usual per patient, sp02 normal.
Dizziness, Headache, Myalgia, Tachypnea, CoughWheeze, NauseaVomiting, Palpitations & Tachycardia & Narrative: Patient
stated that after receiving injection on 01/06/2021, tasted metal in her mouth. No reaction noted in clinic after vaccine
administered. Patient states that after returning home, she began to have chills, headache, and muscle aches. Could not sleep.
On 01/07/2021. Patient continued to experience above symptoms. Approx. 13:50 on 01/07/2021. Patient presented with
415 MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
tachycardic. Epi-pen administered via left lateral thigh. Patient administered 50mg of PO Benadryl, and 2 puffs of albuterol
inhaler. Continuous V/S initiated. Patient began to experience relief of symptoms. HR and blood pressure remained elevated, but
this was expected side effect of epi. SpO2 stabilized around 99% on room air. Patient was monitored for 60 minutes.
Transportation home was arranged and family was present to observe overnight.
416 MODERNA 920787-1 obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered.
Reported sensation of tongue swelling during post-vaccination observation at 10 minutes. Epinephrine was refused and she was
BLOOD PRESSURE 65+ Life
417 MODERNA 909061-1 taken to ED for observation where she was given oral dose of Benadryl and Pepcid. Discharged with instructions to return PRN
and follow up with PCP. Elevated BP noted.
On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance
with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid
BLOOD PRESSURE 65+ Life on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was
418 MODERNA 944219-1
INCREASED years Threatening elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort
cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved
within the last 48 hours. He remains total assist with all cares.
BLOOD PRESSURE 65+ Life Throbbing head ache, difficulty breathing, lips numbness, chest discomfort, upper back, lower legs, fingers tingling/numbness,
419 MODERNA 949967-1
INCREASED years Threatening high blood pressure 148/83, underarm sweating, feels weak
BLOOD PRESSURE 30-39 Life COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker
INCREASED years Threatening route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice
Vaccine Event
421 PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
BLOOD PRESSURE 40-49 Life swollen and itchy, lips tingling, wheezing, blood pressure elevated, pulse thready given 25 mg PO Benadryl, taken to the
INCREASED years Threatening Emergency Room, symptoms persisted, stomach hurt became nauseated, received IV solumedrol, Pepcid, IV fluids, nebulized
BLOOD PRESSURE 40-49 Life prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home
INCREASED years Threatening but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen
BLOOD PRESSURE 50-59 Life vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was
INCREASED years Threatening decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient
BLOOD PRESSURE 65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
INCREASED years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
427 PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
SYSTOLIC INCREASED years Threatening
The patient was seen in my office on 1/19/21 with complaint of heavy vaginal bleeding. A CBC was obtained which revealed an
H/H of 12.2/36.1 and a platelet count of 1 (not 1K, but 1 platelet!) and this was confirmed on smear review. She was
BLOOD SMEAR TEST 40-49 Life
428 MODERNA 958885-1 immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and
she has received platelet transfusions but her platelet count is still critically low. She is also receiving steroids and
immunoglobulin and is under the care of MD (Heme/Onc)
BLOOD SODIUM 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
BLOOD SODIUM 65+ Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital
DECREASED years and treated for worsening AKI and hypotension.
BLOOD SODIUM 60-64 Life
BLOOD SODIUM 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
433 BLOOD SODIUM INCREASED MODERNA Death 958228-1
30-39 Life
434 BLOOD SODIUM NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
435 BLOOD SODIUM NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
436 BLOOD SODIUM NORMAL MODERNA 958913-1
437 BLOOD SODIUM NORMAL PFIZER\BIONTECH 903123-1
438 BLOOD SODIUM NORMAL PFIZER\BIONTECH Death 959179-1
Guillain Barre syndrome/AIDP event. Paresthesia and nerve pain developed in bilateral legs 4 hours after shot and progressed
30-39 Life slowly for 4 days in intensity and area involved. Symptoms progressed distally to superior. On the 5th day symptoms progressed
439 BLOOD TEST MODERNA 926703-1
years Threatening rapidly and involved bilateral legs up to the groin, left arm up to lateral shoulder, and right hand. I went to the hospital and was
admitted to start IVIG treatment for Guillain Barre Syndrome/AIDP.
Vaccine Event
to local er.
12 hours after vaccination began experiencing fever, chills, body aches, slight head ache - lasted around 12 hours Had slight pain
30-39 Life
442 BLOOD TEST MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
spots on brain, thought patient had shingles On 01/10/2021 shingles rash appeared
40-49 Life
443 BLOOD TEST MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
years Threatening
Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf,
40-49 Life
444 BLOOD TEST MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
40-49 Life
445 BLOOD TEST MODERNA 958509-1 Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
years Threatening
50-59 Life
446 BLOOD TEST MODERNA 948471-1 5-6 HOURS AFTER VACCINATION. CONVULSIONS/SEIZURE, HIGH BLOOD PRESSURE, INCREASED HEART RATE,
years Threatening
65+
447 BLOOD TEST MODERNA Death 934539-1 approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January
years
9, 2021
18-29 Life
448 BLOOD TEST PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
30-39 Life
449 BLOOD TEST PFIZER\BIONTECH 950387-1 Swollen tongue and sob with decreased swallow
years Threatening
40-49 Life
450 BLOOD TEST PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
50-59 Life
451 BLOOD TEST PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
452 BLOOD TEST PFIZER\BIONTECH Unknown Death 944155-1
BLOOD THYROID numbness, starting at the injection site traveling down the ulnar aspect of her arm, and nausea. Over the next several hours she
30-39 Life
453 STIMULATING HORMONE MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
BLOOD THYROID Day 1-3 after the dose flu like symptoms Day 3-7 swelling in lymph nodes on left side of body (baseball sized) took ibuprofen and
30-39 Life
454 STIMULATING HORMONE MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
NORMAL rash all over body and face still going on Day 16- present: severe joint pain and fever, unable to obtain any relief
65+
455 BLOOD UREA INCREASED MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
456 BLOOD UREA INCREASED MODERNA Death 958228-1
457 BLOOD UREA INCREASED MODERNA Death 959591-1
458 BLOOD UREA INCREASED PFIZER\BIONTECH Death 959179-1
BLOOD UREA numbness, starting at the injection site traveling down the ulnar aspect of her arm, and nausea. Over the next several hours she
30-39 Life
459 NITROGEN/CREATININE MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
RATIO took PO Benadryl 25mg; however, her symptoms were not alleviated. She was subsequently evaluated in the ED. á Received PO
Racepinephrine x 1.
BLOOD UREA
460 NITROGEN/CREATININE PFIZER\BIONTECH 903123-1
RATIO
BLOOD UREA
461 NITROGEN/CREATININE PFIZER\BIONTECH Death 950441-1
RATIO
30-39 Life
462 BLOOD UREA NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
463 BLOOD UREA NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
464 BLOOD UREA NORMAL MODERNA 958913-1
465 BLOOD UREA NORMAL MODERNA Death 952881-1
Vaccine Event
466 BLOOD UREA NORMAL PFIZER\BIONTECH 903123-1
467 BLOOD UREA NORMAL PFIZER\BIONTECH Death 950441-1
BODY TEMPERATURE 50-59 Life EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED
DECREASED years Threatening 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED
ACHES, SORE THROAT.
8 hours after vaccine severe injection site pain/swelling, severe body aches, 101.0 temp. 16 hours after vaccine woke up from
sleeping with flushed skin, facial swelling, and throat swelling. I immediately took 100mg of Benadryl and went to hospital
BODY TEMPERATURE 40-49 Life emergency room. Approximately 30-40 minutes later symptoms started to lessen. Once at the ER, at the same time symptoms
469 MODERNA 954154-1
INCREASED years Threatening began to resolve, I was given PO Solumedrol and Pepcid. I was monitored and then discharged with RX for prednisone, and
EPIPEN (to use if needed). No other issues with allergic reaction. Mild injection site soreness, mild body aches, 99.3 temp persist
at 36 hours post injection.
"On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating ""I don't care."" repeatedly. C/O head and neck pain.
BODY TEMPERATURE 60-64 T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening.
INCREASED years Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T
99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21."
BODY TEMPERATURE 60-64 Life Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of
471 MODERNA 958913-1
INCREASED years Threatening 105.2F
BODY TEMPERATURE 65+
INCREASED years
BODY TEMPERATURE 65+ hypoxia, secretions,cough, dyspnea Narrative: ALS patient on hospice with ongoing history of aspiration pna, receiving tube
INCREASED years feeds. Developed incr in secretions, hypoxeia, temp and with recently noted clogged feeding tube.
BODY TEMPERATURE 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
INCREASED years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
encephalopathy."
BODY TEMPERATURE 65+
475 PFIZER\BIONTECH Death 921175-1 Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4,
INCREASED years
BODY TEMPERATURE 65+ Life
476 PFIZER\BIONTECH 919620-1 Decompensation and temp 103.6.
BODY TEMPERATURE 65+ Life Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in
INCREASED years Threatening the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%.
BORDETELLA TEST 65+
NEGATIVE years
65+ breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse
479 BRADYCARDIA MODERNA Death 927260-1
years was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple
65+
480 BRADYCARDIA PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
"Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 was called and taken to the
hospital. While in the ambulance, patient coded. Patient was given CPR and ""brought back"". Once at the hospital, patient was
50-59 placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine
481 BRAIN DEATH PFIZER\BIONTECH Death 933739-1
years that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the
ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021. The initial indication from the ICU doctor was the patient had
a mucus plug that she couldn't clear."
Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended
care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site
50-59
482 BRAIN DEATH PFIZER\BIONTECH Death 944595-1 and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the
years
2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life
support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later
65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
483 BRAIN HERNIATION PFIZER\BIONTECH 930894-1
years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
BRAIN NATRIURETIC 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
PEPTIDE INCREASED years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
Pt had vaccination at city site. Waitied 15 min after shot and was cleared to go. Reported to wife that he was very thristy, so they
BRAIN NATRIURETIC 65+ Life stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose
485 MODERNA 917784-1
PEPTIDE NORMAL years Threatening Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and
defib, he had ROSC. Was taken to cath lab for intervention (stents) and is now in ICU.
50-59 Life
486 BRAIN OEDEMA PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
Vaccine Event
BREATH SOUNDS 50-59 Life currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am
487 MODERNA 926787-1
ABNORMAL years Threatening was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident.
were made.
BREATH SOUNDS 65+ 3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on
ABNORMAL years Hospice care ) expired 6:22 am 1-8-21
BREATH SOUNDS 65+
ABNORMAL years
BREATH SOUNDS 65+
490 PFIZER\BIONTECH Death 953865-1 REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS
ABNORMAL years
BRONCHIAL SECRETION 50-59 placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine
RETENTION years that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the
40-49 Life
492 BRONCHOSPASM MODERNA 907075-1 Patient experienced bronchospasm with coughing and tongue itching approximately 10 minutes after the injection.
years Threatening
On Dec. 20, 2020 around 11:30 PM, 2 days after patient received her COVID-19 vaccination, she was found on the bathroom floor
, obtunded, very pale, diaphoretic, nauseous, and complaining of severe chest pain. Paramedics was called and patient was
transported to the nearest emergency room. According to paramedics, on the way to the ER while patient was in the
ambulance,she was noted with a sudden drop in heart rate about 19 beats/minute and have to be given Atropine IV Push, oxygen
and was connected to transcutaneous pacing which improves her heart rate. In the ER patient continued to have chest pain and
BUNDLE BRANCH BLOCK 50-59 Life
493 PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
RIGHT years Threatening
Bundle Branch Block. She had serial ekgs, a chest x-ray, laboratory testing which included Troponin. Her first Troponin level came
back elevated prompting her hospital admission to Telemetry. Her next 2 Troponin level improved and return to normal range and
her chest pain has resolved.. She underwent a Stress Test which came back negative. Patient was admitted for a total of 20
hours in the Telemetry unit with Cardiology consultation before being discharged home last . She was re-evaluated by the
cardiologist yesterday which diagnosed her a chest pain of unknown origin.
On 1/9/2021 observed with elevated respirations of 38-42 per minute, BP manually 72/50. pulse is jumping rapidly between 110-
16 bpm. oxygen sat 76% RA, resident refusing oxygen at first attempt, allowed oxygen to be placed, is now 84% on 4L. resident
BUNDLE BRANCH BLOCK 65+
494 PFIZER\BIONTECH Death 959079-1 shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified, branch block. Received order for
RIGHT years
morphine 2mg per hr as needed for elevated respirations and pain. Dr. also gave orders to D/C Tamsulosin and finasteride.
Resident continue with decreased O2 sats and elevated respirations. Absence of vital signs on 1/10/21 at 826PM.
18-29 Life
495 BURNING SENSATION PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
15 min after receiving Covid 19 vaccine patient started to feel like her heart was racing / felt faint. Burning feeling in upper thigh
40-49 Life and pelvic area. BP 180/100 HR 130. Rapid Response called / transported to ER. Admitted for 24 hr observation.. Solu -medrol,
496 BURNING SENSATION PFIZER\BIONTECH 908973-1
years Threatening Benadryl and Ativan given in ER. Released home the next day. 72 hrs later patient states she has numbness and tingling in hands
and feet. 12/24/2020 patient reports she is feeling better today / no symptoms noted.
40-49 Life
497 BURNING SENSATION PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
Patient started having myalgia, chills, nausea on the next day of the vaccination. on 2nd day (12/29) patient had chest pressure
which made her present to Hospital ED. She had troponin elevation to 1.14. Cardiac Catheterization was done which was
negative. On Trans Thoracic Echocardiogram, patient was found to have hypokinesis of the mid and distal segment with some
C-REACTIVE PROTEIN 65+ Life
498 MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
stress going on in her life or family. Till now extensive infectious as well as inflammatory work up is done to rule out any
secondary causes of cardiomyopathy which till date have remained negative. As a diagnosis of exclusion, her presentation
seems to be COVID-19 vaccine induced Takotsubo Cardiomyopathy
C-REACTIVE PROTEIN 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
INCREASED years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
C-REACTIVE PROTEIN 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
INCREASED years Threatening WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense
C-REACTIVE PROTEIN 50-59 Life Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute
INCREASED years Threatening pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).
C-REACTIVE PROTEIN 65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
Hypotension/ hypotensive; Hypoxia/ hypoxic; Tachypnoea/ tachypnoeic; Unresponsive to stimuli/ unresponsive; Death;
Somnolence/ Drowsy; Hypoglycaemia/ hypoglycaemic; Hypothermia/ hypothermic; Hypophagia/ reduced oral intake; Fall;
Confusional state/ confused; Headache; Chills; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen
saturation decreased/ low saturations; feel unwell; This is a spontaneous report from a contactable physician downloaded from
the Regulatory Agency, manufacturer report number GB-MHRA-ADR 24566650. A 95-year-old female patient received BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at single dose for COVID-19
immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, moderate aortic
stenosis from an unknown date and unknown if ongoing, pulmonary hypertension from an unknown date and unknown if
ongoing, possible papillary fibroelastoma from Jun2019 and unknown if ongoing, non-specifically lethargic from Dec2020 and
unknown if ongoing. The patient had been non-specifically lethargic for 1-2 weeks in early Dec2020. The patient's concomitant
medications were not reported. In the 24-48 hours following vaccine, developed headache and chills. Daughter thought it was all
post-vaccination inflammatory response and that it would settle. Continued to feel unwell, reduced oral intake, 2x falls and
became confused on 25Dec2020. The patient was admitted on 26Dec2020, hypothermic. Consultant review 27Dec2020 and no
diagnosis documented. Leg ulcers and bilateral leg oedema noted, supplemental oxygen commenced due to low saturations in
C-REACTIVE PROTEIN
503 PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
INCREASED
29Dec2020, given intravenous treatment and blood sugars improved. National Early Warning Score (NEWS) of 14 (hypotensive,
hypoxic, tachypnoeic, unresponsive) on 29Dec2020 and Medical Emergency Team (MET) call put out at 06:50. By the time MET
team arrived the patient had died. The patient experienced headache on Dec2020 , chills on Dec2020, hypophagia on
25Dec2020, fall on 25Dec2020, confusional state on 25Dec2020 , hypothermia on 26Dec2020, skin ulcer on Dec2020, oedema
peripheral on Dec2020, oxygen saturation decreased on Dec2020, somnolence on 28Dec2020, hypoglycaemia on 28Dec2020,
hypotension on 29Dec2020, hypoxia on 29Dec2020, tachypnoea on 29Dec2020, unresponsive to stimuli on 29Dec2020, death on
29Dec2020 , feel unwell on 25Dec2020. All the events except feel unwell were reported as serious as hospitalization and death.
The patient underwent lab tests and procedures which included computerised tomogram head: no bleed, C-reactive protein: 37,
echocardiogram: possible papillary fibroelastoma- not investigated in Jun2019, white blood cell count: normal. The patient died
on 29Dec2020. An autopsy was not performed. The outcome of the event feel unwell was unknown, while other remain events
was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of
Death: Headache; Chills; Fall; Hypophagia/ reduced oral intake; Confusional state/ confused; Skin ulcer/ Leg ulcers; Oedema
peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; Somnolence/ Drowsy; Death; Hypoglycaemia/
hypoglycaem
Vaccine Event
C-REACTIVE PROTEIN
504 PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
NORMAL
CARBON DIOXIDE 30-39 Life
Racepinephrine x 1.
Severe headaches, vomiting, dehydration, shortness of breath ... led to trip to Emergency Room at Hospital on 1/16/21 at 10:45
507 MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
electrolyte imbalances , headaches, body aches, dehydration, nausea, shortness of breath. DKA is medical emergency.
CARBON DIOXIDE 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
DECREASED years reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138
CARBON DIOXIDE 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
INCREASED years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
510 CARBON DIOXIDE NORMAL MODERNA 958913-1
511 CARBON DIOXIDE NORMAL PFIZER\BIONTECH Death 950441-1
Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband, patient did not complain of
40-49
512 CARDIAC ARREST MODERNA Death 950057-1 any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of
years
uncertain etiology
65+
513 CARDIAC ARREST MODERNA Death 918487-1 Two days post vaccine patient went into cardiac arrest and passed away.
years
514 CARDIAC ARREST MODERNA Death 927260-1
65+
515 CARDIAC ARREST MODERNA Death 940866-1 pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on
years
65+
516 CARDIAC ARREST MODERNA Death 953129-1 stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went
years
The patient had severe shortness of breath resulting in cardiac arrest on the 5th day after the vaccine. Shortness of breath
65+
517 CARDIAC ARREST MODERNA Death 956994-1 started 12 hours after injection. On the 5th day, the patient was discovered to also have a rash throughout his body, but it is
years
unknown when this rash started.
518 CARDIAC ARREST MODERNA Death 957799-1
years resuscitated
65+
519 CARDIAC ARREST MODERNA Death 963167-1 Narrative: Symptoms: & Cardiac Arrest; Death Treatment: EPINEPHRINE
years
65+ Life stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose
520 CARDIAC ARREST MODERNA 917784-1
years Threatening Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and
On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Full ACLS
18-29
521 CARDIAC ARREST PFIZER\BIONTECH Death 943397-1 was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was
years
intubated. Patient continued into V. Fib arrest and was shocked multiple times.
Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids,
18-29
522 CARDIAC ARREST PFIZER\BIONTECH Death 960841-1 cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours.
years
Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper.
About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after
50-59
523 CARDIAC ARREST PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when
medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
524 CARDIAC ARREST PFIZER\BIONTECH Death 942106-1
50-59
525 CARDIAC ARREST PFIZER\BIONTECH Death 944595-1 and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the
years
60-64 coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression
years of lung cancer
60-64 The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on
years 12/30/20. He had known cardiac disease.
Resident received vaccine per pharmacy at the facility at 5 pm. Approximately 6:45 resident found unresponsive and EMS
65+
528 CARDIAC ARREST PFIZER\BIONTECH Death 915682-1 contacted. Upon EMS arrival at facility, resident went into cardiac arrest, code initiated by EMS and transported to hospital.
years
Resident expired at hospital at approximately 8 pm
65+ vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated,
years cardiac arrest, died 01/07/21.
Vaccine Event
65+ Three hours after receiving COVID 19 vaccination, Patient oxygen level decreased to a critical level and went into cardiac arrest.
years Staff performed full code but was unable to bring back patient from cardiac arrest.
65+
532 CARDIAC ARREST PFIZER\BIONTECH Death 944365-1 Resident expired on 12/30/20, dx cardiac arrest.
years
This is a 94-year-old male who is brought in by ambulance after being found on the floor with unknown downtime. He was in
asystole upon EMS arrival. He remains in asystole. No advanced airway is in place. The patient is getting compressions from
Lucas device upon arrival. It was reported that he was last talked to by family at 2 PM. The patient got his SARS-CoV-2
65+
536 CARDIAC ARREST PFIZER\BIONTECH Death 961434-1 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient
years
remains in asystole. He has rigor mortis. The patient's pupils are fixed and dilated. The patient has compressions paused and
ultrasound is used to evaluate for cardiac activity. None is detected. The patient has no electrical activity on monitor. The
patient's time of death is 2113.
65+
537 CARDIAC ARREST PFIZER\BIONTECH Death 961741-1 Theápatientáreceivedáhisávaccineáináthe.ámorningáofá1/20/2021,áwhileágettingáintoácarátoágoáseeáhisápulmonologist,áaboutá2áhoursáafter,áco
years
65+ Life Rushed to ER. Has now been tubed and put into the ICU and has had full-cardiac arrest less than 24 hours after receiving the
538 CARDIAC ARREST PFIZER\BIONTECH 912574-1
years Threatening vaccine.
Asystole; Circulatory collapse; This is a spontaneous report from a contactable pharmacist received from Agency and
downloaded from the Regulatory Authority-WEB GB-MHRA-WEBCOVID-20201214111558, Safety Report Unique Identifier GB-
MHRA-ADR 24542972 and EU-EC-10007191566 received via Regulatory Authority. An adult female patient received bnt162b2
(batch/lot number not provided), via an unspecified route of administration on 13Dec2020 at single dose for COVID-19
539 CARDIAC ARREST PFIZER\BIONTECH Unknown Death 908245-1 vaccination. The patient's medical history was not reported. Concomitant medication included sildenafil, acetylsalicylic acid,
allopurinol, levothyroxine, spironolactone, amiloride hydrochloride, furosemide and desogestrel. The patient experienced asystole
on 13Dec2020, circulatory collapse on 13Dec2020. The patient died due to asystole and circulatory collapse on 13Dec2020. It
was not reported if an autopsy was performed. No follow-up attempts are possible. Information about batch number is not
obtainable. No further information is expected.; Reported Cause(s) of Death: circulatory collapse; Asystole
cardiac arrest; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162B2
(PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 as single dose for
covid-19 immunization. Medical history included asthma and a little overweight from an unknown date. The patient's
concomitant medications were not reported. The patient experienced cardiac arrest on an unspecified date, which was serious
as it lead to death. The patient died on an unspecified date. It was not reported if an autopsy was performed. This batch/lot
540 CARDIAC ARREST PFIZER\BIONTECH Unknown Death 925616-1 number is not available despite the follow-up attempts made. No further information is expected.; Sender's Comments: The
reported information is limited and does not allow a meaningful assessment of the case. It will be reassessed upon receipt of
follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern
identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities,
Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac arrest
Cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory
authority report number GB-MHRA-WEBCOVID-20210105171610, Safety Report Unique Identifier GB-MHRA-ADR 24558665. A
male patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of
administration on 23Dec2020, at single dose for covid-19 vaccination. Medical history included ongoing dementia, and cardiac
pacemaker insertion on an unknown date. Patient has not had symptoms associated with COVID-19. Unsure if patient was
541 CARDIAC ARREST PFIZER\BIONTECH Unknown Death 944121-1 enrolled in clinical trial. The patient's concomitant medications were not reported. The patient experienced cardiac arrest on
31Dec2020. Had spontaneous cardiac arrest 9 days (to be clarified) after vaccination doubtful implicated but new vaccine of
course. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures
which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The patient died of cardiac arrest on
31Dec2020. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained.;
Reported Cause(s) of Death: Cardiac arrest
This is a spontaneous report from a contactable consumer. This consumer reported different fatal events for four patients. This
is the second of four reports. An 82-year-old female patient in a nursing home received the first dose of BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE lot number: EK4238) via an unspecified route of administration on 04-Jan-2021 at a single dose
for COVID-19 immunisation. Medical history included background of asthma, dementia, depression, gastrointestinal and heart
failure. Concomitant medications were not reported. 4 Hours after the receipt of the vaccine, she was found in her room on the
542 CARDIAC ARREST PFIZER\BIONTECH Unknown Death 944154-1 floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR,
asystole without heart sounds, CPR continued for 23 minutes without any change and death was declared. The events occurred
in Jan 2021. The date of death was in Jan 2021. The outcome of events was fatal. It was unknown if an autopsy was performed.
Sender's Comments: Linked Report(s): IL-PFIZER INC-2021019507 Same reporter, same product, different patient/events;
Reported Cause(s) of Death: was found in her room on the floor with a bruise on her forehead apparently from a fall; was found
in her room on the floor with a bruise on her forehead apparently from a fall.
COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to
UNKNOWN 65+
543 CARDIAC ARREST Death 956962-1 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have
MANUFACTURER years
been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020
cardiac arrest; heart failure; did not feel well, lost consciousness and died; did not feel well, lost consciousness and died; This is
a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19
VACCINE), via an unspecified route of administration on 28Dec2020 08:30 at single dose for covid-19 immunisation. Medical
history included suffered from the past from heart attacks, active heart disease, malignant disease. The patient's concomitant
medications were not reported. A man of 75 years old, who suffers from many different background diseases, died (this morning
28Dec2020) from cardiac arrest, two hours after he received the injection. The man received the injection at 8.30am, and after he
544 CARDIAC DEATH PFIZER\BIONTECH Unknown Death 918721-1
was feeling okay he was released to go home. After a while when he was home he did not feel well, lost consciousness and died,
and he was pronounced dead from heart failure. The patient died on 28Dec2020. It was not reported if an autopsy was
performed. The outcome of the event cardiac arrest and heart failure was fatal while the outcome of the other events was
unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments:
Linked Report(s) : IL-PFIZER INC-2020517177 same reporter, same vaccine, reporting similar events in different patients.;
Reported Cause(s) of Death: heart failure; cardiac arrest
died the day after receiving the first injection of vaccine against Covid-19 in suspected cardiac arrest; This is a spontaneous
report from a web page with a contactable physician as publisher. A multi-sick, elderly patient of an unspecified gender received
the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an
unspecified date at single dose for covid vaccination. The patient medical history was not reported. The patient's concomitant
medications were not reported. The patient died the day after vaccination of a suspected heart stop. The patient died the day
after receiving the first injection of vaccine against covid-19. The patient died on an unspecified date. It was not reported if an
autopsy was performed. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Sender's
545 CARDIAC DEATH PFIZER\BIONTECH Unknown Death 918727-1
Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the
case. In particular the following relevant information is not available: complete medical history and complete demographics,
treatment dates and dose, concomitant medications (if any), event descriptors, autopsy report. The impact of this report on the
action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.;
Reported Cause(s) of Death: suspected heart stop
65+
546 CARDIAC DISORDER MODERNA Death 933846-1 better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death
years
certificate."
547 CARDIAC DISORDER PFIZER\BIONTECH Death 932898-1
548 CARDIAC DISORDER PFIZER\BIONTECH Unknown Death 930431-1 Cardiac event, 2 days after vaccination, patient expired.
Vaccine Event
65+ Life
549 CARDIAC FAILURE PFIZER\BIONTECH 919620-1 Decompensation and temp 103.6.
years Threatening
"heart failure; Death; feeling sick; changes with speech and mobility; changes with speech and mobility; This is a spontaneous
report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-
WEBCOVID-20210111094207, Safety Report Unique Identifier: GB-MHRA-ADR 24577774. A 97-year-old female patient received
the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration
on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not
reported. On 10Jan2021, the patient experienced feeling sick (medically significant), changes with speech and mobility (speech
disorder) (medically significant). On 11Jan2021, the patient experienced death (death, medically significant). On an unspecified
date, the patient experienced heart failure (death, medically significant). The clinical course was reported as follows: ""The
resident had got heart failure."" The patient was feeling sick on 10Jan2021 and was concerned as there were changes with
550 CARDIAC FAILURE PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
low. The ambulance crew called for an out of hours general practitioner (GP) to come and see the patient. The out of hours
general practitioner (GP) visited on 10Jan2021 and advised ""she maybe poorly due to having the Covid-19 vaccine"" that was
administered on the 08Jan2021. The resident passed away at 07:20 on morning 11Jan2021. The patient had not tested positive
for COVID-19 since having the vaccine. The patient had not had symptoms associated with COVID-19. The patient was not
enrolled in a clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative
COVID-19 test on an unspecified date, oxygen saturation (sats): low on 10Jan2021, blood pressure: low on 10Jan2021. The
clinical outcome of the event, death and heart failure, was fatal. The clinical outcome of the event, feeling sick and changes with
speech and mobility, was unknown. The patient died on 11Jan2021 due to heart failure. It was unknown if an autopsy was
performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: heart failure"
Patient did not have any adverse reaction to the COVID vaccine, but we were asked by our health dept to submit a VAERS report
CARDIAC FAILURE 65+ since the patient died between his first and second dose. Received Pfizer Dose #1 12/17/2020. No side effects or adverse
CHRONIC years events noted; lived in 24/7 care facility and monitored twice daily for reaction. Date of death 12/23/2020 from aspiration
pneumonia complicated by end-stage heart failure and ischemic cardiomyopathy. Death was anticipated and not sudden.
CARDIAC FAILURE 65+ Life
552 MODERNA 930611-1 Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP
CONGESTIVE years Threatening
We do not believe that the patient's death was an adverse event from the vaccine. Patient received COVID vaccine from Pfizer
Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7
CARDIAC FAILURE 65+
553 PFIZER\BIONTECH Death 962714-1 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart
CONGESTIVE years
failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden. We were told to report
his death to VAERS even though his death was anticipated and not related to his vaccination.
27-year-old female with past medical history of anxiety, allergic to shellfish, presented for COVID-19 vaccination, developed
18-29 Life shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received
554 CARDIAC FUNCTION TEST MODERNA 956504-1
years Threatening epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. Vitals in the ER Revealed
tachycardia HR 95-105 , Sat 96% on room air not in distress. Patient was admitted for further observation
Had no immediate issues with the vaccine. He had returned from the hospital on 12/21 and had some concerns about his
CARDIAC PACEMAKER 65+
555 PFIZER\BIONTECH Death 945603-1 weight which were shared with his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On
EVALUATION years
1/8/21 staff were called to his room, he was on the floor, bluish skin color. No vital signs found, no heart rhythm heard at 2200.
CARDIAC STRESS TEST 50-59 Life
CARDIAC TELEMETRY 30-39 Life PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath,
ABNORMAL years Threatening dizziness and blurry vision
CARDIAC 60-64 Life
VENTRICULOGRAM LEFT years Threatening
CARDIAC
18-29 Life Patient presented to ED with complaint of chest pain, radiating down left arm, not relieved with Tums. Symptoms started at 0530
559 VENTRICULOGRAM LEFT MODERNA 952782-1
years Threatening 1/12/2020. Patient presented to ED b/c of strong family history of CAD, with father having MI in his 50s.
NORMAL
CARDIO-RESPIRATORY 50-59
560 MODERNA Death 918518-1 syncopal episode - arrested - CPR - death
ARREST years
CARDIO-RESPIRATORY 65+
561 MODERNA Death 940866-1 pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on
ARREST years
Resident was noted unresponsive, no respiration, no blood pressure, no pulse, code blue called according to facility protocol,
562 MODERNA Death 956811-1 resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm
ARREST years
1/18/21
CARDIO-RESPIRATORY 50-59 placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine
ARREST years that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the
CARDIO-RESPIRATORY 50-59 Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD
ARREST years and EMS arrived, resident pronounced at 12:51am.
resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-
year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140),
intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type
two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food,
or other products: none. Concomitant medications included unspecified products (List of any other medications the patient
received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID
vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The
resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted
in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination,
565 PFIZER\BIONTECH Death 944282-1 was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes.
ARREST years
Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged
hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.;
Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all
these pre-existing medical conditions contribute to the patient death. More information including complete medical history,
concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of
the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for
Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired
CARDIO-RESPIRATORY 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
ARREST years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
60-64 Life Pt had 3 vessel CABG on 1/14/21 after presenting to ED with chest pain on 1/9/21. Pt is critically ill following OR after
567 CARDIOGENIC SHOCK PFIZER\BIONTECH 949724-1
years Threatening cardiogenic shock, bleeding. Requiring inotropes and Impella.
CARDIOLIPIN ANTIBODY 30-39 Life Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or
NEGATIVE years Threatening deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively
Acute cardio-respiratory event and died a few hours later; This is a spontaneous report received from a contactable physician by
Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210107093111. Safety
Report Unique Identifier GB-MHRA-ADR 24565959. An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE) at single dose, on 04Jan2021, for COVID-19 immunisation. Patient was elderly and frail and gradually
declining in mobility, communication and memory over the last 12 months. Relevant medical history also included vascular
CARDIOPULMONARY dementia form an unspecified date and unknown if ongoing. Concomitant medications were unknown. Patient was not enrolled
569 PFIZER\BIONTECH Unknown Death 938038-1
FAILURE in clinical trial. COVID-19 virus test was performed twice on an unspecified date, in Dec2020 and on 18Dec2020 and the results
were negative. On 04Jan2021, at 06:00 PM, the patient experienced acute cardio-respiratory event and died a few hours later. It
was unknown if autopsy was done. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have
symptoms associated with COVID-19. The patient was kept comfortable in the nursing home in these last few hours. There was
no way to know whether the vaccine was to blame at all, it was unlikely. No follow-up attempts are possible, information about
lot number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory failure
CARDIOVASCULAR 40-49 Life
570 MODERNA 958509-1 Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
EVALUATION years Threatening
Vaccine Event
571 CARDIOVERSION MODERNA 917784-1
18-29
572 CARDIOVERSION PFIZER\BIONTECH Death 943397-1 was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was
years
40-49 Life Ventricular tachycardia. Defibrillator paced me out of rhythm. I have had my ICD for 3 years. This is the first abnormal rhythm I
573 CARDIOVERSION PFIZER\BIONTECH 904498-1
years Threatening have had where it delivered a therapy to abort it.
574 CARDIOVERSION PFIZER\BIONTECH 909635-1
COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe
adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to
the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor
911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45
50-59 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT
575 CARDIOVERSION PFIZER\BIONTECH Death 955532-1
years 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode
unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED
pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed
until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family
to call us back for funeral arrangements.
"Pt last seen at 1200 by nurse for ID band check. No visible signs of distress noted. Pt states ""I just want to be left alone"". 1230
65+
576 CARDIOVERSION PFIZER\BIONTECH Death 926269-1 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first
years
shock given. 1245 EMT took over, at 1319 EMT called time of death"
Patient was vaccinated in right arm. Within 5 to 10 seconds after vaccination, patient started clinching his hands tightly and
65+
577 CARDIOVERSION PFIZER\BIONTECH Death 955256-1 became unresponsive. Patient was lowered to the floor and did not exhibit a pulse. CPR was initiated and 911 was called. An
years
AED was used and healthcare professionals onsite continued compressions until the paramedics arrived.
I was having episodes of dyspnea and non productive cough starting from 1/1/2021. On 1/13/2021 I experienced severe
30-39 Life dyspnea and had loss of consciousness for 5 seconds and was found down. I was rushed to the hospital and diagnosed with
578 CATHETER PLACEMENT PFIZER\BIONTECH 959401-1
years Threatening multiple pulmonary embolus (about 9) which was treated with direct TPA via catheterization. I then recovered in the ICU and
transitioned to oral anticoagulation and discharged home on 1/15/2021.
CATHETERISATION 50-59 Life
CARDIAC years Threatening
"""Moderna COVID-19 Vaccine EUA"" It has been reported to me that pt. had gone into hospital for a heart catheterization on
CATHETERISATION 50-59
580 MODERNA Death 950108-1 1/12/2021. It was found during this procedure that pt. had suffered a MI. She was release to home the following day and passed
CARDIAC ABNORMAL years
away at her residence on 1/15/2021."
CATHETERISATION 65+ Life
CARDIAC ABNORMAL years Threatening
CATHETERISATION 18-29 Life Patient presented to ED with complaint of chest pain, radiating down left arm, not relieved with Tums. Symptoms started at 0530
585 MODERNA 952782-1
CARDIAC NORMAL years Threatening 1/12/2020. Patient presented to ED b/c of strong family history of CAD, with father having MI in his 50s.
CATHETERISATION 65+ Life
CARDIAC NORMAL years Threatening
"12/23/2020: 2 hr after injection, patient noted swollen lymph nodes, nausea, room spinning (motion sickness-like) sx. Stayed
18-29 Life
587 CELLULITIS MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
12/31/2020: area of welts doubled in size to entire upper left arm; throat starting to close up"
CENTRAL NERVOUS 40-49 Life
588 PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
SYSTEM LESION years Threatening
meds naproxen
CENTRAL VENOUS 18-29 Life
589 PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
CATHETERISATION years Threatening
CEREBELLAR 50-59
590 PFIZER\BIONTECH Death 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
HAEMORRHAGE years
CEREBELLAR 50-59 Life
591 PFIZER\BIONTECH 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
HAEMORRHAGE years Threatening
CEREBRAL ARTERY 65+ Life She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her
OCCLUSION years Threatening body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at
10:31am.
CEREBRAL ARTERY 60-64 Life fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an
STENOSIS years Threatening indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this
30-39 Life
594 CEREBRAL DISORDER MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
595 CEREBRAL HAEMORRHAGE MODERNA 947648-1
65+
596 CEREBRAL HAEMORRHAGE MODERNA Death 959568-1 Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by
years
Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and was intubated. Hole
65+
597 CEREBRAL HAEMORRHAGE PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
symptoms.
598 CEREBRAL HAEMORRHAGE PFIZER\BIONTECH Unknown Death 960437-1
Vaccine Event
60-64 Life fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an
599 CEREBRAL INFARCTION PFIZER\BIONTECH 942237-1
years Threatening indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this
600 CEREBRAL INFARCTION PFIZER\BIONTECH Death 951101-1
CEREBROVASCULAR 40-49 Life
601 MODERNA 931558-1 7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
ACCIDENT years Threatening
Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and
CEREBROVASCULAR 65+ upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard
ACCIDENT years to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to
use his left side. Resident passed away on 1/11/2020.
CEREBROVASCULAR 65+ Resident received Moderna vaccine on 12/23/2020 around 5 pm. At approximately 3:35 am on 12/25/2020, resident had a CVA
ACCIDENT years and died on 1/1/2021 at 3:00 am.
CEREBROVASCULAR 50-59
ACCIDENT years
CEREBROVASCULAR 60-64 Life fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an
ACCIDENT years Threatening indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this
Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided
CEREBROVASCULAR 65+
608 PFIZER\BIONTECH Death 945247-1 weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should
ACCIDENT years
report
CEREBROVASCULAR 65+ CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A
ACCIDENT years STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE
40-49 Life
610 CHEILITIS MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
years Threatening
611 CHEST DISCOMFORT MODERNA 913445-1
Employee received COVID 19 vaccination at 9:45am on 12/30/20. ~15 min. later she developed a rash down her left arm, then
18-29 Life
612 CHEST DISCOMFORT MODERNA 919252-1 down her Rt. arm. about 4 hours later she decided to go to the emergency room for Hearty Palpitations, Fever, Chest discomfort
years Threatening
and feeling of generalized sunburn. Later developed severe headache..
18-29 Life
613 CHEST DISCOMFORT MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
years Threatening
30-39 Life
614 CHEST DISCOMFORT MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
Developed dizziness and nausea within 90minutes of vaccine; then developed tingling, and flushing of my skin. Then rapid heart
rate and chest tightness by 2.5hrs post vaccine. I went to urgent Care and they thought it was an allergic reaction (BP 182/90,
30-39 Life HR 82) and gave me 125mg solumedrol and Benadryl intramuscularly which caused worsened dizziness and a racing heart
years Threatening which caused me to collapse and they gave me a epi pen and called 911. I was transferred to ER and they completed EKG which
was normal and monitored vitals for a few hours and I was released. I continue to remain extremely dizzy and nauseated 2days
after the vaccine.
30-39 Life Saturday she had a ""really bad headache and just layed around all day. I was not able to function at all."" Sunday she still had a
years Threatening headache and added muscle aches. Monday she started feeling ""a lot better"" until 8 PM when she was walking around doing
Patient received COVID-19 Vaccine at 0956 and reported symptoms of itchy face and chest pressure at approximately 1008
during observation period. Pt vital signs were 133/86, HR 130 and oxygen saturation 100% on room air. Pt reported worsening
40-49 Life symptoms of chest pressure and itchiness to face. Provider instructed Epi Pen be given and pt to be transported to ED for further
years Threatening evaluation. EKG obtained and showed sinus tachycardia. Nonrebreather oxygen mask applied with 2L/min and oxygen saturation
remained at 100%. Pt was transported via ambulance to at 1038 and pt reported feeling improved symptoms prior to leaving the
clinic at approximately 1034. Pt stable at time of transfer.
40-49 Life Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found
years Threatening to have a right lower lobe pulmonary embolism. Treated with Xarelto and sent home with outpatient follow up.
50-59 Life
620 CHEST DISCOMFORT MODERNA 929418-1 Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
years Threatening
60-64 Life
621 CHEST DISCOMFORT MODERNA 924078-1 pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse
years Threatening
65+ Life
622 CHEST DISCOMFORT MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
624 CHEST DISCOMFORT PFIZER\BIONTECH 903123-1
Vaccine Event
15 minutes after getting the vaccine began itching that quickly developed into rash/hives to face, neck, chest, abdomen. At 20
minutes post vaccine developed severe leg weakness with lightheadedness, chest tightness, and SOB. 22 minutes out collapsed
to the floor unable to bear weight due to leg weakness and had severe cramping and tingling in legs, still unable to move them.
Was rushed to the ER from employee health and arrived approximately 30 minutes post vaccine administration at that time there
was significant mottling to arms and hands with polar nail beds. Vital signs were stable, no strider. Given Solumedrol, Benadryl,
30-39 Life
625 CHEST DISCOMFORT PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
cyanotic nail beds and mottling to hands/ arms that would come and go. Rash/hives reappeared much worse 2 horse post meds
to face, neck, and upper chest. Was given another series of Solumedrol and Benadryl and admitted to the hospital. I am now 19
hours post vaccine with improved but persistent leg weakness, now able to bear my own weight independently and walk a few
steps, but still having legs cramps and intermittent tingling to feet. Color has improved with resolved mottling/cyanosis. I
continue to have hives reappear with scheduled Benadryl, Solumedrol, and Pepcid.
appropriate.
30-39 Life PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath,
years Threatening dizziness and blurry vision
30-39 Life
629 CHEST DISCOMFORT PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
40-49 Life
630 CHEST DISCOMFORT PFIZER\BIONTECH 908003-1 ANAPHLACTIC REACTION, SOB, CHEST PRESSURE, TIGHTNESS IN THROAT, TACHYCARDIA
years Threatening
40-49 Life
632 CHEST DISCOMFORT PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
10 MINUTES FOLLOWING VACCINE - SOB, COUGH, TIGHTNESS IN CHEST, THRAOT SWELLING, DIFFICULTY SWALLOWING,
LIGHT HEADEDNESS, AND ELEVATED HEART RATE. ORAL AND IM BENADRYL ADMINISTERED, 2 DOSE OF EPINEPHRINE, 2 NEB
TREATMENTS, O2 PLACED. 911 CALLED AND TRANSPORTED TO EMERGENCY FOR FURTHER TREATMENT AND MONITORING.
40-49 Life AT HOSPITAL IV STEROID ADMINISTERED. SYMPTOMS SUBSIDED WITH SECOND DOSE OF EPINEPHRINE, HOWEVER
years Threatening RETURNED 3 HOURS LATER AND ANOTHER DOSE OF BENADRYL ADMINISTERED. ELEVATED HEART RATE CONTINUED AND IV
FLUIDS ADMINISTERED TO ATTEMPT IN BRINGING DOWN HEART RATE. IV FLUIDS WERE NOT EFFECTIVE. HEART RATE (118-
120) REMAINED ELEVATED INTO THE OVERNIGHT HOURS AND SUBSIDED AROUND 1:30A ON 12/29/2020. CONTINUED
HEADACHE, NAUSEA ONSET, FATIGUE, DIFFICULTY SWALLOWING AND COUGH ON 12/29/2020.
40-49 Life
635 CHEST DISCOMFORT PFIZER\BIONTECH 942808-1 receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with
years Threatening
50-59 Life
636 CHEST DISCOMFORT PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
0900 IM Covid 19 vaccine 0905 Sore throat 0920 Dizzy episode followed by headache 0945 Stridor upon deep breath 1000
Facial tingling, top lip and eye swelling 1015 Present to Emergency Services 1040 IV benadryl - Tingling throughout body, stridor
50-59 Life worsening, , visible facial swelling 1045 IV Decadron - Throat swelling worsening, chest heaviness, wheezing 1050 IM
years Threatening Epinephrine 1055 Racemic Epi nebulizer treatment 1100 Facial and throat Swelling reducing, breathing easier, 1105 Breathing
back to normal 1430 Discharged from Emergency Services with prescription for Dexamethasone 4Mg for 3 days, 2 allegra 2x
daily, famotidine 2 x daily
60-64 Life
638 CHEST DISCOMFORT PFIZER\BIONTECH 950759-1 Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed
years Threatening
Vaccine Event
639 CHEST DISCOMFORT PFIZER\BIONTECH Death 953922-1
640 CHEST DISCOMFORT PFIZER\BIONTECH Death 954812-1
Life
641 CHEST DISCOMFORT PFIZER\BIONTECH Unknown 959417-1 minutes later developed symptoms of chest tightness shortness of breath wheezing. Arrived to ED at 1156 and discharged at
Threatening
Tactile fever ,arm pain, headache and malaise in 24 hrs following injection Next day generalized achiness ,retrosternal chest pain
18-29 Life
642 CHEST PAIN MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
EKG ,elevated troponin 3.5 Transferred to hospital troponin 12.1 ng/ml IVIG given SARS IGG positive on admission PCR negative
643 CHEST PAIN MODERNA 952782-1
50-59 Life
644 CHEST PAIN MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
65+
645 CHEST PAIN MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
years
65+
646 CHEST PAIN MODERNA Death 948181-1 Death Chest pain; irreg heart rhythm; evening of vaccine; death on toilet on 1/13/21
years
65+ Life
647 CHEST PAIN MODERNA 924201-1 back pain, presented to Med Center where he was found to have an Acute Coronary Syndrome. Transferred to Medical Center
years Threatening
Patient presented with myalgias, fevers, and chest pain on 1/10/21 and was found to have diffuse ST elevation and elevation
18-29 Life troponin. He was evaluated by cardiology and diagnosed with acute myopericarditis. He was treated with NSAIDs and colchicine.
648 CHEST PAIN PFIZER\BIONTECH 937932-1
years Threatening He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow
up.
40-49 Life
651 CHEST PAIN PFIZER\BIONTECH 909146-1 listed before
years Threatening
40-49 Life
653 CHEST PAIN PFIZER\BIONTECH 949611-1 Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed
years Threatening
Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and
40-49 Life
654 CHEST PAIN PFIZER\BIONTECH 959017-1 started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line
years Threatening
and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.
655 CHEST PAIN PFIZER\BIONTECH Death 942106-1
50-59 Life
656 CHEST PAIN PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
50-59 Life
657 CHEST PAIN PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
years Threatening
60-64
658 CHEST PAIN PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
60-64 Life
659 CHEST PAIN PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
60-64 Life
661 CHEST PAIN PFIZER\BIONTECH 950759-1 Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed
years Threatening
65+
662 CHEST PAIN PFIZER\BIONTECH Death 930466-1 Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination
years
Vaccine Event
"Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the first dose
of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: and Expiration Date: Unknown), via an unspecified
route of administration in the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization; administered in
doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. It was unknown if the
patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not
65+ diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, the patient
663 CHEST PAIN PFIZER\BIONTECH Death 940954-1
years experienced heart attack; which resulted in death and was assessed as medically significant. The patient also experienced the
associated symptoms of cold sweats, chest pain, shortness of breath. Therapeutic measures were taken as a result of heart
attack, which included ""life saving measures"" by the paramedics performed upon arrival with no success. The clinical outcome
of the event, heart attack, was fatal. The patient died on 05Jan2021 due to heart attack; as ruled by the paramedics. It was
unknown if an autopsy was performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE,
were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart attack"
HYPOTENSION; Supraventricular tachycardia (SVT); CHEST PAIN; DIZZINESS; NECK TIGHTNESS; ERYTHEMATOUS RASH;
LOCALISED ITCHING; This is a spontaneous report from a contactable pharmacist and from the Regulatory Agency. The
regulatory authority report number is GB-MHRA-WEBCOVID-20201209123237. A 54-year-old female patient with a medical
history of supraventricular tachycardia (SVT) who has been symptom free for one year with no treatment after four episodes
(date of diagnosis not provided) with no reported concomitant medications who received BNT162B2 (Reported as COVID-19
MRNA VACCINE BIONTECH; Lot number EJ0553) intramuscular on 09Dec2020 at 30 ug for COVID-19 vaccination. The patient
experienced hypotension and supraventricular tachycardia (SVT) on the day of vaccination , at 12:00, associated with chest pain,
dizziness, neck tightness, erythematous rash and localised itching. All the events were considered life-threatening. Clinical
course was as follows: On 09Dec2020,he patient was noted as fit and well, prior to the vaccination. The first dose of vaccine was
given at 10:37. At 12:00, the patient developed a sudden onset of SVT. The patient was visited by anaesthetist, monitored with a
crash trolley and given oxygen. The patient's heart rate was found variable at 180 to 230 beats per minute (BPM) and non-
Life responsive to vagal manoeuvres/carotid sinus massage. Chest pain, dizziness and hypotension was associated with a heart rate
664 CHEST PAIN PFIZER\BIONTECH Unknown 902856-1
Threatening greater than 200 BPM . Non-specific erythematous rash was visible on the neck with no evidence of angioedema, tongue
swelling, mouth swelling or bronchospasm. The patient started complaining of neck itchiness and tightness awaiting for the
ambulance. The patient was given chlorpheniramine, hydrocortisone and normal saline (1000 ml). Adrenaline and adenosin were
withheld. The patient was in SVT with intermittent chest pain when she entered the ambulance. The medicines administered in
the hospital hub setting were in line with the national vaccination program. The patient had not experienced symptoms
associated with COVID-19. The patient had not been tested or has had an inconclusive test for COVID-19 (as reported). The
patient was not enrolled in a clinical trial. The clinical outcome of SVT was reported as recovering. The clinical outcome of
hypotension, chest pain, dizziness, neck tightness, erythematous rash and localised itching was unknown.; Sender's Comments:
The events of supraventricular tachycardia, chest pain, hypotension, dizziness, muscle tightness, rash erythematous and pruritus
are unlisted in the BNT162 Investigator's Brochure. The reported information is limited (e.g. lack of full cardiologic workup, blood
testing etc.). Based on the close temporal relationship between vaccination and onset of the events, there is a reasonable
possibility that the events are related to BNT162 vaccine in a subject with a medical history of SVT.
40-49 Life
665 CHEST X-RAY MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
40-49 Life
666 CHEST X-RAY MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
40-49 Life
667 CHEST X-RAY MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
40-49 Life
668 CHEST X-RAY MODERNA 958509-1 Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
years Threatening
50-59 Life
669 CHEST X-RAY MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
670 CHEST X-RAY MODERNA 958235-1
60-64 Life
671 CHEST X-RAY MODERNA 935090-1 SOB, Sleeplessness,
years Threatening
65+
672 CHEST X-RAY MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
years
673 CHEST X-RAY MODERNA 949967-1
18-29 Life
674 CHEST X-RAY PFIZER\BIONTECH 917712-1 nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under
years Threatening
quick and prepared.
30-39 Life
675 CHEST X-RAY PFIZER\BIONTECH 916890-1 HIVES, SOB, THROAT CLOSING UP, WHEEZING
years Threatening
676 CHEST X-RAY PFIZER\BIONTECH 932366-1
patient felt slightly nauseated at 10 minutes after injection, then developed slight sweating; BP 160/81; 83 at 5:45 and then
158/87 with HR 82 at 5: 52 pm. Her lungs were clear, she was speaking in full sentences and was denying any chest pressure,
her usual sense of asthma exacerbation. At 6:05 it was 164/83 with HR 79 and patient developed a dry cough; we decided to
have her wait just a bit longer, then cough worsened, so at 6:25, decision was made to have patient seen in ER for further
40-49 Life
678 CHEST X-RAY PFIZER\BIONTECH 907101-1 assessment, and en route in wheelchair to ER the dry cough became persistent, spasmodic and patient was unable to speak.
years Threatening
Epi-Pen was injected in right mid thigh, and patient transported to ED urgent eval. She noted immediate palpitations, and slight
improvement of breahting, was able to speak in four word sentences. On arrival to the ED, patient was administered Duonebs,
Albuterol neb, IV Benedryl, IV Solumedrol; CXR was obtained, with results pending. Patient was sent to observation for ongoing
monitoring and assessment of breathing. at 6:30 PM in the ER, she
40-49 Life
679 CHEST X-RAY PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
40-49 Life
680 CHEST X-RAY PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
50-59
681 CHEST X-RAY PFIZER\BIONTECH Death 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years
50-59 Life
682 CHEST X-RAY PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
50-59 Life
683 CHEST X-RAY PFIZER\BIONTECH 938118-1 on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
years Threatening
50-59 Life
685 CHEST X-RAY PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
years Threatening
50-59
686 CHEST X-RAY ABNORMAL MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
Vaccine Event
50-59 Life I was short of breath and went to emergency room on 1/5/2021. I was diagnosed with bilateral pulmonary embolisms. I was
687 CHEST X-RAY ABNORMAL MODERNA 941522-1
years Threatening Covid negative and had no other symptoms.
688 CHEST X-RAY ABNORMAL MODERNA 955945-1
fever.
65+
689 CHEST X-RAY ABNORMAL MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
18-29
690 CHEST X-RAY ABNORMAL PFIZER\BIONTECH Death 960841-1 cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours.
years
691 CHEST X-RAY ABNORMAL PFIZER\BIONTECH 917210-1
692 CHEST X-RAY ABNORMAL PFIZER\BIONTECH 904436-1
40-49 Life
693 CHEST X-RAY ABNORMAL PFIZER\BIONTECH 959017-1 started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line
years Threatening
18-29 Life
694 CHEST X-RAY NORMAL MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
30-39 Life
695 CHEST X-RAY NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
696 CHEST X-RAY NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
30-39 Life
697 CHEST X-RAY NORMAL MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
698 CHEST X-RAY NORMAL MODERNA 946978-1
40-49 Life
699 CHEST X-RAY NORMAL PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
65+
700 CHEST X-RAY NORMAL PFIZER\BIONTECH Death 945247-1 weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should
years
report
65+
701 CHEST X-RAY NORMAL PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
702 CHEST X-RAY NORMAL PFIZER\BIONTECH Death 959929-1
703 CHEST X-RAY NORMAL PFIZER\BIONTECH 953333-1
30-39 Life was elevated to >200/100 initially by EMS. Symptoms improved quickly following epinephrine, with some residual feelings of
704 CHILLS MODERNA 916859-1
years Threatening very mild throat fullness, and I developed chills which improved over time. I was transported to emergency department where I
not recurred.
30-39 Life
705 CHILLS MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
40-49 Life
707 CHILLS MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
40-49 Life
708 CHILLS MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
50-59 Life Facial (cheek) numbness and swelling with slight face droop Swelling continued on 1/7/2021 On 1/8/2021, lip swelling and
years Threatening numbness and tongue numbness By 1/9/2021 4pm, swelling and numbness resolved but chills and muscle aches began
Vaccine Event
fever.
01/06/21 at 6 pm, body aches, and chills 01/07/21 at 12am T102.2, SPO2 62% on room air. Was sent to ER and returned.
60-64 Life
711 CHILLS MODERNA 934156-1 01/08/21 at SPO@ less then 60% on room air, non responsive to verbal tactile stimuli. Responsive to sternal rub only. Was sent
years Threatening
to ER and admitted to ICU.
60-64 Life
712 CHILLS MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
Resident had body aches, a low O2 sat and had chills starting on 12/30/20. He had stated that they had slightly improved. On
65+
713 CHILLS MODERNA Death 921572-1 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again.
years
He later went unresponsive and passed away.
65+ Life
714 CHILLS MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
Employee was awaken at 5:30 am on 1/13/2021 by chills and a feverish feeling. She then became nauseous and faint. She
passed out and was noted by her mother who is a RN to have a seizure. She remained out for several minutes and then aroused.
18-29 Life
715 CHILLS PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
has been on medications for this. Employee stated she has not has any seizure activity in over a year. She did not see medical
attention due to recovering quickly from this.
716 CHILLS PFIZER\BIONTECH 917210-1
had a positive COVID test; had a positive COVID test; O2 Saturation of 80% / Hypoxia; shortness of breath; He has a CT scan
which showed extensive infiltration in the lungs; muscle pain; chills; body aches; low grade fever; cough; This is a spontaneous
report from a contactable physician (pulmonary medicine). This physician reported similar events for 2 patients. This is 1st of 2
reports. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 18Dec2020 at single dose for covid-19 immunization. There were no medical history and concomitant
medications. Caller stated that his close friend who was ER physician (front line worker) and within 24 hours after receiving the
COVID vaccine, developed COVID or symptoms of COVID. Patient received the COVID vaccine on 18Dec2020 and the same night
patient started with a low grade fever, body aches, chills, muscle pain, shortness of breath, cough, O2 saturation of 80%
(hypoxia) and was in the intensive care unit now. Patient swore this was related to the vaccine. This patient tested positive for
30-39 Life COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was
years Threatening admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a
positive COVID test at another hospital. Caller did know that tested positive at the current hospital on 26Dec2020 which was
done to confirm the previous positive test. Caller thought patient had his first positive COVID test either the same day or the next
day after receiving the vaccine. Event of O2 Saturation of 80% / hypoxia was reported as hospitalization from 24Dec2020 and life
threatening; infiltration in the lungs and shortness of breath caused hospitalization from 24Dec2020, muscle pain, chills and
positive COVID test was reported as medically significant; and other events were reported as non-serious. Outcome of O2
saturation of 80% / hypoxia and shortness of breath was not recovered, outcome of cough was recovering; and outcome of other
events were unknown. Information about lot/batch number has been requested. ; Sender's Comments: Based on the information
currently available, a lack of efficacy with suspected vaccine BNT162B2 in this patient cannot be completely excluded.,Linked
Report(s) : US-PFIZER INC-2020519020 same reporter/drug , different patient/AE.
30-39 Life
718 CHILLS PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
30-39 Life
719 CHILLS PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
40-49 Life
721 CHILLS PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
50-59 Life
722 CHILLS PFIZER\BIONTECH 934676-1 Chills Hip pain
years Threatening
50-59 Life
723 CHILLS PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
encephalopathy."
of 1/3/2021.
65+ Life
726 CHILLS PFIZER\BIONTECH 956578-1 Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was
years Threatening
Vaccine Event
727 CHILLS PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
CHLAMYDIA TEST 65+
NEGATIVE years
Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime.
18-29 Life 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-
729 CHOKING PFIZER\BIONTECH 945090-1
years Threatening 2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and
steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.
730 CHOKING PFIZER\BIONTECH 939914-1
30-39 Life
731 CHOLECYSTECTOMY MODERNA 918839-1 Gallbladder removed, septic, 11mm axillary lymph node.
years Threatening
CHRONIC OBSTRUCTIVE
PULMONARY DISEASE
CHRONIC RESPIRATORY 65+
733 PFIZER\BIONTECH Death 962714-1 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart
FAILURE years
734 CIRCULATORY COLLAPSE PFIZER\BIONTECH Unknown Death 908245-1 vaccination. The patient's medical history was not reported. Concomitant medication included sildenafil, acetylsalicylic acid,
patient died after collapsing in his home several hours after he received the vaccine; patient died after collapsing in his home
several hours after he received the vaccine; The initial case was missing the following minimum criteria: the reporter does not
have first-hand knowledge of the reported events and was not identifiable. Upon receipt of follow-up information on 06Jan2021,
this case now contains all required information to be considered valid. This is a spontaneous report from a contactable
healthcare professional via regulatory Authority. The regulatory authority reported similar events for three patients. This is the
first of three reports. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot
Number: EK4237), via an unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization.
Medical history included dementia, cardiac background with pacemaker, atrial fibrillation, heart failure, and penicillin allergy. The
patient was not allergic to polyethylene glycol. The patient's concomitant medications were not reported. On 29Dec2020, the
patient died after collapsing in his home several hours after he received the vaccine. Outcome of collapsing was not recovered.
735 CIRCULATORY COLLAPSE PFIZER\BIONTECH Unknown Death 934465-1
The patient had no pulse when he arrived at the hospital. It was not reported if an autopsy was performed. The cause of death
was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The advance old
patient had underlying cardiac background with pacemaker, atrial fibrillation and heart failure, therefore the pre-existing
cardiovascular medical conditions more likely provide explanations for collapsing lead to the patient death. More information
especially death cause and autopsy results are needed for further meaningful assessment. The impact of this report on the
action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as
appropriate.,Linked Report(s) : IL-PFIZER INC-2021009752 same reporter, product, similar event, different patient;IL-PFIZER INC-
2021009751 same reporter, product, similar event, different patient; Reported Cause(s) of Death: Unknown cause of death
Vaccine Event
Myocardial infarct; Circulatory collapse; This is a spontaneous report from a contactable physician from the regulatory authroity.
The regulatory authority report number is GB-MHRA-ADR 24553112 and GB-MHRA-WEBCOVID-20210104143047. An 82-year-old
male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1688), via an unspecified route of
administration, on 31Dec2020 at a single dose for COVID-19 vaccination. Medical history included mitral valve incompetence
from 08May2020, myocardial ischaemia from 07May2020, acute myocardial infarction from 07May2020, cataract from
29Nov2019, chronic kidney disease from 03Oct2013, colitis ischaemic from 23May2013, basal cell carcinoma from 20Apr2012,
transurethral bladder resection on 06Sep2005, neoplasm malignant (other/unspecified site) from 16Aug2005, debridement
(arthroscopic debridement of patella) on 12Jan2005, and essential hypertension from 2005. The patient had not had symptoms
associated with COVID-19. The patient was not been tested/or had an inconclusive test for COVID-19. The patient was not
736 CIRCULATORY COLLAPSE PFIZER\BIONTECH Unknown Death 936170-1
enrolled in clinical trial. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin
(MANUFACTURER UNKNOWN), betamethasone valerate (BETNOVATE), bisoprolol (MANUFACTURER UNKNOWN), furosemide
(MANUFACTURER UNKNOWN), glyceryl trinitrate (MANUFACTURER UNKNOWN), loperamide (MANUFACTURER UNKNOWN),
omeprazole (MANUFACTURER UNKNOWN), phenoxymethylpenicillin (MANUFACTURER UNKNOWN), and ramipril
(MANUFACTURER UNKNOWN). The patient experienced myocardial infarct and circulatory collapse on 31Dec2020. The event,
myocardial infarct, was reported as fatal. It was reported that the patient collapsed at home the evening after vaccination. The
clinical outcome of myocardial infarct was fatal and of circulatory collapse was not recovered. The patient died on 31Dec2020.
The cause of death was reported as myocardial infarct. It was unknown if an autopsy was performed. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct
737 COAGULATION TEST MODERNA 955565-1
40-49 Life
738 COAGULATION TEST PFIZER\BIONTECH 932420-1 morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx
years Threatening
COAGULATION TEST 50-59 Life
740 COAGULATION TIME MODERNA 919546-1
Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse
crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a
65+ cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting
741 COLD SWEAT MODERNA Death 962940-1
years in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was
placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived
at Medical Center at 2120 and was pronounced dead at 2127.
742 COLD SWEAT PFIZER\BIONTECH Death 940954-1
743 COLOSTOMY PFIZER\BIONTECH 920628-1
of 1/3/2021.
65+
744 COMA PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
symptoms.
1-2
745 COMPLETED SUICIDE PFIZER\BIONTECH Death 958443-1 death by suicide Narrative: death by suicide; 12/26/20, self inflicted gun shot wound; found deceased by family member
years
65+
746 COMPLETED SUICIDE PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
COMPLICATED 50-59 Life was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix
APPENDICITIS years Threatening was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was
COMPLICATION 65+ hypoxia, secretions,cough, dyspnea Narrative: ALS patient on hospice with ongoing history of aspiration pna, receiving tube
ASSOCIATED WITH DEVICE years feeds. Developed incr in secretions, hypoxeia, temp and with recently noted clogged feeding tube.
COMPUTERISED 40-49 Life
TOMOGRAM years Threatening
COMPUTERISED 40-49 Life became ill with fever chills and nausea and left work at 2am. On 12/31 she developed hemianopia. She went to ER and they did
750 MODERNA 941476-1
TOMOGRAM years Threatening CT scan. She was told it was complex migraine. She left and came Home. On 1/1/21 her vision was back to normal. On 1/3 she
751 MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
the hospital now.
752 MODERNA 948471-1 5-6 HOURS AFTER VACCINATION. CONVULSIONS/SEIZURE, HIGH BLOOD PRESSURE, INCREASED HEART RATE,
COMPUTERISED 50-59 Life Pt found unresponsive at home, respiratory distress. Had reported nausea and vointing for two days prior to admit which started
753 MODERNA 958235-1
TOMOGRAM years Threatening 1/15. Acute metabolic encephalopathy and acute renal failure Currently at time of this report still in critical care
COMPUTERISED 65+
754 MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
TOMOGRAM years
COMPUTERISED 65+
755 MODERNA Death 958971-1 Hemorrhagic Stroke, Right Basal Ganglion
TOMOGRAM years
COMPUTERISED 65+ Life
756 MODERNA 957091-1 COVID-19 Vaccine
757 PFIZER\BIONTECH 943359-1 Unprovoked seizure (clonic tonic) 13 days later, requiring hospitalization and testing
758 PFIZER\BIONTECH 932623-1 Acute ischemic stroke, basilar occlusion
Vaccine Event
COMPUTERISED 18-29 Life emergency room with her symptoms. She was admitted back to our facility yesterday, her diagnoses included Acute provoked
759 MODERNA 955565-1
TOMOGRAM ABDOMEN years Threatening left external illiac, femoral, popliteal, and peroneal DVT. Elevated Factor II levels, Elevated APC resistant, May-Thurner Syndrome,
COMPUTERISED 65+
TOMOGRAM ABDOMEN years
COMPUTERISED 50-59
TOMOGRAM ABDOMEN years
TOMOGRAM ABDOMEN years Threatening
COMPUTERISED 60-64 Life which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a
TOMOGRAM ABDOMEN years Threatening perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening
of 1/3/2021.
COMPUTERISED
764 TOMOGRAM ABDOMEN PFIZER\BIONTECH 947687-1
ABNORMAL
At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and
found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary
caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident.
COMPUTERISED 65+ This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER,
TOMOGRAM ABNORMAL years CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the
lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This
primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver
received a call from Castle RN at 0700, resident expired at 0615.
766 MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
TOMOGRAM ABNORMAL years Threatening
COMPUTERISED 30-39 Life COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was
TOMOGRAM ABNORMAL years Threatening admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a
768 PFIZER\BIONTECH 909720-1 with ibuprofen. 12/24- no fever noted but intermittent right lower quadrant pain continued, seen at the Health Clinic, sent to
769 PFIZER\BIONTECH 923000-1 and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from
12/26/20-12/28/20.
COMPUTERISED 60-64 Life which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a
TOMOGRAM ABNORMAL years Threatening perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening
of 1/3/2021.
COMPUTERISED 65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
TOMOGRAM ABNORMAL years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
COMPUTERISED Near syncopal episode approximately 2.5 hours after vaccination. Sudden onset of dizziness, nausea, and diaphoresis. Was
40-49 Life
772 TOMOGRAM CORONARY PFIZER\BIONTECH 914730-1 admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-
years Threatening
ARTERY NORMAL existing conditions and considered to be a healthy adult.
COMPUTERISED 30-39 Life The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and
TOMOGRAM HEAD years Threatening weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
COMPUTERISED 50-59
TOMOGRAM HEAD years
TOMOGRAM HEAD years Threatening
COMPUTERISED 65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
TOMOGRAM HEAD years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
COMPUTERISED 65+ Life She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her
TOMOGRAM HEAD years Threatening body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at
10:31am.
COMPUTERISED 12 hours after vaccination began experiencing fever, chills, body aches, slight head ache - lasted around 12 hours Had slight pain
30-39 Life
778 TOMOGRAM HEAD MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
ABNORMAL spots on brain, thought patient had shingles On 01/10/2021 shingles rash appeared
COMPUTERISED BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with
50-59 Life
779 TOMOGRAM HEAD PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
ABNORMAL unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization
COMPUTERISED
780 TOMOGRAM HEAD PFIZER\BIONTECH Death 951101-1
ABNORMAL
On January 14, 2021, I noticed generalized petechiae all over my body. I went to seek medical care and was found to have
COMPUTERISED
50-59 Life platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my
781 TOMOGRAM HEAD MODERNA 950980-1
years Threatening platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the
NORMAL
hospital getting treatment today.
COMPUTERISED
782 TOMOGRAM HEAD MODERNA Death 927260-1
NORMAL
COMPUTERISED Resident returned to the memory support unit at 1500. Resident was than toileted and transferred in to bed per his request. At
65+
783 TOMOGRAM HEAD PFIZER\BIONTECH Death 961010-1 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro
years
NORMAL Checks with in normal limes Vital signs: 100/52, 100, 97.2, 28. Resident sent to ED for further medical evaluation via EMS.
Vaccine Event
COMPUTERISED diagnosis documented. Leg ulcers and bilateral leg oedema noted, supplemental oxygen commenced due to low saturations in
784 TOMOGRAM HEAD PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
NORMAL 29Dec2020, given intravenous treatment and blood sugars improved. National Early Warning Score (NEWS) of 14 (hypotensive,
hypoglycaem
COMPUTERISED 50-59
TOMOGRAM PELVIS years
TOMOGRAM PELVIS years Threatening
COMPUTERISED
787 TOMOGRAM PELVIS PFIZER\BIONTECH 947687-1
ABNORMAL
COMPUTERISED 50-59
TOMOGRAM SPINE years
TOMOGRAM SPINE years Threatening
TOMOGRAM THORAX years Threatening
COMPUTERISED 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
TOMOGRAM THORAX years Threatening WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense
COMPUTERISED 30-39 Life Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or
TOMOGRAM THORAX years Threatening deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively
COMPUTERISED 50-59
TOMOGRAM THORAX years
COMPUTERISED
796 TOMOGRAM THORAX MODERNA 946978-1
ABNORMAL
COMPUTERISED
797 TOMOGRAM THORAX MODERNA 941522-1
ABNORMAL
COMPUTERISED
798 TOMOGRAM THORAX PFIZER\BIONTECH 959401-1
ABNORMAL
COMPUTERISED
799 TOMOGRAM THORAX PFIZER\BIONTECH Death 951101-1
NORMAL
800 CONDITION AGGRAVATED MODERNA 955945-1
fever.
DVT in right leg 4 days after injection, severe pain in thigh/calf, difficulty walking Placed on Xarelto 15mg 2X daily for 21 days
60-64 Life
801 CONDITION AGGRAVATED MODERNA 952677-1 and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for
years Threatening
2/5/2021 at 7:15am
60-64 Life
802 CONDITION AGGRAVATED MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
65+ Life
803 CONDITION AGGRAVATED MODERNA 930611-1 Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP
years Threatening
65+ Life on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was
years Threatening elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort
65+ Life
806 CONDITION AGGRAVATED MODERNA 952235-1 nausea and vomiting possible cause of diabetic ketoacidosis and svt
years Threatening
18-29 Life
807 CONDITION AGGRAVATED PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
Vaccine Event
she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); she was diagnosed with bilateral
deep vein thrombosis (DVT) and pulmonary embolism (PE); This is a spontaneous report from a contactable nurse (patient). A
22-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an
unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history
included allergy to all fish, and clots. The patient was not pregnant. There were no concomitant medications. The patient
previously received 1st dose of BNT162B2 (lot numer: EH9899) in left arm on 16Dec2020 13:45 for COVID-19 immunisation and
experienced left sided lower back pain on 20Dec2020. No other vaccine received in four weeks. It was reported that the patient
had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain and then received the
18-29 Life
808 CONDITION AGGRAVATED PFIZER\BIONTECH 944289-1 second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral
years Threatening
deep vein thrombosis (DVT) and pulmonary embolism (PE). The patient otherwise healthy and had never had covid. Other than
the clots, she had no other health issues. The patient underwent lab tests and procedures which included nasal swab: negative
on 09Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or
urgent care, hospitalization, and life threatening illness (immediate risk of death from the event), hospitalized for 2 days (in
Jan2021). Adverse event treatment: heparin drip and xarelto at home. Recovered with lasting effects on an unspecified date of
Jan2020. This case was reported as serious, serious criteria was life threatening, caused/prolonged hospitalization.; Sender's
Comments: The underlying risk factors/predisposing condition of thrombotic diathesis have been assessed to have played a
contributory role toward the events.
30-39 Life Monitored x 15 min per guidelines. Began to experience SOB and throat swelling, after which pt presented to the ED for tx, dx
809 CONDITION AGGRAVATED PFIZER\BIONTECH 912785-1
years Threatening acute hypertensive urgency with severe hypertension.
40-49 Life
810 CONDITION AGGRAVATED PFIZER\BIONTECH 930153-1 ITP Plt 2
years Threatening
811 CONDITION AGGRAVATED PFIZER\BIONTECH Death 924464-1
Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen level dropped to 86%, HR was
60-64 Life
812 CONDITION AGGRAVATED PFIZER\BIONTECH 948243-1 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current
years Threatening
status
65+ since the patient died between his first and second dose. Received Pfizer Dose #1 12/17/2020. No side effects or adverse
years events noted; lived in 24/7 care facility and monitored twice daily for reaction. Date of death 12/23/2020 from aspiration
65+ Life Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in
815 CONDITION AGGRAVATED PFIZER\BIONTECH 944663-1
years Threatening the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%.
816 CONDITION AGGRAVATED PFIZER\BIONTECH Unknown Death 928992-1 was serious as it was medically significant, involved hospitalization and lead to death. Clinical course was as follows: the patient
817 CONDITION AGGRAVATED PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
818 CONDITION AGGRAVATED PFIZER\BIONTECH Unknown 902856-1
Less than 5 minutes after vaccine, nose drained, weird taste in mouth, tingle in nose and on tongue. Throat and tongue swelled,
couldn?t speak. Dizzy and slurring speech. Was taken to ambulance outside, BP was 191/101. Given beta blockade. Confused
30-39 Life
819 CONFUSIONAL STATE MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
1/2 hours. Continued steroids for 5 days and had to take benedryl every 4 hours for 3 days or swelling/itching/bad taste in
mouth would return. Sore arm on day 3.
Vaccine Event
820 CONFUSIONAL STATE MODERNA 926787-1
were made.
65+
821 CONFUSIONAL STATE MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
years
822 CONFUSIONAL STATE MODERNA Death 957799-1
years resuscitated
Started feeling a reaction immediately after the vaccine, felt blurred vision, dizziness, racing heartbeat, chest rash and face,
itching all over, difficulty swallowing, tongue tingling and wheezing. Sent to ED. EPI and Benadryl. 1800 Went to see her in the ED,
room 33. She has red rash to neck, shaky hands itching to neck and chest. ED Dr to discharge, she stated husband to pick her up
and she will follow up with OH tomorrow. --------------------------------------------------------------------------------------------------------------------RN ED gave
her Epinephrine 0.3 mg, Methylprednisolone 125mg, Diphenhydramine HCL 50 mg, Zofran 4mg, Lorazepam 1 mg, Hydroxyzine
30-39 Life
823 CONFUSIONAL STATE PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------- RN 12/29/2020 1715 called to check on patient. left voicemail for her to call OH. ???????..? 12/29/2020 1838 left
voicemail for patient to call OH. ??????????????????????. 12/30/20 2030 spoke with her. Tuesday 12/29 3pm-4pm dizziness,
confusion, sob. Wheezing. Ambulance called. Hospital admitted. Intubated for less than 24 hours. Breathing treatments, epi drip.
Now just on steroids and walking around and feeling better. Still admitted at hospital. Hoping discharged tomorrow. --------------------
------------------------------------------------------RN
824 CONFUSIONAL STATE PFIZER\BIONTECH 939190-1
encephalopathy."
65+
826 CONFUSIONAL STATE PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver, asthma, and heart condition
65+ was tested for COVID-19 on 01/07/21, received 1st dose of Pfizer COVID-19 vaccine on 01/08/21, positive test result for COVID-
827 CONFUSIONAL STATE PFIZER\BIONTECH Death 954251-1
years 19 received on 01/09/21. She was sent to the hospital and admitted on 01/12/21 after O2 was 70% and was in a confused state.
Patient passed away on 01/17/21.
828 CONFUSIONAL STATE PFIZER\BIONTECH Death 959929-1
65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
years Threatening and confused (beyond baseline)
830 CONFUSIONAL STATE PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
Life
831 CONFUSIONAL STATE PFIZER\BIONTECH Unknown 907573-1 gastrooesophageal reflux disease and anxiety. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) in
Threatening
CONSCIOUSNESS 50-59 Life currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am
832 MODERNA 926787-1
FLUCTUATING years Threatening was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident.
were made.
833 CONSTIPATION MODERNA 955565-1
Vaccine Event
18-29 Life
834 CONTUSION MODERNA 932915-1 Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
years Threatening
65+ Life
835 CONTUSION PFIZER\BIONTECH 908869-1 WNL (exceptions: SCr 1.24, TBil 1.7); CBC with platelet count of 1,000 resulting in patient admission to Hospital. At admission he
years Threatening
836 CONTUSION PFIZER\BIONTECH Unknown Death 944154-1 floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR,
CORONARY ARTERIAL 65+ Life stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose
837 MODERNA 917784-1
STENT INSERTION years Threatening Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and
CORONARY ARTERIAL 65+ Life
STENT INSERTION years Threatening
CORONARY ARTERIAL 50-59 Life
STENT INSERTION years Threatening
CORONARY ARTERY 60-64 Life Pt had 3 vessel CABG on 1/14/21 after presenting to ED with chest pain on 1/9/21. Pt is critically ill following OR after
BYPASS years Threatening cardiogenic shock, bleeding. Requiring inotropes and Impella.
CORONARY ARTERY 65+ Life
DISEASE years Threatening
CORONARY ARTERY 40-49 Life I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not
OCCLUSION years Threatening sure if these are related but I felt I should report it.
CORONARY ARTERY 50-59 Life
CORONARY ARTERY 50-59 Life
CORONARY ARTERY 65+ Life
STENOSIS years Threatening
30-39
846 COUGH MODERNA Death 939050-1 develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory
years
30-39 Life
847 COUGH MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
40-49 Life
848 COUGH MODERNA 907075-1 Patient experienced bronchospasm with coughing and tongue itching approximately 10 minutes after the injection.
years Threatening
40-49 Life
849 COUGH MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
850 COUGH MODERNA 946978-1
40-49 Life
851 COUGH MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
50-59 Life
852 COUGH MODERNA 920787-1 obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered.
years Threatening
65+ hypoxia, secretions,cough, dyspnea Narrative: ALS patient on hospice with ongoing history of aspiration pna, receiving tube
853 COUGH MODERNA Death 956966-1
years feeds. Developed incr in secretions, hypoxeia, temp and with recently noted clogged feeding tube.
65+
854 COUGH MODERNA Death 958069-1 Started with cough, mild shortness of breath and feeling terrible in evening of 1/19.
years
18-29 Life
855 COUGH PFIZER\BIONTECH 917712-1 nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under
years Threatening
quick and prepared.
Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At
1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was
18-29 Life performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing
856 COUGH PFIZER\BIONTECH 944450-1
years Threatening and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair
which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression
on monitor.
30-39 Life
858 COUGH PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
Approximately 2 minutes after injection, felt flushed and tingly. This subsided, but developed a cough. Felt fine enough to leave
the vaccination area after being monitored for 15 minutes. Cough continued, and developed a scratchy throat that eventually led
30-39 Life to swelling of the throat at approximately 30-35 mins post administration. Sought care in the ED, where I was tachycardic and
years Threatening hypertensive. Received IV Benadryl, steroids, and IV fluids. Discharged home, but symptoms returned around 2pm. Sought care
in a different ED, where I remained hypertensive and tachycardic. Received additional IV fluids, IV Benadryl and steroids.
Eventually was treated with IM epinephrine after my heart rate was decreased to about 100bpm with IV metoprolol.
Vaccine Event
Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing and throat irritation at 20-25
minutes post vaccination, tongue and lip numbness and throat tightness at 25-30 minutes, dry hacking cough at 30 minutes.
30-39 Life
862 COUGH PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
coughing, speaking 1-2 word sentences, with tachycardia and tachypnea. Treated with IM epinephrine, IV solumedrol and IV
Benadryl and IV Benadryl with marked improvement in symptoms.
40-49 Life
866 COUGH PFIZER\BIONTECH 907101-1 assessment, and en route in wheelchair to ER the dry cough became persistent, spasmodic and patient was unable to speak.
years Threatening
40-49 Life Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen
years Threatening and kept in ER for observation overnight. Symptoms resolved.
40-49 Life
869 COUGH PFIZER\BIONTECH 928209-1 Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
years Threatening
40-49 Life
870 COUGH PFIZER\BIONTECH 930897-1 Shortness of breath, cough, rash on face and neck, arthralgia
years Threatening
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips,
was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing,
vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol,
Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe,
throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was
transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting,
difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol,
Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration)
40-49 Life
871 COUGH PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange
feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following
morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given
Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted
rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement.
Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic
nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest
and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
50-59 Life
872 COUGH PFIZER\BIONTECH 912826-1 Itching, cough. Given benadryl 50mg and epinephrine 0.3 in vaccine clinic, and taken to ED for further tx.
years Threatening
50-59 Life
873 COUGH PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
Vaccine Event
50-59 Life
874 COUGH PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
60-64
875 COUGH PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
possible myocardial infarction; Dyspnoea; unwell; Cough; This is a spontaneous report from a contactable physician downloaded
from the Regulatory Agency. Regulatory authority GB-MHRA-WEBCOVID-20210105105739, other manufacturer number is GB-
MHRA-ADR 24556743. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:
EJ0553-v0003), via unspecified route of administration on 19Dec2020 at single dose for COVID-19 vaccination. Medical history
included diabetes mellitus, angiocardiogram, cardiac failure, hypertension, all from unspecified date and unknown if ongoing and
cerebrovascular accident from 2001 and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Patient
has not been tested/or has had an inconclusive test for COVID-19. Unsure if patient is enrolled in clinical trial. Concomitant
65+ medication included amlodipine, acetylsalicylic acid (ASPIRIN (E.C.)), atorvastatin, bisoprolol, fluticasone propionate
876 COUGH PFIZER\BIONTECH Death 929023-1
years (FLIXONASE), folic acid, colecalciferol (FULTIUM-D3), furosemide, latanoprost, levothyroxine, insulin aspart (NOVORAPID),
ramipril and insulin detemir (LEVEMIR). On 24Dec2020, the patient experienced a cough. It was noted that the patient's son and
wife had already been coughing but no coronavirus tests had been done at the time of this event. On an unknown date, the
patient experienced dyspnoea. It was noted that the he had become increasingly short of breath and unwell. On 28Dec2020, the
patient died. It was noted to be a possible myocardial infarction. The patients COVID test score was unknown. The autopsy was
awaited at the time of this report. The outcome of the event possible myocardial infarction was fatal, while other events were
unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: possible
myocardial infarction
At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113,
20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set
of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021,
65+
877 COUGH PFIZER\BIONTECH Death 946225-1 resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately
years
2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248
doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident
passed away.
65+
878 COUGH PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
After vaccination, patient tested positive for COVID-19. Patient was very ill and had numerous chronic health issues prior to
65+
879 COVID-19 MODERNA Death 917117-1 vaccination. Facility had a number of patients who had already tested positive for COVID-19. Vaccination continued in an effort
years
to prevent this patient from contracting the virus or to mitigate his risk. This was unsuccessful and patient died.
At the time of vaccination, there was an outbreak of residents who had already tested positive for COVID 19 at the nursing home
65+ where patient was a resident. About a week later, patient tested positive for COVID 19. She had a number of chronic, underlying
880 COVID-19 MODERNA Death 917790-1
years health conditions. The vaccine did not have enough time to prevent COVID 19. There is no evidence that the vaccination caused
patient's death. It simply didn't have time to save her life.
Prior to the administration of the COVID 19 vaccine, the nursing home had an outbreak of COVID-19. Patient was vaccinated and
65+
881 COVID-19 MODERNA Death 917793-1 about a week later she tested positive for COVID-19. She had underlying thyroid and diabetes disease. She died as a result of
years
COVID-19 and her underlying health conditions and not as a result of the vaccine.
65+
882 COVID-19 MODERNA Death 962318-1 "Called to schedule second vaccine and daughter reports that he died on01/19/2021 with ""COVID"""
years
Patient diagnosed with COVID on January 9, 2021 after being exposed to family member that was under quarantine in the same
65+
883 COVID-19 MODERNA Death 963235-1 household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on
years
January 18, 2021
6-17 Life
884 COVID-19 PFIZER\BIONTECH 921641-1 decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without
years Threatening
885 COVID-19 PFIZER\BIONTECH 920224-1
65+ Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test result came back positive 1/2/2021
886 COVID-19 PFIZER\BIONTECH Death 920832-1
years Deceased 1/4/2021
65+
887 COVID-19 PFIZER\BIONTECH Death 930386-1 Patient received first dose of vaccine on 12/28, developed COVID-19 infection shortly thereafter and expired on 1/6/2021.
years
65+
888 COVID-19 PFIZER\BIONTECH Death 930418-1 Patient received first dose of vaccine on 12/28, developed COVID-19 infection shortly thereafter and expired on 1/4/2021
years
65+ patient expired 1/15/2021; had been treated as outpatient for pneumonia, likely COVID-19 but no positive test result in December
889 COVID-19 PFIZER\BIONTECH Death 962784-1
years 2020. PMH diabetes
COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous report from a contactable consumer. An 80-year-old
female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of
administration on 02Jan2021 for COVID-19 immunization. Medical history included Alzheimer's and others. No known allergies.
Concomitant medications included unspecified medications. The reporter's mother in law was tested for COVID-19 at a nursing
facility on 25Dec2020 and she was negative. On 02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she
developed a high fever, needed oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her death
was listed as pneumonia, respiratory failure and COVID-19. No autopsy performed. No treatment received. No one knew if the
vaccination contributed to her death. It was hard to know if her death was due to the administration of the vaccine or it
exacerbated the COVID19 symptoms which led to her death. Since this was unknown, it could have been a possibility. The
reporter wanted to give us this information because we might want to consider having high risk population, patients with
underlying conditions, older population tested for COVID-19 prior to the vaccination, as this is not currently a recommendation or
890 COVID-19 PFIZER\BIONTECH Unknown Death 934966-1
a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did
not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are medications the patient received within 2
weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has
been tested for COVID-19. The outcome of the events was fatal. Information about Lot/Batch has been requested.; Sender's
Comments: The association between the fatal event lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2
can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia, respiratory failure and COVID-19;
Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and
COVID-19
Vaccine Event
SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician received by Regulatory
Agency . The regulatory authority report number is GB-MHRA-ADR 24558365 & GB-MHRA-WEBCOVID-20210105143744. A
patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified
route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and
891 COVID-19 PFIZER\BIONTECH Unknown Death 944118-1 concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced SARS-coV-2
infection on 27Dec2020. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive
covid-19 test on an unspecified date. The clinical outcome of SARS-coV-2 infection was fatal. The patient died on an unspecified
date. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be
obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection
50-59 Life
892 COVID-19 PNEUMONIA MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
60-64
893 COVID-19 PNEUMONIA PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
65+
894 COVID-19 PNEUMONIA PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
895 CRANIOTOMY MODERNA 919546-1
65+
896 CRANIOTOMY PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
symptoms.
897 CREPITATIONS MODERNA Death 962940-1
65+
898 CREPITATIONS PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
50-59 Life
899 CRITICAL ILLNESS MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
900 CRITICAL ILLNESS PFIZER\BIONTECH 949724-1
901 CRYPTOCOCCUS TEST PFIZER\BIONTECH 949941-1
encephalopathy."
CSF CELL COUNT 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
encephalopathy."
903 CSF CULTURE NEGATIVE PFIZER\BIONTECH 949941-1
encephalopathy."
904 CSF GLUCOSE NORMAL PFIZER\BIONTECH 949941-1
encephalopathy."
CSF LACTATE 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
DEHYDROGENASE NORMAL years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
encephalopathy."
CSF LYMPHOCYTE COUNT 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
ABNORMAL years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
encephalopathy."
CSF NEUTROPHIL COUNT 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
encephalopathy."
908 CSF PROTEIN INCREASED PFIZER\BIONTECH 949941-1
encephalopathy."
CSF RED BLOOD CELL 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
COUNT POSITIVE years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
encephalopathy."
910 CSF TEST NORMAL PFIZER\BIONTECH 949941-1
encephalopathy."
Vaccine Event
18-29 Life
911 CULTURE NEGATIVE PFIZER\BIONTECH 944289-1 second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral
years Threatening
50-59 Life
912 CULTURE NEGATIVE PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
913 CULTURE NEGATIVE PFIZER\BIONTECH 947687-1
resident expired; This is a spontaneous report from a contactable healthcare professional. An 82-year-old male patient received
the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm
on 05Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included metabolic encephalopathy from,
failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness,
hyperlipidemia, chronic kidney disease (CKD), dementia. Known allergies was none. The patient took unspecified concomitant
medication. On 11Jan2021, the resident expired. The patient underwent lab tests and procedures which included nasal swab:
negative on 09Jan2021. There was no treatment given for the event. The patient died on 11Jan2021. An autopsy was not
65+ performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude
914 CULTURE NEGATIVE PFIZER\BIONTECH Death 953590-1
years a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure
and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive
(FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic
kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient. The impacts of
this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the
appropriate.; Reported Cause(s) of Death: resident expired
915 CULTURE STOOL PFIZER\BIONTECH 953333-1
CULTURE TISSUE 65+
916 MODERNA Death 934539-1 approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January
SPECIMEN years
9, 2021
917 CULTURE URINE PFIZER\BIONTECH 929689-1
cultures.
65+
918 CULTURE URINE PFIZER\BIONTECH Death 919108-1 Fever, Malaise
years
919 CULTURE URINE PFIZER\BIONTECH 953333-1
18-29 Life
920 CULTURE URINE NEGATIVE MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
65+
921 CULTURE URINE NEGATIVE PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
922 CULTURE URINE NEGATIVE PFIZER\BIONTECH Death 959179-1
60-64 Life Patient developed a septic knee (history of arthroplasty) need for immediate surgery, hospitalization and months to years of
923 CULTURE WOUND POSITIVE MODERNA 919593-1
years Threatening antibiotics in his future now.
18-29 Life Blurred vision, difficulty breathing (pale skin/blue lips), profuse sweating, muscle fatigue, headache. This lasted about 15
924 CYANOSIS MODERNA 939216-1
years Threatening minutes. Until severity went down. Followed by 20 minutes of profuse sweating and headache. I thought I was going to die
925 CYANOSIS MODERNA 956504-1
18-29 Life
926 CYANOSIS PFIZER\BIONTECH 944289-1 second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral
years Threatening
30-39 Life
927 CYANOSIS PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
65+
928 CYANOSIS PFIZER\BIONTECH Death 945603-1 weight which were shared with his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On
years
60-64 Life
929 CYTOKINE STORM MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
Vaccine Event
18-29 Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive
930 DEATH MODERNA Death 936805-1
years and subsequently expired at home on 1/11/21.
30-39
931 DEATH MODERNA Death 939050-1 develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory
years
40-49 The patient was found deceased at home about 24 hours after immunization. Date of Death:: 12/29/2020; estimated time of
years death 6:00pm
40-49
933 DEATH MODERNA Death 933578-1 Pronounced dead 1/9/2021 at 12:42. Received first dose of vaccine 1/8/2021
years
40-49 possibly got it at clinic, possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole
years day but that in the middle of the night the pt passed away.
50-59
935 DEATH MODERNA Death 918518-1 syncopal episode - arrested - CPR - death
years
50-59
936 DEATH MODERNA Death 920815-1 Found deceased in her home, unknown cause, 6 days after vaccine.
years
50-59 Patient had been diagnosed with COVID-19 on Dec. 11th, 2020. Symptoms were thought to have started on 12/5/2020. Received
years Moderna vaccine on 12/23. Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful
50-59 Patient received COVID vaccination around 12:15pm. Patient was monitored for the appropriate amount of time by nursing staff.
years Patient passed away at 2:15pm.
50-59
939 DEATH MODERNA Death 935511-1 Patient received the 1st dose of Moderna and was found deceased in her home the next day.
years
50-59
940 DEATH MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
50-59 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated
years further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at
medical center.
50-59
942 DEATH MODERNA Death 950108-1 1/12/2021. It was found during this procedure that pt. had suffered a MI. She was release to home the following day and passed
years
50-59
943 DEATH MODERNA Death 964401-1 Pt died 4 days after vaccine, no known reaction to the vaccination
years
60-64
944 DEATH MODERNA Death 918065-1 1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm
years
Patient was vaccinated Dec 30, 2020. Prime dose of Moderna vaccine. Observed for full 15 minutes post-injection. No
complaints when asked during observation. Released. Subsequently, vaccine clinic staff learned from the patient's supervisor
60-64
945 DEATH MODERNA Death 923993-1 that on Jan 4, 2021 that the patient had expired on Jan 2, 2021. By report from the supervisor, the patient was found dead at his
years
home. The patient's primary care provider was unaware of his death when contacted by this reporter today (Jan 6, 2021).
Electronic Medical Record without any information since the vaccination.
60-64
946 DEATH MODERNA Death 930154-1 Notified today that he passed away. No other details known at this time.
years
60-64
947 DEATH MODERNA Death 937569-1 patient reported expired 1/7/2021
years
60-64 This person was found to be deceased on routine rounds during the night, 3am. No symptoms of reaction noted post vaccine.
years No injection site reaction. No reports of any allergic reaction.
60-64 Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and
years started CPR. 911 arrived and pronounced resident dead at 1:01 am.
60-64 T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening.
years Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T
60-64
951 DEATH MODERNA Death 951688-1 Resident expired 1/17/21
years
60-64
952 DEATH MODERNA Death 952713-1 Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21
years
60-64 No immediate reaction. Patient-reported deceased four days later on Jan. 19, 2021. As of this date cause of death is unknown to
years our clinic.
60-64
954 DEATH MODERNA Death 963610-1 Patient deceased on 01/17/2021
years
65+ Patient had mild hypotension, decreased oral intake, somnolence starting 3 days after vaccination and death 5 days after
years administration. He did have advanced dementia and was hospice eligible based on history of aspiration pneumonia.
65+ My grandmother died a few hours after receiving the moderna covid vaccine booster 1. While I don?t expect that the events are
years related, the treating hospital did not acknowledge this and I wanted to be sure a report was made.
Resident in our long term care facility who received first dose of Moderna COVID-19 Vaccine on 12/22/2020, only documented
65+ side effect was mild fatigue after receiving. She passed away on 12/27/2020 of natural causes per report. Has previously been
years in & out of hospice care, resided in nursing home for 9+ years, elderly with dementia. Due to proximity of vaccination we felt we
should report the death, even though it is not believed to be related.
65+
958 DEATH MODERNA Death 915880-1 Patient died within 12 hours of receiving the vaccine.
years
65+
959 DEATH MODERNA Death 917117-1 vaccination. Facility had a number of patients who had already tested positive for COVID-19. Vaccination continued in an effort
years
65+
961 DEATH MODERNA Death 917793-1 about a week later she tested positive for COVID-19. She had underlying thyroid and diabetes disease. She died as a result of
years
65+
962 DEATH MODERNA Death 918487-1 Two days post vaccine patient went into cardiac arrest and passed away.
years
65+
963 DEATH MODERNA Death 920326-1 Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21
years
65+
964 DEATH MODERNA Death 921547-1 DEATH ON 1/4/2021, RESIDENT RECIEVED VACCINE ON 1/2/20
years
65+
965 DEATH MODERNA Death 921572-1 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again.
years
65+
966 DEATH MODERNA Death 924126-1 resident expired 1/1/2021
years
65+
967 DEATH MODERNA Death 924186-1 Resident expired 1/3/21
years
65+ This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER,
years CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the
65+
969 DEATH MODERNA Death 925154-1 Deceased
years
65+
970 DEATH MODERNA Death 925264-1 PT was found deceased in his home on 1/5/2021
years
65+ Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities
years (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day.
65+
973 DEATH MODERNA Death 928513-1 Resident passed away in her sleep
years
Patient received vaccine on 1/4/2021. He was in Hospice for CHF and renal failure, but was able to get up in his wheelchair and
65+
974 DEATH MODERNA Death 929997-1 eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow.
years
No localizing neurologic findings. He was too lethargic to get up in chair.
65+
975 DEATH MODERNA Death 930876-1 Death
years
65+
976 DEATH MODERNA Death 933846-1 better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death
years
certificate."
Vaccine Event
Staff reported that patient was found Friday morning (Jan 8) sitting at a table with his head tilted forward and unresponsive to
verbal or physical stimuli. Staff lowered patient to floor and started CPR. EMS was called and continued CPR at scene, however
65+
977 DEATH MODERNA Death 934050-1 they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of
years
patient show that he had a fall about 1 hr. prior. It is unknown if this fall contributed to patient's death. An autopsy has been
requested.
The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was
65+ not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020
years and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the
reporter indicates his daughter reports his test was positive.
65+
979 DEATH MODERNA Death 934539-1 approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January
years
9, 2021
65+
980 DEATH MODERNA Death 935222-1 Patient was reported to be deceased at home by law enforcement on 1/7/21
years
The facility had positive cases of COVID when we were able to begin vaccinating residents. Within about a week of vaccination,
65+
981 DEATH MODERNA Death 937127-1 patient was tested positive for COVID. He was 91 years old and his immune system did not have the time to allow the vaccine to
years
begin working before exposure. His age was a major contributing factor to his death.
65+
982 DEATH MODERNA Death 937434-1 Pt expired due to possible cardiac arrest. Unsure if this was vaccine related.
years
"Patient received vaccine on 1/8/2021. On 1/9/2021 I checked on patient via phone for symptoms or problems and he reported
65+ none but mild soreness at injection site. On 1/10/2021 family friend called me to tell me that patient had expired at about 8:00
years pm. Patient reportedly complained of ""pain"" unspecific and collapsed at home. Hospital reportedly told family that it appeared
to be a ""heart attack""."
65+ Patient received her vaccination on 1/12/21 administered by pharmacy*+. She expired on 1/12/21 an approximately 7:30pm.
years Resident did not have any adverse reactions and was a hospice patient.
65+
985 DEATH MODERNA Death 940866-1 pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on
years
65+ upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard
years to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to
65+
987 DEATH MODERNA Death 941607-1 vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went
years
65+
988 DEATH MODERNA Death 943362-1 Pt collapsed at home approx 5:30 pm and died
years
65+ No adverse reactions observed after administration of medication. Patient starting complaining of shortness of breath around
years 0500 the following morning. SP02 checked in the 80s. Patient expired 01/09/2021;
65+
990 DEATH MODERNA Death 944641-1 Patient died on 1/21-2021
years
65+ Resident received Moderna vaccine on 12/23/2020 around 5 pm. At approximately 3:35 am on 12/25/2020, resident had a CVA
years and died on 1/1/2021 at 3:00 am.
65+
992 DEATH MODERNA Death 947662-1 Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death
years
65+
993 DEATH MODERNA Death 947841-1 Patient had no immediate effects from the vaccine, but died approximately 8 hours after receiving first dose of vaccine.
years
65+
994 DEATH MODERNA Death 948181-1 Death Chest pain; irreg heart rhythm; evening of vaccine; death on toilet on 1/13/21
years
65+
995 DEATH MODERNA Death 948428-1 We got a call from a home health nurse Brandu Talamo, stating that the patient passed away.
years
65+ Resident had lunch on 01/14/21 and after lunch around 2:00pm, he vomited and stopped breathing. We coded the resident and
years 911 paramedics came. They pronounced him dead at 2:18pm.
65+
997 DEATH MODERNA Death 949630-1 pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5
years
65+
998 DEATH MODERNA Death 950979-1 Headache after dose was given at 10:00 a.m Died at after 7:30 pm the same night the dose was given.
years
"Narrative: Patient with severe aphasia and only able to say ""hey, hey, hey"" or ""uh huh"" or shake his head no as a way to
communicate. Patient previously able to ambulate with significant limp and hyperextension of right knee, but mostly wheelchair
bound over last several years as he had had a slow and steady decline in overall health and mobility. Patient developed
aggressive behavior of shouting ""hey"" and grabbing of groin in 2016. This was worked up with CT scans, labs, referral to
urology, neurology, and referrals to psychiatry. The exact etiology of this action was never able to be affirmed, but thought to be
more psychiatrically related. It improved significantly with addition of antipsychotics, worsened when antipsychotics were
reduced, and improved again with addition of injectable antipsychotic on 12-10-2020.Patient suffered from falls on occasion
given his significantly impaired physical mobility. His last documented fall was 8-31-2019. Patient began utilizing wheelchair
65+ most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would
years often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply
refuse. We attempted to hide medications in his food/fluid (with wife's blessing) and when he detected this he would
occasionally refuse to eat. Patient previously on DOAC. After pharmacy review in 12/2020 it was recommended to discontinue
this as no clear indication to continue use. He was high fall risk and would often refuse this medication as well since 10/2020.
Noted to be in NSR on EKGs and decision made to discontinue the DOAC. Patient had no evidence of adverse effects noted after
vaccination on December 28th. Patient seen by provider on the morning of his death (1/4/2021) with no noticeable significant
change in health condition. Temperature 36.8Con January 4th at 19:45. During routine bedtime cares, patient suddenly collapsed
and death was pronounced January 4, 2021 at 20:05. Autopsy was requested from next of kin and no autopsy was granted.
Symptoms: & DEATH Treatment:"
65+
1001 DEATH MODERNA Death 953129-1 stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went
years
65+ Patient was living in a nursing home with positive cases when administered. His age and chronic condition was such that he did
years not have time after the vaccination to avoid exposure or develop immunity.
65+
1003 DEATH MODERNA Death 953785-1 Death
years
65+
1004 DEATH MODERNA Death 953858-1 patient started to decline 1/10/2021, patient seen at facility by medical professional - patient deceased 1/13/2021
years
65+ On 1/13/2021, resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced
years deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history.
65+ resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac
years applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021
65+ Patient died 1 week after vaccination. According to family was having very rapid decline in status in recent weeks and they did
years not think related to vaccination.
65+
1008 DEATH MODERNA Death 956811-1 resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm
years
1/18/21
years resuscitated
65+
1011 DEATH MODERNA Death 959167-1 Patient received COVID 19 vaccine 01/14/2021. Patient died in his sleep 01/16/2021.
years
Patient died 4 days after immunization. Probably unrelated to immunization, as patient has been in poor health and was
65+
1012 DEATH MODERNA Death 959272-1 receiving hospice services. I have no details related to his illness or symptoms. Daughter is the HIPAA/emergency contact and
years
will have all the information needed.
65+
1013 DEATH MODERNA Death 959356-1 Pt passed away the day after the vaccine was given.
years
65+
1014 DEATH MODERNA Death 959568-1 Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by
years
65+
1015 DEATH MODERNA Death 961845-1 Narrative:
years
Vaccine Event
65+
1016 DEATH MODERNA Death 962318-1 "Called to schedule second vaccine and daughter reports that he died on01/19/2021 with ""COVID"""
years
65+
1018 DEATH MODERNA Death 963016-1 unknown. Event occurred after leaving vaccination site
years
65+
1019 DEATH MODERNA Death 963163-1 Narrative:
years
65+
1020 DEATH MODERNA Death 963167-1 Narrative: Symptoms: & Cardiac Arrest; Death Treatment: EPINEPHRINE
years
65+
1021 DEATH MODERNA Death 963235-1 household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on
years
January 18, 2021
65+
1022 DEATH MODERNA Death 963269-1 Patient passed away on 01/18/2021
years
65+
1023 DEATH MODERNA Death 963388-1 Patient died unexpectedly 5 days after receiving vaccine (1/10/2021).
years
1-2
1024 DEATH PFIZER\BIONTECH Death 958443-1 death by suicide Narrative: death by suicide; 12/26/20, self inflicted gun shot wound; found deceased by family member
years
18-29
1025 DEATH PFIZER\BIONTECH Death 960841-1 cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours.
years
30-39 LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased
1026 DEATH PFIZER\BIONTECH Death 921667-1
years somewhere between 1/3/2021 and 1/4/2021. Cause of death is unknown, and an autopsy is being performed.
30-39
1027 DEATH PFIZER\BIONTECH Death 948418-1 Expired on 1/12/2021; unknown cause of death
years
40-49 unsure if related to vaccine, but was notified by her next of kin that she died on 1/4/2021. No reports of side effects or
years hospitalization were reported to the facility prior to the notification of death.
50-59
1029 DEATH PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
50-59
1032 DEATH PFIZER\BIONTECH Death 944595-1 and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the
years
50-59
1034 DEATH PFIZER\BIONTECH Death 955597-1 Death
years
50-59 Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD
years and EMS arrived, resident pronounced at 12:51am.
50-59
1036 DEATH PFIZER\BIONTECH Death 958072-1 Death 3 days after receiving 2nd dose of COVID vaccine, unknown if related to vaccine administration.
years
60-64
1037 DEATH PFIZER\BIONTECH Death 914805-1 RESIDENT CODED AND EXPIRED
years
60-64
1038 DEATH PFIZER\BIONTECH Death 914917-1 Death by massive heart attack. Pfizer-BioNTech COVID-19 Vaccine EUA
years
60-64
1039 DEATH PFIZER\BIONTECH Death 933090-1 Patient died, I have a copy of his vaccination card
years
60-64
1040 DEATH PFIZER\BIONTECH Death 935815-1 Difficulty breathing, death.
years
60-64
1041 DEATH PFIZER\BIONTECH Death 944439-1 Resident expired on 1/2/21.
years
60-64
1042 DEATH PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
60-64 approximately 3 hours prior to expiring the patient was experiencing forceful emesis. later was found to have expired, patient
years was comfort care only.
60-64
1044 DEATH PFIZER\BIONTECH Death 962716-1 Patient deceased
years
Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted
from vaccine administration, but reporting as required because pt died 7 days later. Narrative: Reporting this event because
patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was
60-64
1045 DEATH PFIZER\BIONTECH Death 964629-1 administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine
years
or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as
monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to
underlying terminal illness.
65+ Vaccine administered with no immediate adverse reaction at 11:29am. Vaccine screening questions were completed and
years resident was not feeling sick and temperature was 98F. At approximately 1:30pm the resident passed away.
Vaccine Event
the patient died; This is a spontaneous report from a contactable consumer through a Pfizer employee. A 98-99 years old patient
of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration possibly on 27Dec2020 at
single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The
65+ patient died on 29Dec2020. Event details: The Pfizer employee was informed, by a member of the Covid vaccine team at the
years ministry of health, that an elderly person 98-99 years old, who used to stay in an elderly home, who also had other serious
diseases and received the vaccine possibly on 27Dec2020, had died this morning (29Dec2020). As it was mentioned to the
Pfizer employee, they were 'sure' that the cause of death did not related to the vaccine. It was not reported if an autopsy was
performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death
65+
1048 DEATH PFIZER\BIONTECH Death 914604-1 Spouse awoke 12/20 and found spouse dead. Client was not transferred to hospital.
years
65+ Injection given on 12/28/20 - no adverse events and no issues yesterday; Death today, 12/30/20, approx.. 2am today (unknown if
years related - Administrator marked as natural causes)
65+ pt passed away with an hour to hour and 1/2 of receiving vaccine. per nursing home staff they did not expect pt to make it many
years more days. pt was unresponsive in room when shot was given. per nursing home staff pt was 14 + days post covid
65+ pt was a nursing home pt. pt received first dose of covid vaccine. pt was monitored for 15 minutes after getting shot. staff
years reported that pt was 15 days post covid. Pt passed away with in 90 minutes of getting vaccine
pt received vaccine at covid clinic on 12/30 at approximately 3:30, pt vomited 4 minutes after receiving shot--dark brown vomit,
65+
1053 DEATH PFIZER\BIONTECH Death 915562-1 staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night. Pt had
years
DNR on file. pt passed away at approximately 10pm. Staff reported pt was 14 + days post covid
65+
1054 DEATH PFIZER\BIONTECH Death 915682-1 contacted. Upon EMS arrival at facility, resident went into cardiac arrest, code initiated by EMS and transported to hospital.
years
65+
1055 DEATH PFIZER\BIONTECH Death 915920-1 Resident received vaccine in am and expired that afternoon.
years
65+
1056 DEATH PFIZER\BIONTECH Death 918388-1 Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
years
65+ Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test result came back positive 1/2/2021
years Deceased 1/4/2021
"deceased on 31Dec2020 with no previous side effect; This is a spontaneous report from a contactable physician via ""Pfizer"".
An 87-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot
Number: ""not known because vaccination team vaccinated at care home""), via an unspecified route of administration on
29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included upper respiratory tract infection,
changing patient weakness; both from an unknown date and unknown if ongoing. Concomitant medications were not reported.
The patient experienced: deceased on 31Dec2020 with no previous side effect; which resulted in death on 31Dec2020. The
clinical course was reported as follows: the patient received the first dose of the PFIZER-BIONTECH COVID-19 MRNA VACCINE
on 29Dec2020; and the patient was deceased on 31Dec2020 with no previous side effect. The patient received the vaccination
with a negative COVID-test on 25Dec2020; ""in case of upper respiratory tract infection and changing patient weakness"". The
65+ physician reported that ""after good breakfast at 09:13 found without vital signs during routine control."" The clinical outcome of
years the event was fatal. The patient died on 31Dec2020 due to unknown cause of death. It was unknown if an autopsy was
performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be
requested during follow up.; Sender's Comments: The limited information available does not allow a meaningful assessment by
the company. The advance old patient had upper respiratory tract infection, changing patient weakness; further information such
as complete medical history, concomitant treatments, particularly death cause and autopsy results are needed for fully medical
assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures
for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics
Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: deceased on 31Dec2020 with no previous side
effect"
Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and sluggish and developed a rash on forearms.
65+
1059 DEATH PFIZER\BIONTECH Death 921481-1 He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of
years
codition reported, doctor and Hospice ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on 1/4/2021
The resident was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over
65+
1060 DEATH PFIZER\BIONTECH Death 921880-1 the last 2 days. He was 96 and had been on hospice care for a little while. Noone noticed any side effects from vaccine after it
years
was given
65+
1061 DEATH PFIZER\BIONTECH Death 925556-1 Expired 1/05/2021
years
65+
1062 DEATH PFIZER\BIONTECH Death 926269-1 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first
years
65+
1063 DEATH PFIZER\BIONTECH Death 926462-1 Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021
years
65+
1064 DEATH PFIZER\BIONTECH Death 926568-1 patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020
years
65+ Patient was vaccinated at 11am and was found at the facility in his room deceased at approximately 3:00pm. Nurse did not have
years cause of death
65+ 3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on
years Hospice care ) expired 6:22 am 1-8-21
65+
1069 DEATH PFIZER\BIONTECH Death 930386-1 Patient received first dose of vaccine on 12/28, developed COVID-19 infection shortly thereafter and expired on 1/6/2021.
years
65+
1070 DEATH PFIZER\BIONTECH Death 930418-1 Patient received first dose of vaccine on 12/28, developed COVID-19 infection shortly thereafter and expired on 1/4/2021
years
65+
1071 DEATH PFIZER\BIONTECH Death 930912-1 Diarrhea followed by death 24 hrs after vaccination
years
65+ 1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not
years breathing. EMS performed CPR and patient deceased
65+
1073 DEATH PFIZER\BIONTECH Death 932787-1 RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21, NO ADVERSE REACTIONS NOTED
years
65+
1074 DEATH PFIZER\BIONTECH Death 934059-1 Acute anterior MI with death
years
Patient went to bed around 11pm on Saturday PM and sometime between then and 1:30am on Sunday morning got up and went
into the living room without waking up her husband (which is normal). At 1:30am, the husband got up to use the restroom and
65+ she was out of bed then, but the husband did not know if she was having any problems at this time. When he got up at 7:45am,
years she was in the recliner and did not move or anything, which is normal for her. At 8:45am, the husband went back into the living
room and tried to wake his wife and that is when he noticed there was no pulse and he called 9-1-1 at this time. EMS got on
scene and did CPR for 30 mins and she was pronounced dead at 9:21am.
65+
1076 DEATH PFIZER\BIONTECH Death 935343-1 There were no adverse reactions. Resident Died, she had a history of issues with her health prior to the vaccine.
years
65+
1077 DEATH PFIZER\BIONTECH Death 935767-1 My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!!
years
65+
1078 DEATH PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
65+
1079 DEATH PFIZER\BIONTECH Death 937444-1 Resident was found deceased at approximately 6pm in her apartment
years
Hospice Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21 resident had decreased appetite noted in am but ate
100% of meal at dinner. 1/9/21 resident had decreased appetite with emesis x 2, loose BM x 2. Call placed to hospice. 1/10/21
65+ 5:44 am resident able to take HS meds, ingest 2 cups of shake. No emesis or loose stool noted. 12PM nurse noted resident not
years eating meals but ingesting milkshake and medications without any problems. Hospice contacted for change in condition. 1:00
pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am
Resident had blood in stool. Resident denies any pain, on 2L of O2 for comfort.
Vaccine Event
patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. An 81-year-old
male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into the right arm on 07Jan2021
at 0.3 mL, single for covid-19 immunization. There was no medical history and no concomitant medications. On 08Jan2021, the
patient passed away after receiving the COVID vaccine. The patient died on 08Jan2021. An autopsy was not performed.
Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The
patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he
potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by
65+
1081 DEATH PFIZER\BIONTECH Death 940822-1 the reporting nurse per The Agency. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested
years
during follow-up .; Sender's Comments: Based on the limited information available, it is medically not possible to make
meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the
known safety profile. However case will be reevaluated when additional information is received during the follow-up The impact
Investigators, as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine
Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old
female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve
replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the
reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the
65+
1084 DEATH PFIZER\BIONTECH Death 941215-1 COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete
years
a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's
mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday
06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day.
The autopsy was unknown. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch
number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown
65+ little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient
years was found unresponsive and pronounced dead later that day.
65+
1087 DEATH PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
1088 DEATH PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
symptoms.
65+ Systemic: reported by staff patient expired under suspicious circumstnces after receiving vaccine. Patient was on hospice,
years reported not expected to pass this soon; symptoms lasted 0 days
resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-
year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140),
intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type
two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food,
or other products: none. Concomitant medications included unspecified products (List of any other medications the patient
received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID
vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The
resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted
in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination,
65+
1090 DEATH PFIZER\BIONTECH Death 944282-1 was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes.
years
Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged
hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.;
Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all
these pre-existing medical conditions contribute to the patient death. More information including complete medical history,
concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of
the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for
Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired
65+
1091 DEATH PFIZER\BIONTECH Death 944365-1 Resident expired on 12/30/20, dx cardiac arrest.
years
65+
1092 DEATH PFIZER\BIONTECH Death 944998-1 On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.
years
71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10am, B/P 99/60, O2 sats,
65+ 95% (trach w/O2). At 11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test
years and assessment (the facility is experiencing an outbreak), and found the patient unresponsive on the bathroom floor. CPR was
immediately started; no shock advised per AED; 12:15pm EMS arrived and took over. At 12:38pm, EMT called time of death.
65+
1094 DEATH PFIZER\BIONTECH Death 945247-1 weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should
years
report
"83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the
middle of the night with c/o feeling ""blah"", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was
65+
1095 DEATH PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
years
unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived
and took over. At or around 6:30am, EMT called time of death"
No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitalizations related to a renal
stone recently. Had a tooth that was bothering her, went to see her dentist and it was extracted on 1/6/21. On 1/10 they noted
65+
1096 DEATH PFIZER\BIONTECH Death 945578-1 feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not
years
eating. Compassionate visit with family. Family did not want hospice, did not feel it was needed, said, what more could they do
for her than you're already doing? On 1/11 at 1950 was determined to be deceased.
65+
1097 DEATH PFIZER\BIONTECH Death 946225-1 resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately
years
passed away.
died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild).
A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an
unspecified route of administration, on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The
patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced
fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021, which was reported as fatal. The
65+
1098 DEATH PFIZER\BIONTECH Death 947642-1 clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the
years
middle of night. It was reported that it was not clear what exactly happened, but they are looking into this. The clinical outcome
of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of
death was not reported. An autopsy was not performed (was reported to be taking place soon). The batch/lot number for the
vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days
after receiving the vaccine
Vaccine Event
65+
1099 DEATH PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
65+
1100 DEATH PFIZER\BIONTECH Death 948228-1 Patient reportedly expired the day following receipt of the vaccine.
years
65+ "The patient stated "" I just feel Blah"". vital signs obtained. 156/75 p-84 spo2 94% via NC 2L. T-96.7, c/o feeling restless, c/o
years nausea with no vomiting. Patient observed at 0600 nonresponsive, CPR initiated, and EMS notified Patient expired"
65+
1102 DEATH PFIZER\BIONTECH Death 949657-1 Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired
years
65+
1103 DEATH PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
65+
years
65+
1106 DEATH PFIZER\BIONTECH Death 951678-1 Heart attack death medical test
years
65+
1107 DEATH PFIZER\BIONTECH Death 952204-1 Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep.
years
65+
1108 DEATH PFIZER\BIONTECH Death 952799-1 On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed
years
resident expired; This is a spontaneous report from a contactable healthcare professional. An 82-year-old male patient received
the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm
on 05Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included metabolic encephalopathy from,
failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness,
hyperlipidemia, chronic kidney disease (CKD), dementia. Known allergies was none. The patient took unspecified concomitant
medication. On 11Jan2021, the resident expired. The patient underwent lab tests and procedures which included nasal swab:
negative on 09Jan2021. There was no treatment given for the event. The patient died on 11Jan2021. An autopsy was not
65+ performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude
years a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure
and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive
(FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic
kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient. The impacts of
this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the
appropriate.; Reported Cause(s) of Death: resident expired
65+
1110 DEATH PFIZER\BIONTECH Death 953754-1 patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia
years
65+
1111 DEATH PFIZER\BIONTECH Death 953865-1 REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS
years
71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver, asthma, and heart condition
65+ was tested for COVID-19 on 01/07/21, received 1st dose of Pfizer COVID-19 vaccine on 01/08/21, positive test result for COVID-
years 19 received on 01/09/21. She was sent to the hospital and admitted on 01/12/21 after O2 was 70% and was in a confused state.
Patient passed away on 01/17/21.
65+
years
Resident received vaccination on January 15, 2021. She was found unresponsive with shallow respirations on the morning of
65+
1115 DEATH PFIZER\BIONTECH Death 955390-1 January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away
years
later that day.
65+
1116 DEATH PFIZER\BIONTECH Death 955436-1 patient received vaccine 12/29. Unexpected death 1/5.
years
65+
1117 DEATH PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on
65+
1118 DEATH PFIZER\BIONTECH Death 956761-1 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He
years
did say that he felt tired, but he often complained of feeling tired over time.
65+
1119 DEATH PFIZER\BIONTECH Death 956843-1 Resident was found deceased in his bed at 7:15 am.
years
65+
1120 DEATH PFIZER\BIONTECH Death 958914-1 Death on 1/15/2020
years
65+ Unknown as to any correlation with vaccine as this was a hospice patient that was already experiencing decline. Patient became
years Jaundice for approximately one week prior to expiring.
65+ Per Nursing Staff- patient died within 24 hours of receiving the vaccine. patient has hospice. Please contact director of nursing
years for more details.
65+
1124 DEATH PFIZER\BIONTECH Death 959747-1 per staff at facility patient died 24 hours post vaccination. Please contact Director of Nursing for further details.
years
"died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a
Pfizer-sponsored program, Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-
BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose
for COVID-19 immunization; administered by the nursing home. Medical history included glaucoma from an unknown date and
unknown if ongoing. Concomitant medications included: ""used a sav for skin tears"", and ""eye drops for glaucoma"" from an
unknown date to an unknown date. On 07Jan2021, the patient experienced: tested positive for COVID (medically significant).
The patient died (death, medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated
that in regard to the patient's height and weight: ""was probably getting down to about five foot eight. Shrinking."" The reporter
stated that If she remembered correctly, they were trying to maintain the patient's weight 135 to 136 pounds. The reporter stated
that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died
on 17Jan2021. The reporter stated that she ""wanted Pfizer to know that the little old people in the nursing might not be strong
enough for the vaccine."" The reporter stated that she was ""not calling to complaining."" The reporter stated that there was
nothing wrong with her dad. He was elderly with no health issues. ""He was literally on no medications. The only reason he was
65+
1126 DEATH PFIZER\BIONTECH Death 960460-1 in the nursing home was because he was afraid to walk."" The reporter stated that she received a call about giving the patient the
years
vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine, the patient tested positive
for COVID ""like all the other people"" (no further details provided). The reporter stated that her dad had no symptoms of COVID.
The director of nursing said the patient was doing so well. The patient ate his lunch, he laid down for nap, and at 14:30 he was
gone. The patient ""went peacefully in his sleep."" The reporter then again stated that the patient literally had nothing wrong with
him. ""They were shocked. They fed him and he took a nap. He was sleeping, but it was eternally."" The reporter stated that, ""it
might not have been the Pfizer vaccine, maybe his heart wore out."" In regard to an autopsy: the reporter stated that they would
get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on
07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none. It was unknown if there
were additional vaccines administered on the same date of the Pfizer suspect, but the reporter doubted it. There were no prior
vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event,
died, was fatal. The clinical outcome of the event, tested positive for COVID, was unknown. The patient died on 17Jan2021 due
to an unknown cause of death. An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH
COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: died"
Vaccine Event
At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team
would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can
help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and
maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and
proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the
day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop
occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in
and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a
thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we
got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the
patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes
ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and
had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I
65+ then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all
years the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for
Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was
monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to
announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After
speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the
vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing
her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to
vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At
approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually
not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021,
they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the
consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating
state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the
clinic.
65+
1128 DEATH PFIZER\BIONTECH Death 961434-1 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient
years
1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient
65+
1129 DEATH PFIZER\BIONTECH Death 961776-1 appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08:
years
Pronounced deceased.
tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable
consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant
medications were not reported. Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and
65+
1131 DEATH PFIZER\BIONTECH Death 962307-1 couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon
years
after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an
autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown. No follow-
up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped
breathing
65+ Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock; Aneurysm of arteriovenous
years dialysis fistula; expired 1/16/2021
65+
1134 DEATH PFIZER\BIONTECH Death 962714-1 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart
years
65+
1137 DEATH PFIZER\BIONTECH Death 962827-1 appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the
years
On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was experiencing N/V and some
65+ throat swelling. Patient subsequently collapsed and expired before she could be brought to an emergency room. During
years investigation by Coroners Office, it has been reported that Patient may have gotten some takeout food while she was out. Labs
are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine.
65+
1140 DEATH PFIZER\BIONTECH Death 964617-1 Death, which I believe is unrelated to vaccination
years
Pt on hospice in facility for severe cardiomyopathy unable to perform interventions received vaccine without adverse sequelae
died 5 days later. Reporting as required. Narrative: Reporting as required patient death 5 days after immunization with Pfizer
vaccine. However, no adverse sequelae were noted to the vaccine in the 15minute observation period, nor in the days following
65+
1141 DEATH PFIZER\BIONTECH Death 964636-1 the immunization related to the vaccine. The patient denied any prior severe reaction to this vaccine or its components, and the
years
patient gave verbal consent to receive the vaccine. Patient had been in the facility on hospice since 11/18/20 for severe
decompensated HF and newly diagnosed cardiomyopathy, unable to perform interventions, also LE ischemic wounds with very
poor potential to heal due to advanced PVD.
loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on
12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd
65+ vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He
years experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9
with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was
most consistent with an aspiration pneumonia.
65+
1143 DEATH PFIZER\BIONTECH Death 964671-1 Death on 1-5-21
years
65+
1144 DEATH PFIZER\BIONTECH Death 964724-1 Death 1-15-21
years
Diarrhoea; This is a spontaneous report from a contactable other healthcare professional via Agency and downloaded from the
Regulatory Authority GB-MHRA-WEBCOVID-20201212222117, Safety Report Unique Identifier GB-MHRA-ADR 24542707 and EU-
EC-10007191252. An elderly patient of an unspecified gender received bnt162b2 (batch/lot number not provided), via an
1145 DEATH PFIZER\BIONTECH Unknown Death 907575-1 unspecified route of administration in 2020 at single dose for COVID-19 immunisation. The patient's medical history and
concomitant medications were not reported. The patient experienced diarrhoea in 2020. The patient died due to diarrhoea on
10Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on the lot/batch
number not obtainable. No further information is expected.; Reported Cause(s) of Death: diarrhoea
1146 DEATH PFIZER\BIONTECH Unknown Death 908245-1 vaccination. The patient's medical history was not reported. Concomitant medication included sildenafil, acetylsalicylic acid,
Vaccine Event
found dead in his bed; This is a spontaneous report from a contactable healthcare professional received via the Ministry of
Health department of epidemiology. The department of epidemiology reported similar events for two patients. This is the second
of two reports. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;
Lot Number: EK4175), via an unspecified route of administration on 24Dec2020 as a single dose for COVID-19 immunization.
Medical history included schizophrenia, very heavy smoker for almost 50 years, emphysema, and tumor resection in the bladder.
The patient's concomitant medications were not reported. On 28Dec2020, the patient was found dead in his bed. It was reported
that the patient did not have any complaints in the days following the vaccination. Then, on 28Dec2020, the patient was found
dead. The cause of death was unknown. It was not reported if an autopsy was performed.; Sender's Comments: A reasonable
1147 DEATH PFIZER\BIONTECH Unknown Death 918722-1
possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until
further information regarding clinical course and death cause is provided. Of note, the patient did not have any complaints in the
days following the vaccination. The case was confounded by the patient's underlying conditions. The impact of this report on the
appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 same reporter, same vaccine, reporting similar events in different
patients.; Reported Cause(s) of Death: found dead in his bed
Sudden death; This is a spontaneous report from a contactable physician and consumer. A 41-year-old female patient received
the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 30Dec2020 at
0.3 mL single dose for COVID-19 immunisation. Medical history included hypertension. The patient's concomitant medications
were not reported. On 01Jan2021, the patient experienced sudden death. The clinical course was as follows: The patient didn't
experience any adverse event at the moment of inoculation with COVID-19 vaccine or the following days. On 01Jan2021, at
lunch time, two days after receiving the vaccine, the patient was found unresponsive in her bed by her partner. The cause of
1148 DEATH PFIZER\BIONTECH Unknown Death 923219-1 death was unknown. It was reported that an autopsy would be performed in the next days; the results were not yet available. The
lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The
Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death
cardiac arrest; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162B2
(PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 as single dose for
covid-19 immunization. Medical history included asthma and a little overweight from an unknown date. The patient's
concomitant medications were not reported. The patient experienced cardiac arrest on an unspecified date, which was serious
as it lead to death. The patient died on an unspecified date. It was not reported if an autopsy was performed. This batch/lot
1149 DEATH PFIZER\BIONTECH Unknown Death 925616-1 number is not available despite the follow-up attempts made. No further information is expected.; Sender's Comments: The
Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac arrest
1150 DEATH PFIZER\BIONTECH Unknown Death 928992-1 was serious as it was medically significant, involved hospitalization and lead to death. Clinical course was as follows: the patient
Death; Loose stools; Vomited; This is a spontaneous report from a contactable other healthcare professional by Pfizer from the
Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20201230164020. An elderly
female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Batch: EJ1677, Expiration date: Feb2021) via an
unspecified route on 29Dec2020 at single dose for Covid-19 vaccination. Medical history included dementia and a history of
urinary tract infection and delirium, all from an unknown date and unknown of ongoing. Concomitant medication included
influenza vaccine (INFLUENZA VIRUS, Batch: 4924B1A) for influenza immunization. Patient has not had symptoms associated
with COVID-19. Patient is not enrolled in clinical trial. No known allergies. The patient had not tested positive for COVID-19 since
having the vaccine. On the 29Dec2020 the patient experienced loose stools and vomited. The patient underwent lab tests and
procedures which included COVID-19 virus test: no -negative on 08Dec2020. The patient died on the 30Dec2020 at 11:25 am in
the morning. It was unknown if a postmortem was going to be carried out, after talking to the general practice surgery they
advised that the general practitioner was only passed notification of the patient's death that afternoon (04Jan2021). It was
advised that they may go to the coroner but couldn't give a definitive answer until the general practitioner had looked at the
notification. It was not reported if an autopsy was performed. No follow up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: Death
1152 DEATH PFIZER\BIONTECH Unknown Death 929027-1 his daughter, he complained about pain in the arm and swelling in the arm of vaccination on an unspecified date of Dec2020. At
SEPSIS; respiratory distress; PLEURAL EFFUSION; This is a spontaneous report received from other healthcare professional via
the Division of epidemiology of the Ministry of Health. The other healthcare professional reported similar events for three
patients. This is the third of three reports. A 91-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19
VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history
included known background of blood pressure disease, diabetes, malignant bladder from an unknown date and unknown if
ongoing. The patient's concomitant medications were not reported. Patient was received at the emergency room 3 days after
receiving the corona vaccine in Jan2021, with fever, vomiting more than 40 times, in respiratory distress, was hospitalized in
internal medicine department with sepsis diagnosis due to respiratory distress and pleural effusion, intubated, his condition was
serious, patient passed away on 04Jan2021. Cause of death was reported as sepsis, respiratory distress and pleural effusion. It
was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.
Information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information currently provided, the
fatal events sepsis, respiratory distress and pleural effusion are more likely attributed to intercurrent infectious conditions
associated with the advanced old patient underlying diseases . The impact of this report on the benefit/risk profile of the Pfizer
promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER
INC-2020519349 same reporter, product, similar event, different patient;IL-PFIZER INC-2021009751 same reporter, product,
similar event, different patient; Reported Cause(s) of Death: SEPSIS; respiratory distress; PLEURAL EFFUSION
1154 DEATH PFIZER\BIONTECH Unknown Death 930431-1 Cardiac event, 2 days after vaccination, patient expired.
Death within 24 hours after dose; This is a spontaneous report from a contactable consumer downloaded from the regulatory
authority (GB-MHRA-EYC 00236003 and GB-MHRA-ADR 24545815). A 78-year-old male patient received BNT162B2
(COMIRNATY), via an unspecified route of administration, on 20Dec2020 at 16:00 as a single dose for COVID-19 immunization.
Medical history included cardiac disease and lung disease. The patient had no known allergies. Concomitant medications
included an unspecified hypertensive taken for hypertension, an unspecified drug for ischaemic heart disease, and an
unspecified drug for chronic obstructive pulmonary disease (COPD). The patient experienced death within 24 hours after dose
1155 DEATH PFIZER\BIONTECH Unknown Death 933230-1 on 21Dec2020. The event was reported as fatal. The clinical course was reported as follows: The patient was observed for 15
minutes after the dose was given and had no side effects. In the evening, the patient felt well. The patient received the
vaccination as he was a high risk patient, elderly, and with a background of cardiac and lung disease. The clinical outcome of
death within 24 hours after dose was fatal. The patient died on 21Dec2020. The cause of death was unexplained. It was
unknown if an autopsy was performed. The reporter assessed the causality between the vaccination and death as unlikely. No
follow-up attempts possible; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death
unexplained
Death; Head ache and dizziness; Head ache and dizziness; Spitting blood; Vomiting blood; Nose bleed; This is a spontaneous
report a contactable consumer downloaded from the Regulatory Authority(GB-MHRA-WEBCOVID-20201220100831 and GB-
MHRA-ADR 24545199). A male patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of
administration, on 17Dec2020 as a single dose for COVID-19 immunisation. Medical history included vitamin D3 deficiency and
asthma. Concomitant medications included colecalciferol (MANUFACTURER UNKNOWN) for vitamin deficiency and salbutamol
sulfate (VENTOLINE) for asthma. The patient experienced nose bleed on 17Dec2020, head ache and dizziness, spitting blood,
and vomiting blood on 18Dec2020, and death on 20Dec2020. All of the events were reported as fatal. It was reported that a
healthcare professional advised the patient to take unspecified pain medication after explaining mild and strong side effects to
help with pain. The patient underwent lab tests and procedures which included COVID-19 virus test: No - negative COVID-19 test
on an unspecified date. Therapeutic measures were taken as a result of nose bleed, head ache and dizziness, spitting blood, and
vomiting blood as aforementioned. The clinical outcome of nose bleed, head ache and dizziness, spitting blood, vomiting blood,
and death was fatal. The patient died on 20Dec2020. The cause of death was unexplained. It was not reported if an autopsy was
performed. It was also reported that since the vaccination, the patient had not been tested positive for COVID-19. No follow-up
attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death unexplained
Vaccine Event
patient died after collapsing in his home several hours after he received the vaccine; patient died after collapsing in his home
several hours after he received the vaccine; The initial case was missing the following minimum criteria: the reporter does not
have first-hand knowledge of the reported events and was not identifiable. Upon receipt of follow-up information on 06Jan2021,
this case now contains all required information to be considered valid. This is a spontaneous report from a contactable
healthcare professional via regulatory Authority. The regulatory authority reported similar events for three patients. This is the
first of three reports. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot
Number: EK4237), via an unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization.
Medical history included dementia, cardiac background with pacemaker, atrial fibrillation, heart failure, and penicillin allergy. The
patient was not allergic to polyethylene glycol. The patient's concomitant medications were not reported. On 29Dec2020, the
patient died after collapsing in his home several hours after he received the vaccine. Outcome of collapsing was not recovered.
The patient had no pulse when he arrived at the hospital. It was not reported if an autopsy was performed. The cause of death
was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The advance old
patient had underlying cardiac background with pacemaker, atrial fibrillation and heart failure, therefore the pre-existing
cardiovascular medical conditions more likely provide explanations for collapsing lead to the patient death. More information
especially death cause and autopsy results are needed for further meaningful assessment. The impact of this report on the
appropriate.,Linked Report(s) : IL-PFIZER INC-2021009752 same reporter, product, similar event, different patient;IL-PFIZER INC-
2021009751 same reporter, product, similar event, different patient; Reported Cause(s) of Death: Unknown cause of death
Death in connection with the vaccination and/or Covid19 disease / positivity; Death in connection with the vaccination and/or
Covid19 disease / positivity; This is a spontaneous report from a contactable physician. This physician reported similar events
for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19
immunization. The patient's medical history and concomitant medications were not reported. It was reported 2 deceased were
autopsied, death in connection with the vaccination or Covid19 disease / positivity.; Sender's Comments: The information
currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as
related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk
response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER
INC-2021006738 same reporter, same product, same event, different patient; Reported Cause(s) of Death: Death in connection
with the vaccination and/or Covid19 disease / positivity; Death in connection with the vaccination and/or Covid19 disease /
positivity
1159 DEATH PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
Sepsis; Acute bronchopneumonia; This is a spontaneous report received from a contactable physician downloaded from the
Regulatory Authority (GB-MHRA-EYC 00236063 and GB-MHRA-ADR 24546059). An 85-year-old female patient received the first
dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 15Dec2020 as a single dose for COVID-19
vaccination. The patient's medical history was not reported. Concomitant medications included pregabalin (MANUFACTURER
UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), candesartan
(MANUFACTURER UNKNOWN), and levothyroxine (MANUFACTURER UNKNOWN). The patient experienced acute
bronchopneumonia on 18Dec2020 and sepsis on an unspecified date. The events caused hospitalization and were reported as
fatal. The clinical course was reported as follows: The patient was brought to the hospital by ambulance with severe sepsis and
bronchopneumonia. She was resuscitated but unfortunately died shortly after arriving. The family reported that the patient
received the coronavirus vaccine on 15Dec2020. It was reported that it is unclear from the family history whether she was unwell
before she received the vaccine. The clinical outcome of acute bronchopneumonia and sepsis was fatal. The patient died on
19Dec2020. The cause of death was reported as acute bronchopneumonia and sepsis. It was not reported if an autopsy was
performed. No follow-up attempts are possible; information on batch number cannot be obtained.; Sender's Comments: The
information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular
the following relevant information is not available: medical history, autopsy report.; Reported Cause(s) of Death: Sepsis; Acute
bronchopneumonia
Lower respiratory tract infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory
Authority GB-MHRA-EYC 00236087, Safety Report Unique Identifier: GB-MHRA-ADR 24546153 . A 83-year-old female patient
received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 18Dec2020 at single dose for covid-19
immunization. Medical history included vascular dementia from an unknown date and unknown if ongoing, severely frail from an
unknown date and unknown if ongoing. This patient was severely frail as a result of vascular dementia and was a permanent
nursing home resident. Concomitant medication included amoxicillin, doxycycline, sodium valproate, quetiapine, omeprazole,
paracetamol. The patient experienced lower respiratory tract infection (LRTI) on an unspecified date. Patient died on 22Dec2020
1161 DEATH PFIZER\BIONTECH Unknown Death 934782-1 within 5 days of receiving Covid vaccine, had been on antibiotics for LRTI for 2 days and had appeared to be improving,
temperature was settled before vaccine was administered. She had a negative Covid swab at the onset of her symptoms. It
would seem more likely that this patient died as a result of an evolving LRTI than as a result of receiving Covid vaccination. She
was changed to amoxicillin 2 days before she died. The other outcome for Death was: Died 22Dec2020 but cause of death felt to
be due to LRTI not vaccine. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on
batch number cannot be obtained.; Sender's Comments: The underlying predisposing condition (severely frail, lower respiratory
tract infection) have been assessed to have played a major role toward the event.; Reported Cause(s) of Death: Lower respiratory
tract infection
Death; This is a spontaneous report from a contactable consumer and a physician downloaded from the Regulatory Authority
number GB-MHRA-WEBCOVID-20201222043330 and Safety Report Unique Identifier GB-MHRA-ADR 24545938. A 78-year-old
male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: EJ0553) via an
unspecified route of administration on 20Dec2020 around 15:45 at single dose in left upper arm for COVID-19 vaccination. The
patient ongoing medical history included Depression, Hypertension, chronic obstructive pulmonary disease and ischaemic heart
disease. Patient is not enrolled in clinical trial. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient
has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken for Depression. The
patient was taking unspecified concomitant medications for hypertension, chronic obstructive pulmonary disease (COPD) and
ischaemic heart disease. The patient experienced death in Dec2020 (reported as in the evening of the 20Dec2020 or morning of
21Dec2020). Specifically, it was reported that the patient had the first dose of the vaccine at around 15:45 on 20Dec2020 and
was observed for 15 minutes after with no side effects, the patient then left the site with family member. He was well that
evening, he lived alone but spoke on the phone in the evening and felt well. On the 21Dec2020, after went to check on him and he
was found in his bed passed away. When seeing the body, it was assumed that he had passed away in the evening of the
20Dec2020 or morning of 21Dec2020. Although unlikely, it was less than 24 hours after taking the vaccine. Patient has not
tested positive for COVID-19 since having the vaccine. The patient was found dead in his flat the next day on 21Dec2020 by next
of kin. He was dropped of home by family after the vaccination, he spoke to his family on the night after having the vaccination
and told them he was feeling fine and was going to bed. He did not respond to telephone calls the next day (on Monday
21Dec2020) so the family went over to his flat and found he had passed away. The patient was registered at another surgery.
Screening questions were asked, no contra indication found. It was not reported if an autopsy was performed. No follow-up
attempts are possible. No further information is expected.; Reported Cause(s) of Death: death
Fever; This is a spontaneous report from a newsletter, from a contactable consumer (profession unspecified). Regulatory
authority report number was not provided. An elderly female patient received bnt162b2 (COMIRNATY, Solution for injection, lot
number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for
COVID-19 immunization. Medical history included ongoing dementia in a palliative state. The patient's concomitant medications
were not reported. The verbatim narrative was reported as follows: 'Status report on suspected side effects from vaccination
against covid-19. The report on the second death was received on 05Jan2020. It concerns an elderly female with dementia in a
palliative state. The female was vaccinated with Comirnaty, had fever on an unspecified date and passed away three days later.
The information in the report is very brief and will seek additional information from the reporter. Currently, has no information on
the female's confirmed cause of death and there is no established causality with the vaccine.' The patient died on an unspecified
date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible;
information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: had fever and passed away three days
later
Vaccine Event
heart attack; This is a spontaneous report from a non-contactable consumer (discovered on news page and heard in news). An
elderly female patient (elderly than 90-year old from home for elderly) received bnt162b2 (COMIRNATY) via unspecified route of
administration on unspecified date at single dose for COVID-19 immunization (other details not reported). Medical history
included heart attack. Concomitant medications were not reported. patient experienced heart attack six hours after vaccination
that obviously occurred after repeated heart attack. It was stated that heart attack was not connected to the vaccination. There
was no acute allergic reaction. Case was further investigated (independent committee) and confirmed the vaccination was not
reason of death. Patient died from heart attack, it was unknown if autopsy was done. Information on batch number has been
request.; Sender's Comments: Fatal heart attack is not related to bnt162b2 use; the advanced old patient had pre-existing
medical condition including previous episode of heart attack thus the underlying cardiovascular provided an explanation for the
event onset.; Reported Cause(s) of Death: heart attack
Death; This is a spontaneous report from a contactable Physician. An elderly male patient received BNT162B2 (COVID vaccine),
via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. The
patient's medical history and concomitant medications were not reported. The patient experienced death in Jan2021. It was
unknown if an autopsy was performed. It was unknown if any treatment was received for the event. It was unknown if the patient
was diagnosed with COVID prior vaccination or if the patient had been tested for COVID post vaccination. Seriousness criteria
for the event was reported as death and hospitalization. Pfizer is a marketing authorization holder of [COVID vaccine] in the
country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another
1165 DEATH PFIZER\BIONTECH Unknown Death 934963-1 marketing authorization holder of [COVID vaccine] has submitted the same report to the regulatory authorities. Information
about lot/batch number has been requested.; Sender's Comments: Current information is very limited for full assessment.
Further information such medical history, concomitant medications, concurrent illness and event term details especially death
cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer
promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death:
Death
COVID-19
Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in connection with the vaccination and/or
COVID-19 disease/positivity; This is a spontaneous report from a contactable physician. This physician reported similar events
for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose for COVID-19
immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, there was
death in connection with the vaccination and/or COVID-19 disease/positivity. It was reported that: two deceased were autopsied,
whose death was in connection with the vaccination or COVID-19 disease/positivity. The clinical outcome of death in connection
with the vaccination and/or COVID-19 disease/positivity was fatal. The patient died on an unspecified date. The cause of death
1168 DEATH PFIZER\BIONTECH Unknown Death 937724-1 was reported as: death in connection with the vaccination and/or COVID-19 disease/positivity. An autopsy was performed, and
the results were not reported.; Sender's Comments: The association between the event lack of effect (death was in connection
with the vaccination or COVID-19 disease positivity) with BNT162b2 can not be fully excluded given the limited information. The
impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety
review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and
Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021006905 same reporter, same product, same event, different
patient; Reported Cause(s) of Death: Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in
connection with the vaccination and/or COVID-19 disease/positivity
death following BNT 162b2 vaccination; This is a spontaneous report from a contactable consumer. A patient of unspecified age
and gender received BNT162B2 (COMIRNATY; PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of
1169 DEATH PFIZER\BIONTECH Unknown Death 937985-1 administration on an unspecified date as the first single dose for COVID-19 immunization. The patient's medical history and
concomitant medications were not reported. Death following BNT162B2 vaccination was noted on an unspecified date. The
patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: death
Acute cardio-respiratory event and died a few hours later; This is a spontaneous report received from a contactable physician by
Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210107093111. Safety
Report Unique Identifier GB-MHRA-ADR 24565959. An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE) at single dose, on 04Jan2021, for COVID-19 immunisation. Patient was elderly and frail and gradually
declining in mobility, communication and memory over the last 12 months. Relevant medical history also included vascular
dementia form an unspecified date and unknown if ongoing. Concomitant medications were unknown. Patient was not enrolled
in clinical trial. COVID-19 virus test was performed twice on an unspecified date, in Dec2020 and on 18Dec2020 and the results
were negative. On 04Jan2021, at 06:00 PM, the patient experienced acute cardio-respiratory event and died a few hours later. It
was unknown if autopsy was done. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have
symptoms associated with COVID-19. The patient was kept comfortable in the nursing home in these last few hours. There was
no way to know whether the vaccine was to blame at all, it was unlikely. No follow-up attempts are possible, information about
lot number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory failure
died; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. A patient of unspecified
age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on an
unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not
reported. It was reported the patient was a doctor, died after the vaccine with no apparent disease. It was not reported if an
autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported
Cause(s) of Death: Unknown cause of death
Death; Malaise; Vomiting; This is a spontaneous report received from a contactable physician from the Regulatory Agency (RA).
The Regulatory Authority report number is GB-MHRA-WEBCOVID-20210105172532, Safety Report Unique Identifier GB-MHRA-
ADR 24558660. An 81-year-old female patient received bnt162b2 (BNT162B2) (lot# EJ1688), via an unspecified route of
administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included vascular dementia
(advanced dementia), dementia Alzheimer's type (vascular and Alzheimer's mixed dementia), oral intake reduced (patient known
to not be eating or drinking), fluid intake reduced, (patient known to not be eating or drinking), general physical health
1172 DEATH PFIZER\BIONTECH Unknown Death 939332-1 deterioration (patient known to be declining); all from an unknown date and unknown if ongoing. Concomitant medications were
not reported. The patient experienced death on 03Jan2021, malaise on 01Jan2021 with fatal outcome, vomiting on 01Jan2021
with fatal outcome. It was reported that 48 hours after vaccination the patient became unwell, vomited and then died on
03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Dec2020.
Patient has been not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. It
was not known whether vaccine caused reaction. No follow-up attempts are possible. No further information is expected.;
Reported Cause(s) of Death: Malaise; Vomiting; Death
breathless on exertion; This is a spontaneous report received from a contactable other health professional received from the
United Kingdom's Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is
GB-MHRA-ADR 24561910, other case identifier number: GB-MHRA-WEBCOVID-20210106094618. An 80-years-old male patient
received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot no: EJ1688), via an unspecified route of administration on
30Dec2020 single dose for covid-19 immunisation. Medical history included Bowen's disease, basal cell carcinoma, chronic
kidney disease and essential hypertension, all unknown if ongoing. Concomitant medication included alfacalcidol (unknown
manufacturer), amlodipine (unknown manufacturer), atorvastatin (unknown manufacturer), clopidogrel (unknown manufacturer),
prazosin (unknown manufacturer), sodium bicarbonate (unknown manufacturer), folic acid (unknown manufacturer), furosemide
(unknown manufacturer). The patient experienced breathless on exertion on 02Jan2021. The patient died on 02Jan2021 due to
the event. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on
unknown date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information
expected.; Reported Cause(s) of Death: Dyspnoea exertional
Vaccine Event
Death; Vomiting; This is a spontaneous report from a contactable other health professional from the Regulatory Agency. The
regulatory authority report number is GB-MHRA-ADR 24573192. An elderly female patient received the bnt162b2 (PFIZER-
BIONTECH COVID-19 MRNA VACCINE; Lot Number: BJ1688 and EJ1688; as reported), via an unspecified route of administration
on 05Jan2021 at 12:26 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications
were not reported. The patient had not had symptoms associated with COVID-19; and was not enrolled in the clinical trial. On
05Jan2021 at 12:51, the patient experienced vomiting (non-serious); 25 minutes post vaccine (had further vomiting episodes).
On 07Jan2021 at 01:00, the patient experienced death; which caused death, and was medically significant. The patient had not
tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19
virus test: no-negative COVID-19 test on an unspecified date. The clinical outcome of the event, vomiting, was unknown. The
clinical outcome of the event, death, was fatal. The patient died on 07Jan2021 at 01:00 due to unknown cause of death. An
autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of
Death: Death
thrombopenia; pulmonary embolism; neutropenia fever; This is a spontaneous report from a Pfizer-sponsored program . A
contactable consumer reported for a patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an
unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical
history and concomitant medications were not reported. The patient experienced thrombopenia, pulmonary embolism and
neutropenia fever on an unspecified date. The clinical outcome of thrombopenia, pulmonary embolism and neutropenia fever
was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. The batch/lot number for the
vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: thrombopenia;
pulmonary embolism; neutropenia fever
Sudden death; This is a spontaneous report from a contactable physician from the regulatory authority. The regulatory authority
report number is GB-MHRA-ADR 24556755. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19
mRNA VACCINE; Lot number EJ0553), via an unspecified route of administration on 19Dec2020 as single dose for COVID-19
immunization. Medical history included Waldenstrom's macroglobulinemia for Waldenstrom's macroglobulinaemia, memory
impairment, with recent memory problems, cerebrovascular accident , with previous CVA, joint swelling , reported as slight ankle
swelling awaiting head CT scan and bloods, oesophagitis, and cholesterol, all from an unknown date and unknown if ongoing.
Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) for Waldenstrom's macroglobulinaemia,
lansoprazol (MANUFACTURER UNKNOWN) for oesophagitis, simvastatin (MANUFACTURER UNKNOWN) for blood cholesterol.
The patient had sudden death on 29Dec2020. The patient died on 29Dec2020. It was not reported if an autopsy was performed.
The reporter did not think the COVID vaccination caused the patients death; It did not appear to be related. The patient was seen
by the physician on the 24th (not otherwise specified), and was fine. The patients son also saw the patient on the 28th (not
otherwise specified) and also fine with no side effects from the jab. No follow-up attempts are possible. No further information
is expected.; Sender's Comments: Based on the information currently provided, the company considers the patient death is
unrelated to the vaccine use; the advance old patient having multiple pre-existing medical conditions including Waldenstrom's
macroglobulinaemia and cerebrovascular accident, which more likely led the patient to sudden death.; Reported Cause(s) of
Death: Sudden death unexplained
1177 DEATH PFIZER\BIONTECH Unknown Death 944118-1 concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced SARS-coV-2
1178 DEATH PFIZER\BIONTECH Unknown Death 944121-1 enrolled in clinical trial. The patient's concomitant medications were not reported. The patient experienced cardiac arrest on
1179 DEATH PFIZER\BIONTECH Unknown Death 944154-1 floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR,
1181 DEATH PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
patient died while there were no other complaints at that time; This is a spontaneous report received from a contactable
consumer (Pfizer colleague). A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of
administration on 07Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant
1182 DEATH PFIZER\BIONTECH Unknown Death 947270-1 medications were not reported. The patient died 3 days after the vaccination while there were no other complaints at that time
on 10Jan2021. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The family assessed there was
a causal relationship with the vaccine. Information on the lot/batch number has been requested.; Reported Cause(s) of Death:
died 3 days after the vaccination while there were no other complaints
Died in sleep; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority.
Regulatory authority report number was GB-MHRA-ADR 24556999 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-
20210105122200. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:
EJ1688), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 vaccination. Medical history
included craniotomy in 2019, acute subdural haematoma in 2019, and ongoing bedridden following a craniotomy for an acute
subdural haematoma from 2019. The patient was not enrolled in clinical trial. Concomitant medications included atorvastatin
(MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), ferrous sulfate (MANUFACTURER UNKNOWN),
finasteride (MANUFACTURER UNKNOWN), flucloxacillin (MANUFACTURER UNKNOWN), colecalciferol (FULTIUM D3), gabapentin
(MANUFACTURER UNKNOWN), hypromellose (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER
UNKNOWN), betamethasone dipropionate/clotrimazole (LOTRIDERM) , macrogol (MANUFACTURER UNKNOWN), tramadol
hydrochloride (MAROL), omeprazole (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN), paracetamol
(MANUFACTURER UNKNOWN), senna spp. (MANUFACTURER UNKNOWN), and influenza vaccine inact sag 4v (FLUCELVAX
TETRA). On 05Jan2021, the patient died in his sleep. The clinical course was as follows: The patient had not had symptoms
associated with COVID-19. The patient received the vaccination on 31Dec2020. The patient had tested negative for COVID-19
since having the vaccine on an unknown date. There were no other reactions noted but the patient died in his sleep overnight on
05Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Died in sleep
tested Covid positive/suspected COVID-19; tested Covid positive/suspected COVID-19; Shortness of breath; Fall; This is a
spontaneous report from a contactable physician from the Regulatory Agency. The regulatory authority report number is GB-
MHRA-WEBCOVID-20210106123053. An 81-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation.
Medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection, shortness of
breath on 03Jan2021. Reaction to vaccine is none. Patient was admitted with fall and on the floor for 5 hours on 03Jan2021. He
was tested COVID positive on admission on 03Jan2021. So he tested positive about two weeks after first dose of Pfizer COVID-
19 vaccine. Patient was suspected COVID-19 from 03Jan2021. The patient underwent lab test included COVID-19 virus test: Yes
- Positive COVID-19 test (03Jan2021). Outcome of the events was fatal. The patient died on 03Jan2021. It was unknown if an
autopsy was performed. Cause of death reported as SARS-CoV-2 infection/suspected COVID-19, shortness of breath and fall. No
follow-up attempts possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2
infection/suspected COVID-19; SARS-CoV-2 infection/suspected COVID-19; shortness of breath; Fall
1185 DEATH PFIZER\BIONTECH Unknown Death 950935-1 Resident expired
Vaccine Event
Death (death certificate: uncertain type of death); evening vomiting; This is a spontaneous report from a non-contactable
physician the Regulatory Authority. This is a report received from the Regulatory Authority. Regulatory authority report number
was DE-PEI-CADRPEI-2021011672. A 79-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EJ6796),
intramuscular on 30Dec2020 as a single dose for COVID-19 immunization. Medical history included especially autoimmune
encephalopathy of paraneoplastic origin and suspected urothelial carcinoma of the bladder. The patient's concomitant
1186 DEATH PFIZER\BIONTECH Unknown Death 952914-1 medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) on
03Dec2020 for immunization and was tolerated. On 31Dec2020 (also reported as 30Dec2020), the patient developed evening
vomiting which was dark in color and most likely food related. On 31Dec2020 at 04:35, the patient died. It was not reported if an
autopsy was performed. The clinical outcome of vomiting was reported as fatal; however, the cause of death was reported as
unknown cause of death. The vomiting and unknown cause of death were reported as medially significant and fatal. No follow-
up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death
his platelet levels dropped and he had a hemorrhagic stroke; his platelet levels dropped and he had a hemorrhagic stroke; This is
a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19
immunization. The relevant medical history and concomitant medications were not reported. The patient died 2 weeks after his
COVID shot because his platelet levels dropped and he had a hemorrhagic stroke. No further information provided. The autopsy
was unknown. The outcome of the events was fatal. Information on the lot/ batch number has been requested.; Reported
Cause(s) of Death: his platelet levels dropped and he had a hemorrhagic stroke; his platelet levels dropped and he had a
hemorrhagic stroke
expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar
death events for 8 patients. This report is for 5th of 8 patients. A patient of unspecified age and gender received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for
COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired
before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy
1188 DEATH PFIZER\BIONTECH Unknown Death 955879-1 was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information
provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related
to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical
course before death, complete medical history and concomitant medication and autopsy report, becomes available.,Linked
Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired
before receiving the second dose
passed unexpectedly; This is a spontaneous report from a contactable nurse communicated to a Pfizer colleague. This nurse
reported similar death events for 8 patients. This report is for 8th of 8 patients. A patient of unspecified age and gender received
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for
COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient passed
unexpectedly on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed.
Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report
does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug
per company guidance. This case will be reassessed when additional information, particularly the clinical course before death,
complete medical history and concomitant medication and autopsy report, becomes available. The case will be reassessed if
additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated
as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any
safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595
same drug, reporter and event but different patient; Reported Cause(s) of Death: passed unexpectedly
1190 DEATH PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
death events for 8 patients. This report is for 1st of 8 patient. A patient of unspecified age and gender received first dose of
bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for
covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired
before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about
Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died
following the vaccine use; further information such as patient demographics, complete medical history, concomitant
medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful
1191 DEATH PFIZER\BIONTECH Unknown Death 960426-1 evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for
Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034597 same drug, reporter and event but
different patient;US-PFIZER INC-2021034598 same drug, reporter and event but different patient;US-PFIZER INC-2021034599
same drug, reporter and event but different patient;US-PFIZER INC-2021034600 same drug, reporter and event but different
patient;US-PFIZER INC-2021034601 same drug, reporter and event but different patient;US-PFIZER INC-2021034603 same drug,
reporter and event but different patient;US-PFIZER INC-2021034596 same drug, reporter and event but different patient.;
Reported Cause(s) of Death: expired before receiving the second dose
events for 8 patients. This report is for 2nd of 8 patients. A patient of unspecified age and gender received the first dose of
covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before
receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch
number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the
vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent
illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of
this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
Investigators, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose
events for 8 patients. This report is for 3rd of 8 patients. A patient of unspecified age and gender received the first dose of
covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before
receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch
number is requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely
1193 DEATH PFIZER\BIONTECH Unknown Death 960428-1 exclude the possible causality between the reported death and the administration of COVID 19 vaccine, bnt162b2. However,
more information on the patient's underlying medical condition, concomitant medications, patient's age group, clinical course
and relevant lab tests would be helpful for the Company to make a more meaningful causality assessment. The impact of this
appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: expired before
receiving the second dose
events for 8 patients. This report is for 4th of 8 patient. A patient of unspecified age and gender received the first dose bnt162b2
(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19
immunization. The patient's medical history and concomitant medications were not reported. The patient expired before
receiving the second dose on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was
performed. Information about Lot/Batch number has been requested.; Sender's Comments: Current information is very limited
1194 DEATH PFIZER\BIONTECH Unknown Death 960429-1 for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete
medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results
are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as
part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any
safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595
same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose
7 residents expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse
reported similar events for 8 patients. This report is for 6th of 8 patients. A patient of unspecified age and gender received first
dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at
SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The
patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.
Information on the lot/batch number has been requested.; Sender's Comments: The event death is assessed as related to
BNT162b2 vaccine and documented as such in the global safety database until sufficient information is available to allow an
unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of
Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory
authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug,
reporter and event but different patient; Reported Cause(s) of Death: 7 residents expired before receiving the second dose
Vaccine Event
death events for 8 patients. This report is for 7th of 8 patient. A patient of unspecified age and gender received first dose of
covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired
before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about
Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died
1196 DEATH PFIZER\BIONTECH Unknown Death 960431-1 following the vaccine use; further information such as patient demographics, complete medical history, concomitant
medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful
evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for
Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but
different patient; Reported Cause(s) of Death: expired before receiving the second dose
died; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an 83-year-old
female patient (reporter mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an
unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included
hospice care and dementia. The patient's concomitant medications were not reported. The patient died one day after getting
vaccine. She was reportedly in good health the day before receiving vaccine. She was on hospice, frail, but in good condition and
checked by a hospice nurse the day before which she reported her in good health considering. She was with dementia but stable
in her health. The reporter read investigating 23 deaths of people receiving vaccine in similar conditions. The patient died on an
unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: died
Death; This is a spontaneous report from four non-contactable consumers via a Pfizer-sponsored program Corporate (Pfizer)
Social Media Platforms. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an
unspecified route of administration, on 28Dec2020 at a single dose for COVID-19 immunization. Ongoing medical history
included Alzheimer's Disease, encephalopathy, hypertension, acute kidney failure, urinary retention and recent urinary tract
infection (UTI), all from an unspecified date. Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN),
bisacodyl (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER
1199 DEATH PFIZER\BIONTECH Unknown Death 963902-1 UNKNOWN), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), loperamide (MANUFACTURER
UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), senna alexandrina (SENNA PLUS), vitamin d3 (MANUFACTURER
UNKNOWN). The patient had no known drug allergies. The patient experienced death on 30Dec2020. The vaccine was given on
28Dec2020 with no adverse events and no issues on 29Dec2020. The patient died on 30Dec2020, at approximately 2:00 AM. It
was unknown if an autopsy was performed. It was unknown if the event was related to the suspect drug, the administrator
marked as natural causes. No follow-up attempts are possible; information about batch/lot number cannot be obtained.;
Reported Cause(s) of Death: Death
UNKNOWN 65+
1200 DEATH Death 956962-1 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have
MANUFACTURER years
65+
1201 DECREASED APPETITE MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
1202 DECREASED APPETITE MODERNA Death 941561-1
65+
1203 DECREASED APPETITE MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
years
65+ resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac
1204 DECREASED APPETITE MODERNA Death 955425-1
years applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021
65+ Life
1205 DECREASED APPETITE MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
1206 DECREASED APPETITE PFIZER\BIONTECH Death 934968-1
50-59 Life
1207 DECREASED APPETITE PFIZER\BIONTECH 923000-1 and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from
years Threatening
12/26/20-12/28/20.
1208 DECREASED APPETITE PFIZER\BIONTECH 947687-1
65+
1210 DECREASED APPETITE PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
1211 DECREASED APPETITE PFIZER\BIONTECH Death 945578-1 feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not
years
Vaccine Event
65+
1212 DECREASED APPETITE PFIZER\BIONTECH Death 962827-1 appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the
years
1214 DEEP VEIN THROMBOSIS MODERNA 955565-1
1215 DEEP VEIN THROMBOSIS MODERNA 946978-1
60-64 Life
1216 DEEP VEIN THROMBOSIS MODERNA 952677-1 and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for
years Threatening
2/5/2021 at 7:15am
18-29 Life
1217 DEEP VEIN THROMBOSIS PFIZER\BIONTECH 944289-1 second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral
years Threatening
40-49 Life
1218 DEEP VEIN THROMBOSIS PFIZER\BIONTECH 956642-1 Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now
years Threatening
50-59 Life
1219 DEEP VEIN THROMBOSIS PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
60-64 Life
1220 DEHYDRATION MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
1221 DEHYDRATION PFIZER\BIONTECH Death 934968-1
1222 DEMENTIA MODERNA Death 914621-1
1223 DEMENTIA PFIZER\BIONTECH Death 942072-1
65+
1224 DEMENTIA PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
DEPRESSED LEVEL OF 50-59 Life currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am
1225 MODERNA 926787-1
CONSCIOUSNESS years Threatening was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident.
were made.
DEPRESSED LEVEL OF 50-59 Life
CONSCIOUSNESS years Threatening
DEPRESSED LEVEL OF 65+ resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac
CONSCIOUSNESS years applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021
Vaccine Event
DEPRESSED LEVEL OF 50-59 Life
CONSCIOUSNESS years Threatening
1229 DIABETIC KETOACIDOSIS MODERNA 958235-1
60-64 Life
1230 DIABETIC KETOACIDOSIS MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
65+ Life
1231 DIABETIC KETOACIDOSIS MODERNA 952235-1 nausea and vomiting possible cause of diabetic ketoacidosis and svt
years Threatening
1232 DIALYSIS MODERNA 950787-1
O had the vaccine at 9 am this morning waited 15 mins after vaccine before leaving while driving I had a pounding heart rate and
hot I rolled down the window felt better. 1 hour later while at home.e started with nausea diarrhea rapid heart rate headed to
18-29 Life
1233 DIARRHOEA MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
hives on chest they took me emergency while there I had sever pounding heart and vomiting treated with meds sent home with
medication and benadryl
1234 DIARRHOEA MODERNA 935478-1
to local er.
1235 DIARRHOEA PFIZER\BIONTECH 917210-1
65+
1236 DIARRHOEA PFIZER\BIONTECH Death 930912-1 Diarrhea followed by death 24 hrs after vaccination
years
1237 DIARRHOEA PFIZER\BIONTECH Death 938974-1
1238 DIARRHOEA PFIZER\BIONTECH 953333-1
Diarrhoea; This is a spontaneous report from a contactable other healthcare professional via Agency and downloaded from the
Regulatory Authority GB-MHRA-WEBCOVID-20201212222117, Safety Report Unique Identifier GB-MHRA-ADR 24542707 and EU-
EC-10007191252. An elderly patient of an unspecified gender received bnt162b2 (batch/lot number not provided), via an
1239 DIARRHOEA PFIZER\BIONTECH Unknown Death 907575-1 unspecified route of administration in 2020 at single dose for COVID-19 immunisation. The patient's medical history and
concomitant medications were not reported. The patient experienced diarrhoea in 2020. The patient died due to diarrhoea on
10Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on the lot/batch
number not obtainable. No further information is expected.; Reported Cause(s) of Death: diarrhoea
1240 DIARRHOEA PFIZER\BIONTECH Unknown Death 929016-1
50-59 Life
1241 DIASTOLIC DYSFUNCTION PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
years Threatening
1242 DIASTOLIC DYSFUNCTION PFIZER\BIONTECH Death 959179-1
1243 DIET REFUSAL MODERNA Death 958228-1
DIFFERENTIAL WHITE 18-29 Life shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received
1244 MODERNA 956504-1
BLOOD CELL COUNT years Threatening epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. Vitals in the ER Revealed
DIFFERENTIAL WHITE 40-49 Life
BLOOD CELL COUNT years Threatening
meds naproxen
DIFFERENTIAL WHITE
1246 BLOOD CELL COUNT PFIZER\BIONTECH Death 950441-1
ABNORMAL
Death (death certificate: uncertain type of death); evening vomiting; This is a spontaneous report from a non-contactable
physician the Regulatory Authority. This is a report received from the Regulatory Authority. Regulatory authority report number
was DE-PEI-CADRPEI-2021011672. A 79-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EJ6796),
intramuscular on 30Dec2020 as a single dose for COVID-19 immunization. Medical history included especially autoimmune
encephalopathy of paraneoplastic origin and suspected urothelial carcinoma of the bladder. The patient's concomitant
1247 DISCOLOURED VOMIT PFIZER\BIONTECH Unknown Death 952914-1 medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) on
03Dec2020 for immunization and was tolerated. On 31Dec2020 (also reported as 30Dec2020), the patient developed evening
vomiting which was dark in color and most likely food related. On 31Dec2020 at 04:35, the patient died. It was not reported if an
autopsy was performed. The clinical outcome of vomiting was reported as fatal; however, the cause of death was reported as
unknown cause of death. The vomiting and unknown cause of death were reported as medially significant and fatal. No follow-
up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death
30-39 Life
1248 DISCOMFORT PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
1249 DISCOMFORT PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
1250 DISORIENTATION MODERNA 947648-1
40-49 Life
1251 DISORIENTATION PFIZER\BIONTECH 909146-1 listed before
years Threatening
1252 DIZZINESS MODERNA 956504-1
30-39 Life
1253 DIZZINESS MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
Vaccine Event
30-39 Life
1255 DIZZINESS MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
to local er.
after the vaccine.
40-49 Life
1259 DIZZINESS MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
40-49 Life
1260 DIZZINESS MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
40-49 Life
1261 DIZZINESS MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
years Threatening
40-49 Life
1262 DIZZINESS MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
40-49 Life
1263 DIZZINESS MODERNA 958509-1 Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
years Threatening
50-59 Life
1264 DIZZINESS MODERNA 929418-1 Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
years Threatening
65+
1266 DIZZINESS MODERNA Death 933846-1 better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death
years
certificate."
65+ Life
1267 DIZZINESS MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
18-29 Life
1268 DIZZINESS PFIZER\BIONTECH 935180-1 Scratchy throat, dizziness and eventually feeling like her throat is closing in
years Threatening
Approx 10-15 post vaccine, employee said she felt lightheaded and like her heart was racing. Within 10 minutes she said she felt
18-29 Life
1269 DIZZINESS PFIZER\BIONTECH 936715-1 difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee
years Threatening
was transported to the Emergency Dep't and then to intensive care. She was placed on an Epi drip.
1270 DIZZINESS PFIZER\BIONTECH 903123-1
30-39 Life
1271 DIZZINESS PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
1272 DIZZINESS PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
30-39 Life
1274 DIZZINESS PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
30-39 Life and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was
years Threatening altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on
Vaccine Event
12 minutes after injection, I felt flushed and dizzy. They hooked me up to a vital sign monitor which showed my heart increasing
to 133 bpm, SaO2 98%. A manual blood pressure check was 168/110. My heart felt like it was pounding, I was hot and sweating.
After 10 minutes or so, I felt increasingly dizzy and my vision started fading. VS still showed tachycardia and hypertension. It
40-49 Life
1281 DIZZINESS PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
me to the Emergency Department. I became very cold and shaky. My hands and feet became a little mottled. They gave me 50
mg IV benedryl, 20 mg IV pepcid, a dose of solumedrol, and IM epinephrine 0.3mg, and 1 Liter of fluid. My symptoms resolved
and I was discharged home a couple hours later.
40-49 Life
1284 DIZZINESS PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
Near syncopal episode approximately 2.5 hours after vaccination. Sudden onset of dizziness, nausea, and diaphoresis. Was
40-49 Life
1286 DIZZINESS PFIZER\BIONTECH 914730-1 admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-
years Threatening
existing conditions and considered to be a healthy adult.
40-49 Life
1287 DIZZINESS PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
40-49 Life
1288 DIZZINESS PFIZER\BIONTECH 921989-1 Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
years Threatening
40-49 Life
1292 DIZZINESS PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
50-59
1293 DIZZINESS PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
50-59 Life Pt expressed feeling tachycardic, jittery, shaky, site edema, shortness of breath and dizziness. Pt received epipen 0.3 mg IM
years Threatening injection x1 dose and benadryl PO, responded favorably and transported to ED for follow up care.
50-59 Life
1295 DIZZINESS PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
Vaccine Event
ACHES, SORE THROAT.
50-59 Life
1297 DIZZINESS PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
50-59 Life
1298 DIZZINESS PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
60-64 Life
1300 DIZZINESS PFIZER\BIONTECH 909577-1 Dizziness, dyspnea, neck swelling
years Threatening
1301 DIZZINESS PFIZER\BIONTECH Death 932346-1
65+ little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient
years was found unresponsive and pronounced dead later that day.
65+
1303 DIZZINESS PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
1305 DIZZINESS PFIZER\BIONTECH Unknown Death 933232-1
1306 DIZZINESS PFIZER\BIONTECH Unknown 902856-1
Life
1307 DIZZINESS PFIZER\BIONTECH Unknown 907573-1 gastrooesophageal reflux disease and anxiety. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) in
Threatening
Life
1308 DIZZINESS PFIZER\BIONTECH Unknown 959417-1 minutes later developed symptoms of chest tightness shortness of breath wheezing. Arrived to ED at 1156 and discharged at
Threatening
1309 DRAIN PLACEMENT PFIZER\BIONTECH 947687-1
1310 DRY EYE PFIZER\BIONTECH 907042-1
Within 3 minutes of vaccination patient became fully flushed head and neck, with rapid heart rate (112), and feeling like her
40-49 Life airways were tightening.. Nurse immediately called for response, administered Epipen, when response arrived applied oxygen
1311 DRY THROAT MODERNA 914309-1
years Threatening and transported to ED. Solumedrol 125 mg, Bendadryl 25 mg, and Famotidine 20 mg, she responded well and was released
home with Rx Prednisone 40 mg x 3 days. Only residual effect was a dry/sore throat.
50-59 Life
1312 DRY THROAT PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
30-39 Life
1313 DYSARTHRIA MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
Vaccine Event
1314 DYSARTHRIA PFIZER\BIONTECH 941401-1
40-49 Life
1315 DYSGEUSIA MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
29yo female patient reports feeling her throat tingling and closing sensation in her throat with a metallic taste and diaphoretic
approximately 3 minutes after receiving vaccine. She did not report these sensations until about 15min after injection. EMS
18-29 Life
1316 DYSGEUSIA PFIZER\BIONTECH 951689-1 assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min
years Threatening
after injection and EMS arrived to transport patient down to ER within 1-2 minutes after Epipen administered. Patient was
monitored in ER and recovered well
30-39 Life
1317 DYSGEUSIA PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
"5 minutes after the Pfizer Covid-19 vaccine administration, the patient developed flushing, hives, felt warm and eventually short
of breath. She started to wheeze and was wheeled into ER c/o ""I can't breathe while holding throat and thrashing with facial
flushness noted. PT took 2 Benadryls and had several Epi shots. She was then discharged from the ER and later on that day,
started to feel short of breath again. In the ED today she was audibly gasping for air, however had no wheezing, had a normal
50-59 Life
1318 DYSKINESIA PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
prior to coming. She was then admitted to the hospital for further observation. While on the floor, she started to feel short of
breath again (about 9 am on 12/18/2020), which required an RRT . Patient received another dose of diphenhydramine IV,
methylprednisolone 125 mg IV and several doses of IM epinephrine. She also required oxygen. She was then transferred to an
ICU for further care."
65+
1319 DYSKINESIA PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
30-39 Life
1320 DYSPHAGIA MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
1321 DYSPHAGIA MODERNA 929391-1 vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for
years Threatening
65+
1322 DYSPHAGIA MODERNA Death 929997-1 eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow.
years
65+ Life
1323 DYSPHAGIA MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
40 min after injection my throat and tongue started to feel weird and tight, pharmacy at my work hospital gave me 25 mg
30-39 Life
1324 DYSPHAGIA PFIZER\BIONTECH 903324-1 Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn?t
years Threatening
swallow. I went to nearest emergency room hospital they administered decadron orally, Pepcid P.O., and Toradol via IM.
30-39 Life
1325 DYSPHAGIA PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
1326 DYSPHAGIA PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
30-39 Life
1327 DYSPHAGIA PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
1328 DYSPHAGIA PFIZER\BIONTECH 936011-1
Trouble swallowing, tingling around the mouth within 5 minutes of vaccine administration. IV started with 25mg Benadryl within
5 minutes of symptom onset. Transfer to ER at 1430. Symptoms unresolved, hr - 120, bp 140/100, O2 sats 100, resp: 21
Additional 25mg Benadryl, 125mg solumedrol, 1ml Ativan given IV at 1435. Symptoms began to resolve, patient discharged at
30-39 Life
1329 DYSPHAGIA PFIZER\BIONTECH 936026-1 1600 to home with instructions to return if needed. Patient returned to ER Sunday January 10 at 1300 complaining of throat
years Threatening
tightness. Patient was seen by doctor, no acute distress and airway issues seen. Patient elected to stay for 50mg benadryl and
40mg prednisone PO. Patient was discharged to home with script for 40mg prednisone q day for 3 days. Patient feels any
remaining allergic symptoms have resolved.
30-39 Life
1330 DYSPHAGIA PFIZER\BIONTECH 950387-1 Swollen tongue and sob with decreased swallow
years Threatening
30-39 Life
1331 DYSPHAGIA PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
40-49 Life
1332 DYSPHAGIA PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
1334 DYSPHAGIA PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
Vaccine Event
First Day after the injection I had a headache and nausea the entire day into the next day. The second day I still had the headache
40-49 Life
1335 DYSPHAGIA PFIZER\BIONTECH 938829-1 and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I
years Threatening
struggled to breath. I immediately drank liquid Benadryl and called my doctor in the morning.
40-49 Life
1337 DYSPHAGIA PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
50-59 Life
1339 DYSPHAGIA PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
ACHES, SORE THROAT.
Patient stated he stopped his blood pressure medications 3 days prior to vaccination due to a previous reaction to losartan, a
medication he was no longer taking. Patient took aspirin and a MVI on day of vaccination and drank lemon water. Patient
developed tingling sensation in his mouth after eating dinner around 18:00. Patient stated he ate tacos with apple cider and
60-64 Life noticed tingling after dinner. Patient stated he took two benadryl with no relief. His tongue continued to swell and he took two
years Threatening additional benadryl at 22:00. Once he developed difficulty swallowing he went to the emergency department. Patient presented
to the ED with tongue swelling and difficulty swallowing. At 23:57 he was adminsitered 0.3mg of epinephrine IM,
diphenhydramine 25mg IV, famotidine 40mg IV, dexamethasone 10mg IV at 0114, methylprednisolone 60mg q6hrs started at
0417, diphenhydramine 25mg q6hrs IV started at 0416, albuterol 2.5mg via neb q6hrs started at 0710
60-64 Life approximately 30 minutes after receiving vaccination i began to develop tongue and lip swelling as well as difficulty swallowing
years Threatening and breathing , i then proceeded immediately to the nearest er
65+
1343 DYSPHAGIA PFIZER\BIONTECH Death 945247-1 weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should
years
report
Patient developed a hoarsenss of voice and tightness of throat and flushed feeling immediately following vaccination. Epi Pen
30-39 Life
1344 DYSPHONIA MODERNA 947019-1 was administered and 50 mg Benadryl given p.o., EMS transport to ED after administration of solumedrol 125 mg - received
years Threatening
Pepcid and Zofran and NS IV in the ED. Discharged from ED with prednisone 40 mg daily x 4 day with Epi Pen prescription.
40-49 Life
1345 DYSPHONIA MODERNA 932614-1 Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing Hoarse voice
years Threatening
40-49 Life
1346 DYSPHONIA MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
40-49 Life
1347 DYSPHONIA MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
years Threatening
50-59 Life
1348 DYSPHONIA MODERNA 938443-1 immediate tingling of lips, followed by fullness of posterior oropharynx, hoarseness and pruritus
years Threatening
18-29 Life
1349 DYSPHONIA PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
1350 DYSPHONIA PFIZER\BIONTECH 945090-1
30-39 Life
1351 DYSPHONIA PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
1352 DYSPHONIA PFIZER\BIONTECH 909278-1 Rapid onset of hoarseness, throat tingling and tightness
years Threatening
appropriate.
Vaccine Event
50-59 Life
1356 DYSPHONIA PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
1357 DYSPNOEA MODERNA 939216-1
30-39 Life
1359 DYSPNOEA MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
not recurred.
Immediate warm rush to my head and body. Heart was beating out of my chest and difficultly breathing. Heart rate spiked to 150
30-39 Life
1361 DYSPNOEA MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
years Threatening
since which has been 3 days.
to local er.
30-39 Life
1363 DYSPNOEA MODERNA 952707-1 episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV,
years Threatening
40-49 Life
1366 DYSPNOEA MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
40-49 Life
1369 DYSPNOEA MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
40-49 Life
1370 DYSPNOEA MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
50-59 Life
1371 DYSPNOEA MODERNA 920787-1 obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered.
years Threatening
50-59 Life
1372 DYSPNOEA MODERNA 924050-1 anaphylaxis, dyspnea
years Threatening
were made.
50-59 Life
1375 DYSPNOEA MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
Vaccine Event
60-64 Life
1376 DYSPNOEA MODERNA 924078-1 pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse
years Threatening
60-64 Life
1377 DYSPNOEA MODERNA 935090-1 SOB, Sleeplessness,
years Threatening
60-64 Life
1378 DYSPNOEA MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
65+
1379 DYSPNOEA MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
65+ No adverse reactions observed after administration of medication. Patient starting complaining of shortness of breath around
1380 DYSPNOEA MODERNA Death 943889-1
years 0500 the following morning. SP02 checked in the 80s. Patient expired 01/09/2021;
65+
1383 DYSPNOEA MODERNA Death 956994-1 started 12 hours after injection. On the 5th day, the patient was discovered to also have a rash throughout his body, but it is
years
65+
1384 DYSPNOEA MODERNA Death 958069-1 Started with cough, mild shortness of breath and feeling terrible in evening of 1/19.
years
65+ Life
1386 DYSPNOEA MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
18-29 Life
1388 DYSPNOEA PFIZER\BIONTECH 904334-1 Angioedema, hives, tachycardia, shortness of breath
years Threatening
18-29 Life
1389 DYSPNOEA PFIZER\BIONTECH 936715-1 difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee
years Threatening
1390 DYSPNOEA PFIZER\BIONTECH 944450-1
on monitor.
30-39 Life
1393 DYSPNOEA PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
1394 DYSPNOEA PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
Within a few minutes of taking the vaccine, my lower lip began swelling. I was moved to the emergency department of Hospital
30-39 Life and monitored and treated for four hours. Then I was released. At around 1:30 p.m. I felt my skin singling and started having
years Threatening difficulty breathing. Since I was no longer at my work (Hospital) I went to the closest hospital. This reaction was much worse. My
husband drove. My heart rate increased. I was released at around 6:30 pm
10 minutes after receiving vaccination, a significant increase in HR was noted, along with a tingling sensation through out body.
Also, scratchy throat was noted. Alert by patient made to staff at vaccination site. Sweating noted and shortness of breath at
30-39 Life
1398 DYSPNOEA PFIZER\BIONTECH 914103-1 that time. Epi pen given via L thigh IM. PIV started and benadryl and solumedrol given. Relief of symptoms noted very shortly
years Threatening
after Epi administration. Taken to ER for 4 hour observation. Sent home after 4 hours and given prednisone to be taken at home,
50mg daily for 4 days. No further adverse symptoms noted.
30-39 Life
1399 DYSPNOEA PFIZER\BIONTECH 914596-1 Anaphalaxis reaction, stridor an unable to breathe. Happened in 30 seconds
years Threatening
30-39 Life
1400 DYSPNOEA PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
30-39 Life
1401 DYSPNOEA PFIZER\BIONTECH 916890-1 HIVES, SOB, THROAT CLOSING UP, WHEEZING
years Threatening
Vaccine Event
appropriate.
30-39 Life
1407 DYSPNOEA PFIZER\BIONTECH 950387-1 Swollen tongue and sob with decreased swallow
years Threatening
40-49 Life
1411 DYSPNOEA PFIZER\BIONTECH 908003-1 ANAPHLACTIC REACTION, SOB, CHEST PRESSURE, TIGHTNESS IN THROAT, TACHYCARDIA
years Threatening
40-49 Life
1412 DYSPNOEA PFIZER\BIONTECH 909146-1 listed before
years Threatening
Adverse reaction post Covid vaccine. Waited for 20 min post vaccine. Experienced S/S Heart palpitations, shortness of breath,
40-49 Life
1414 DYSPNOEA PFIZER\BIONTECH 911943-1 tingling in extremities, diaphoretic after leaving clinic observation. Drove back to hospital, escorted by pre surgical testing
years Threatening
hospital staff and taken by wheelchair to ED.
40-49 Life
1416 DYSPNOEA PFIZER\BIONTECH 913854-1 anxiety, tachycardia, flushing, diaphoresis, HTN, SOB
years Threatening
40-49 Life
1417 DYSPNOEA PFIZER\BIONTECH 921989-1 Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
years Threatening
40-49 Life
1419 DYSPNOEA PFIZER\BIONTECH 928209-1 Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
years Threatening
Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives
40-49 Life to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency
years Threatening Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia,
hypotension. Treatment continued.
40-49 Life
1421 DYSPNOEA PFIZER\BIONTECH 930897-1 Shortness of breath, cough, rash on face and neck, arthralgia
years Threatening
Vaccine Event
40-49 Life
1423 DYSPNOEA PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
40-49 Life
1424 DYSPNOEA PFIZER\BIONTECH 938829-1 and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I
years Threatening
40-49 Life
1426 DYSPNOEA PFIZER\BIONTECH 942808-1 receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with
years Threatening
40-49 Life
1427 DYSPNOEA PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old
female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer
EL 3302), via an unspecified route of administration on 09Jan2021 07:30 am at single dose at left arm for covid-19
immunization. Medical history included diabetes, high blood pressure, allergies. The patient's concomitant medications were not
reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed
40-49 Life
1428 DYSPNOEA PFIZER\BIONTECH 946098-1 with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 10Jan2021 14:30,
years Threatening
patient woke up with throat closing up and struggled the breath. Patient immediately drank a dose of diphenhydramine
hydrochloride (BENADRYL). Patient did that two more time in the evening of 10Jan2021. Patient called the doctor in the
morning. Events were considered serious per life-threatening. The adverse events resulted in doctor or other healthcare
professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient received treatment liquid
diphenhydramine hydrochloride, epinephrine (EPI-PEN) for events. Outcome of events was recovered in Jan2021.
40-49 Life
1429 DYSPNOEA PFIZER\BIONTECH 949611-1 Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed
years Threatening
40-49 Life
1430 DYSPNOEA PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
50-59
1432 DYSPNOEA PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
1433 DYSPNOEA PFIZER\BIONTECH Death 933739-1
Vaccine Event
50-59 Life
1435 DYSPNOEA PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
Subject received vaccination Wednesday Dec 16th in the afternoon. He became symptomatic (shortness of breath, low grade
50-59 Life
1437 DYSPNOEA PFIZER\BIONTECH 912271-1 fever) the next day. Went to the Emergency room on Saturday Dec. 26th, 2020 due to shortness of breath, had an 02 Sat of 60%,
years Threatening
and was hospitalized in the ICU at another hospital (due to bed unavailability).
Shortly after receiving the vaccine (within 10 minutes) the patient's tongue swelled, facial redness, gasping for air. This resident
was marked for a 30 minute observation due to previous anaphylaxis type reaction. Immediately administered 0.3mg
50-59 Life
1438 DYSPNOEA PFIZER\BIONTECH 916268-1 epinephrine x 1 dose. Then administered 50mg IM Diphenhydramine. This treatment course resolved the adverse reaction.
years Threatening
Patient was monitored onsite at facility. Her husband came to pick her up and take her home. Tried to reach patient several
hours after but was unable to at this time.
ACHES, SORE THROAT.
50-59 Life
1441 DYSPNOEA PFIZER\BIONTECH 954723-1 itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
years Threatening
50-59 Life
1442 DYSPNOEA PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
60-64
1443 DYSPNOEA PFIZER\BIONTECH Death 935815-1 Difficulty breathing, death.
years
No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her baclofen pump was refilled
with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days. On 1/8/21 at
60-64 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary
years physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At
0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat
heard or pulse found.
60-64 Life
1445 DYSPNOEA PFIZER\BIONTECH 909577-1 Dizziness, dyspnea, neck swelling
years Threatening
she is better but still not good; not to be able to breath; sore right arm; This is a spontaneous report from a contactable nurse
(patient herself). A 62-year-old female patient received bnt162b2 (BNT162B2, lot EK5730), intramuscular on 18Dec2020 at single
dose for immunisation. Medical history included asthma (hospitalized on Jan2020 and has not had any issues since that time,
referring to her asthma) diabetes, high blood pressure, swelling, sciatica, blood cholesterol abnormal, rosacea, reflux, allergies,
sinus congestion, shingles and post carpal tunnel surgery. Concomitant medications included lisinopril, hydrochlorothiazide,
gabapentin, rosuvastatin, metformin, glipizide, doxycycline, sucralfate, cetirizine hydrochloride (ZYRTEC), pseudoephedrine,
ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and tramadol. The patient
reported that she not to be able to breath (seriousness criteria-life threatening) on 22Dec2020. She woke up this morning and
could not breathe and there was no reason for her to not be able to breath. She thought she may have had a reaction to the
COVID vaccine. It was the only thing she could think of that might have caused her not to be able to breathe this morning. As
60-64 Life
1446 DYSPNOEA PFIZER\BIONTECH 911462-1 treatment for not to be able to breath, she used Budesonide and Levosalbutamol in her nebulizer. She had sore right arm on
years Threatening
18Dec2020. She informed that she had done everything she can and she was better but still not good. She planned to take the
second dose of the COVID Vaccine because she thought it was more important to be protected. She suspected that the vaccine
was related to the events sore right arm and could not breathe. The outcome of the event not to be able to breath was
recovering; for sore right arm was recovered on unknown date in Dec2020; for she is better but still not good was unknown.;
Sender's Comments: Severe allergic reaction including anaphylaxis is the known risk factor; a possible causal association
between administration of BNT162B2 and the onset of not being able to breath cannot be excluded, considering the plausible
60-64 Life
1448 DYSPNOEA PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
60-64 Life
1449 DYSPNOEA PFIZER\BIONTECH 950759-1 Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed
years Threatening
65+
1450 DYSPNOEA PFIZER\BIONTECH Death 915562-1 staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night. Pt had
years
Resident became SOB, congested and hypoxic requiring oxygen, respiratory treatments and suctioning. Stabilized after
65+
1451 DYSPNOEA PFIZER\BIONTECH Death 918418-1 treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations.
years
Resident was a DNR on Hospice.
65+
1452 DYSPNOEA PFIZER\BIONTECH Death 921175-1 Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4,
years
Vaccine Event
65+
1454 DYSPNOEA PFIZER\BIONTECH Death 930466-1 Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination
years
65+
1456 DYSPNOEA PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
1457 DYSPNOEA PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
65+
1459 DYSPNOEA PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
65+ Life Congestion Shortness of breath Tachycardia Transferred out 911. Per hospital, patient had a myocardial infarction, is
years Threatening unresponsive, and on hospice services.
1461 DYSPNOEA PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
Dyspnoea; suspected pulmonary edema; This is a spontaneous report downloaded from the regulatory authority DK-DKMA-WBS-
0028304. Report was received from a contactable physician via from the regulatory authority. An 80-year-old female patient
received bnt162b2 (COMIRNATY, lot EJ6797, expiration date 30Apr2021), intramuscularly on 03Jan2021 at single dose for covid-
19 immunisation. Medical history included dementia with lewy bodies from an unknown date and unknown if ongoing,
osteoporosis from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. No
1462 DYSPNOEA PFIZER\BIONTECH Unknown Death 934765-1 previous drug was given. The patient's concomitant medications were not reported. On 04Jan2021 around 12, approximately 25
hours after the vaccination the patient developed dyspnoea and pulmonary edema. 4 hours later she died. The patient did not
experience any allergic symptoms. Events reported as dyspnoea and suspected pulmonary edema. The ADRs were by the
reporter reported as fatal. No treatment due to the ADRs was reported. Reported cause of death was pulmonary edema.
Outcome of event dyspnoea also reported as not recovered. There was no information regarding test results. It was not reported
if an autopsy was performed.; Reported Cause(s) of Death: Pulmonary edema; Dyspnoea
1463 DYSPNOEA PFIZER\BIONTECH Unknown Death 944155-1
1464 DYSPNOEA PFIZER\BIONTECH Unknown Death 947357-1
Life
1465 DYSPNOEA PFIZER\BIONTECH Unknown 959417-1 minutes later developed symptoms of chest tightness shortness of breath wheezing. Arrived to ED at 1156 and discharged at
Threatening
Vaccine Event
1466 DYSPNOEA EXERTIONAL MODERNA 946978-1
1467 DYSPNOEA EXERTIONAL PFIZER\BIONTECH 939914-1
kidney disease and essential hypertension, all unknown if ongoing. Concomitant medication included alfacalcidol (unknown
1468 DYSPNOEA EXERTIONAL PFIZER\BIONTECH Unknown Death 939334-1
manufacturer), amlodipine (unknown manufacturer), atorvastatin (unknown manufacturer), clopidogrel (unknown manufacturer),
1469 DYSSTASIA MODERNA 944219-1
40-49 Life
1470 EAR PAIN PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
Resident returned to the memory support unit at 1500. Resident was than toileted and transferred in to bed per his request. At
65+
1471 ECCHYMOSIS PFIZER\BIONTECH Death 961010-1 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro
years
Checks with in normal limes Vital signs: 100/52, 100, 97.2, 28. Resident sent to ED for further medical evaluation via EMS.
40-49 Life
1472 ECHOCARDIOGRAM MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
40-49 Life
1473 ECHOCARDIOGRAM MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
years Threatening
50-59 Life
1474 ECHOCARDIOGRAM MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
60-64 Life
1475 ECHOCARDIOGRAM MODERNA 935090-1 SOB, Sleeplessness,
years Threatening
1476 ECHOCARDIOGRAM PFIZER\BIONTECH 953888-1
ECHOCARDIOGRAM 65+ Life
ECHOCARDIOGRAM 65+ Life
ECHOCARDIOGRAM 40-49 Life
ECHOCARDIOGRAM 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
ABNORMAL years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
ECHOCARDIOGRAM 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
ABNORMAL years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
ECHOCARDIOGRAM 65+
1483 PFIZER\BIONTECH Death 961434-1 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient
ABNORMAL years
Vaccine Event
ECHOCARDIOGRAM
ABNORMAL
hypoglycaem
ECHOCARDIOGRAM 30-39 Life dyspnea and had loss of consciousness for 5 seconds and was found down. I was rushed to the hospital and diagnosed with
NORMAL years Threatening multiple pulmonary embolus (about 9) which was treated with direct TPA via catheterization. I then recovered in the ICU and
ECHOCARDIOGRAM 40-49 Life Palpitations, shortness of breath, chest tightness, presyncope, which led to New onset atrial fibrillation with rapid ventricular
NORMAL years Threatening response and required synchronized cardioversion and hospitalization. Discharged on anticoagulation and beta-blocker.
EJECTION FRACTION 65+ Life
EJECTION FRACTION 65+ Life
EJECTION FRACTION 40-49 Life
EJECTION FRACTION 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
1495 ELECTROCARDIOGRAM MODERNA 955565-1
30-39 Life Itchy throat, red eyes after 30 minutes. EMS on site gave IV Benadryl, epi pen shot and took to ER for monitoring. Vitals were
years Threatening good so he was discharged.
30-39 Life
1497 ELECTROCARDIOGRAM MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
to local er.
40-49 Life
1499 ELECTROCARDIOGRAM MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
50-59 Life
1501 ELECTROCARDIOGRAM MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
60-64 Life
1502 ELECTROCARDIOGRAM MODERNA 935090-1 SOB, Sleeplessness,
years Threatening
1503 ELECTROCARDIOGRAM MODERNA Death 957799-1
years resuscitated
65+ Life
1505 ELECTROCARDIOGRAM MODERNA 952235-1 nausea and vomiting possible cause of diabetic ketoacidosis and svt
years Threatening
Vaccine Event
1506 ELECTROCARDIOGRAM PFIZER\BIONTECH 938868-1
40-49 Life
1508 ELECTROCARDIOGRAM PFIZER\BIONTECH 908003-1 ANAPHLACTIC REACTION, SOB, CHEST PRESSURE, TIGHTNESS IN THROAT, TACHYCARDIA
years Threatening
40-49 Life
1509 ELECTROCARDIOGRAM PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
40-49 Life
1510 ELECTROCARDIOGRAM PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
50-59 Life
1511 ELECTROCARDIOGRAM PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
50-59 Life
1512 ELECTROCARDIOGRAM PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
60-64 Life
1514 ELECTROCARDIOGRAM PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
60-64 Life
1515 ELECTROCARDIOGRAM PFIZER\BIONTECH 950759-1 Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed
years Threatening
ELECTROCARDIOGRAM 30-39 Life
1517 MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
ELECTROCARDIOGRAM 40-49 Life symptoms of chest pressure and itchiness to face. Provider instructed Epi Pen be given and pt to be transported to ED for further
1518 MODERNA 941563-1
ABNORMAL years Threatening evaluation. EKG obtained and showed sinus tachycardia. Nonrebreather oxygen mask applied with 2L/min and oxygen saturation
ELECTROCARDIOGRAM 50-59 Life freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove
1519 MODERNA 955945-1
ABNORMAL years Threatening me to the emergency department. I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday
fever.
ELECTROCARDIOGRAM 65+ Life
ELECTROCARDIOGRAM 30-39 Life to swelling of the throat at approximately 30-35 mins post administration. Sought care in the ED, where I was tachycardic and
ABNORMAL years Threatening hypertensive. Received IV Benadryl, steroids, and IV fluids. Discharged home, but symptoms returned around 2pm. Sought care
ELECTROCARDIOGRAM 30-39 Life PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath,
ABNORMAL years Threatening dizziness and blurry vision
1524 PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
ELECTROCARDIOGRAM 60-64
ABNORMAL years
testing.
Vaccine Event
ELECTROCARDIOGRAM 65+ Life altered mental status, weakness, and dysarthria. She was taken from her assisted living facility to the hospital and MRI showed a
ABNORMAL years Threatening small stroke in the right medial thalamus. She was also found to have new onset atrial fibrillation. She was treated appropriately
AMBULATORY years Threatening
ELECTROCARDIOGRAM 30-39 Life Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy,
CHANGE years Threatening ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
ELECTROCARDIOGRAM 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
CHANGE years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
1531 MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
1532 MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
ELECTROCARDIOGRAM 30-39 Life HR 82) and gave me 125mg solumedrol and Benadryl intramuscularly which caused worsened dizziness and a racing heart
1533 MODERNA 951572-1
NORMAL years Threatening which caused me to collapse and they gave me a epi pen and called 911. I was transferred to ER and they completed EKG which
after the vaccine.
ELECTROCARDIOGRAM 30-39 Life Saturday she had a ""really bad headache and just layed around all day. I was not able to function at all."" Sunday she still had a
1534 MODERNA 956527-1
NORMAL years Threatening headache and added muscle aches. Monday she started feeling ""a lot better"" until 8 PM when she was walking around doing
1535 MODERNA 924078-1 pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse
ELECTROCARDIOGRAM 30-39 Life dyspnea and had loss of consciousness for 5 seconds and was found down. I was rushed to the hospital and diagnosed with
NORMAL years Threatening multiple pulmonary embolus (about 9) which was treated with direct TPA via catheterization. I then recovered in the ICU and
ELECTROCARDIOGRAM 40-49 Life My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my
NORMAL years Threatening heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for
ELECTROCARDIOGRAM PR 18-29 Life
SHORTENED years Threatening
ELECTROCARDIOGRAM 65+
QRS COMPLEX ABNORMAL years
ELECTROCARDIOGRAM QT 60-64
PROLONGED years
testing.
ELECTROCARDIOGRAM ST 40-49 Life
SEGMENT ABNORMAL years Threatening
ELECTROCARDIOGRAM ST 18-29 Life performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing
SEGMENT DEPRESSION years Threatening and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair
on monitor.
ELECTROCARDIOGRAM ST 18-29 Life troponin. He was evaluated by cardiology and diagnosed with acute myopericarditis. He was treated with NSAIDs and colchicine.
SEGMENT ELEVATION years Threatening He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow
up.
ELECTROCARDIOGRAM ST 40-49 Life I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not
SEGMENT ELEVATION years Threatening sure if these are related but I felt I should report it.
ELECTROCARDIOGRAM ST 60-64 Life
SEGMENT ELEVATION years Threatening
Vaccine Event
ELECTROCARDIOGRAM T 30-39 Life
WAVE ABNORMAL years Threatening
ELECTROCARDIOGRAM T 40-49 Life
1547 PFIZER\BIONTECH 914730-1 admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-
WAVE INVERSION years Threatening
30-39 Life
1548 ELECTROENCEPHALOGRAM PFIZER\BIONTECH 943359-1 Unprovoked seizure (clonic tonic) 13 days later, requiring hospitalization and testing
years Threatening
ELECTROENCEPHALOGRAM 50-59 placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine
ABNORMAL years that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the
60-64 Life
1550 ELECTROLYTE IMBALANCE MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
ENDOTRACHEAL 30-39
1551 MODERNA Death 939050-1 develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory
INTUBATION years
ENDOTRACHEAL 30-39 Life
1552 MODERNA 929391-1 vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for
INTUBATION years Threatening
1553 MODERNA 907022-1 push once; Famotidine 20 mg IV push once; Dexamethasone 10 mg IV push once Patient was intubated and put on propofol and
ENDOTRACHEAL 18-29
1555 PFIZER\BIONTECH Death 943397-1 was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was
INTUBATION years
1556 PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
------------------------------------------------------RN
ENDOTRACHEAL 30-39 Life and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was
INTUBATION years Threatening altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on
ENDOTRACHEAL 65+ vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated,
INTUBATION years cardiac arrest, died 01/07/21.
ENDOTRACHEAL 65+
1559 PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
INTUBATION years
symptoms.
ENDOTRACHEAL 65+
INTUBATION years
ENDOTRACHEAL 65+ Life Rushed to ER. Has now been tubed and put into the ICU and has had full-cardiac arrest less than 24 hours after receiving the
INTUBATION years Threatening vaccine.
ENDOTRACHEAL 65+ Life
1562 PFIZER\BIONTECH 912602-1 Hospitalized 12/29, has now been tubed and put into the ICU
ENDOTRACHEAL serious, patient passed away on 04Jan2021. Cause of death was reported as sepsis, respiratory distress and pleural effusion. It
INTUBATION was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.
1564 ENLARGED UVULA MODERNA 916859-1
not recurred.
1565 ENLARGED UVULA MODERNA 914392-1
40-49 Life
1566 ENLARGED UVULA PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
Vaccine Event
ENTEROVIRUS TEST 65+
NEGATIVE years
EOSINOPHIL COUNT 30-39 Life
EOSINOPHIL COUNT 30-39 Life
Racepinephrine x 1.
EOSINOPHIL COUNT 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
EOSINOPHIL COUNT 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
1572 EOSINOPHIL PERCENTAGE PFIZER\BIONTECH Death 950441-1
EOSINOPHIL PERCENTAGE 30-39 Life
EOSINOPHIL PERCENTAGE 30-39 Life
Racepinephrine x 1.
EOSINOPHIL PERCENTAGE 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
40-49 Life
1576 EPISTAXIS MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
1577 EPISTAXIS PFIZER\BIONTECH Unknown Death 933232-1
18-29 Life
1578 ERYTHEMA MODERNA 930079-1 Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
years Threatening
1579 ERYTHEMA MODERNA 955565-1
1580 ERYTHEMA MODERNA 914392-1
65+
1581 ERYTHEMA MODERNA Death 920326-1 Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21
years
65+
1582 ERYTHEMA MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
65+ Life
1583 ERYTHEMA MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
30-39 Life
1584 ERYTHEMA PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
Vaccine Event
40-49 Life
1585 ERYTHEMA PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
40-49 Life
1586 ERYTHEMA PFIZER\BIONTECH 921989-1 Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
years Threatening
1587 ERYTHEMA PFIZER\BIONTECH 936666-1
50-59 Life
1588 ERYTHEMA PFIZER\BIONTECH 916268-1 epinephrine x 1 dose. Then administered 50mg IM Diphenhydramine. This treatment course resolved the adverse reaction.
years Threatening
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept
repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if
50-59 Life she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At
1589 ERYTHEMA PFIZER\BIONTECH 919629-1
years Threatening this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another
30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels
were about 88-89% which is low for her but she said she felt fine and is currently working right now.
50-59 Life
1590 ERYTHEMA PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
65+ Life
1591 ERYTHEMA PFIZER\BIONTECH 924658-1 Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.
years Threatening
Pt was 18 weeks pregnant at the time of the vaccine. Second pregnancy. Pt is a physician. Pregnancy was entirely normal up to
EXPOSURE DURING 40-49 Life
1592 PFIZER\BIONTECH 958755-1 that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently
PREGNANCY years Threatening
delivered at 18 weeks. Baby was stillborn. Ultrasound done 1/15/2021 normal. Lethal event for the fetus. The patient did well.
1593 EXPOSURE TO SARS-COV-2 MODERNA 914392-1
1594 EXPOSURE TO SARS-COV-2 MODERNA Death 917790-1
65+
1595 EXPOSURE TO SARS-COV-2 MODERNA Death 963235-1 household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on
years
January 18, 2021
1596 EXPOSURE TO SARS-COV-2 PFIZER\BIONTECH Death 945241-1
30-39 Life
1597 EYE PAIN MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
40-49 Life
1598 EYE SWELLING MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
65+ Life
1599 EYE SWELLING MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
Was given the vaccine and about 5 minutes later started having swelling and my eyes and face. It was watched for a few
30-39 Life
1600 EYE SWELLING PFIZER\BIONTECH 912137-1 minutes and was assessed by EMS and taken to the emergency department. I was given epinephrine, Benadryl, Solu-Medrol,
years Threatening
Pepcid, IV fluids, DuoNebs and observed overnight. I was given multiple rounds of Benadryl, steroids, Pepcid, DuoNebs
30-39 Life
1601 EYE SWELLING PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
1602 EYE SWELLING PFIZER\BIONTECH 907042-1
1603 EYE SWELLING PFIZER\BIONTECH 952294-1
1604 FACIAL PARALYSIS MODERNA 932367-1
1605 FACIAL PARESIS PFIZER\BIONTECH 932366-1
10:31am.
1608 FAECALOMA MODERNA 955565-1
65+
1609 FALL MODERNA Death 921572-1 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again.
years
65+
1610 FALL MODERNA Death 934050-1 they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of
years
requested.
65+
1611 FALL MODERNA Death 958745-1 Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found
years
Vaccine Event
65+
1612 FALL PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
1613 FALL PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
1614 FALL PFIZER\BIONTECH 944663-1
1615 FALL PFIZER\BIONTECH Unknown Death 944154-1 floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR,
1616 FALL PFIZER\BIONTECH Unknown Death 947357-1
1617 FALL PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
1618 FATIGUE MODERNA 946978-1
1619 FATIGUE MODERNA 926787-1
were made.
1620 FATIGUE MODERNA Death 914621-1
65+
1621 FATIGUE MODERNA Death 960752-1 Extreme Fatigue
years
18-29 Life
1622 FATIGUE PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
30-39 Life
1623 FATIGUE PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
1624 FATIGUE PFIZER\BIONTECH 902854-1
Vaccine Event
50-59
1626 FATIGUE PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
ACHES, SORE THROAT.
50-59 Life
1628 FATIGUE PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
1629 FATIGUE PFIZER\BIONTECH Death 920545-1
65+
1630 FATIGUE PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on
65+
1631 FATIGUE PFIZER\BIONTECH Death 956761-1 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He
years
did say that he felt tired, but he often complained of feeling tired over time.
65+
1632 FATIGUE PFIZER\BIONTECH Death 962307-1 couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon
years
breathing
65+
1633 FATIGUE PFIZER\BIONTECH Death 962827-1 appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the
years
Patient reports no symptoms until 1/8/21 at which time a rash developed along with fatigue and fevers. Patient was seen in ED
65+ Life
1636 FATIGUE PFIZER\BIONTECH 943741-1 1/8 and 1/11/21. Was admitted 1/11/21 with Concern for STevens Johnson and sepsis. Patient subsequently developed full
years Threatening
body macular rash and mucosal lesions. Fevers to 102-104.
Life
1637 FATIGUE PFIZER\BIONTECH Unknown 907573-1 gastrooesophageal reflux disease and anxiety. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) in
Threatening
65+ Life
1638 FEAR MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
At first I has some injection site pain and soreness nothing too bad. But around 01:30 I awoke with a really high fever. My fever
was 102.8 when I first woke up. I was very nauseous and my fever felt worse. My thermometer would not read any more until my
50-59 Life
1639 FEAR PFIZER\BIONTECH 941118-1 temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I
years Threatening
was actually scare for my life. In March I actually caught coronavirus and developed anti bodies for Covid. I can only guess my
body was fighting for it's life.
1640 FEBRILE NEUTROPENIA PFIZER\BIONTECH Unknown Death 940950-1
65+
1641 FEEDING DISORDER MODERNA Death 929997-1 eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow.
years
"Patient was monitored for >15 minutes after vaccination. Patient told a nurse that her knees felt weak. Patient then fainted and
18-29 Life was laying on the floor when i arrived. Patient reported she felt like she was ""floating"" and she did not want to ""fall"". She was
1642 FEELING ABNORMAL MODERNA 912930-1
years Threatening also nausea and wanted to vomit and did not end up vomiting anything up. Patient fainted several more times. Her BP was
around 143/80 and unsure about the pulse. Patient then become unresponsive for 20-30 seconds."
30-39 Life
1644 FEELING ABNORMAL MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
years Threatening
Vaccine Event
to local er.
fever.
65+
1647 FEELING ABNORMAL MODERNA Death 958069-1 Started with cough, mild shortness of breath and feeling terrible in evening of 1/19.
years
1648 FEELING ABNORMAL PFIZER\BIONTECH 952478-1
40-49 Life
1649 FEELING ABNORMAL PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
1650 FEELING ABNORMAL PFIZER\BIONTECH 919629-1
65+
1651 FEELING ABNORMAL PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
years
1652 FEELING ABNORMAL PFIZER\BIONTECH Death 949547-1
1653 FEELING ABNORMAL PFIZER\BIONTECH Death 959929-1
1654 FEELING COLD MODERNA 955945-1
fever.
40-49 Life
1655 FEELING COLD PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
1656 FEELING COLD PFIZER\BIONTECH 952803-1
Life
1657 FEELING DRUNK PFIZER\BIONTECH Unknown 907573-1 gastrooesophageal reflux disease and anxiety. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) in
Threatening
18-29 Life
1658 FEELING HOT MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
30-39 Life
1659 FEELING HOT MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
years Threatening
1660 FEELING HOT MODERNA 914392-1
1661 FEELING HOT PFIZER\BIONTECH 944450-1
on monitor.
40-49 Life
1663 FEELING HOT PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
Vaccine Event
50-59
1664 FEELING HOT PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
50-59 Life
1665 FEELING HOT PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
ACHES, SORE THROAT.
1667 FEELING JITTERY MODERNA 956527-1
1668 FEELING JITTERY PFIZER\BIONTECH 905544-1
1669 FIBRIN D DIMER PFIZER\BIONTECH 903123-1
FIBRIN D DIMER 40-49 Life respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed
1670 MODERNA 946978-1
INCREASED years Threatening multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered
FIBRIN D DIMER 40-49 Life Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found
1671 MODERNA 954442-1
INCREASED years Threatening to have a right lower lobe pulmonary embolism. Treated with Xarelto and sent home with outpatient follow up.
FIBRIN D DIMER 50-59 Life I was short of breath and went to emergency room on 1/5/2021. I was diagnosed with bilateral pulmonary embolisms. I was
1672 MODERNA 941522-1
INCREASED years Threatening Covid negative and had no other symptoms.
FIBRIN D DIMER 30-39 Life Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or
INCREASED years Threatening deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively
FIBRIN D DIMER 30-39 Life
FIBRIN D DIMER 50-59 Life Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute
INCREASED years Threatening pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).
1676 FIBRIN D DIMER NORMAL PFIZER\BIONTECH 917210-1
40-49 Life
1677 FIBRIN D DIMER NORMAL PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
1678 FIBRIN D DIMER NORMAL PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
1679 FLANK PAIN MODERNA 955565-1
50-59 Life
1680 FLANK PAIN MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
Vaccine Event
FLUID BALANCE
ASSESSMENT
WITHIN 30 SECONDS OF RECEIVING VACCINE PATIENT STATED THAT SHE DID NOT FEEL WELL. HER FACE BECAME FLUSHED.
18-29 Life
1682 FLUSHING MODERNA 953997-1 HER LIPS BECAME NUMB AND HER TONGUE AND THROAT STARTED SWELLING. AN EPIPEN WAS ADMINISTERED AND 911
years Threatening
CALLED. AFTER THE EPIPEN SYMPTOMS BEGAN TO RESOLVE. EMS CHECKED HER OUT AND SHE REFUSED TRANSPORT.
Within 3 minutes of receiving vaccine felt flush and throat swelling, responded to Epi Pen and Benadryl p.o. EMS took him to ED
30-39 Life
1683 FLUSHING MODERNA 938820-1 where he remained several hours receiving 1 liter NS 125 mg solumedrol IV, discharge with 4 days of prednisone 40 mg daily and
years Threatening
a prescription for an Epi Pen. As of 1.12 he is totally okay with no after effects.
30-39 Life
1684 FLUSHING MODERNA 947019-1 was administered and 50 mg Benadryl given p.o., EMS transport to ED after administration of solumedrol 125 mg - received
years Threatening
1685 FLUSHING MODERNA 951572-1
after the vaccine.
40-49 Life emergency room. Approximately 30-40 minutes later symptoms started to lessen. Once at the ER, at the same time symptoms
years Threatening began to resolve, I was given PO Solumedrol and Pepcid. I was monitored and then discharged with RX for prednisone, and
60-64 Life
1688 FLUSHING MODERNA 924078-1 pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse
years Threatening
1689 FLUSHING PFIZER\BIONTECH 944450-1
on monitor.
40-49 Life
1692 FLUSHING PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
1693 FLUSHING PFIZER\BIONTECH 913854-1 anxiety, tachycardia, flushing, diaphoresis, HTN, SOB
years Threatening
40-49 Life
1694 FLUSHING PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
Vaccine Event
50-59 Life
1696 FLUSHING PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
50-59 Life
1697 FLUSHING PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
ACHES, SORE THROAT.
on 12/24/2020 the resident was sleepy and stayed in bed most of the shift. He stated he was doing okay but requested pain
65+
1699 FOAMING AT MOUTH MODERNA Death 909095-1 medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
years
foam coming from mouth and unresponsive. He was not breathing and with no pulse
40-49 Life
1700 FOETAL DEATH PFIZER\BIONTECH 958755-1 that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently
years Threatening
FORCED EXPIRATORY
VOLUME DECREASED
1702 FULL BLOOD COUNT MODERNA 956504-1
Received vaccine at 1:30 pm yesterday, noted onset of symptoms at 8:45 pm. Numbness and tingling to mouth and bilateral
upper and lower extremities, mild vision change, feeling of some swelling to bilateral eyelids. Also swelling to lips. She also did
30-39 Life
1703 FULL BLOOD COUNT MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
multivitamin/pre-natal vitamins. Patient was prescribed Pepcid 20 mg BID, Medrol 4 mg dose pack 21 pill taper until complete.
Also given Benadryl 25 mg - 50 mg every 4 - 6 hours for allergy symptoms. And provided with an Epi-Pen for home.
40-49 Life
1704 FULL BLOOD COUNT MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
1705 FULL BLOOD COUNT MODERNA 916746-1
40-49 Life
1706 FULL BLOOD COUNT MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
50-59 Life
1707 FULL BLOOD COUNT MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
65+
1708 FULL BLOOD COUNT MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
65+
1709 FULL BLOOD COUNT MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
years
1710 FULL BLOOD COUNT MODERNA Death 959591-1
30-39 Life
1711 FULL BLOOD COUNT PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
1712 FULL BLOOD COUNT PFIZER\BIONTECH 932366-1
40-49 Life
1713 FULL BLOOD COUNT PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
Vaccine Event
40-49 Life
1714 FULL BLOOD COUNT PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
50-59 Life
1715 FULL BLOOD COUNT PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
60-64
1717 FULL BLOOD COUNT PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
60-64 Life
1718 FULL BLOOD COUNT PFIZER\BIONTECH 909577-1 Dizziness, dyspnea, neck swelling
years Threatening
cultures.
65+
1720 FULL BLOOD COUNT PFIZER\BIONTECH Death 919108-1 Fever, Malaise
years
FULL BLOOD COUNT 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
ABNORMAL years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
FULL BLOOD COUNT 30-39 Life
1722 MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
FULL BLOOD COUNT 50-59 Life 12/30 9:30 am developed angioedema. Swelling of face, lips, tight throat. Also had bright red rash over body trunk and arms.
1723 MODERNA 914392-1
NORMAL years Threatening Both palms were red, hot and painful.
FULL BLOOD COUNT 65+ Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be
NORMAL years resuscitated
1725 PFIZER\BIONTECH 904334-1 Angioedema, hives, tachycardia, shortness of breath
FULL BLOOD COUNT 60-64 Life noticed tingling after dinner. Patient stated he took two benadryl with no relief. His tongue continued to swell and he took two
NORMAL years Threatening additional benadryl at 22:00. Once he developed difficulty swallowing he went to the emergency department. Patient presented
50-59 Life
1728 GAIT DISTURBANCE MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
60-64 Life
1729 GAIT DISTURBANCE MODERNA 952677-1 and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for
years Threatening
2/5/2021 at 7:15am
1730 GAIT DISTURBANCE PFIZER\BIONTECH 951817-1
1731 GAIT INABILITY MODERNA 958913-1
1732 GAIT INABILITY PFIZER\BIONTECH Death 959929-1
GASTROINTESTINAL 65+ without complications."" Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS
HAEMORRHAGE years increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation
GENE MUTATION
1734 IDENTIFICATION TEST PFIZER\BIONTECH 951560-1
NEGATIVE
GENERAL PHYSICAL 60-64 Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and
CONDITION ABNORMAL years started CPR. 911 arrived and pronounced resident dead at 1:01 am.
GENERAL PHYSICAL 65+
1736 MODERNA Death 947662-1 Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death
HEALTH DETERIORATION years
1737 MODERNA Death 953858-1 patient started to decline 1/10/2021, patient seen at facility by medical professional - patient deceased 1/13/2021
Vaccine Event
GENERAL PHYSICAL 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
HEALTH DETERIORATION years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
1739 PFIZER\BIONTECH Death 962827-1 appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the
GENERAL PHYSICAL 65+ due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP;
HEALTH DETERIORATION years progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening
GENERAL PHYSICAL 65+ vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He
HEALTH DETERIORATION years experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9
GENERALISED TONIC- 30-39 Life
CLONIC SEIZURE years Threatening
1743 GLOBULIN PFIZER\BIONTECH Death 950441-1
GLOMERULAR FILTRATION 30-39 Life
RATE years Threatening
Racepinephrine x 1.
GLOMERULAR FILTRATION 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
RATE years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
GLOMERULAR FILTRATION 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
RATE years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
GLOMERULAR FILTRATION 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
RATE DECREASED years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
30-39 Life
1748 GLOSSODYNIA PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
1749 GRAM STAIN NEGATIVE PFIZER\BIONTECH 949941-1
encephalopathy."
1750 GRAM STAIN POSITIVE PFIZER\BIONTECH 904436-1
30-39 Life
1751 GRANULOCYTE COUNT MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
GRANULOCYTE 30-39 Life
PERCENTAGE years Threatening
GRIP STRENGTH 65+ upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard
DECREASED years to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to
GUILLAIN-BARRE 30-39 Life slowly for 4 days in intensity and area involved. Symptoms progressed distally to superior. On the 5th day symptoms progressed
1754 MODERNA 926703-1
SYNDROME years Threatening rapidly and involved bilateral legs up to the groin, left arm up to lateral shoulder, and right hand. I went to the hospital and was
GUILLAIN-BARRE 50-59 Life
GUILLAIN-BARRE 30-39 Life Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by neurology and diagnosed
SYNDROME years Threatening with Guillain- Barre Syndrome thought to be secondary to the Pfizer Covid Vaccine
Patient developed symptoms of Guillain-Barre syndrome on January 15, 2021 and was admitted the Hospital. She was
GUILLAIN-BARRE 40-49 Life
1757 PFIZER\BIONTECH 956709-1 diagnosed and eventually required ICU level care and has been treated with plasmapheresis. She is currently still in the ICU but is
stable.
1-2
1758 GUN SHOT WOUND PFIZER\BIONTECH Death 958443-1 death by suicide Narrative: death by suicide; 12/26/20, self inflicted gun shot wound; found deceased by family member
years
1759 HAEMATEMESIS PFIZER\BIONTECH Death 938974-1
Vaccine Event
1760 HAEMATEMESIS PFIZER\BIONTECH Unknown Death 933232-1
1761 HAEMATOCHEZIA PFIZER\BIONTECH Death 938974-1
40-49 Life
1762 HAEMATOCRIT DECREASED MODERNA 958885-1 immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and
years Threatening
1763 HAEMATOCRIT DECREASED MODERNA Death 952881-1
1764 HAEMATOCRIT DECREASED MODERNA 917784-1
1765 HAEMATOCRIT DECREASED PFIZER\BIONTECH 904436-1
1766 HAEMATOCRIT DECREASED PFIZER\BIONTECH Death 959179-1
18-29 Life
1767 HAEMATOCRIT NORMAL MODERNA 932915-1 Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
years Threatening
30-39 Life
1768 HAEMATOCRIT NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
1769 HAEMATOCRIT NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
65+ Life
1770 HAEMATOCRIT NORMAL MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
1771 HAEMATOCRIT NORMAL PFIZER\BIONTECH 903123-1
1772 HAEMATOCRIT NORMAL PFIZER\BIONTECH Death 950441-1
65+
1773 HAEMATOMA PFIZER\BIONTECH Death 961010-1 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro
years
65+
1774 HAEMATURIA PFIZER\BIONTECH Death 937773-1 Patient was sent to the ED due to significant hematuria. He was afebrile.
years
40-49 Life
1775 HAEMOGLOBIN DECREASED MODERNA 958885-1 immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and
years Threatening
1776 HAEMOGLOBIN DECREASED MODERNA Death 952881-1
50-59 Life
1777 HAEMOGLOBIN DECREASED PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
1778 HAEMOGLOBIN DECREASED PFIZER\BIONTECH Death 938974-1
1779 HAEMOGLOBIN DECREASED PFIZER\BIONTECH Death 959179-1
1780 HAEMOGLOBIN INCREASED PFIZER\BIONTECH 930894-1
18-29 Life
1781 HAEMOGLOBIN NORMAL MODERNA 932915-1 Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
years Threatening
30-39 Life
1782 HAEMOGLOBIN NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
Vaccine Event
30-39 Life
1783 HAEMOGLOBIN NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
40-49 Life
1784 HAEMOGLOBIN NORMAL MODERNA 933935-1 Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine. Clinically suspicious for ITP.
years Threatening
1785 HAEMOGLOBIN NORMAL MODERNA 958913-1
65+ Life
1786 HAEMOGLOBIN NORMAL MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
1787 HAEMOGLOBIN NORMAL MODERNA 917784-1
1788 HAEMOGLOBIN NORMAL PFIZER\BIONTECH 903123-1
1789 HAEMOGLOBIN NORMAL PFIZER\BIONTECH Death 950441-1
1790 HAEMOLYTIC ANAEMIA PFIZER\BIONTECH Unknown Death 944155-1
1791 HAEMOPTYSIS PFIZER\BIONTECH Death 924464-1
1792 HAEMOPTYSIS PFIZER\BIONTECH Unknown Death 933232-1
1793 HAEMORRHAGE PFIZER\BIONTECH 949724-1
HAEMORRHAGE 65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
INTRACRANIAL years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
65+
1795 HAEMORRHAGIC STROKE MODERNA Death 958971-1 Hemorrhagic Stroke, Right Basal Ganglion
years
immunization. The relevant medical history and concomitant medications were not reported. The patient died 2 weeks after his
1796 HAEMORRHAGIC STROKE PFIZER\BIONTECH Unknown Death 955878-1
COVID shot because his platelet levels dropped and he had a hemorrhagic stroke. No further information provided. The autopsy
hemorrhagic stroke
1797 HAEMORRHAGIC STROKE PFIZER\BIONTECH Unknown Death 960437-1
1798 HEAD INJURY PFIZER\BIONTECH Unknown Death 944154-1 floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR,
18-29 Life
1799 HEADACHE MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
18-29 Life
1800 HEADACHE MODERNA 919252-1 down her Rt. arm. about 4 hours later she decided to go to the emergency room for Hearty Palpitations, Fever, Chest discomfort
years Threatening
1801 HEADACHE MODERNA 939216-1
not recurred.
Vaccine Event
30-39 Life
1805 HEADACHE MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
40-49 Life
1806 HEADACHE MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
40-49 Life
1807 HEADACHE MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
1808 HEADACHE MODERNA Death 950073-1
60-64 Life
1809 HEADACHE MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
60-64 Life
1810 HEADACHE MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
65+
1811 HEADACHE MODERNA Death 948164-1 Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21
years
65+
1812 HEADACHE MODERNA Death 950979-1 Headache after dose was given at 10:00 a.m Died at after 7:30 pm the same night the dose was given.
years
65+ Life
1813 HEADACHE MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
1815 HEADACHE MODERNA Unknown 953397-1
30-39 Life
1816 HEADACHE PFIZER\BIONTECH 936618-1 Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
years Threatening
30-39 Life
1817 HEADACHE PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
30-39 Life
1818 HEADACHE PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
1819 HEADACHE PFIZER\BIONTECH 913061-1
40-49 Life
1820 HEADACHE PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
40-49 Life
1821 HEADACHE PFIZER\BIONTECH 928209-1 Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
years Threatening
Vaccine Event
40-49 Life
1823 HEADACHE PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
40-49 Life
1824 HEADACHE PFIZER\BIONTECH 938829-1 and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I
years Threatening
40-49 Life
1826 HEADACHE PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
ACHES, SORE THROAT.
50-59 Life
1828 HEADACHE PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
50-59 Life
1829 HEADACHE PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
50-59 Life
1831 HEADACHE PFIZER\BIONTECH 954723-1 itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
years Threatening
60-64 Life
1832 HEADACHE PFIZER\BIONTECH 950759-1 Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed
years Threatening
1833 HEADACHE PFIZER\BIONTECH Death 932346-1
65+
1834 HEADACHE PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
symptoms.
65+
1835 HEADACHE PFIZER\BIONTECH Death 944998-1 On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.
years
1839 HEADACHE PFIZER\BIONTECH Unknown Death 933232-1
Vaccine Event
1840 HEADACHE PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
50-59 Life
1841 HEART RATE DECREASED PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
18-29 Life
1842 HEART RATE INCREASED MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
1843 HEART RATE INCREASED MODERNA 916859-1
not recurred.
30-39 Life
1844 HEART RATE INCREASED MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
years Threatening
30-39 Life
1845 HEART RATE INCREASED MODERNA 929391-1 vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for
years Threatening
after the vaccine.
40-49 Life
1850 HEART RATE INCREASED MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
were made.
50-59 Life
1852 HEART RATE INCREASED MODERNA 948471-1 5-6 HOURS AFTER VACCINATION. CONVULSIONS/SEIZURE, HIGH BLOOD PRESSURE, INCREASED HEART RATE,
years Threatening
fever.
1855 HEART RATE INCREASED PFIZER\BIONTECH 904553-1
30-39 Life
1856 HEART RATE INCREASED PFIZER\BIONTECH 914103-1 that time. Epi pen given via L thigh IM. PIV started and benadryl and solumedrol given. Relief of symptoms noted very shortly
years Threatening
Vaccine Event
40-49 Life
1858 HEART RATE INCREASED PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
1859 HEART RATE INCREASED PFIZER\BIONTECH 909146-1 listed before
years Threatening
40-49 Life
1860 HEART RATE INCREASED PFIZER\BIONTECH 909614-1 Fever, muscle aches, hypertension, rapid heart heart
years Threatening
50-59 Life
1864 HEART RATE INCREASED PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
50-59 Life
1865 HEART RATE INCREASED PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
65+
1867 HEART RATE INCREASED PFIZER\BIONTECH Death 959079-1 shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified, branch block. Received order for
years
Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs
65+ Life of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and
years Threatening white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low
oxygen levels. Resident not responding to stimuli.
1869 HEART RATE INCREASED PFIZER\BIONTECH Unknown 902856-1
65+
1870 HEART RATE IRREGULAR MODERNA Death 948181-1 Death Chest pain; irreg heart rhythm; evening of vaccine; death on toilet on 1/13/21
years
1871 HEART RATE IRREGULAR PFIZER\BIONTECH 944450-1
on monitor.
1872 HEART RATE IRREGULAR PFIZER\BIONTECH Death 954812-1
1873 HEART RATE IRREGULAR PFIZER\BIONTECH Unknown 902856-1
HEART SOUNDS 65+ breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse
ABNORMAL years was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple
1875 HEMIANOPIA MODERNA 941476-1
Vaccine Event
30-39
1876 HEMIPARESIS MODERNA Death 939050-1 develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory
years
50-59 Life
1877 HEMIPARESIS PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
1878 HEMIPARESIS PFIZER\BIONTECH 942237-1
65+
1879 HEMIPARESIS PFIZER\BIONTECH Death 945247-1 weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should
years
report
1880 HEMIPLEGIA MODERNA Death 941561-1
1881 HEPATIC ENZYME PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
HEPATIC ENZYME 65+
INCREASED years
HEPATITIS B TEST 50-59 Life platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my
1883 MODERNA 950980-1
NEGATIVE years Threatening platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the
HEPATITIS C ANTIBODY 50-59 Life Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute
NEGATIVE years Threatening pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).
HEPATITIS C TEST 50-59 Life platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my
1885 MODERNA 950980-1
HERPES SIMPLEX TEST 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
encephalopathy."
30-39 Life
1887 HERPES ZOSTER MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
1888 HERPES ZOSTER MODERNA Unknown 953397-1
65+
1889 HIP FRACTURE MODERNA Death 921572-1 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again.
years
1890 HIV TEST NEGATIVE MODERNA 950980-1
65+
1891 HOSPICE CARE MODERNA Death 920326-1 Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21
years
65+
1892 HOSPICE CARE MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
65+
1893 HOSPICE CARE PFIZER\BIONTECH Death 918418-1 treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations.
years
65+
1894 HOSPICE CARE PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
1895 HOSPICE CARE PFIZER\BIONTECH 928378-1
Vaccine Event
1896 HOT FLUSH MODERNA 935478-1
to local er.
40-49 Life
1897 HOT FLUSH MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
years Threatening
50-59
1898 HOT FLUSH PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
HUMAN CHORIONIC 40-49 Life
GONADOTROPIN NEGATIVE years Threatening
HUMAN 65+
METAPNEUMOVIRUS TEST years
65+
1901 HUMAN RHINOVIRUS TEST PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
40-49 Life
1902 HYPERCOAGULATION MODERNA 931558-1 7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
years Threatening
1903 HYPERHIDROSIS MODERNA 939216-1
30-39 Life
1904 HYPERHIDROSIS MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
1905 HYPERHIDROSIS MODERNA 949967-1
18-29 Life
1906 HYPERHIDROSIS PFIZER\BIONTECH 951689-1 assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min
years Threatening
30-39 Life
1907 HYPERHIDROSIS PFIZER\BIONTECH 914103-1 that time. Epi pen given via L thigh IM. PIV started and benadryl and solumedrol given. Relief of symptoms noted very shortly
years Threatening
1908 HYPERHIDROSIS PFIZER\BIONTECH 934749-1
30-39 Life
1909 HYPERHIDROSIS PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
40-49 Life
1910 HYPERHIDROSIS PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
1911 HYPERHIDROSIS PFIZER\BIONTECH 907101-1 assessment, and en route in wheelchair to ER the dry cough became persistent, spasmodic and patient was unable to speak.
years Threatening
40-49 Life
1912 HYPERHIDROSIS PFIZER\BIONTECH 909146-1 listed before
years Threatening
40-49 Life
1913 HYPERHIDROSIS PFIZER\BIONTECH 911943-1 tingling in extremities, diaphoretic after leaving clinic observation. Drove back to hospital, escorted by pre surgical testing
years Threatening
40-49 Life
1914 HYPERHIDROSIS PFIZER\BIONTECH 913854-1 anxiety, tachycardia, flushing, diaphoresis, HTN, SOB
years Threatening
40-49 Life
1915 HYPERHIDROSIS PFIZER\BIONTECH 914730-1 admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-
years Threatening
Vaccine Event
50-59 Life
1917 HYPERHIDROSIS PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
50-59 Life
1918 HYPERHIDROSIS PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
encephalopathy."
65+
1921 HYPERHIDROSIS PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
1922 HYPERHIDROSIS PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
UNKNOWN 65+
1923 HYPERHIDROSIS Death 956962-1 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have
MANUFACTURER years
1924 HYPERKALAEMIA PFIZER\BIONTECH Death 959179-1
1925 HYPERNATRAEMIA MODERNA Death 958228-1
18-29 Life
1926 HYPERSENSITIVITY MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
1927 HYPERSENSITIVITY MODERNA 956527-1
1928 HYPERSENSITIVITY MODERNA 954154-1
18-29 Life
1929 HYPERSENSITIVITY PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
30-39 Life
1930 HYPERSENSITIVITY PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
Life
1931 HYPERSENSITIVITY PFIZER\BIONTECH Unknown 907573-1 gastrooesophageal reflux disease and anxiety. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) in
Threatening
40-49 Life
1932 HYPERTENSION MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
50-59 Life
1933 HYPERTENSION MODERNA 948471-1 5-6 HOURS AFTER VACCINATION. CONVULSIONS/SEIZURE, HIGH BLOOD PRESSURE, INCREASED HEART RATE,
years Threatening
Vaccine Event
1934 HYPERTENSION PFIZER\BIONTECH 909147-1
40-49 Life
1937 HYPERTENSION PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
1938 HYPERTENSION PFIZER\BIONTECH 909146-1 listed before
years Threatening
40-49 Life
1939 HYPERTENSION PFIZER\BIONTECH 909614-1 Fever, muscle aches, hypertension, rapid heart heart
years Threatening
40-49 Life
1940 HYPERTENSION PFIZER\BIONTECH 913854-1 anxiety, tachycardia, flushing, diaphoresis, HTN, SOB
years Threatening
40-49 Life
1941 HYPERTENSION PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
40-49 Life
1942 HYPERTENSION PFIZER\BIONTECH 942808-1 receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with
years Threatening
50-59 Life
1943 HYPERTENSION PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
HYPERTENSIVE 65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
EMERGENCY years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
1946 HYPERTENSIVE URGENCY PFIZER\BIONTECH 912785-1
1947 HYPERTENSIVE URGENCY PFIZER\BIONTECH Death 963057-1
HYPERTROPHY OF TONGUE 30-39 Life
1948 PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
PAPILLAE years Threatening
30-39 Life
1949 HYPOAESTHESIA MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
30-39 Life
1950 HYPOAESTHESIA MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
30-39 Life
1951 HYPOAESTHESIA MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
years Threatening
PATIENT REPORTING ITCHING AT 30 MINUTES POST INJECTION. AT 1.5 HOURS POST INJECTION PATIENT REPORTED ITCHY
THROAT AND NUMBESS OF LEFT SIDE OF FACE. AT THAT TIME ADVISED TO GO TO EMERGENCY ROOM. NEXT DAY WHEN I
30-39 Life
1952 HYPOAESTHESIA MODERNA 924524-1 FOLLOWED UP WITH PATIENT, SHE REPORTED HER AIRWAY STARTED TO CLOSE AND SHE RECEIVED EPINEPHRINE, AFTER 5
years Threatening
HOURS HER STARTED TO CLOSE AGAIN AND RECEIVED ANOTHER DOSE OF EPINEPHERINE, WAS RELEASED FROM HOSPITAL
ROUGHLY 15-16 HOURS AFTER GOING TO ER.
1953 HYPOAESTHESIA MODERNA 932367-1
1954 HYPOAESTHESIA MODERNA 949967-1
30-39 Life
1955 HYPOAESTHESIA PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
1956 HYPOAESTHESIA PFIZER\BIONTECH 932366-1
Vaccine Event
30-39 Life
1957 HYPOAESTHESIA PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
1958 HYPOAESTHESIA PFIZER\BIONTECH 908973-1
40-49 Life
1959 HYPOAESTHESIA PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
50-59 Life
1960 HYPOAESTHESIA PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
18-29 Life
1961 HYPOAESTHESIA ORAL MODERNA 953997-1 HER LIPS BECAME NUMB AND HER TONGUE AND THROAT STARTED SWELLING. AN EPIPEN WAS ADMINISTERED AND 911
years Threatening
30-39 Life
1962 HYPOAESTHESIA ORAL MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
30-39 Life
1963 HYPOAESTHESIA ORAL MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
years Threatening
1964 HYPOAESTHESIA ORAL MODERNA 932367-1
1965 HYPOAESTHESIA ORAL MODERNA 949967-1
10 minutes after receiving vaccine, patient reported numbness across upper lip which progressed to her tongue. Felt tingling and
18-29 Life dryness of tongue and swelling. No difficulty breathing or swallowing, no chest pain, no wheezing, no rash, no itching. Taken to
1966 HYPOAESTHESIA ORAL PFIZER\BIONTECH 915464-1
years Threatening ED and given methylprednisolone 125mg IV, diphenhydramine 50mg IV, famotidine 20mg PO. Patient improved and monitored x
4 hours with resolution of symptoms. Prescribed prednisone 50mg po x 4 days.
30-39 Life
1967 HYPOAESTHESIA ORAL PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
1968 HYPOAESTHESIA ORAL PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
30-39 Life
1969 HYPOAESTHESIA ORAL PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
30-39 Life
1970 HYPOAESTHESIA ORAL PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
40-49 Life
1971 HYPOAESTHESIA ORAL PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
Vaccine Event
1972 HYPOAESTHESIA ORAL PFIZER\BIONTECH 939914-1
50-59 Life
1973 HYPOAESTHESIA ORAL PFIZER\BIONTECH 954723-1 itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
years Threatening
65+
1974 HYPOGLYCAEMIA PFIZER\BIONTECH Death 962827-1 appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the
years
1975 HYPOGLYCAEMIA PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
1976 HYPOKALAEMIA PFIZER\BIONTECH 936011-1
65+ Life
1977 HYPOKINESIA MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
60-64 Life
1978 HYPOKINESIA PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
1979 HYPOPHAGIA MODERNA Death 910363-1
65+
1980 HYPOPHAGIA MODERNA Death 947662-1 Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death
years
65+
1981 HYPOPHAGIA MODERNA Death 949630-1 pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5
years
1982 HYPOPHAGIA PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
65+
1983 HYPOPNOEA PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
65+
1984 HYPOPNOEA PFIZER\BIONTECH Death 955390-1 January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away
years
later that day.
HYPORESPONSIVE TO 65+
1985 MODERNA Death 947662-1 Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death
STIMULI years
HYPORESPONSIVE TO 65+ Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital
STIMULI years and treated for worsening AKI and hypotension.
HYPORESPONSIVE TO 50-59 Life
1987 PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
STIMULI years Threatening
HYPORESPONSIVE TO 65+
1988 PFIZER\BIONTECH Death 945578-1 feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not
STIMULI years
1989 HYPOTENSION MODERNA 927223-1
Vaccine Event
60-64 Life
1990 HYPOTENSION MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
1991 HYPOTENSION MODERNA Death 910363-1
65+
1992 HYPOTENSION MODERNA Death 949630-1 pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5
years
1993 HYPOTENSION MODERNA Death 959591-1
1994 HYPOTENSION PFIZER\BIONTECH 904436-1
1996 HYPOTENSION PFIZER\BIONTECH Death 928062-1
65+
1997 HYPOTENSION PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
65+ Life
1999 HYPOTENSION PFIZER\BIONTECH 924658-1 Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.
years Threatening
2000 HYPOTENSION PFIZER\BIONTECH Unknown Death 944155-1
2001 HYPOTENSION PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
2002 HYPOTENSION PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
2003 HYPOTENSION PFIZER\BIONTECH Unknown 902856-1
UNKNOWN 65+
2004 HYPOTENSION Death 956962-1 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have
MANUFACTURER years
65+
2005 HYPOTHERMIA PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
Vaccine Event
2006 HYPOTHERMIA PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
2007 HYPOTONIA MODERNA Death 941561-1
65+
2008 HYPOTONIA MODERNA Death 941607-1 vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went
years
2009 HYPOTONIA MODERNA 944219-1
2010 HYPOTONIA PFIZER\BIONTECH 930894-1
2011 HYPOTONIA PFIZER\BIONTECH 932145-1
10:31am.
50-59
2012 HYPOXIA MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
50-59 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated
2013 HYPOXIA MODERNA Death 946293-1
years further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at
medical center.
65+
2014 HYPOXIA MODERNA Death 949630-1 pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5
years
2015 HYPOXIA MODERNA Death 956966-1
6-17 Life
2016 HYPOXIA PFIZER\BIONTECH 921641-1 decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without
years Threatening
2017 HYPOXIA PFIZER\BIONTECH 920224-1
50-59 Life
2018 HYPOXIA PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
65+
2019 HYPOXIA PFIZER\BIONTECH Death 918418-1 treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations.
years
65+
2020 HYPOXIA PFIZER\BIONTECH Death 926462-1 Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021
years
2021 HYPOXIA PFIZER\BIONTECH Death 928062-1
65+
2022 HYPOXIA PFIZER\BIONTECH Death 953865-1 REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS
years
2023 HYPOXIA PFIZER\BIONTECH Death 963057-1
2024 HYPOXIA PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
Vaccine Event
UNKNOWN 65+
2025 HYPOXIA Death 956962-1 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have
MANUFACTURER years
died the day after receiving the first injection of vaccine against Covid-19 in suspected cardiac arrest; This is a spontaneous
report from a web page with a contactable physician as publisher. A multi-sick, elderly patient of an unspecified gender received
the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an
unspecified date at single dose for covid vaccination. The patient medical history was not reported. The patient's concomitant
medications were not reported. The patient died the day after vaccination of a suspected heart stop. The patient died the day
after receiving the first injection of vaccine against covid-19. The patient died on an unspecified date. It was not reported if an
autopsy was performed. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Sender's
2026 ILLNESS PFIZER\BIONTECH Unknown Death 918727-1
Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the
case. In particular the following relevant information is not available: complete medical history and complete demographics,
treatment dates and dose, concomitant medications (if any), event descriptors, autopsy report. The impact of this report on the
action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.;
Reported Cause(s) of Death: suspected heart stop
IMMATURE GRANULOCYTE 30-39 Life
COUNT INCREASED years Threatening
Racepinephrine x 1.
IMMATURE GRANULOCYTE 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
COUNT INCREASED years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
IMMATURE GRANULOCYTE 30-39 Life
PERCENTAGE INCREASED years Threatening
Racepinephrine x 1.
IMMATURE GRANULOCYTE 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
PERCENTAGE INCREASED years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
IMMEDIATE POST- 18-29 Life
2031 MODERNA 953997-1 HER LIPS BECAME NUMB AND HER TONGUE AND THROAT STARTED SWELLING. AN EPIPEN WAS ADMINISTERED AND 911
INJECTION REACTION years Threatening
2032 MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
IMMEDIATE POST- 30-39 Life felt dizzy. looked in the mirror and saw my neck and chest covered in red rash and hives. felt hot flush again. dr came in noticed
2033 MODERNA 935478-1
INJECTION REACTION years Threatening hives all over both my arms as well. felt sob and if someone was holding my neck with their hand. given benadryl and epi taken
to local er.
2034 MODERNA 947019-1 was administered and 50 mg Benadryl given p.o., EMS transport to ED after administration of solumedrol 125 mg - received
IMMEDIATE POST- 40-49 Life to experience symptoms of anaphylaxis. Was immediately placed in a treatment room and received treatment by the ER
2035 MODERNA 916746-1
INJECTION REACTION years Threatening physician, which included oxygen, intravenous Benadryl, Solumedrol, and Normal Saline. Was observed for several hours and
2036 MODERNA 938443-1 immediate tingling of lips, followed by fullness of posterior oropharynx, hoarseness and pruritus
2037 PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
------------------------------------------------------RN
IMMEDIATE POST- 30-39 Life and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was
INJECTION REACTION years Threatening altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on
2039 PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
2040 PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
2041 PFIZER\BIONTECH 953402-1 Was feeling anxious right after vaccine given. Laid in cot for a short time, then stated her throat felt like it was closing.
IMMEDIATE POST- 65+
2042 PFIZER\BIONTECH Death 955256-1 became unresponsive. Patient was lowered to the floor and did not exhibit a pulse. CPR was initiated and 911 was called. An
INJECTION REACTION years
IMMUNE 40-49 Life
2043 MODERNA 933935-1 Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine. Clinically suspicious for ITP.
THROMBOCYTOPENIA years Threatening
IMMUNE 50-59 Life platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my
2044 MODERNA 950980-1
THROMBOCYTOPENIA years Threatening platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the
IMMUNE Life 1day after vaccine,developed severe headache & later blister in head officially Shingle . Then decreased platelet count fatally to
2045 MODERNA Unknown 953397-1
THROMBOCYTOPENIA Threatening 29(ITP).now hospitalized getting treatment.
IMMUNE 40-49 Life
2046 PFIZER\BIONTECH 930153-1 ITP Plt 2
IMMUNE 40-49 Life
2047 PFIZER\BIONTECH 959017-1 started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line
IMMUNOGLOBULIN 18-29 Life
THERAPY years Threatening
IMMUNOGLOBULIN 30-39 Life slowly for 4 days in intensity and area involved. Symptoms progressed distally to superior. On the 5th day symptoms progressed
2049 MODERNA 926703-1
THERAPY years Threatening rapidly and involved bilateral legs up to the groin, left arm up to lateral shoulder, and right hand. I went to the hospital and was
IMMUNOGLOBULIN 50-59 Life platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my
2051 MODERNA 950980-1
THERAPY years Threatening platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the
Vaccine Event
IMMUNOGLOBULIN 65+ Life
2055 IMPAIRED DRIVING ABILITY PFIZER\BIONTECH 959746-1
18-29 Life
2056 IMPAIRED WORK ABILITY MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
50-59 Life
2057 IMPAIRED WORK ABILITY PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
65+
2058 INCONTINENCE PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
INCORRECT ROUTE OF
65+ Life
2059 PRODUCT PFIZER\BIONTECH 964622-1 Narrative:
years Threatening
ADMINISTRATION
INFLUENZA A VIRUS TEST 65+
NEGATIVE years
65+
2061 INFLUENZA B VIRUS TEST PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
30-39 Life
2062 INFLUENZA LIKE ILLNESS MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
18-29 Life
2063 INFLUENZA LIKE ILLNESS PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
2064 INFLUENZA LIKE ILLNESS PFIZER\BIONTECH Death 951101-1
2065 INFLUENZA VIRUS TEST MODERNA 949967-1
INFLUENZA VIRUS TEST 30-39 Life
NEGATIVE years Threatening
INFLUENZA VIRUS TEST 50-59 Life freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove
2067 MODERNA 955945-1
NEGATIVE years Threatening me to the emergency department. I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday
fever.
INFLUENZA VIRUS TEST 65+
NEGATIVE years
INFLUENZA VIRUS TEST 65+
NEGATIVE years
Vaccine Event
INJECTION SITE 30-39 Life
ERYTHEMA years Threatening
INJECTION SITE 30-39 Life
HYPOAESTHESIA years Threatening
Racepinephrine x 1.
2072 INJECTION SITE OEDEMA PFIZER\BIONTECH 905544-1
18-29 Life
2073 INJECTION SITE PAIN MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
2074 INJECTION SITE PAIN MODERNA 916859-1
not recurred.
30-39 Life
2075 INJECTION SITE PAIN MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
40-49 Life
2076 INJECTION SITE PAIN MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
2077 INJECTION SITE PAIN MODERNA 954154-1
2078 INJECTION SITE PAIN MODERNA Death 940602-1
2079 INJECTION SITE PAIN PFIZER\BIONTECH 903123-1
30-39 Life
2080 INJECTION SITE PAIN PFIZER\BIONTECH 936618-1 Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
years Threatening
50-59 Life
2081 INJECTION SITE PAIN PFIZER\BIONTECH 941118-1 temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I
years Threatening
2082 INJECTION SITE PAIN PFIZER\BIONTECH Death 962325-1
INJECTION SITE 40-49 Life few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and
PARAESTHESIA years Threatening told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-
18-29 Life
2084 INJECTION SITE PRURITUS MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
40-49 Life
2085 INJECTION SITE PRURITUS MODERNA 931558-1 7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
years Threatening
2086 INJECTION SITE PRURITUS PFIZER\BIONTECH 930508-1
18-29 Life
2087 INJECTION SITE REACTION MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
40-49 Life
2088 INJECTION SITE SWELLING MODERNA 931558-1 7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
years Threatening
2089 INJECTION SITE SWELLING MODERNA 954154-1
18-29 Life
2090 INJECTION SITE WARMTH MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
40-49 Life
2091 INJECTION SITE WARMTH MODERNA 931558-1 7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
years Threatening
40-49 Life
2092 INSOMNIA MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
60-64 Life
2093 INSOMNIA MODERNA 935090-1 SOB, Sleeplessness,
years Threatening
2094 INTENSIVE CARE MODERNA 913445-1
40-49 Life
2095 INTENSIVE CARE MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
years Threatening
Vaccine Event
60-64 Life
2100 INTENSIVE CARE MODERNA 934156-1 01/08/21 at SPO@ less then 60% on room air, non responsive to verbal tactile stimuli. Responsive to sternal rub only. Was sent
years Threatening
60-64 Life
2101 INTENSIVE CARE MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
65+
2102 INTENSIVE CARE MODERNA Death 959568-1 Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by
years
65+ Life
2104 INTENSIVE CARE MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
65+ Life
2105 INTENSIVE CARE MODERNA 930611-1 Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP
years Threatening
18-29 Life
2106 INTENSIVE CARE PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
18-29 Life
2107 INTENSIVE CARE PFIZER\BIONTECH 936715-1 difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee
years Threatening
2108 INTENSIVE CARE PFIZER\BIONTECH 920224-1
40-49 Life
2111 INTENSIVE CARE PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
40-49 Life
2112 INTENSIVE CARE PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
40-49 Life
2113 INTENSIVE CARE PFIZER\BIONTECH 956709-1 diagnosed and eventually required ICU level care and has been treated with plasmapheresis. She is currently still in the ICU but is
years Threatening
stable.
2114 INTENSIVE CARE PFIZER\BIONTECH Death 933739-1
50-59
2115 INTENSIVE CARE PFIZER\BIONTECH Death 944595-1 and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the
years
50-59 Life
2116 INTENSIVE CARE PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
50-59 Life
2117 INTENSIVE CARE PFIZER\BIONTECH 912271-1 fever) the next day. Went to the Emergency room on Saturday Dec. 26th, 2020 due to shortness of breath, had an 02 Sat of 60%,
years Threatening
50-59 Life
2118 INTENSIVE CARE PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
Vaccine Event
65+
2120 INTENSIVE CARE PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
65+
2121 INTENSIVE CARE PFIZER\BIONTECH Death 955390-1 January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away
years
later that day.
65+ Life Rushed to ER. Has now been tubed and put into the ICU and has had full-cardiac arrest less than 24 hours after receiving the
years Threatening vaccine.
65+ Life
2124 INTENSIVE CARE PFIZER\BIONTECH 912602-1 Hospitalized 12/29, has now been tubed and put into the ICU
years Threatening
65+ Life
2126 INTENSIVE CARE PFIZER\BIONTECH 956578-1 Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was
years Threatening
anaphylaxis; This is a spontaneous report from a contactable physician reporting on behalf of patient. A patient of unspecified
age and gender received single dose of BNT162B2 (batch/lot number and exp date not reported), via an unspecified route of
administration on an unspecified date for immunisation. The patient's medical history and concomitant medications were not
reported. On an unspecified date, the patient experienced anaphylaxis with a very protracted course requiring an epi dose for 4.5
days and was still in the ICU (date/s unspecified) following administration of the COVID vaccine. The physician would like to use
a drop of leftover vaccine from one of the vials to do a future skin test after the patient is stable. They were unsure if they needed
Life
2127 INTENSIVE CARE PFIZER\BIONTECH Unknown 911511-1 permission as this was standard practice in allergy to test afterwards but wanted to check in with the company. The outcome of
Threatening
event was unknown. Information about batch/lot number has been requested.; Sender's Comments: A possible causal
association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible
INTERNATIONAL 30-39 Life The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and
NORMALISED RATIO years Threatening weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
INTERNATIONAL
2129 NORMALISED RATIO PFIZER\BIONTECH 904436-1
INCREASED
INTERNATIONAL
NORMAL
INTERNATIONAL next 48 hours. 12/21/2020: Patient had blood drawn (CMP, PT/INR, CBC) at lab. 12/22/2020: Labs resulted; CMP and PT/INR
65+ Life
2131 NORMALISED RATIO PFIZER\BIONTECH 908869-1 WNL (exceptions: SCr 1.24, TBil 1.7); CBC with platelet count of 1,000 resulting in patient admission to Hospital. At admission he
years Threatening
NORMAL received 80 mg of prednisone, 40 g of IV Ig and a unit of platelets. 12/23/2020: Continued hospitalization. Patient's platelets
INTERNATIONAL
NORMAL
2133 INTESTINAL RESECTION PFIZER\BIONTECH 920628-1
of 1/3/2021.
INTRACEREBRAL 65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
HAEMATOMA EVACUATION years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
2135 INTRACRANIAL ANEURYSM MODERNA Death 924664-1
65+
2136 INTRACRANIAL ANEURYSM PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
symptoms.
50-59 Life
2137 INTRACRANIAL MASS PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
ISCHAEMIC 65+ since the patient died between his first and second dose. Received Pfizer Dose #1 12/17/2020. No side effects or adverse
CARDIOMYOPATHY years events noted; lived in 24/7 care facility and monitored twice daily for reaction. Date of death 12/23/2020 from aspiration
2139 ISCHAEMIC STROKE MODERNA 941476-1
2140 ISCHAEMIC STROKE PFIZER\BIONTECH 932145-1
10:31am.
65+ Life
2141 ISCHAEMIC STROKE PFIZER\BIONTECH 932623-1 Acute ischemic stroke, basilar occlusion
years Threatening
65+ Unknown as to any correlation with vaccine as this was a hospice patient that was already experiencing decline. Patient became
2142 JAUNDICE PFIZER\BIONTECH Death 959147-1
years Jaundice for approximately one week prior to expiring.
2143 JAUNDICE PFIZER\BIONTECH Unknown Death 944155-1
Vaccine Event
2144 LABORATORY TEST MODERNA 955565-1
40-49 Life
2146 LABORATORY TEST MODERNA 931558-1 7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
years Threatening
40-49 Life
2148 LABORATORY TEST MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
years Threatening
fever.
60-64 Life
2151 LABORATORY TEST MODERNA 934156-1 01/08/21 at SPO@ less then 60% on room air, non responsive to verbal tactile stimuli. Responsive to sternal rub only. Was sent
years Threatening
60-64 Life
2152 LABORATORY TEST MODERNA 935090-1 SOB, Sleeplessness,
years Threatening
65+ Life
2153 LABORATORY TEST MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
65+ Life
2154 LABORATORY TEST MODERNA 952235-1 nausea and vomiting possible cause of diabetic ketoacidosis and svt
years Threatening
2155 LABORATORY TEST PFIZER\BIONTECH 909165-1
30-39 Life
2156 LABORATORY TEST PFIZER\BIONTECH 916890-1 HIVES, SOB, THROAT CLOSING UP, WHEEZING
years Threatening
30-39 Life
2158 LABORATORY TEST PFIZER\BIONTECH 943359-1 Unprovoked seizure (clonic tonic) 13 days later, requiring hospitalization and testing
years Threatening
30-39 Life
2159 LABORATORY TEST PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
2160 LABORATORY TEST PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
50-59 Life
2162 LABORATORY TEST PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
60-64 Life
2163 LABORATORY TEST PFIZER\BIONTECH 909577-1 Dizziness, dyspnea, neck swelling
years Threatening
cultures.
2165 LABORATORY TEST PFIZER\BIONTECH Death 928062-1
2166 LABORATORY TEST PFIZER\BIONTECH Death 962966-1
LABORATORY TEST 40-49 Life 10: Nausea Minutes 23-25: Neck tightness (like doing unsupported crunches and holding my head up) Minute 27: Inability to
NORMAL years Threatening swallow and inability to speak EMS on site administered EpiPen auto-injection to left thigh, immediate improvement in
LABORATORY TEST 65+
2168 PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
NORMAL years
soon as discovered.
65+
2169 LACTIC ACIDOSIS PFIZER\BIONTECH Death 962827-1 appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the
years
2170 LACUNAR INFARCTION PFIZER\BIONTECH 942237-1
2171 LAPAROSCOPIC SURGERY PFIZER\BIONTECH 951817-1
50-59 Life
2172 LAPAROSCOPIC SURGERY PFIZER\BIONTECH 923000-1 and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from
years Threatening
12/26/20-12/28/20.
LARGE INTESTINE 60-64 Life which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a
PERFORATION years Threatening perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening
of 1/3/2021.
LEFT VENTRICULAR 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
DYSFUNCTION years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
Vaccine Event
LEFT VENTRICULAR END- negative. On Trans Thoracic Echocardiogram, patient was found to have hypokinesis of the mid and distal segment with some
65+ Life
2175 DIASTOLIC PRESSURE MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
INCREASED stress going on in her life or family. Till now extensive infectious as well as inflammatory work up is done to rule out any
LEFT VENTRICULAR END- for pulmonary embolus. My EKG showed some mild ST changes and a troponin I level was elevated at 0.08 (normal 0.04).
40-49 Life
2176 DIASTOLIC PRESSURE PFIZER\BIONTECH 949611-1 Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed
years Threatening
INCREASED which showed regional wall motion abnormalities consistent with Takotsubo cardiomyopathy and an ejection fraction of 45%. I
LEFT VENTRICULAR 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
HYPERTROPHY years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
18-29 Life
2178 LETHARGY MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
years Threatening
2179 LETHARGY MODERNA 926787-1
were made.
2180 LETHARGY MODERNA Death 950073-1
2181 LETHARGY MODERNA 958913-1
65+
2182 LETHARGY MODERNA Death 929997-1 eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow.
years
2183 LETHARGY MODERNA Death 959591-1
50-59
2184 LETHARGY PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
50-59 Life
2185 LETHARGY PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
65+
2186 LETHARGY PFIZER\BIONTECH Death 921481-1 He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of
years
2187 LETHARGY PFIZER\BIONTECH Death 928062-1
65+
2188 LETHARGY PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
2189 LEUKAEMIA PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
50-59
2190 LIFE SUPPORT PFIZER\BIONTECH Death 944595-1 and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the
years
2191 LIMB DISCOMFORT PFIZER\BIONTECH 902854-1
2192 LIMB DISCOMFORT PFIZER\BIONTECH Death 920545-1
65+
2193 LIMB DISCOMFORT PFIZER\BIONTECH Death 962307-1 couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon
years
breathing
40-49 Life
2194 LIP PRURITUS PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
Vaccine Event
2195 LIP PRURITUS PFIZER\BIONTECH 952803-1
2196 LIP SWELLING MODERNA 913445-1
18-29 Life
2197 LIP SWELLING MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
years Threatening
30-39 Life
2198 LIP SWELLING MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
50-59 Life
2200 LIP SWELLING MODERNA 929418-1 Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
years Threatening
65+ Life
2202 LIP SWELLING MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
65+ Life
2203 LIP SWELLING MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
2204 LIP SWELLING PFIZER\BIONTECH 944450-1
on monitor.
30-39 Life
2206 LIP SWELLING PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
30-39 Life
2207 LIP SWELLING PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
2208 LIP SWELLING PFIZER\BIONTECH 928209-1 Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
years Threatening
40-49 Life
2209 LIP SWELLING PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
30-39 Life
2215 LIVEDO RETICULARIS PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
Vaccine Event
40-49 Life
2216 LIVEDO RETICULARIS PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
2217 LIVEDO RETICULARIS PFIZER\BIONTECH Death 942085-1
65+
2218 LIVEDO RETICULARIS PFIZER\BIONTECH Death 945578-1 feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not
years
60-64
2219 LIVER FUNCTION TEST PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
2220 LIVER FUNCTION TEST PFIZER\BIONTECH 929689-1
cultures.
2221 LIVER FUNCTION TEST PFIZER\BIONTECH Death 928062-1
LIVER FUNCTION TEST 65+ CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A
ABNORMAL years STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE
LIVER FUNCTION TEST 65+ without complications."" Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS
INCREASED years increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation
LIVER FUNCTION TEST 50-59 Life 12/30 9:30 am developed angioedema. Swelling of face, lips, tight throat. Also had bright red rash over body trunk and arms.
2224 MODERNA 914392-1
NORMAL years Threatening Both palms were red, hot and painful.
LIVER FUNCTION TEST 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
NORMAL years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
50-59 Life
2226 LIVER INJURY PFIZER\BIONTECH 955096-1 Acute liver injury requiring transplant evaluation and acute kidney injury
years Threatening
LIVING IN RESIDENTIAL
2227 PFIZER\BIONTECH Unknown Death 934782-1 within 5 days of receiving Covid vaccine, had been on antibiotics for LRTI for 2 days and had appeared to be improving,
INSTITUTION
tract infection
65+
2228 LOCALISED OEDEMA MODERNA Death 920326-1 Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21
years
65+
2229 LOSS OF CONSCIOUSNESS MODERNA Death 959568-1 Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by
years
18-29 Life
2230 LOSS OF CONSCIOUSNESS PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
2231 LOSS OF CONSCIOUSNESS PFIZER\BIONTECH 909165-1
2232 LOSS OF CONSCIOUSNESS PFIZER\BIONTECH 959401-1
65+
2233 LOSS OF CONSCIOUSNESS PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
65+
2234 LOSS OF CONSCIOUSNESS PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
2235 LOSS OF CONSCIOUSNESS PFIZER\BIONTECH Death 964653-1
Vaccine Event
2236 LOSS OF CONSCIOUSNESS PFIZER\BIONTECH Unknown Death 918721-1
LOSS OF PERSONAL
2237 INDEPENDENCE IN DAILY MODERNA 944219-1
ACTIVITIES
LOW DENSITY 50-59 Life thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now
2238 MODERNA 919546-1
LIPOPROTEIN INCREASED years Threatening extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)
LOWER RESPIRATORY
2239 PFIZER\BIONTECH Unknown Death 934782-1 within 5 days of receiving Covid vaccine, had been on antibiotics for LRTI for 2 days and had appeared to be improving,
TRACT INFECTION
tract infection
50-59 Life
2240 LUMBAR PUNCTURE MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
2241 LUNG CONSOLIDATION PFIZER\BIONTECH 917210-1
50-59
2242 LUNG INFILTRATION MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
65+
2243 LUNG INFILTRATION MODERNA Death 920368-1 ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu
years
18-29
2244 LUNG INFILTRATION PFIZER\BIONTECH Death 960841-1 cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours.
years
2245 LUNG INFILTRATION PFIZER\BIONTECH 917210-1
2246 LUNG INFILTRATION PFIZER\BIONTECH 920224-1
60-64
2247 LUNG INFILTRATION PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
2248 LUNG INFILTRATION PFIZER\BIONTECH Death 928062-1
LUNG NEOPLASM 60-64 coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression
MALIGNANT years of lung cancer
2250 LUNG OPACITY PFIZER\BIONTECH 917210-1
18-29 Life
2251 LYMPHADENOPATHY MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
30-39 Life
2252 LYMPHADENOPATHY MODERNA 918839-1 Gallbladder removed, septic, 11mm axillary lymph node.
years Threatening
30-39 Life
2253 LYMPHADENOPATHY MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
Vaccine Event
LYMPHOCYTE COUNT 30-39 Life
Racepinephrine x 1.
LYMPHOCYTE COUNT 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
LYMPHOCYTE COUNT 30-39 Life
LYMPHOCYTE COUNT 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
LYMPHOCYTE COUNT 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
LYMPHOCYTE 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
PERCENTAGE years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
LYMPHOCYTE 30-39 Life
PERCENTAGE DECREASED years Threatening
LYMPHOCYTE 30-39 Life
PERCENTAGE DECREASED years Threatening
Racepinephrine x 1.
LYMPHOCYTE 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
PERCENTAGE INCREASED years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
2263 LYMPHOCYTOSIS PFIZER\BIONTECH Unknown Death 944155-1
MAGNETIC RESONANCE 30-39 Life slowly for 4 days in intensity and area involved. Symptoms progressed distally to superior. On the 5th day symptoms progressed
2264 MODERNA 926703-1
IMAGING years Threatening rapidly and involved bilateral legs up to the groin, left arm up to lateral shoulder, and right hand. I went to the hospital and was
MAGNETIC RESONANCE 30-39 Life
2265 MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
IMAGING years Threatening
MAGNETIC RESONANCE 40-49 Life became ill with fever chills and nausea and left work at 2am. On 12/31 she developed hemianopia. She went to ER and they did
2266 MODERNA 941476-1
IMAGING years Threatening CT scan. She was told it was complex migraine. She left and came Home. On 1/1/21 her vision was back to normal. On 1/3 she
MAGNETIC RESONANCE 65+ Life
2267 MODERNA 957091-1 COVID-19 Vaccine
IMAGING years Threatening
MAGNETIC RESONANCE 30-39 Life Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by neurology and diagnosed
IMAGING years Threatening with Guillain- Barre Syndrome thought to be secondary to the Pfizer Covid Vaccine
MAGNETIC RESONANCE 30-39 Life The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and
IMAGING years Threatening weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
IMAGING BRAIN years Threatening
IMAGING BRAIN years Threatening
MAGNETIC RESONANCE taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face
40-49 Life
2272 IMAGING BRAIN PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
ABNORMAL then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right
meds naproxen
MAGNETIC RESONANCE
2273 IMAGING BRAIN PFIZER\BIONTECH 942237-1
ABNORMAL
MAGNETIC RESONANCE Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and was intubated. Hole
65+
2274 IMAGING BRAIN PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
ABNORMAL symptoms.
MAGNETIC RESONANCE
2275 IMAGING BRAIN PFIZER\BIONTECH 941401-1
ABNORMAL
IMAGING BRAIN NORMAL years Threatening
IMAGING NECK years Threatening
Vaccine Event
18-29 Life
2278 MALAISE MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
18-29 Life
2279 MALAISE MODERNA 953997-1 HER LIPS BECAME NUMB AND HER TONGUE AND THROAT STARTED SWELLING. AN EPIPEN WAS ADMINISTERED AND 911
years Threatening
2280 MALAISE MODERNA 941476-1
65+ Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities
2281 MALAISE MODERNA Death 926600-1
years (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day.
65+ not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020
2282 MALAISE MODERNA Death 934263-1
years and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the
2283 MALAISE PFIZER\BIONTECH 904436-1
2284 MALAISE PFIZER\BIONTECH Death 934968-1
50-59 Life
2285 MALAISE PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
encephalopathy."
65+
2288 MALAISE PFIZER\BIONTECH Death 919108-1 Fever, Malaise
years
65+
2290 MALAISE PFIZER\BIONTECH Death 944998-1 On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.
years
65+
2292 MALAISE PFIZER\BIONTECH Death 952204-1 Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep.
years
2293 MALAISE PFIZER\BIONTECH Unknown Death 918721-1
2294 MALAISE PFIZER\BIONTECH Unknown Death 928992-1 was serious as it was medically significant, involved hospitalization and lead to death. Clinical course was as follows: the patient
2295 MALAISE PFIZER\BIONTECH Unknown Death 939332-1 deterioration (patient known to be declining); all from an unknown date and unknown if ongoing. Concomitant medications were
Vaccine Event
2296 MALAISE PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
2297 MALAISE PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
I am currently breastfeeding my 5-month-old son. I received my first vaccine on 12/28/2020 and directly breastfed within 4 hours
of receiving the vaccine. Two days after my vaccine my son was at daycare and had two large diarrhea blowouts and two large
MATERNAL EXPOSURE 30-39 Life emeses followed by a 1-minute episode where he was limp with entire body cyanosis and in-and-out of consciousness. He also
DURING BREAST FEEDING years Threatening had a maculopapular rash on his torso. EMS was called. He was observed in the emergency department for a few hours then
recovered well without intervention and did not require hospitalization. EKG was normal. He has continued to be well and back to
baseline since the event.
2299 MAY-THURNER SYNDROME MODERNA 955565-1
MEAN CELL HAEMOGLOBIN
2300 CONCENTRATION MODERNA Death 952881-1
DECREASED
2301 CONCENTRATION PFIZER\BIONTECH 903123-1
DECREASED
2302 CONCENTRATION PFIZER\BIONTECH Death 950441-1
DECREASED
MEAN CELL HAEMOGLOBIN 18-29 Life
2303 MODERNA 932915-1 Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
CONCENTRATION NORMAL years Threatening
Racepinephrine x 1.
MEAN CELL HAEMOGLOBIN 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
Racepinephrine x 1.
MEAN CELL HAEMOGLOBIN 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
MEAN CELL HAEMOGLOBIN 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
Vaccine Event
MEAN CELL VOLUME 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
MEAN CELL VOLUME 18-29 Life
Racepinephrine x 1.
MEAN CELL VOLUME 60-64 Life Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of
2316 MODERNA 958913-1
MEAN CELL VOLUME 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
MEAN PLATELET VOLUME 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
INCREASED years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
MEAN PLATELET VOLUME 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
MEAN PLATELET VOLUME 30-39 Life
MEAN PLATELET VOLUME 30-39 Life
Racepinephrine x 1.
MECHANICAL 50-59 Life thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now
2322 MODERNA 919546-1
VENTILATION years Threatening extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)
MECHANICAL 50-59 Life
VENTILATION years Threatening
MECHANICAL 30-39 Life and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was
VENTILATION years Threatening altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on
MECHANICAL 50-59 placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine
VENTILATION years that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the
MECHANICAL 60-64 Life
2326 PFIZER\BIONTECH 948243-1 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current
VENTILATION years Threatening
status
MECHANICAL 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
VENTILATION years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
40-49 Life
2328 MEMORY IMPAIRMENT PFIZER\BIONTECH 932420-1 morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx
years Threatening
40-49 Life
2329 MENTAL IMPAIRMENT MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
2330 MENTAL IMPAIRMENT PFIZER\BIONTECH 949941-1
encephalopathy."
50-59 Life
2331 MENTAL STATUS CHANGES PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
2332 MENTAL STATUS CHANGES PFIZER\BIONTECH 941401-1
METABOLIC FUNCTION 18-29 Life shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received
2333 MODERNA 956504-1
TEST years Threatening epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. Vitals in the ER Revealed
METABOLIC FUNCTION 30-39 Life
2334 MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
TEST years Threatening
2335 MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
Vaccine Event
METABOLIC FUNCTION 40-49 Life to experience symptoms of anaphylaxis. Was immediately placed in a treatment room and received treatment by the ER
2336 MODERNA 916746-1
TEST years Threatening physician, which included oxygen, intravenous Benadryl, Solumedrol, and Normal Saline. Was observed for several hours and
METABOLIC FUNCTION 50-59 Life Pt found unresponsive at home, respiratory distress. Had reported nausea and vointing for two days prior to admit which started
2338 MODERNA 958235-1
TEST years Threatening 1/15. Acute metabolic encephalopathy and acute renal failure Currently at time of this report still in critical care
METABOLIC FUNCTION 65+
TEST years
TEST years
METABOLIC FUNCTION 65+ Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be
TEST years resuscitated
METABOLIC FUNCTION 65+ admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse
TEST years reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138
METABOLIC FUNCTION 65+ Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital
TEST years and treated for worsening AKI and hypotension.
2344 PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
METABOLIC FUNCTION 30-39 Life The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and
TEST years Threatening weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
METABOLIC FUNCTION 30-39 Life Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy,
TEST years Threatening ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
meds naproxen
METABOLIC FUNCTION 50-59 Life was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix
TEST years Threatening was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was
METABOLIC FUNCTION 60-64
TEST years
testing.
2351 PFIZER\BIONTECH Death 945603-1 weight which were shared with his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On
TEST years
TEST ABNORMAL years Threatening
METABOLIC FUNCTION 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
TEST ABNORMAL years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
TEST NORMAL years Threatening
METABOLIC FUNCTION 50-59 Life 12/30 9:30 am developed angioedema. Swelling of face, lips, tight throat. Also had bright red rash over body trunk and arms.
2355 MODERNA 914392-1
TEST NORMAL years Threatening Both palms were red, hot and painful.
2356 PFIZER\BIONTECH 904334-1 Angioedema, hives, tachycardia, shortness of breath
METABOLIC FUNCTION 60-64 Life noticed tingling after dinner. Patient stated he took two benadryl with no relief. His tongue continued to swell and he took two
TEST NORMAL years Threatening additional benadryl at 22:00. Once he developed difficulty swallowing he went to the emergency department. Patient presented
METABOLIC FUNCTION 65+ Life
Vaccine Event
METAMYELOCYTE 60-64
PERCENTAGE years
testing.
2361 MIGRAINE MODERNA 941476-1
65+
2362 MOBILITY DECREASED MODERNA Death 929997-1 eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow.
years
2363 MOBILITY DECREASED MODERNA 944219-1
30-39 Life
2364 MOBILITY DECREASED PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
40-49 Life
2365 MOBILITY DECREASED PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
2366 MOBILITY DECREASED PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
MONOCYTE COUNT 30-39 Life
MONOCYTE COUNT 30-39 Life
Racepinephrine x 1.
MONOCYTE COUNT 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
MONOCYTE COUNT 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
2371 MONOCYTE PERCENTAGE PFIZER\BIONTECH 903123-1
2372 MONOCYTE PERCENTAGE PFIZER\BIONTECH Death 950441-1
MONOCYTE PERCENTAGE 30-39 Life
MONOCYTE PERCENTAGE 30-39 Life
Racepinephrine x 1.
2375 MONOPARESIS PFIZER\BIONTECH 932145-1
10:31am.
18-29 Life
2376 MOUTH HAEMORRHAGE MODERNA 932915-1 Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
years Threatening
Vaccine Event
30-39 Life
2377 MOUTH SWELLING MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
2378 MOUTH SWELLING PFIZER\BIONTECH 929526-1
appropriate.
2379 MOUTH SWELLING PFIZER\BIONTECH 939914-1
40-49 Life
2380 MOUTH SWELLING PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
2381 MOVEMENT DISORDER PFIZER\BIONTECH Death 951101-1
65+ Life
2382 MUCOSAL INFLAMMATION PFIZER\BIONTECH 943741-1 1/8 and 1/11/21. Was admitted 1/11/21 with Concern for STevens Johnson and sepsis. Patient subsequently developed full
years Threatening
MUSCLE CONTRACTIONS 65+
INVOLUNTARY years
2384 MUSCLE FATIGUE MODERNA 939216-1
30-39 Life
2385 MUSCLE RIGIDITY MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
2386 MUSCLE SPASMS PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
2387 MUSCLE SPASMS PFIZER\BIONTECH 951560-1
2388 MUSCLE TIGHTNESS MODERNA 954442-1
2389 MUSCLE TIGHTNESS PFIZER\BIONTECH 954720-1
2390 MUSCLE TIGHTNESS PFIZER\BIONTECH Unknown 902856-1
Vaccine Event
2391 MUSCLE TWITCHING MODERNA 926787-1
were made.
2392 MUSCULAR WEAKNESS MODERNA 912930-1
50-59 Life
2393 MUSCULAR WEAKNESS MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
30-39 Life
2394 MUSCULAR WEAKNESS PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
2395 MUSCULAR WEAKNESS PFIZER\BIONTECH 932366-1
50-59 Life
2396 MUSCULAR WEAKNESS PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
65+
2397 MUSCULAR WEAKNESS PFIZER\BIONTECH Death 948150-1 decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds
years
MUSCULOSKELETAL 65+
STIFFNESS years
MUSCULOSKELETAL 65+ Life of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and
STIFFNESS years Threatening white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low
2400 MYALGIA MODERNA 956527-1
40-49 Life
2401 MYALGIA MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
2402 MYALGIA MODERNA 932367-1
60-64 Life
2403 MYALGIA MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
65+ Life
2404 MYALGIA MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
2405 MYALGIA PFIZER\BIONTECH 937932-1
up.
Vaccine Event
40-49 Life
2407 MYALGIA PFIZER\BIONTECH 909614-1 Fever, muscle aches, hypertension, rapid heart heart
years Threatening
ACHES, SORE THROAT.
50-59 Life
2409 MYALGIA PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
2410 MYALGIA PFIZER\BIONTECH Death 959929-1
MYCOBACTERIUM
2411 TUBERCULOSIS COMPLEX MODERNA Death 950073-1
TEST NEGATIVE
MYCOPLASMA TEST 65+
NEGATIVE years
60-64
2413 MYELOCYTE PERCENTAGE PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
50-59
2414 MYOCARDIAL INFARCTION MODERNA Death 950108-1 1/12/2021. It was found during this procedure that pt. had suffered a MI. She was release to home the following day and passed
years
65+
2415 MYOCARDIAL INFARCTION MODERNA Death 930487-1 Medical docter state patient has a acute cardiac attack
years
2416 MYOCARDIAL INFARCTION MODERNA Death 940602-1
2417 MYOCARDIAL INFARCTION PFIZER\BIONTECH 930889-1
50-59 Life
2418 MYOCARDIAL INFARCTION PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
years Threatening
60-64
2419 MYOCARDIAL INFARCTION PFIZER\BIONTECH Death 914917-1 Death by massive heart attack. Pfizer-BioNTech COVID-19 Vaccine EUA
years
60-64 Life
2420 MYOCARDIAL INFARCTION PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
65+
2421 MYOCARDIAL INFARCTION PFIZER\BIONTECH Death 930466-1 Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination
years
65+
2422 MYOCARDIAL INFARCTION PFIZER\BIONTECH Death 937444-1 Resident was found deceased at approximately 6pm in her apartment
years
2423 MYOCARDIAL INFARCTION PFIZER\BIONTECH Death 940954-1
Vaccine Event
65+
2424 MYOCARDIAL INFARCTION PFIZER\BIONTECH Death 951678-1 Heart attack death medical test
years
2425 MYOCARDIAL INFARCTION PFIZER\BIONTECH Death 953922-1
2426 MYOCARDIAL INFARCTION PFIZER\BIONTECH 928378-1
2427 MYOCARDIAL INFARCTION PFIZER\BIONTECH Unknown Death 936170-1
MYOCARDIAL NECROSIS 40-49 Life
2428 MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
MARKER years Threatening
MYOCARDIAL NECROSIS 40-49 Life
MARKER INCREASED years Threatening
2430 MYOCARDITIS PFIZER\BIONTECH 937932-1
up.
N-TERMINAL
PROHORMONE BRAIN 60-64 Life
NATRIURETIC PEPTIDE years Threatening
INCREASED
N-TERMINAL About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.
PROHORMONE BRAIN 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
NATRIURETIC PEPTIDE years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
NORMAL after the injection.
30-39 Life
2433 NAIL BED DISORDER PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
18-29 Life
2434 NAUSEA MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
2435 NAUSEA MODERNA 912930-1
18-29 Life
2436 NAUSEA MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
18-29 Life
2437 NAUSEA MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
years Threatening
30-39 Life
2438 NAUSEA MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
after the vaccine.
Began itching and wheezing approximately 5 minutes after the injection. Gave first epi dose. Throat started tightening, and
30-39 Life
2441 NAUSEA MODERNA 959996-1 nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in
years Threatening
ambulance. ER treated with breathing treatment, IV steroids, IV Benadryl, IV Pepcid and IV zofran. Was observed for 6.5 hours.
40-49 Life
2444 NAUSEA MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
Patient woke apx 0200 complaining of nausea to group home staff. Vitals were checked at that time and WNL. Patient went
50-59
2445 NAUSEA MODERNA Death 959001-1 back to bed. When staff went to wake patient apx 0530, he was unresponsive and had no pulse. Chest compressions were
years
started and EMS called.
50-59 Life
2446 NAUSEA MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
60-64 Life
2448 NAUSEA MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
65+ Life
2449 NAUSEA MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
Vaccine Event
65+ Life
2450 NAUSEA MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
65+ Life
2451 NAUSEA MODERNA 952235-1 nausea and vomiting possible cause of diabetic ketoacidosis and svt
years Threatening
65+ Life
2452 NAUSEA MODERNA 956597-1 Pulmonary Edema, fever, nausea, vomiting
years Threatening
18-29 Life
2453 NAUSEA PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
30-39 Life
2454 NAUSEA PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
30-39 Life
2455 NAUSEA PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
2456 NAUSEA PFIZER\BIONTECH 907042-1
40-49 Life
2457 NAUSEA PFIZER\BIONTECH 907101-1 assessment, and en route in wheelchair to ER the dry cough became persistent, spasmodic and patient was unable to speak.
years Threatening
Initially started with nausea around min 5, shortly after then itching on arms. Around min 15 ?lump? sensation in throat. Around
40-49 Life
2458 NAUSEA PFIZER\BIONTECH 908157-1 min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth. Sent to ER, received IM Epi, IV: Steroids,
years Threatening
Benadryl, Zofran, Pepcid, Albuterol inhaler.
40-49 Life
2460 NAUSEA PFIZER\BIONTECH 914730-1 admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-
years Threatening
40-49 Life
2461 NAUSEA PFIZER\BIONTECH 928209-1 Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
years Threatening
40-49 Life
2462 NAUSEA PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
40-49 Life
2463 NAUSEA PFIZER\BIONTECH 938829-1 and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I
years Threatening
40-49 Life
2465 NAUSEA PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
50-59
2466 NAUSEA PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
50-59 Life
2468 NAUSEA PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
50-59 Life
2469 NAUSEA PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
50-59 Life
2470 NAUSEA PFIZER\BIONTECH 941118-1 temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I
years Threatening
Vaccine Event
50-59 Life
2472 NAUSEA PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
years Threatening
60-64
2473 NAUSEA PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
65+
2474 NAUSEA PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
2475 NAUSEA PFIZER\BIONTECH Death 944998-1 On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.
years
65+
2476 NAUSEA PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
years
2477 NAUSEA PFIZER\BIONTECH Death 949547-1
65+
2480 NAUSEA PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
2484 NECK PAIN MODERNA Death 950073-1
60-64 Life
2485 NECK PAIN PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
2486 NEURALGIA MODERNA 926703-1
NEUROLOGICAL 30-39 Life slowly for 4 days in intensity and area involved. Symptoms progressed distally to superior. On the 5th day symptoms progressed
2487 MODERNA 926703-1
EXAMINATION years Threatening rapidly and involved bilateral legs up to the groin, left arm up to lateral shoulder, and right hand. I went to the hospital and was
NEUTROPHIL COUNT 60-64
DECREASED years
testing.
NEUTROPHIL COUNT 30-39 Life
NEUTROPHIL COUNT 30-39 Life
Racepinephrine x 1.
Vaccine Event
NEUTROPHIL COUNT 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
NORMAL years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
NEUTROPHIL COUNT 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
NEUTROPHIL COUNT 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
2494 NEUTROPHIL PERCENTAGE PFIZER\BIONTECH 903123-1
NEUTROPHIL PERCENTAGE 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
NEUTROPHIL PERCENTAGE 30-39 Life
Racepinephrine x 1.
NEUTROPHIL TOXIC 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
GRANULATION PRESENT years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
NIH STROKE SCALE 65+ Life She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her
ABNORMAL years Threatening body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at
10:31am.
50-59 Life
2501 NITRITE URINE PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
OBSTRUCTIVE AIRWAYS 30-39 Life
2502 MODERNA 924524-1 FOLLOWED UP WITH PATIENT, SHE REPORTED HER AIRWAY STARTED TO CLOSE AND SHE RECEIVED EPINEPHRINE, AFTER 5
DISORDER years Threatening
OBSTRUCTIVE AIRWAYS 40-49 Life airways were tightening.. Nurse immediately called for response, administered Epipen, when response arrived applied oxygen
2503 MODERNA 914309-1
DISORDER years Threatening and transported to ED. Solumedrol 125 mg, Bendadryl 25 mg, and Famotidine 20 mg, she responded well and was released
2504 MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
2505 MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
2506 PFIZER\BIONTECH 921989-1 Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
2507 OCULAR DISCOMFORT PFIZER\BIONTECH 907042-1
2508 OCULAR HYPERAEMIA MODERNA 915199-1
2509 OEDEMA MODERNA Death 952881-1
65+ Life
2510 OEDEMA MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
2511 OEDEMA PERIPHERAL MODERNA 955565-1
2512 OEDEMA PERIPHERAL PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
2513 OESOPHAGEAL PAIN PFIZER\BIONTECH 913239-1
Vaccine Event
2514 OMENTECTOMY PFIZER\BIONTECH 947687-1
30-39 Life
2515 OPISTHOTONUS MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
2516 ORAL PRURITUS MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
40-49 Life
2517 ORAL PRURITUS PFIZER\BIONTECH 908157-1 min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth. Sent to ER, received IM Epi, IV: Steroids,
years Threatening
40-49 Life
2518 ORAL PRURITUS PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
40-49 Life
2519 ORAL PRURITUS PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
OROPHARYNGEAL 30-39 Life Saturday she had a ""really bad headache and just layed around all day. I was not able to function at all."" Sunday she still had a
2520 MODERNA 956527-1
DISCOMFORT years Threatening headache and added muscle aches. Monday she started feeling ""a lot better"" until 8 PM when she was walking around doing
OROPHARYNGEAL 50-59 Life
DISCOMFORT years Threatening
2522 PFIZER\BIONTECH 903324-1 Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn?t
2523 PFIZER\BIONTECH 908157-1 min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth. Sent to ER, received IM Epi, IV: Steroids,
OROPHARYNGEAL 65+ he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative. On 12/30/2020,
DISCOMFORT years patient complained of sternal pressure and was transferred to the hospital. The patient died 12/31/2020 and records obtained
2525 OROPHARYNGEAL PAIN MODERNA 914309-1
2526 OROPHARYNGEAL PAIN PFIZER\BIONTECH 929526-1
appropriate.
ACHES, SORE THROAT.
50-59 Life
2528 OROPHARYNGEAL PAIN PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
Vaccine Event
ORTHOSTATIC 30-39 Life PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath,
HYPOTENSION years Threatening dizziness and blurry vision
2531 OXYGEN SATURATION PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
OXYGEN SATURATION 40-49 Life respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed
2532 MODERNA 946978-1
DECREASED years Threatening multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered
OXYGEN SATURATION 50-59 Life
2533 MODERNA 920787-1 obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered.
OXYGEN SATURATION 50-59 Life currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am
2534 MODERNA 926787-1
DECREASED years Threatening was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident.
were made.
OXYGEN SATURATION 60-64
2535 MODERNA Death 952713-1 Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21
DECREASED years
OXYGEN SATURATION 65+
2536 MODERNA Death 921572-1 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again.
DECREASED years
OXYGEN SATURATION 30-39 Life COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker
DECREASED years Threatening route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice
OXYGEN SATURATION 50-59 Life she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At
DECREASED years Threatening this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another
OXYGEN SATURATION 60-64 Life
status
2540 PFIZER\BIONTECH Death 918418-1 treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations.
DECREASED years
OXYGEN SATURATION 65+ 3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on
DECREASED years Hospice care ) expired 6:22 am 1-8-21
OXYGEN SATURATION 65+ Three hours after receiving COVID 19 vaccination, Patient oxygen level decreased to a critical level and went into cardiac arrest.
DECREASED years Staff performed full code but was unable to bring back patient from cardiac arrest.
DECREASED years
OXYGEN SATURATION 65+ 1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB
DECREASED years on 1/14/2021 at 1325
OXYGEN SATURATION 65+ Life
2545 PFIZER\BIONTECH 924658-1 Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.
OXYGEN SATURATION 65+ Life of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and
DECREASED years Threatening white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low
Vaccine Event
OXYGEN SATURATION
DECREASED
OXYGEN SATURATION
2548 PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
DECREASED
65+
2549 OXYGEN THERAPY MODERNA Death 949630-1 pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5
years
18-29 Life
2550 PAIN MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
30-39 Life
2551 PAIN MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
2552 PAIN MODERNA 954154-1
40-49 Life
2553 PAIN MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
50-59 Life
2554 PAIN MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
60-64 Life
2555 PAIN MODERNA 934156-1 01/08/21 at SPO@ less then 60% on room air, non responsive to verbal tactile stimuli. Responsive to sternal rub only. Was sent
years Threatening
60-64 Life
2556 PAIN MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
65+
2557 PAIN MODERNA Death 921572-1 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again.
years
2558 PAIN MODERNA Death 940602-1
65+ Life
2559 PAIN MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
2560 PAIN PFIZER\BIONTECH 920224-1
Vaccine Event
30-39 Life
2561 PAIN PFIZER\BIONTECH 936618-1 Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
years Threatening
40-49 Life
2562 PAIN PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
2563 PAIN PFIZER\BIONTECH 939914-1
2564 PAIN PFIZER\BIONTECH Death 942106-1
2565 PAIN PFIZER\BIONTECH Death 942085-1
60-64 Life
2566 PAIN PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
65+
2567 PAIN PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
65+
2568 PAIN PFIZER\BIONTECH Death 959079-1 shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified, branch block. Received order for
years
18-29 Life
2569 PAIN IN EXTREMITY MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
2570 PAIN IN EXTREMITY MODERNA 955565-1
30-39 Life
2571 PAIN IN EXTREMITY MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
30-39 Life
2572 PAIN IN EXTREMITY MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
40-49 Life
2573 PAIN IN EXTREMITY MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
2574 PAIN IN EXTREMITY MODERNA 914392-1
60-64 Life
2575 PAIN IN EXTREMITY MODERNA 952677-1 and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for
years Threatening
2/5/2021 at 7:15am
65+
2576 PAIN IN EXTREMITY MODERNA Death 909095-1 medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
years
65+
2577 PAIN IN EXTREMITY MODERNA Death 933846-1 better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death
years
certificate."
18-29 Life
2578 PAIN IN EXTREMITY PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
2579 PAIN IN EXTREMITY PFIZER\BIONTECH 909165-1
30-39 Life
2580 PAIN IN EXTREMITY PFIZER\BIONTECH 957555-1 upper lobe pulmonary artery consistent with pulmonary embolus). I was discharged on Xarelto and advised to follow up with a
years Threatening
50-59 Life
2582 PAIN IN EXTREMITY PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
years Threatening
she is better but still not good; not to be able to breath; sore right arm; This is a spontaneous report from a contactable nurse
(patient herself). A 62-year-old female patient received bnt162b2 (BNT162B2, lot EK5730), intramuscular on 18Dec2020 at single
dose for immunisation. Medical history included asthma (hospitalized on Jan2020 and has not had any issues since that time,
referring to her asthma) diabetes, high blood pressure, swelling, sciatica, blood cholesterol abnormal, rosacea, reflux, allergies,
sinus congestion, shingles and post carpal tunnel surgery. Concomitant medications included lisinopril, hydrochlorothiazide,
gabapentin, rosuvastatin, metformin, glipizide, doxycycline, sucralfate, cetirizine hydrochloride (ZYRTEC), pseudoephedrine,
ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and tramadol. The patient
reported that she not to be able to breath (seriousness criteria-life threatening) on 22Dec2020. She woke up this morning and
could not breathe and there was no reason for her to not be able to breath. She thought she may have had a reaction to the
COVID vaccine. It was the only thing she could think of that might have caused her not to be able to breathe this morning. As
60-64 Life
2583 PAIN IN EXTREMITY PFIZER\BIONTECH 911462-1 treatment for not to be able to breath, she used Budesonide and Levosalbutamol in her nebulizer. She had sore right arm on
years Threatening
18Dec2020. She informed that she had done everything she can and she was better but still not good. She planned to take the
second dose of the COVID Vaccine because she thought it was more important to be protected. She suspected that the vaccine
was related to the events sore right arm and could not breathe. The outcome of the event not to be able to breath was
recovering; for sore right arm was recovered on unknown date in Dec2020; for she is better but still not good was unknown.;
Sender's Comments: Severe allergic reaction including anaphylaxis is the known risk factor; a possible causal association
between administration of BNT162B2 and the onset of not being able to breath cannot be excluded, considering the plausible
Vaccine Event
of 1/3/2021.
2585 PAIN IN EXTREMITY PFIZER\BIONTECH Unknown Death 929027-1 his daughter, he complained about pain in the arm and swelling in the arm of vaccination on an unspecified date of Dec2020. At
2586 PALLIATIVE CARE PFIZER\BIONTECH Unknown Death 934881-1
later
2587 PALLOR MODERNA 939216-1
65+
2588 PALLOR MODERNA Death 909095-1 medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
years
2589 PALLOR MODERNA Death 962940-1
40-49 Life
2590 PALLOR PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
2591 PALLOR PFIZER\BIONTECH Death 934968-1
50-59 Life
2592 PALLOR PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
18-29 Life
2593 PALPITATIONS MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
18-29 Life
2594 PALPITATIONS MODERNA 919252-1 down her Rt. arm. about 4 hours later she decided to go to the emergency room for Hearty Palpitations, Fever, Chest discomfort
years Threatening
18-29 Life
2595 PALPITATIONS MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
years Threatening
30-39 Life
2596 PALPITATIONS MODERNA 922264-1 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal
years Threatening
2597 PALPITATIONS MODERNA 951572-1
after the vaccine.
40-49 Life
2598 PALPITATIONS MODERNA 938425-1 showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021.
years Threatening
40-49 Life
2599 PALPITATIONS MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
18-29 Life
2600 PALPITATIONS PFIZER\BIONTECH 936715-1 difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee
years Threatening
2601 PALPITATIONS PFIZER\BIONTECH 903123-1
Vaccine Event
30-39 Life
2602 PALPITATIONS PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
40-49 Life
2604 PALPITATIONS PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
2606 PALPITATIONS PFIZER\BIONTECH 907101-1 assessment, and en route in wheelchair to ER the dry cough became persistent, spasmodic and patient was unable to speak.
years Threatening
40-49 Life
2609 PALPITATIONS PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
40-49 Life
2610 PALPITATIONS PFIZER\BIONTECH 911943-1 tingling in extremities, diaphoretic after leaving clinic observation. Drove back to hospital, escorted by pre surgical testing
years Threatening
40-49 Life
2612 PALPITATIONS PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
60-64 Life
2613 PALPITATIONS PFIZER\BIONTECH 950759-1 Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed
years Threatening
65+ Narrative: Symptoms: Palpitations & Syncope Treatment: EPINEPHRINE 1 MG ONCE ,EPINEPHRINE 1 MG ONCE ,SODIUM
2614 PALPITATIONS PFIZER\BIONTECH Death 951519-1
years BICARBONATE 50 ML ONCE
2615 PANCYTOPENIA PFIZER\BIONTECH Death 928062-1
65+
2616 PANIC DISORDER PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
18-29 Life
2617 PARAESTHESIA MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
18-29 Life
2618 PARAESTHESIA MODERNA 947718-1 Tingling and throat swelling to Moderna COVID-19 Vaccine EUA
years Threatening
30-39 Life
2619 PARAESTHESIA MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
2620 PARAESTHESIA MODERNA 916859-1
not recurred.
30-39 Life
2622 PARAESTHESIA MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
after the vaccine.
18-29 Life
2625 PARAESTHESIA PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
30-39 Life
2626 PARAESTHESIA PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
2627 PARAESTHESIA PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
Vaccine Event
2628 PARAESTHESIA PFIZER\BIONTECH 904553-1
30-39 Life
2630 PARAESTHESIA PFIZER\BIONTECH 914103-1 that time. Epi pen given via L thigh IM. PIV started and benadryl and solumedrol given. Relief of symptoms noted very shortly
years Threatening
30-39 Life
2631 PARAESTHESIA PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
30-39 Life
2633 PARAESTHESIA PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
2636 PARAESTHESIA PFIZER\BIONTECH 909146-1 listed before
years Threatening
40-49 Life
2637 PARAESTHESIA PFIZER\BIONTECH 911943-1 tingling in extremities, diaphoretic after leaving clinic observation. Drove back to hospital, escorted by pre surgical testing
years Threatening
40-49 Life
2638 PARAESTHESIA PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
30-39 Life
2642 PARAESTHESIA ORAL MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
30-39 Life
2643 PARAESTHESIA ORAL MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
40-49 Life
2644 PARAESTHESIA ORAL MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
Patient presented to receive COVID-19 vaccine, received vaccine at approximately 10 am. Patient waited 15 minutes for
observation and left observation area without complaining of any sx. Patient returned a few minutes after reporting tongue
40-49 Life
2645 PARAESTHESIA ORAL MODERNA 922279-1 tingling which eventually got to her lips. . No difficulty breathing or any other sx. No history of allergies. NP/RN administered PO
years Threatening
Benadryl 25 mg. As of report of this iReport no additional symptoms or intervention needed. Last vitals: 131/83 75spo2. BP
higher than usual per patient, sp02 normal.
40-49 Life
2646 PARAESTHESIA ORAL MODERNA 932614-1 Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing Hoarse voice
years Threatening
50-59 Life
2647 PARAESTHESIA ORAL MODERNA 938443-1 immediate tingling of lips, followed by fullness of posterior oropharynx, hoarseness and pruritus
years Threatening
Vaccine Event
2648 PARAESTHESIA ORAL PFIZER\BIONTECH 915464-1
on monitor.
30-39 Life
2650 PARAESTHESIA ORAL PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
30-39 Life
2651 PARAESTHESIA ORAL PFIZER\BIONTECH 936026-1 1600 to home with instructions to return if needed. Patient returned to ER Sunday January 10 at 1300 complaining of throat
years Threatening
30-39 Life
2652 PARAESTHESIA ORAL PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
30-39 Life
2654 PARAESTHESIA ORAL PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
2655 PARAESTHESIA ORAL PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
2657 PARAESTHESIA ORAL PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
40-49 Life
2659 PARAESTHESIA ORAL PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
50-59 Life
2660 PARAESTHESIA ORAL PFIZER\BIONTECH 954723-1 itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
years Threatening
Vaccine Event
2662 PATHOLOGY TEST PFIZER\BIONTECH 947687-1
30-39 Life
2663 PCO2 DECREASED MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
2664 PCO2 INCREASED PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
2665 PELVIC ABSCESS PFIZER\BIONTECH 947687-1
2666 PELVIC PAIN PFIZER\BIONTECH 947687-1
PERCUTANEOUS 65+ Life
CORONARY INTERVENTION years Threatening
50-59 Life Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute
2668 PERICARDITIS PFIZER\BIONTECH 919087-1
years Threatening pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).
PERIPHERAL CIRCULATORY 40-49 Life minute (bpm) - pulse oximetry, no trace. No wheeze, no erythema of oral mucosa, no swelling. Started clawing at her neck and
FAILURE years Threatening described feeling of itching internally. It was reported the patient carried an adrenalin autoinjector (EPIPEN). The patient was
2670 PERIPHERAL COLDNESS PFIZER\BIONTECH 934745-1
40-49 Life
2671 PERIPHERAL SWELLING MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
40-49 Life
2672 PERIPHERAL SWELLING MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
18-29 Life
2673 PERIPHERAL SWELLING PFIZER\BIONTECH 902946-1 Swelling of hands follwed by angioedema
years Threatening
Vaccine Event
18-29 Life
2674 PERIPHERAL SWELLING PFIZER\BIONTECH 944289-1 second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral
years Threatening
30-39 Life
2675 PERIPHERAL SWELLING PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
2676 PERIPHERAL SWELLING PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
2677 PERIPHERAL SWELLING PFIZER\BIONTECH Unknown Death 929027-1 his daughter, he complained about pain in the arm and swelling in the arm of vaccination on an unspecified date of Dec2020. At
2678 PETECHIAE MODERNA 950980-1
65+ Life
2679 PETECHIAE PFIZER\BIONTECH 908869-1 WNL (exceptions: SCr 1.24, TBil 1.7); CBC with platelet count of 1,000 resulting in patient admission to Hospital. At admission he
years Threatening
PHARYNGEAL 30-39 Life
2680 PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
HYPOAESTHESIA years Threatening
PHARYNGEAL 40-49 Life few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and
HYPOAESTHESIA years Threatening told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-
65+ Life
2682 PHARYNGEAL OEDEMA MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
2683 PFIZER\BIONTECH 951689-1 assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min
PARAESTHESIA years Threatening
2684 PFIZER\BIONTECH 909278-1 Rapid onset of hoarseness, throat tingling and tightness
2685 PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
Vaccine Event
PHARYNGEAL 30-39 Life Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably,
PARAESTHESIA years Threatening speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her
PHARYNGEAL 40-49 Life few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and
PARAESTHESIA years Threatening told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-
2688 PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
18-29 Life
2689 PHARYNGEAL SWELLING MODERNA 908685-1 throat swelling, SVT
years Threatening
18-29 Life
2690 PHARYNGEAL SWELLING MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
18-29 Life
2691 PHARYNGEAL SWELLING MODERNA 930079-1 Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
years Threatening
18-29 Life
2692 PHARYNGEAL SWELLING MODERNA 947718-1 Tingling and throat swelling to Moderna COVID-19 Vaccine EUA
years Threatening
18-29 Life
2693 PHARYNGEAL SWELLING MODERNA 953997-1 HER LIPS BECAME NUMB AND HER TONGUE AND THROAT STARTED SWELLING. AN EPIPEN WAS ADMINISTERED AND 911
years Threatening
30-39 Life
2694 PHARYNGEAL SWELLING MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
2695 PHARYNGEAL SWELLING MODERNA 916859-1
not recurred.
30-39 Life
2697 PHARYNGEAL SWELLING MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
Within 3 minutes of receiving vaccine felt flush and throat swelling, responded to Epi Pen and Benadryl p.o. EMS took him to ED
30-39 Life
2698 PHARYNGEAL SWELLING MODERNA 938820-1 where he remained several hours receiving 1 liter NS 125 mg solumedrol IV, discharge with 4 days of prednisone 40 mg daily and
years Threatening
a prescription for an Epi Pen. As of 1.12 he is totally okay with no after effects.
40-49 Life
2699 PHARYNGEAL SWELLING MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
Vaccination given 1314 and sent to waiting room for monitoring. Began to have itching at 1325. PO benadryl administered. Then
with throat swelling. Epinephrine administered by EMS/Fire at 1:32pm: 0.5mg IM right arm. 1342 improving 1350 itching/throat
40-49 Life swelling returning while EMS/Fire on phone with medical director. 1352 second dose of epinephrine administered by De Pere
years Threatening EMS/Fire: 0.5mg IM left arm Medical Director on site for evaluation. Client given option to transport to hospital or stay for
monitoring with EMS/Dr. Condition improving, chose to stay for monitoring. Client improved and up walking halls 1513 Client
cleared to be released home via private transport
65+ Life
2702 PHARYNGEAL SWELLING MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
2703 PHARYNGEAL SWELLING PFIZER\BIONTECH 945090-1
30-39 Life
2704 PHARYNGEAL SWELLING PFIZER\BIONTECH 903324-1 Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn?t
years Threatening
Vaccine Event
30-39 Life
2709 PHARYNGEAL SWELLING PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
40-49 Life
2710 PHARYNGEAL SWELLING PFIZER\BIONTECH 911943-1 tingling in extremities, diaphoretic after leaving clinic observation. Drove back to hospital, escorted by pre surgical testing
years Threatening
40-49 Life
2712 PHARYNGEAL SWELLING PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
40-49 Life
2714 PHARYNGEAL SWELLING PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
2717 PHARYNGEAL SWELLING PFIZER\BIONTECH Death 962966-1
40-49 Life
2718 PLASMAPHERESIS PFIZER\BIONTECH 956709-1 diagnosed and eventually required ICU level care and has been treated with plasmapheresis. She is currently still in the ICU but is
years Threatening
stable.
PLATELET COUNT 18-29 Life
PLATELET COUNT 50-59 Life platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my
2722 MODERNA 950980-1
DECREASED years Threatening platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the
PLATELET COUNT 65+ Life
2723 MODERNA 953404-1 Severe rash. Platelets drop to almost needing transfusion
PLATELET COUNT Life 1day after vaccine,developed severe headache & later blister in head officially Shingle . Then decreased platelet count fatally to
2724 MODERNA Unknown 953397-1
DECREASED Threatening 29(ITP).now hospitalized getting treatment.
2725 PFIZER\BIONTECH 930153-1 ITP Plt 2
Vaccine Event
PLATELET COUNT 60-64
DECREASED years
testing.
PLATELET COUNT 65+ Life
PLATELET COUNT 65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
DECREASED years Threatening and confused (beyond baseline)
PLATELET COUNT immunization. The relevant medical history and concomitant medications were not reported. The patient died 2 weeks after his
DECREASED COVID shot because his platelet levels dropped and he had a hemorrhagic stroke. No further information provided. The autopsy
hemorrhagic stroke
PLATELET COUNT having the hemorrhagic stroke. The reporter already had thrombocytopenia and she was debating what she should do about
DECREASED getting vaccine. Outcome of the events was fatal. Information on the lot/batch number has been requested.; Sender's
30-39 Life
2733 PLATELET COUNT NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
30-39 Life
2734 PLATELET COUNT NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
2735 PLATELET COUNT NORMAL MODERNA 958913-1
2736 PLATELET COUNT NORMAL PFIZER\BIONTECH 903123-1
2738 PLATELET COUNT NORMAL PFIZER\BIONTECH Death 950441-1
2739 PLATELET COUNT NORMAL PFIZER\BIONTECH Death 959179-1
40-49 Life
2741 PLATELET TRANSFUSION MODERNA 958885-1 immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and
years Threatening
2742 PLATELET TRANSFUSION MODERNA 950980-1
65+ Life
2743 PLATELET TRANSFUSION PFIZER\BIONTECH 908869-1 WNL (exceptions: SCr 1.24, TBil 1.7); CBC with platelet count of 1,000 resulting in patient admission to Hospital. At admission he
years Threatening
Vaccine Event
2744 PLEURAL EFFUSION PFIZER\BIONTECH Unknown Death 929028-1
2745 PNEUMONIA MODERNA 946978-1
2746 PNEUMONIA MODERNA 955945-1
fever.
65+
2747 PNEUMONIA PFIZER\BIONTECH Death 953754-1 patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia
years
2748 PNEUMONIA PFIZER\BIONTECH Death 962784-1
2749 PNEUMONIA PFIZER\BIONTECH Unknown Death 934781-1
bronchopneumonia
2750 PNEUMONIA PFIZER\BIONTECH Unknown Death 934966-1
COVID-19
2751 PNEUMONIA ASPIRATION PFIZER\BIONTECH Death 962764-1
2752 PNEUMONIA ASPIRATION PFIZER\BIONTECH Death 964653-1
30-39 Life
2753 PO2 DECREASED MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
POLYMERASE CHAIN 65+ Life Throbbing head ache, difficulty breathing, lips numbness, chest discomfort, upper back, lower legs, fingers tingling/numbness,
2754 MODERNA 949967-1
REACTION years Threatening high blood pressure 148/83, underarm sweating, feels weak
POLYMERASE CHAIN 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
REACTION years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
encephalopathy."
POLYMERASE CHAIN 65+
REACTION years
30-39 Life
2757 POOR QUALITY SLEEP PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
65+
2758 POSTURE ABNORMAL MODERNA Death 934050-1 they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of
years
requested.
Vaccine Event
2759 POSTURE ABNORMAL PFIZER\BIONTECH Death 955532-1
65+
2760 POSTURE ABNORMAL PFIZER\BIONTECH Death 949657-1 Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired
years
40-49 Life
2761 POSTURING PFIZER\BIONTECH 932420-1 morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx
years Threatening
30-39 Life
2762 PREGNANCY TEST PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
40-49 Life
2763 PREMATURE DELIVERY PFIZER\BIONTECH 958755-1 that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently
years Threatening
PREMATURE SEPARATION 40-49 Life
OF PLACENTA years Threatening
2765 PRESYNCOPE PFIZER\BIONTECH 909635-1
40-49 Life
2766 PRESYNCOPE PFIZER\BIONTECH 914730-1 admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-
years Threatening
2767 PRESYNCOPE PFIZER\BIONTECH 934745-1
PROCALCITONIN 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
PROCALCITONIN 40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
INCREASED years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
PROCALCITONIN 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
INCREASED years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
40-49 Life
2771 PROCALCITONIN NORMAL PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
2772 PRODUCTIVE COUGH MODERNA Death 962940-1
18-29 Life
2773 PRODUCTIVE COUGH PFIZER\BIONTECH 917712-1 nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under
years Threatening
quick and prepared.
2774 PROTEIN C PFIZER\BIONTECH 951560-1
2775 PROTEIN S NORMAL PFIZER\BIONTECH 951560-1
30-39 Life
2776 PROTEIN TOTAL NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
2777 PROTEIN TOTAL NORMAL MODERNA 958913-1
2778 PROTEIN TOTAL NORMAL MODERNA Death 958228-1
2779 PROTEIN TOTAL NORMAL PFIZER\BIONTECH 903123-1
2780 PROTEIN TOTAL NORMAL PFIZER\BIONTECH 904436-1
2781 PROTEIN TOTAL NORMAL PFIZER\BIONTECH Death 950441-1
PROTHROMBIN LEVEL 18-29 Life emergency room with her symptoms. She was admitted back to our facility yesterday, her diagnoses included Acute provoked
2782 MODERNA 955565-1
INCREASED years Threatening left external illiac, femoral, popliteal, and peroneal DVT. Elevated Factor II levels, Elevated APC resistant, May-Thurner Syndrome,
2783 PROTHROMBIN TIME PFIZER\BIONTECH 932366-1
Vaccine Event
2784 PROTHROMBIN TIME PFIZER\BIONTECH 947687-1
PROTHROMBIN TIME 65+ Life
PROTHROMBIN TIME 60-64 Life
PROLONGED years Threatening
2787 PRURITUS MODERNA 913445-1
30-39 Life
2788 PRURITUS MODERNA 924524-1 FOLLOWED UP WITH PATIENT, SHE REPORTED HER AIRWAY STARTED TO CLOSE AND SHE RECEIVED EPINEPHRINE, AFTER 5
years Threatening
30-39 Life
2789 PRURITUS MODERNA 959996-1 nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in
years Threatening
40-49 Life
2790 PRURITUS MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
Vaccination given 1314 and sent to waiting room for monitoring. Began to have itching at 1325. PO benadryl administered. Then
with throat swelling. Epinephrine administered by EMS/Fire at 1:32pm: 0.5mg IM right arm. 1342 improving 1350 itching/throat
40-49 Life swelling returning while EMS/Fire on phone with medical director. 1352 second dose of epinephrine administered by De Pere
years Threatening EMS/Fire: 0.5mg IM left arm Medical Director on site for evaluation. Client given option to transport to hospital or stay for
monitoring with EMS/Dr. Condition improving, chose to stay for monitoring. Client improved and up walking halls 1513 Client
cleared to be released home via private transport
50-59 Life
2794 PRURITUS MODERNA 938443-1 immediate tingling of lips, followed by fullness of posterior oropharynx, hoarseness and pruritus
years Threatening
65+ Life
2795 PRURITUS MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
65+ Life
2796 PRURITUS MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
18-29 Life
2797 PRURITUS PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
2798 PRURITUS PFIZER\BIONTECH 944450-1
on monitor.
18-29 Life
2799 PRURITUS PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
30-39 Life
2800 PRURITUS PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
30-39 Life
2801 PRURITUS PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
30-39 Life
2802 PRURITUS PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
30-39 Life
2803 PRURITUS PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
30-39 Life
2804 PRURITUS PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
2805 PRURITUS PFIZER\BIONTECH 908157-1 min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth. Sent to ER, received IM Epi, IV: Steroids,
years Threatening
40-49 Life
2806 PRURITUS PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
Vaccine Event
40-49 Life
2807 PRURITUS PFIZER\BIONTECH 942808-1 receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with
years Threatening
50-59 Life
2809 PRURITUS PFIZER\BIONTECH 912826-1 Itching, cough. Given benadryl 50mg and epinephrine 0.3 in vaccine clinic, and taken to ED for further tx.
years Threatening
50-59 Life
2811 PRURITUS PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
50-59 Life
2812 PRURITUS PFIZER\BIONTECH 954723-1 itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
years Threatening
2813 PRURITUS PFIZER\BIONTECH Unknown 902856-1
2814 PULMONARY CONGESTION PFIZER\BIONTECH Death 928062-1
65+
2815 PULMONARY CONGESTION PFIZER\BIONTECH Death 953865-1 REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS
years
2816 PULMONARY EMBOLISM MODERNA 946978-1
40-49 Life
2818 PULMONARY EMBOLISM MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
18-29 Life
2820 PULMONARY EMBOLISM PFIZER\BIONTECH 944289-1 second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral
years Threatening
2821 PULMONARY EMBOLISM PFIZER\BIONTECH 951560-1
30-39 Life
2822 PULMONARY EMBOLISM PFIZER\BIONTECH 957555-1 upper lobe pulmonary artery consistent with pulmonary embolus). I was discharged on Xarelto and advised to follow up with a
years Threatening
Vaccine Event
2823 PULMONARY EMBOLISM PFIZER\BIONTECH 959401-1
50-59 Life
2824 PULMONARY EMBOLISM PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
2825 PULMONARY EMBOLISM PFIZER\BIONTECH Unknown Death 940950-1
PULMONARY HILAR 40-49 Life
ENLARGEMENT years Threatening
PULMONARY IMAGING 65+ vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated,
PROCEDURE ABNORMAL years cardiac arrest, died 01/07/21.
2828 PULMONARY INFARCTION PFIZER\BIONTECH 951560-1
2829 PULMONARY OEDEMA MODERNA Death 924664-1
65+ Life
2830 PULMONARY OEDEMA MODERNA 956597-1 Pulmonary Edema, fever, nausea, vomiting
years Threatening
Dyspnoea; suspected pulmonary edema; This is a spontaneous report downloaded from the regulatory authority DK-DKMA-WBS-
0028304. Report was received from a contactable physician via from the regulatory authority. An 80-year-old female patient
received bnt162b2 (COMIRNATY, lot EJ6797, expiration date 30Apr2021), intramuscularly on 03Jan2021 at single dose for covid-
19 immunisation. Medical history included dementia with lewy bodies from an unknown date and unknown if ongoing,
osteoporosis from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. No
2831 PULMONARY OEDEMA PFIZER\BIONTECH Unknown Death 934765-1 previous drug was given. The patient's concomitant medications were not reported. On 04Jan2021 around 12, approximately 25
hours after the vaccination the patient developed dyspnoea and pulmonary edema. 4 hours later she died. The patient did not
experience any allergic symptoms. Events reported as dyspnoea and suspected pulmonary edema. The ADRs were by the
reporter reported as fatal. No treatment due to the ADRs was reported. Reported cause of death was pulmonary edema.
Outcome of event dyspnoea also reported as not recovered. There was no information regarding test results. It was not reported
if an autopsy was performed.; Reported Cause(s) of Death: Pulmonary edema; Dyspnoea
2832 PULSE ABNORMAL PFIZER\BIONTECH 907042-1
50-59
2833 PULSE ABSENT MODERNA Death 959001-1 back to bed. When staff went to wake patient apx 0530, he was unresponsive and had no pulse. Chest compressions were
years
65+
2834 PULSE ABSENT MODERNA Death 909095-1 medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
years
65+ Resident exhibited no adverse events during 30 minute monitoring following vaccine administration. Resident found without
2835 PULSE ABSENT MODERNA Death 919537-1
years pulse at 1900.
65+
2837 PULSE ABSENT MODERNA Death 940866-1 pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on
years
65+
2838 PULSE ABSENT MODERNA Death 944732-1 Resident found unresponsive and without pulse at 05:45am.
years
65+
2840 PULSE ABSENT MODERNA Death 956811-1 resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm
years
1/18/21
65+
2841 PULSE ABSENT MODERNA Death 958745-1 Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found
years
2842 PULSE ABSENT PFIZER\BIONTECH Death 942106-1
65+
2845 PULSE ABSENT PFIZER\BIONTECH Death 918388-1 Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
years
65+
2846 PULSE ABSENT PFIZER\BIONTECH Death 918418-1 treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations.
years
65+
2848 PULSE ABSENT PFIZER\BIONTECH Death 926269-1 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first
years
Vaccine Event
65+
2851 PULSE ABSENT PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
years
65+
2852 PULSE ABSENT PFIZER\BIONTECH Death 945603-1 weight which were shared with his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On
years
65+ Resident was found without a pulse and not breathing 20 minutes after vaccine administration. Upon MD review, no signs of
years anaphylaxis were noted.
65+
2854 PULSE ABSENT PFIZER\BIONTECH Death 952799-1 On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed
years
65+
2855 PULSE ABSENT PFIZER\BIONTECH Death 955256-1 became unresponsive. Patient was lowered to the floor and did not exhibit a pulse. CPR was initiated and 911 was called. An
years
2856 PULSE ABSENT PFIZER\BIONTECH 934745-1
PULSELESS ELECTRICAL 65+ awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of headache,
ACTIVITY years nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently. Per her
PULSELESS ELECTRICAL 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
ACTIVITY years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
PULSELESS ELECTRICAL 65+
ACTIVITY years
18-29
2860 PUPIL FIXED PFIZER\BIONTECH Death 943397-1 was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was
years
Patient did not display any obvious signs or symptoms; the vaccination was administered at approximately 10:00 AM and the
patient continued throughout her day without any complaints or signs of adverse reaction. Patient was helped to bed by the
65+ nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's
2861 PUPIL FIXED PFIZER\BIONTECH Death 924456-1
years COVID-19 specimen collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to the room to check on
the resident and prepare her to move to a COVID-19 care area the patient was found unresponsive, no movement, no chest rises,
noted regurgitated small amount of food to mouth left side, lying on left side. Pupils non reactive.
2862 PUPIL FIXED PFIZER\BIONTECH Death 950441-1
65+
2863 PUPIL FIXED PFIZER\BIONTECH Death 961434-1 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient
years
40-49 Life
2864 PURPURA PFIZER\BIONTECH 959017-1 started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line
years Threatening
18-29 Life
2865 PYREXIA MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
18-29 Life
2866 PYREXIA MODERNA 919252-1 down her Rt. arm. about 4 hours later she decided to go to the emergency room for Hearty Palpitations, Fever, Chest discomfort
years Threatening
30-39 Life
2867 PYREXIA MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
30-39 Life
2868 PYREXIA MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
2869 PYREXIA MODERNA 941476-1
40-49 Life
2870 PYREXIA MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
50-59
2871 PYREXIA MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
were made.
Vaccine Event
fever.
60-64 Life
2874 PYREXIA MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
65+
2875 PYREXIA MODERNA Death 922977-1 Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily
years
65+
2876 PYREXIA MODERNA Death 958745-1 Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found
years
65+ Life
2877 PYREXIA MODERNA 956597-1 Pulmonary Edema, fever, nausea, vomiting
years Threatening
18-29
2878 PYREXIA PFIZER\BIONTECH Death 960841-1 cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours.
years
2879 PYREXIA PFIZER\BIONTECH 937932-1
up.
18-29 Life
2880 PYREXIA PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
30-39 Life
2883 PYREXIA PFIZER\BIONTECH 936618-1 Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
years Threatening
30-39 Life
2884 PYREXIA PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
40-49 Life
2886 PYREXIA PFIZER\BIONTECH 909614-1 Fever, muscle aches, hypertension, rapid heart heart
years Threatening
40-49 Life
2887 PYREXIA PFIZER\BIONTECH 909720-1 with ibuprofen. 12/24- no fever noted but intermittent right lower quadrant pain continued, seen at the Health Clinic, sent to
years Threatening
40-49 Life
2889 PYREXIA PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
50-59 Life
2890 PYREXIA PFIZER\BIONTECH 912271-1 fever) the next day. Went to the Emergency room on Saturday Dec. 26th, 2020 due to shortness of breath, had an 02 Sat of 60%,
years Threatening
50-59 Life
2891 PYREXIA PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
50-59 Life
2892 PYREXIA PFIZER\BIONTECH 941118-1 temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I
years Threatening
50-59 Life
2893 PYREXIA PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
Vaccine Event
50-59 Life
2894 PYREXIA PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
of 1/3/2021.
cultures.
60-64 Life
2898 PYREXIA PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
2899 PYREXIA PFIZER\BIONTECH Death 914690-1
65+
2900 PYREXIA PFIZER\BIONTECH Death 919108-1 Fever, Malaise
years
65+
2901 PYREXIA PFIZER\BIONTECH Death 930466-1 Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination
years
65+
2903 PYREXIA PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild).
A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an
unspecified route of administration, on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The
patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced
fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021, which was reported as fatal. The
65+
2904 PYREXIA PFIZER\BIONTECH Death 947642-1 clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the
years
middle of night. It was reported that it was not clear what exactly happened, but they are looking into this. The clinical outcome
of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of
death was not reported. An autopsy was not performed (was reported to be taking place soon). The batch/lot number for the
vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days
after receiving the vaccine
65+
2905 PYREXIA PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
65+ 1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB
years on 1/14/2021 at 1325
65+
2907 PYREXIA PFIZER\BIONTECH Death 956365-1 when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on
years
65+ Life
2911 PYREXIA PFIZER\BIONTECH 943741-1 1/8 and 1/11/21. Was admitted 1/11/21 with Concern for STevens Johnson and sepsis. Patient subsequently developed full
years Threatening
65+ Life
2912 PYREXIA PFIZER\BIONTECH 956578-1 Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was
years Threatening
2913 PYREXIA PFIZER\BIONTECH Unknown Death 929028-1
Vaccine Event
later
COVID-19
2916 QUARANTINE MODERNA 914392-1
65+
2917 RADIAL PULSE ABNORMAL PFIZER\BIONTECH Death 936738-1 nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency
years
60-64
2918 RALES PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
18-29 Life
2919 RASH MODERNA 919252-1 down her Rt. arm. about 4 hours later she decided to go to the emergency room for Hearty Palpitations, Fever, Chest discomfort
years Threatening
2920 RASH MODERNA 935478-1
to local er.
30-39 Life
2921 RASH MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
30-39 Life
2922 RASH MODERNA 959400-1 above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2
years Threatening
40-49 Life
2923 RASH MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
40-49 Life
2926 RASH MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
years Threatening
65+
2928 RASH MODERNA Death 956994-1 started 12 hours after injection. On the 5th day, the patient was discovered to also have a rash throughout his body, but it is
years
65+ Life
2929 RASH MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
65+ Life
2930 RASH MODERNA 953404-1 Severe rash. Platelets drop to almost needing transfusion
years Threatening
18-29 Life
2931 RASH PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
2932 RASH PFIZER\BIONTECH 903123-1
30-39 Life
2933 RASH PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
30-39 Life
2934 RASH PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
Vaccine Event
30-39 Life
2935 RASH PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
30-39 Life
2936 RASH PFIZER\BIONTECH 944283-1 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness
years Threatening
40-49 Life
2939 RASH PFIZER\BIONTECH 930897-1 Shortness of breath, cough, rash on face and neck, arthralgia
years Threatening
40-49 Life
2941 RASH PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
40-49 Life
2942 RASH PFIZER\BIONTECH 959017-1 started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line
years Threatening
50-59 Life
2943 RASH PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
65+
2944 RASH PFIZER\BIONTECH Death 921481-1 He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of
years
65+
2945 RASH PFIZER\BIONTECH Death 946225-1 resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately
years
passed away.
65+ Life
2946 RASH PFIZER\BIONTECH 943741-1 1/8 and 1/11/21. Was admitted 1/11/21 with Concern for STevens Johnson and sepsis. Patient subsequently developed full
years Threatening
2947 RASH PFIZER\BIONTECH Unknown 902856-1
2948 RASH ERYTHEMATOUS MODERNA 935478-1
to local er.
30-39 Life
2949 RASH ERYTHEMATOUS MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
2950 RASH ERYTHEMATOUS MODERNA 914392-1
Vaccine Event
65+ Life
2951 RASH ERYTHEMATOUS MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
2952 RASH ERYTHEMATOUS PFIZER\BIONTECH 903123-1
30-39 Life
2953 RASH ERYTHEMATOUS PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
2954 RASH ERYTHEMATOUS PFIZER\BIONTECH 907042-1
40-49 Life
2955 RASH ERYTHEMATOUS PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
2956 RASH ERYTHEMATOUS PFIZER\BIONTECH Unknown 902856-1
30-39 Life
2957 RASH MACULAR MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
18-29 Life
2958 RASH MACULAR PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
65+ Life
2959 RASH MACULAR PFIZER\BIONTECH 943741-1 1/8 and 1/11/21. Was admitted 1/11/21 with Concern for STevens Johnson and sepsis. Patient subsequently developed full
years Threatening
30-39 Life
2960 RASH PAPULAR MODERNA 950640-1 Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red
years Threatening
65+ Life
2961 RASH PAPULAR MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
30-39 Life
2962 RASH PRURITIC MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
2963 RASH PRURITIC PFIZER\BIONTECH 907042-1
40-49 Life
2964 RASH PRURITIC PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
RED BLOOD CELL COUNT 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
Vaccine Event
RED BLOOD CELL COUNT 65+ Life stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose
2966 MODERNA 917784-1
DECREASED years Threatening Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and
RED BLOOD CELL COUNT 18-29 Life
Racepinephrine x 1.
RED BLOOD CELL COUNT 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
RED BLOOD CELL COUNT 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
RED BLOOD CELL 30-39 Life
NUCLEATED MORPHOLOGY years Threatening
RED BLOOD CELL 30-39 Life
NUCLEATED MORPHOLOGY years Threatening
Racepinephrine x 1.
RED BLOOD CELL
2974 NUCLEATED MORPHOLOGY PFIZER\BIONTECH Death 950441-1
PRESENT
RED BLOOD CELL negative. On Trans Thoracic Echocardiogram, patient was found to have hypokinesis of the mid and distal segment with some
65+ Life
2975 SEDIMENTATION RATE MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
INCREASED stress going on in her life or family. Till now extensive infectious as well as inflammatory work up is done to rule out any
RED BLOOD CELL
2976 SEDIMENTATION RATE PFIZER\BIONTECH 903123-1
INCREASED
RED BLOOD CELL
2977 SEDIMENTATION RATE PFIZER\BIONTECH 919087-1
NORMAL
RED CELL DISTRIBUTION 30-39 Life
WIDTH INCREASED years Threatening
Racepinephrine x 1.
RED CELL DISTRIBUTION 65+ orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on
WIDTH INCREASED years 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on
WIDTH NORMAL years Threatening
WIDTH NORMAL years Threatening
RED CELL DISTRIBUTION 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
WIDTH NORMAL years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
RED CELL DISTRIBUTION 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
WIDTH NORMAL years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
2984 REGURGITATION PFIZER\BIONTECH Death 924456-1
2985 RENAL FUNCTION TEST MODERNA 958235-1
2986 RESPIRATION ABNORMAL MODERNA Death 950073-1
2987 RESPIRATION ABNORMAL MODERNA Death 927260-1
65+
2988 RESPIRATORY ARREST MODERNA Death 909095-1 medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
years
2989 RESPIRATORY ARREST MODERNA Death 949474-1
Vaccine Event
65+
2990 RESPIRATORY ARREST MODERNA Death 956811-1 resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm
years
1/18/21
2991 RESPIRATORY ARREST PFIZER\BIONTECH Death 955532-1
50-59 Life
2992 RESPIRATORY ARREST PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
65+
2993 RESPIRATORY ARREST PFIZER\BIONTECH Death 918388-1 Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
years
65+
2994 RESPIRATORY ARREST PFIZER\BIONTECH Death 918418-1 treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations.
years
65+
2997 RESPIRATORY ARREST PFIZER\BIONTECH Death 926269-1 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first
years
65+
3000 RESPIRATORY ARREST PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
years
65+ Resident was found without a pulse and not breathing 20 minutes after vaccine administration. Upon MD review, no signs of
years anaphylaxis were noted.
65+ 1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB
years on 1/14/2021 at 1325
65+
3003 RESPIRATORY ARREST PFIZER\BIONTECH Death 962307-1 couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon
years
breathing
65+
3004 RESPIRATORY DEPRESSION MODERNA Death 922977-1 Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily
years
3005 RESPIRATORY DISTRESS MODERNA 946978-1
50-59
3006 RESPIRATORY DISTRESS MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
3007 RESPIRATORY DISTRESS MODERNA 958235-1
30-39 Life
3008 RESPIRATORY DISTRESS PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
3009 RESPIRATORY DISTRESS PFIZER\BIONTECH Death 914690-1
3010 RESPIRATORY DISTRESS PFIZER\BIONTECH Death 964653-1
Vaccine Event
3011 RESPIRATORY DISTRESS PFIZER\BIONTECH Unknown Death 929028-1
30-39
3012 RESPIRATORY FAILURE MODERNA Death 939050-1 develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory
years
50-59
3013 RESPIRATORY FAILURE MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
50-59 Life
3014 RESPIRATORY FAILURE MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
65+ Life
3015 RESPIRATORY FAILURE MODERNA 930611-1 Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP
years Threatening
50-59 Life
3016 RESPIRATORY FAILURE PFIZER\BIONTECH 944169-1 altered mental status, hypoxic, fever 39.3, agitated
years Threatening
3017 RESPIRATORY FAILURE PFIZER\BIONTECH Death 962390-1
3018 RESPIRATORY FAILURE PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
3019 RESPIRATORY FAILURE PFIZER\BIONTECH Unknown Death 934966-1
COVID-19
RESPIRATORY RATE 50-59
3020 PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
DECREASED years
RESPIRATORY RATE 65+
INCREASED years
RESPIRATORY RATE 65+
INCREASED years
RESPIRATORY RATE 65+ Life of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and
INCREASED years Threatening white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low
RESPIRATORY SYNCYTIAL 65+
VIRUS TEST NEGATIVE years
Vaccine Event
RESPIRATORY TRACT 18-29 Life
3025 PFIZER\BIONTECH 917712-1 nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under
CONGESTION years Threatening
quick and prepared.
RESPIRATORY TRACT 40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
CONGESTION years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
RESPIRATORY TRACT 65+
3027 PFIZER\BIONTECH Death 918418-1 treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations.
CONGESTION years
RESPIRATORY TRACT 65+
3028 PFIZER\BIONTECH Death 946225-1 resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately
CONGESTION years
passed away.
RESPIRATORY TRACT 65+ Life Congestion Shortness of breath Tachycardia Transferred out 911. Per hospital, patient had a myocardial infarction, is
CONGESTION years Threatening unresponsive, and on hospice services.
RESPIRATORY VIRAL 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
PANEL years Threatening WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense
RESPIRATORY VIRAL 60-64 Life rod bacteremia, although urinalysis was negative, urine culture pending. Patient has since defervesced after receiving 1 dose of
PANEL years Threatening cefepime. Overall the most likely cause of fever seems to be urosepsis w/ bacteremia, pending confirmation with urine & blood
cultures.
RESPIRATORY VIRAL 65+
PANEL years
soon as discovered.
3033 RESTLESSNESS PFIZER\BIONTECH Death 934968-1
65+
3034 RESTLESSNESS PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
years
3035 RESTLESSNESS PFIZER\BIONTECH Death 949547-1
3036 RESTLESSNESS PFIZER\BIONTECH Unknown Death 934764-1 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac
50-59
3037 RESUSCITATION MODERNA Death 918518-1 syncopal episode - arrested - CPR - death
years
50-59 Patient had been diagnosed with COVID-19 on Dec. 11th, 2020. Symptoms were thought to have started on 12/5/2020. Received
3038 RESUSCITATION MODERNA Death 928933-1
years Moderna vaccine on 12/23. Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful
50-59
3039 RESUSCITATION MODERNA Death 959001-1 back to bed. When staff went to wake patient apx 0530, he was unresponsive and had no pulse. Chest compressions were
years
60-64 Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and
years started CPR. 911 arrived and pronounced resident dead at 1:01 am.
65+
3042 RESUSCITATION MODERNA Death 934050-1 they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of
years
requested.
65+
3043 RESUSCITATION MODERNA Death 940866-1 pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on
years
65+
3044 RESUSCITATION MODERNA Death 956811-1 resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm
years
1/18/21
Vaccine Event
3045 RESUSCITATION MODERNA 917784-1
3046 RESUSCITATION PFIZER\BIONTECH Death 933739-1
65+
3049 RESUSCITATION PFIZER\BIONTECH Death 918388-1 Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
years
65+
3050 RESUSCITATION PFIZER\BIONTECH Death 926269-1 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first
years
65+
3054 RESUSCITATION PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
years
65+
3057 RESUSCITATION PFIZER\BIONTECH Death 955256-1 became unresponsive. Patient was lowered to the floor and did not exhibit a pulse. CPR was initiated and 911 was called. An
years
65+
3059 RESUSCITATION PFIZER\BIONTECH Death 961434-1 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient
years
65+
3060 RESUSCITATION PFIZER\BIONTECH Death 961776-1 appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08:
years
3061 RESUSCITATION PFIZER\BIONTECH Unknown Death 934781-1
bronchopneumonia
3062 RESUSCITATION PFIZER\BIONTECH Unknown Death 944154-1 floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR,
3063 RESUSCITATION PFIZER\BIONTECH Unknown Death 944155-1
65+ Life
3064 RETCHING MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
Vaccine Event
50-59 Life
3065 RETCHING PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
3066 RETCHING PFIZER\BIONTECH 920994-1
ACHES, SORE THROAT.
30-39 Life
3067 RHINORRHOEA MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
RUSSELL'S VIPER VENOM 30-39 Life Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or
TIME NORMAL years Threatening deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively
3069 SALIVA ALTERED PFIZER\BIONTECH 939190-1
SARS-COV-2 ANTIBODY 18-29 Life
TEST NEGATIVE years Threatening
65+
3073 SARS-COV-2 TEST MODERNA Death 963235-1 household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on
years
January 18, 2021
3074 SARS-COV-2 TEST MODERNA 949967-1
30-39 Life
3075 SARS-COV-2 TEST PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
30-39 Life
3076 SARS-COV-2 TEST PFIZER\BIONTECH 916890-1 HIVES, SOB, THROAT CLOSING UP, WHEEZING
years Threatening
3077 SARS-COV-2 TEST PFIZER\BIONTECH Death 929023-1
SARS-COV-2 TEST 18-29 Life
SARS-COV-2 TEST 40-49 Life respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed
3080 MODERNA 946978-1
NEGATIVE years Threatening multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered
SARS-COV-2 TEST 40-49 Life Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found
3081 MODERNA 954442-1
NEGATIVE years Threatening to have a right lower lobe pulmonary embolism. Treated with Xarelto and sent home with outpatient follow up.
SARS-COV-2 TEST 50-59
3082 MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
NEGATIVE years
SARS-COV-2 TEST 50-59 Life I was short of breath and went to emergency room on 1/5/2021. I was diagnosed with bilateral pulmonary embolisms. I was
3083 MODERNA 941522-1
NEGATIVE years Threatening Covid negative and had no other symptoms.
SARS-COV-2 TEST 50-59 Life platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my
3084 MODERNA 950980-1
SARS-COV-2 TEST 50-59 Life freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove
3085 MODERNA 955945-1
NEGATIVE years Threatening me to the emergency department. I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday
fever.
SARS-COV-2 TEST 65+ breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse
NEGATIVE years was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple
SARS-COV-2 TEST 65+ most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would
NEGATIVE years often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply
Vaccine Event
started with left sided lower back pain; This is a spontaneous report from a contactable Nurse (patient). A 22-year-old female
patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration at left arm on
16Dec2020 13:45 at single dose for covid-19 immunization. Medical history included allergies for All fish. The patient's
concomitant medications were not reported. The patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started
with left sided lower back pain. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency
3088 PFIZER\BIONTECH 946096-1 room/department or urgent care, Hospitalization (2 days), Life threatening illness (immediate risk of death from the event). The
patient received the Heparin drip and xarelto at home for the event. The patient was not pregnant. The patient received the covid
test post vaccination on 09Jan2021. Test type was Nasal Swab. The result was negative. The outcome of the event was
recovered with sequel on unspecified date.; Sender's Comments: From the information provided it is unclear what is the nature of
the reported event and what are the reasons that have put the subject at immediate risk of death. The event is considered
possibly related to the suspect product based on the positive temporal association.
SARS-COV-2 TEST 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
NEGATIVE years Threatening to take benadryl 50 mg PO q 4 hours. Also developed red facial rash (unknown time) Pain at injection site began the morning
SARS-COV-2 TEST 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
NEGATIVE years Threatening WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense
SARS-COV-2 TEST 30-39 Life dyspnea and had loss of consciousness for 5 seconds and was found down. I was rushed to the hospital and diagnosed with
NEGATIVE years Threatening multiple pulmonary embolus (about 9) which was treated with direct TPA via catheterization. I then recovered in the ICU and
3092 PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
SARS-COV-2 TEST 50-59 placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine
NEGATIVE years that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the
3094 PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
SARS-COV-2 TEST 50-59 Life was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix
NEGATIVE years Threatening was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was
NEGATIVE years
testing.
SARS-COV-2 TEST 60-64 Life noticed tingling after dinner. Patient stated he took two benadryl with no relief. His tongue continued to swell and he took two
NEGATIVE years Threatening additional benadryl at 22:00. Once he developed difficulty swallowing he went to the emergency department. Patient presented
SARS-COV-2 TEST 60-64 Life rod bacteremia, although urinalysis was negative, urine culture pending. Patient has since defervesced after receiving 1 dose of
NEGATIVE years Threatening cefepime. Overall the most likely cause of fever seems to be urosepsis w/ bacteremia, pending confirmation with urine & blood
cultures.
SARS-COV-2 TEST 65+ Within 24 hours of receiving the vaccine, fever and respiratory distress, and anxiety developed requiring oxygen, morphine and
NEGATIVE years ativan. My Mom passed away on the evening of 12/26/2020.
SARS-COV-2 TEST 65+
3101 PFIZER\BIONTECH Death 935767-1 My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!!
NEGATIVE years
SARS-COV-2 TEST 65+
NEGATIVE years
SARS-COV-2 TEST 65+ (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20
NEGATIVE years minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on
Vaccine Event
SARS-COV-2 TEST 65+ Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age
NEGATIVE years 87. No evidence of acute vaccine reaction.
SARS-COV-2 TEST 65+
3105 PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
NEGATIVE years
SARS-COV-2 TEST 65+
3106 PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
NEGATIVE years
SARS-COV-2 TEST 65+
3107 PFIZER\BIONTECH Death 953865-1 REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS
NEGATIVE years
SARS-COV-2 TEST 65+ he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative. On 12/30/2020,
NEGATIVE years patient complained of sternal pressure and was transferred to the hospital. The patient died 12/31/2020 and records obtained
SARS-COV-2 TEST 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
NEGATIVE years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
SARS-COV-2 TEST 65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
NEGATIVE years Threatening and confused (beyond baseline)
SARS-COV-2 TEST with COVID-19. Patient is not enrolled in clinical trial. No known allergies. The patient had not tested positive for COVID-19 since
NEGATIVE having the vaccine. On the 29Dec2020 the patient experienced loose stools and vomited. The patient underwent lab tests and
SARS-COV-2 TEST kidney disease and essential hypertension, all unknown if ongoing. Concomitant medication included alfacalcidol (unknown
NEGATIVE manufacturer), amlodipine (unknown manufacturer), atorvastatin (unknown manufacturer), clopidogrel (unknown manufacturer),
SARS-COV-2 TEST 05Jan2021 at 12:51, the patient experienced vomiting (non-serious); 25 minutes post vaccine (had further vomiting episodes).
NEGATIVE On 07Jan2021 at 01:00, the patient experienced death; which caused death, and was medically significant. The patient had not
Death: Death
SARS-COV-2 TEST
3114 PFIZER\BIONTECH Unknown Death 944121-1 enrolled in clinical trial. The patient's concomitant medications were not reported. The patient experienced cardiac arrest on
NEGATIVE
SARS-COV-2 TEST
3115 PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
NEGATIVE
Died in sleep; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority.
Regulatory authority report number was GB-MHRA-ADR 24556999 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-
20210105122200. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:
EJ1688), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 vaccination. Medical history
included craniotomy in 2019, acute subdural haematoma in 2019, and ongoing bedridden following a craniotomy for an acute
subdural haematoma from 2019. The patient was not enrolled in clinical trial. Concomitant medications included atorvastatin
(MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), ferrous sulfate (MANUFACTURER UNKNOWN),
SARS-COV-2 TEST finasteride (MANUFACTURER UNKNOWN), flucloxacillin (MANUFACTURER UNKNOWN), colecalciferol (FULTIUM D3), gabapentin
NEGATIVE (MANUFACTURER UNKNOWN), hypromellose (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER
UNKNOWN), betamethasone dipropionate/clotrimazole (LOTRIDERM) , macrogol (MANUFACTURER UNKNOWN), tramadol
hydrochloride (MAROL), omeprazole (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN), paracetamol
(MANUFACTURER UNKNOWN), senna spp. (MANUFACTURER UNKNOWN), and influenza vaccine inact sag 4v (FLUCELVAX
TETRA). On 05Jan2021, the patient died in his sleep. The clinical course was as follows: The patient had not had symptoms
associated with COVID-19. The patient received the vaccination on 31Dec2020. The patient had tested negative for COVID-19
since having the vaccine on an unknown date. There were no other reactions noted but the patient died in his sleep overnight on
05Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Died in sleep
3117 MODERNA Death 939050-1 develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory
POSITIVE years
3118 MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
POSITIVE years Threatening
SARS-COV-2 TEST 50-59 Life 12/30 9:30 am developed angioedema. Swelling of face, lips, tight throat. Also had bright red rash over body trunk and arms.
3119 MODERNA 914392-1
POSITIVE years Threatening Both palms were red, hot and painful.
3121 MODERNA Death 952713-1 Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21
POSITIVE years
3122 MODERNA Death 963610-1 Patient deceased on 01/17/2021
POSITIVE years
Vaccine Event
SARS-COV-2 TEST 65+
3123 MODERNA Death 917117-1 vaccination. Facility had a number of patients who had already tested positive for COVID-19. Vaccination continued in an effort
POSITIVE years
SARS-COV-2 TEST 65+ where patient was a resident. About a week later, patient tested positive for COVID 19. She had a number of chronic, underlying
POSITIVE years health conditions. The vaccine did not have enough time to prevent COVID 19. There is no evidence that the vaccination caused
SARS-COV-2 TEST 65+
3125 MODERNA Death 917793-1 about a week later she tested positive for COVID-19. She had underlying thyroid and diabetes disease. She died as a result of
POSITIVE years
SARS-COV-2 TEST 65+
3126 MODERNA Death 922977-1 Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily
POSITIVE years
SARS-COV-2 TEST 65+ not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020
POSITIVE years and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the
The facility had positive cases of COVID when we were able to begin vaccinating residents. Within about a week of vaccination,
SARS-COV-2 TEST 65+
3128 MODERNA Death 937127-1 patient was tested positive for COVID. He was 91 years old and his immune system did not have the time to allow the vaccine to
POSITIVE years
begin working before exposure. His age was a major contributing factor to his death.
SARS-COV-2 TEST 65+ The facility had positive cases for COVID 19 when the vaccine was received and administered to patient. With her advanced age
POSITIVE years and chronic conditions, she did not have time to build immunity between the time of vaccination and her testing positive.
SARS-COV-2 TEST 65+ The facility had a number of positive COVID 19 cases prior to patients vaccination. Due to her advanced age, chronic condition,
POSITIVE years and exposure, patient did not have the time to build immunity after exposure before becoming positive.
SARS-COV-2 TEST 65+
3131 MODERNA Death 956903-1 mi Narrative: patient with asymptomatic covid 19, covid positive 12/10/2020.
POSITIVE years
3132 PFIZER\BIONTECH 921641-1 decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without
SARS-COV-2 TEST 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
POSITIVE years Threatening WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense
SARS-COV-2 TEST 30-39 Life COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was
POSITIVE years Threatening admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a
SARS-COV-2 TEST 65+ Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test result came back positive 1/2/2021
POSITIVE years Deceased 1/4/2021
SARS-COV-2 TEST 65+ nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's
POSITIVE years COVID-19 specimen collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to the room to check on
SARS-COV-2 TEST 65+
POSITIVE years
"died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a
Pfizer-sponsored program, Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-
BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose
for COVID-19 immunization; administered by the nursing home. Medical history included glaucoma from an unknown date and
unknown if ongoing. Concomitant medications included: ""used a sav for skin tears"", and ""eye drops for glaucoma"" from an
unknown date to an unknown date. On 07Jan2021, the patient experienced: tested positive for COVID (medically significant).
The patient died (death, medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated
that in regard to the patient's height and weight: ""was probably getting down to about five foot eight. Shrinking."" The reporter
stated that If she remembered correctly, they were trying to maintain the patient's weight 135 to 136 pounds. The reporter stated
that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died
on 17Jan2021. The reporter stated that she ""wanted Pfizer to know that the little old people in the nursing might not be strong
enough for the vaccine."" The reporter stated that she was ""not calling to complaining."" The reporter stated that there was
nothing wrong with her dad. He was elderly with no health issues. ""He was literally on no medications. The only reason he was
SARS-COV-2 TEST 65+
3138 PFIZER\BIONTECH Death 960460-1 in the nursing home was because he was afraid to walk."" The reporter stated that she received a call about giving the patient the
POSITIVE years
vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine, the patient tested positive
for COVID ""like all the other people"" (no further details provided). The reporter stated that her dad had no symptoms of COVID.
The director of nursing said the patient was doing so well. The patient ate his lunch, he laid down for nap, and at 14:30 he was
gone. The patient ""went peacefully in his sleep."" The reporter then again stated that the patient literally had nothing wrong with
him. ""They were shocked. They fed him and he took a nap. He was sleeping, but it was eternally."" The reporter stated that, ""it
might not have been the Pfizer vaccine, maybe his heart wore out."" In regard to an autopsy: the reporter stated that they would
get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on
07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none. It was unknown if there
were additional vaccines administered on the same date of the Pfizer suspect, but the reporter doubted it. There were no prior
vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event,
died, was fatal. The clinical outcome of the event, tested positive for COVID, was unknown. The patient died on 17Jan2021 due
to an unknown cause of death. An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH
COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: died"
SARS-COV-2 TEST underlying conditions, older population tested for COVID-19 prior to the vaccination, as this is not currently a recommendation or
POSITIVE a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did
COVID-19
SARS-COV-2 TEST
3140 PFIZER\BIONTECH Unknown Death 944118-1 concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced SARS-coV-2
POSITIVE
SARS-COV-2 TEST breath on 03Jan2021. Reaction to vaccine is none. Patient was admitted with fall and on the floor for 5 hours on 03Jan2021. He
POSITIVE was tested COVID positive on admission on 03Jan2021. So he tested positive about two weeks after first dose of Pfizer COVID-
SCAN MYOCARDIAL 30-39 Life PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath,
PERFUSION NORMAL years Threatening dizziness and blurry vision
Vaccine Event
40-49 Life
3143 SCAN WITH CONTRAST MODERNA 931558-1 7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
years Threatening
SCAN WITH CONTRAST 40-49 Life days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night.
ABNORMAL years Threatening Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery
SCAN WITH CONTRAST 40-49 Life
3146 SECRETION DISCHARGE MODERNA Death 956966-1
Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband, patient did not complain of
40-49
3147 SEIZURE MODERNA Death 950057-1 any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of
years
uncertain etiology
40-49 Life
3148 SEIZURE MODERNA 955491-1 Systemic: Anaphylaxis-Severe, Systemic: Seizure-Severe
years Threatening
50-59 Life
3149 SEIZURE MODERNA 948471-1 5-6 HOURS AFTER VACCINATION. CONVULSIONS/SEIZURE, HIGH BLOOD PRESSURE, INCREASED HEART RATE,
years Threatening
18-29 Life
3150 SEIZURE PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
60-64 Life
3151 SEIZURE PFIZER\BIONTECH 948243-1 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current
years Threatening
status
3152 SEIZURE PFIZER\BIONTECH 944663-1
3153 SEIZURE LIKE PHENOMENA MODERNA 926787-1
were made.
3154 SEIZURE LIKE PHENOMENA PFIZER\BIONTECH 934745-1
SENSATION OF FOREIGN 30-39 Life Saturday she had a ""really bad headache and just layed around all day. I was not able to function at all."" Sunday she still had a
3155 MODERNA 956527-1
BODY years Threatening headache and added muscle aches. Monday she started feeling ""a lot better"" until 8 PM when she was walking around doing
SENSATION OF FOREIGN 30-39 Life
3156 PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
BODY years Threatening
SENSATION OF FOREIGN 30-39 Life Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably,
BODY years Threatening speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her
SENSATION OF FOREIGN 40-49 Life
3158 PFIZER\BIONTECH 908157-1 min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth. Sent to ER, received IM Epi, IV: Steroids,
BODY years Threatening
65+ Life
3159 SENSITIVE SKIN PFIZER\BIONTECH 924658-1 Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.
years Threatening
30-39 Life
3160 SENSORY DISTURBANCE MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
3161 SENSORY LOSS PFIZER\BIONTECH 930777-1
30-39 Life
3162 SEPSIS MODERNA 918839-1 Gallbladder removed, septic, 11mm axillary lymph node.
years Threatening
50-59
3163 SEPSIS MODERNA Death 941811-1 having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered.
years
3164 SEPSIS PFIZER\BIONTECH Death 963057-1
3165 SEPSIS PFIZER\BIONTECH 909031-1
3166 SEPSIS PFIZER\BIONTECH 953333-1
65+ Life
3167 SEPSIS PFIZER\BIONTECH 956578-1 Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was
years Threatening
Vaccine Event
3168 SEPSIS PFIZER\BIONTECH Unknown Death 929028-1
3169 SEPSIS PFIZER\BIONTECH Unknown Death 934781-1
bronchopneumonia
3170 SEPTIC SHOCK PFIZER\BIONTECH Death 962390-1
SERUM FERRITIN 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
3172 SHIFT TO THE LEFT PFIZER\BIONTECH 930894-1
50-59 Life
3173 SINUS BRADYCARDIA PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
3174 SINUS TACHYCARDIA MODERNA 941563-1
60-64
3175 SINUS TACHYCARDIA PFIZER\BIONTECH Death 956458-1 an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline
years
testing.
65+
3176 SINUS TACHYCARDIA PFIZER\BIONTECH Death 959079-1 shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified, branch block. Received order for
years
18-29 Life
3177 SKIN DISCOLOURATION MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
30-39 Life
3178 SKIN DISCOLOURATION PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
65+
3179 SKIN DISCOLOURATION PFIZER\BIONTECH Death 945578-1 feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not
years
3180 SKIN DISCOLOURATION PFIZER\BIONTECH 934745-1
18-29 Life
3181 SKIN DISCOMFORT MODERNA 919252-1 down her Rt. arm. about 4 hours later she decided to go to the emergency room for Hearty Palpitations, Fever, Chest discomfort
years Threatening
3182 SKIN LESION PFIZER\BIONTECH 917210-1
Vaccine Event
3183 SKIN ULCER PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
30-39 Life
3184 SKIN WARM MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
40-49 Life
3185 SKIN WARM MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
65+
3186 SKIN WARM MODERNA Death 920326-1 Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21
years
65+
3187 SKIN WARM MODERNA Death 958745-1 Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found
years
65+ Life
3188 SKIN WARM PFIZER\BIONTECH 924658-1 Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.
years Threatening
3189 SKIN WARM PFIZER\BIONTECH 934745-1
3190 SLEEP DISORDER MODERNA 954154-1
30-39 Life
3191 SLEEP DISORDER PFIZER\BIONTECH 936618-1 Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
years Threatening
30-39 Life
3192 SLEEP DISORDER PFIZER\BIONTECH 939194-1 both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the
years Threatening
3193 SLEEP DISORDER PFIZER\BIONTECH 939914-1
3194 SLEEP DISORDER PFIZER\BIONTECH 951817-1
50-59 Life
3195 SLEEP DISORDER PFIZER\BIONTECH 941118-1 temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I
years Threatening
65+
3196 SLUGGISHNESS PFIZER\BIONTECH Death 921481-1 He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of
years
18-29 Life
3197 SOMNOLENCE MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
65+
3198 SOMNOLENCE MODERNA Death 909095-1 medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
years
3199 SOMNOLENCE MODERNA Death 910363-1
65+
3200 SOMNOLENCE MODERNA Death 947662-1 Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death
years
18-29 Life
3201 SOMNOLENCE PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
Vaccine Event
3202 SOMNOLENCE PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
3203 SPEECH DISORDER MODERNA 955945-1
fever.
65+
3205 SPEECH DISORDER MODERNA Death 929997-1 eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow.
years
3206 SPEECH DISORDER MODERNA Death 941561-1
3208 SPEECH DISORDER PFIZER\BIONTECH 945090-1
30-39 Life
3209 SPEECH DISORDER PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
40-49 Life
3211 SPEECH DISORDER PFIZER\BIONTECH 907101-1 assessment, and en route in wheelchair to ER the dry cough became persistent, spasmodic and patient was unable to speak.
years Threatening
40-49 Life
3213 SPEECH DISORDER PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
50-59 Life
3214 SPEECH DISORDER PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
3215 SPEECH DISORDER PFIZER\BIONTECH Death 951101-1
3216 SPEECH DISORDER PFIZER\BIONTECH Unknown Death 945725-1 speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was
3217 SPUTUM CULTURE PFIZER\BIONTECH 917210-1
Vaccine Event
STAPHYLOCOCCUS TEST 65+
NEGATIVE years
3219 STATUS ASTHMATICUS PFIZER\BIONTECH 906988-1
3220 STENT PLACEMENT PFIZER\BIONTECH 930889-1
60-64 Life
3221 STENT PLACEMENT PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
40-49 Life
3222 STILLBIRTH PFIZER\BIONTECH 958755-1 that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently
years Threatening
STREPTOCOCCUS TEST 30-39 Life
50-59 Life
3224 STRESS CARDIOMYOPATHY MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
65+ Life
3225 STRESS CARDIOMYOPATHY MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
40-49 Life
3226 STRESS CARDIOMYOPATHY PFIZER\BIONTECH 949611-1 Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed
years Threatening
40-49 Life
3227 STRIDOR MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
30-39 Life
3228 STRIDOR PFIZER\BIONTECH 914596-1 Anaphalaxis reaction, stridor an unable to breathe. Happened in 30 seconds
years Threatening
3229 STRIDOR PFIZER\BIONTECH 934749-1
40-49
3232 SUDDEN CARDIAC DEATH PFIZER\BIONTECH Death 939270-1 Sudden cardiac death
years
had a vaccination on 12/31/2020 late morning passed away early morning 01/01/2020. This is a 93 year old with significant
65+
3233 SUDDEN DEATH MODERNA Death 926797-1 heart issues. EF of 20% among other comorbidities. He died suddenly approximately 0430, it is unlikely it was related to
years
receiving the vaccine.
65+ Sudden death without warning symptoms 4 days after vaccine. Many medical problems which most likely explain the outcome
3234 SUDDEN DEATH MODERNA Death 957116-1
years but spouse feels it is related and it is a new vaccine. Monitor for pattern?
65+
3235 SUDDEN DEATH MODERNA Death 958935-1 Sudden Death within 24 hours of vaccine
years
65+
3236 SUDDEN DEATH PFIZER\BIONTECH Death 934507-1 Resident died suddenly and expectantly on 01/05/2021
years
65+
3237 SUDDEN DEATH PFIZER\BIONTECH Death 946959-1 Sudden death 18 hours post vaccine .
years
3238 SUDDEN DEATH PFIZER\BIONTECH Unknown Death 923219-1 death was unknown. It was reported that an autopsy would be performed in the next days; the results were not yet available. The
Vaccine Event
"Sudden death; This is a spontaneous report downloaded from the regulatory authority DK-DKMA-WBS-0028211. Report was
received from a contactable nurse via regulatory authority. A 94-years-old female patient received BNT162B2 (COMIRNATY) (Lot
# EJ6797, exp date 30Apr2021), via intramuscular on 30Dec2020 at first single dose for covid-19 immunization. Medical history
included ongoing periodic obstipation (periodic treated), ongoing dementia, ongoing atrial fibrillation, ongoing depression, tibia
fracture from 01Nov2020 (treated conservatively). Concomitant medication included apixaban (ELIQUIS) from 09Apr2018 to
unknown date for atrial fibrillation, sertraline from 20Jun2018 to unknown date for depression. The patient had not received
3239 SUDDEN DEATH PFIZER\BIONTECH Unknown Death 934763-1 BNT162B2 before. The patient experienced sudden death on 01Jan2021. There was no immediate illness until the time of
vaccination and the nurse described that she ""seemed like herself and fresh"". The ADRs were by the reporter reported as fatal.
Reported cause of death: Unknown caused of death, sudden death. No treatment due to the death was described. There is no
information regarding test results. An autopsy was not performed. Causality: The doctor who issued the death certificate does
not suspect that it is the COVID-19 vaccine that is the cause of her death. She slept quietly in, and was old. Due to reporting
obligation this case is reported. If the regulatory authority receives supplemental significant information regarding this case the
case will be re-submitted.; Reported Cause(s) of Death: Sudden death; Unknown cause of death"
Sudden death; This is a spontaneous report from a contactable physician from the regulatory authority. The regulatory authority
report number is GB-MHRA-ADR 24556755. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19
mRNA VACCINE; Lot number EJ0553), via an unspecified route of administration on 19Dec2020 as single dose for COVID-19
immunization. Medical history included Waldenstrom's macroglobulinemia for Waldenstrom's macroglobulinaemia, memory
impairment, with recent memory problems, cerebrovascular accident , with previous CVA, joint swelling , reported as slight ankle
swelling awaiting head CT scan and bloods, oesophagitis, and cholesterol, all from an unknown date and unknown if ongoing.
Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) for Waldenstrom's macroglobulinaemia,
lansoprazol (MANUFACTURER UNKNOWN) for oesophagitis, simvastatin (MANUFACTURER UNKNOWN) for blood cholesterol.
3240 SUDDEN DEATH PFIZER\BIONTECH Unknown Death 944114-1
The patient had sudden death on 29Dec2020. The patient died on 29Dec2020. It was not reported if an autopsy was performed.
The reporter did not think the COVID vaccination caused the patients death; It did not appear to be related. The patient was seen
by the physician on the 24th (not otherwise specified), and was fine. The patients son also saw the patient on the 28th (not
otherwise specified) and also fine with no side effects from the jab. No follow-up attempts are possible. No further information
is expected.; Sender's Comments: Based on the information currently provided, the company considers the patient death is
unrelated to the vaccine use; the advance old patient having multiple pre-existing medical conditions including Waldenstrom's
macroglobulinaemia and cerebrovascular accident, which more likely led the patient to sudden death.; Reported Cause(s) of
Death: Sudden death unexplained
SUPRAVENTRICULAR 18-29 Life
3241 MODERNA 908685-1 throat swelling, SVT
TACHYCARDIA years Threatening
SUPRAVENTRICULAR 65+ Life
3242 MODERNA 952235-1 nausea and vomiting possible cause of diabetic ketoacidosis and svt
SUPRAVENTRICULAR 65+
TACHYCARDIA years
SUPRAVENTRICULAR 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
TACHYCARDIA years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
SUPRAVENTRICULAR Life responsive to vagal manoeuvres/carotid sinus massage. Chest pain, dizziness and hypotension was associated with a heart rate
3245 PFIZER\BIONTECH Unknown 902856-1
TACHYCARDIA Threatening greater than 200 BPM . Non-specific erythematous rash was visible on the neck with no evidence of angioedema, tongue
18-29 Life Acute appendicitis, onset morning of 1/1/2021 (Reporting this because Pfizer covid vaccine had 3-4x higher risk of appendicitis,
3246 SURGERY MODERNA 916710-1
years Threatening although data not reported for Moderna covid vaccine)
18-29 Life
3247 SWELLING MODERNA 930079-1 Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
years Threatening
40-49 Life
3248 SWELLING MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
3249 SWELLING PFIZER\BIONTECH 945090-1
30-39 Life
3250 SWELLING PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
40-49 Life
3251 SWELLING PFIZER\BIONTECH 921989-1 Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
years Threatening
3252 SWELLING PFIZER\BIONTECH 952803-1
60-64 Life
3253 SWELLING PFIZER\BIONTECH 909577-1 Dizziness, dyspnea, neck swelling
years Threatening
40-49 Life
3254 SWELLING FACE MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
3255 SWELLING FACE MODERNA 954154-1
65+ Life
3258 SWELLING FACE MODERNA 928461-1 eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP,
years Threatening
Was given the vaccine and about 5 minutes later started having swelling and my eyes and face. It was watched for a few
30-39 Life
3259 SWELLING FACE PFIZER\BIONTECH 912137-1 minutes and was assessed by EMS and taken to the emergency department. I was given epinephrine, Benadryl, Solu-Medrol,
years Threatening
Pepcid, IV fluids, DuoNebs and observed overnight. I was given multiple rounds of Benadryl, steroids, Pepcid, DuoNebs
Vaccine Event
40-49 Life
3260 SWELLING FACE PFIZER\BIONTECH 920784-1 ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins
years Threatening
meds naproxen
40-49 Life
3261 SWELLING FACE PFIZER\BIONTECH 921989-1 Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
years Threatening
3262 SWELLING FACE PFIZER\BIONTECH 939914-1
30-39 Life
3266 SWELLING OF EYELID MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
30-39 Life
3267 SWELLING OF EYELID MODERNA 929391-1 vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for
years Threatening
18-29 Life
3268 SWOLLEN TONGUE MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
18-29 Life
3269 SWOLLEN TONGUE MODERNA 930079-1 Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
years Threatening
18-29 Life
3270 SWOLLEN TONGUE MODERNA 953997-1 HER LIPS BECAME NUMB AND HER TONGUE AND THROAT STARTED SWELLING. AN EPIPEN WAS ADMINISTERED AND 911
years Threatening
30-39 Life
3271 SWOLLEN TONGUE MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
30-39 Life
3272 SWOLLEN TONGUE MODERNA 952707-1 episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV,
years Threatening
50-59 Life
3273 SWOLLEN TONGUE MODERNA 920787-1 obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered.
years Threatening
50-59 Life
3274 SWOLLEN TONGUE MODERNA 929418-1 Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
years Threatening
Reported sensation of tongue swelling during post-vaccination observation at 10 minutes. Epinephrine was refused and she was
65+ Life
3275 SWOLLEN TONGUE MODERNA 909061-1 taken to ED for observation where she was given oral dose of Benadryl and Pepcid. Discharged with instructions to return PRN
years Threatening
and follow up with PCP. Elevated BP noted.
65+ Life
3276 SWOLLEN TONGUE MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
3277 SWOLLEN TONGUE PFIZER\BIONTECH 915464-1
Vaccine Event
30-39 Life
3279 SWOLLEN TONGUE PFIZER\BIONTECH 950387-1 Swollen tongue and sob with decreased swallow
years Threatening
30-39 Life
3280 SWOLLEN TONGUE PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
40-49 Life
3283 SWOLLEN TONGUE PFIZER\BIONTECH 908157-1 min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth. Sent to ER, received IM Epi, IV: Steroids,
years Threatening
40-49 Life
3285 SWOLLEN TONGUE PFIZER\BIONTECH 928209-1 Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
years Threatening
50-59 Life
3286 SWOLLEN TONGUE PFIZER\BIONTECH 916268-1 epinephrine x 1 dose. Then administered 50mg IM Diphenhydramine. This treatment course resolved the adverse reaction.
years Threatening
3290 SYNCOPE MODERNA 912930-1
after the vaccine.
40-49 Life
3292 SYNCOPE MODERNA 958509-1 Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
years Threatening
50-59
3293 SYNCOPE MODERNA Death 918518-1 syncopal episode - arrested - CPR - death
years
3294 SYNCOPE MODERNA Death 940602-1
65+
3295 SYNCOPE MODERNA Death 943362-1 Pt collapsed at home approx 5:30 pm and died
years
65+ most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would
3296 SYNCOPE MODERNA Death 951518-1
years often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply
18-29 Life
3298 SYNCOPE PFIZER\BIONTECH 941576-1 She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and
years Threatening
Vaccine Event
30-39 Life
3299 SYNCOPE PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
50-59
3300 SYNCOPE PFIZER\BIONTECH Death 921768-1 she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours,
years
50-59 Life
3301 SYNCOPE PFIZER\BIONTECH 944270-1 reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was
years Threatening
Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old
female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve
replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the
reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the
65+
3302 SYNCOPE PFIZER\BIONTECH Death 941215-1 COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete
years
a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's
mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday
06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day.
The autopsy was unknown. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch
number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown
65+ Narrative: Symptoms: Palpitations & Syncope Treatment: EPINEPHRINE 1 MG ONCE ,EPINEPHRINE 1 MG ONCE ,SODIUM
3303 SYNCOPE PFIZER\BIONTECH Death 951519-1
years BICARBONATE 50 ML ONCE
65+
3305 SYNCOPE PFIZER\BIONTECH Death 961741-1 Theápatientáreceivedáhisávaccineáináthe.ámorningáofá1/20/2021,áwhileágettingáintoácarátoágoáseeáhisápulmonologist,áaboutá2áhoursáafter,áco
years
SYSTEMIC INFLAMMATORY 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
RESPONSE SYNDROME years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
3308 TACHYCARDIA MODERNA 956504-1
40-49 Life
3309 TACHYCARDIA MODERNA 914821-1 Rash, Itching and swelling of left arm. Progressed to tachycardia in the 150's, hypertension 200/114. Tingling of lips, dizziness
years Threatening
40-49 Life
3310 TACHYCARDIA MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
50-59 Life
3311 TACHYCARDIA MODERNA 920787-1 obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered.
years Threatening
60-64 Life
3312 TACHYCARDIA MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
years Threatening
18-29 Life
3313 TACHYCARDIA PFIZER\BIONTECH 904334-1 Angioedema, hives, tachycardia, shortness of breath
years Threatening
30-39 Life
3314 TACHYCARDIA PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
3315 TACHYCARDIA PFIZER\BIONTECH 909147-1
30-39 Life
3318 TACHYCARDIA PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
Vaccine Event
30-39 Life
3320 TACHYCARDIA PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
30-39 Life
3321 TACHYCARDIA PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
3322 TACHYCARDIA PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
3324 TACHYCARDIA PFIZER\BIONTECH 908003-1 ANAPHLACTIC REACTION, SOB, CHEST PRESSURE, TIGHTNESS IN THROAT, TACHYCARDIA
years Threatening
40-49 Life
3325 TACHYCARDIA PFIZER\BIONTECH 913854-1 anxiety, tachycardia, flushing, diaphoresis, HTN, SOB
years Threatening
40-49 Life
3328 TACHYCARDIA PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
40-49 Life
3329 TACHYCARDIA PFIZER\BIONTECH 942808-1 receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with
years Threatening
40-49 Life
3330 TACHYCARDIA PFIZER\BIONTECH 956870-1 Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
years Threatening
50-59 Life
3332 TACHYCARDIA PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
50-59 Life
3333 TACHYCARDIA PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
3334 TACHYCARDIA PFIZER\BIONTECH Death 959929-1
Vaccine Event
3336 TACHYPHRENIA PFIZER\BIONTECH Death 934968-1
30-39 Life
3337 TACHYPNOEA MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
40-49 Life
3338 TACHYPNOEA MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
65+
3339 TACHYPNOEA MODERNA Death 949630-1 pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5
years
30-39 Life
3340 TACHYPNOEA PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
3341 TACHYPNOEA PFIZER\BIONTECH 917210-1
3342 TACHYPNOEA PFIZER\BIONTECH 934749-1
30-39 Life
3343 TACHYPNOEA PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
3344 TACHYPNOEA PFIZER\BIONTECH Unknown Death 958809-1 Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to
hypoglycaem
30-39 Life
3345 TASTE DISORDER MODERNA 928240-1 and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3
years Threatening
50-59 Life
3346 TENDERNESS PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted
from vaccine administration, but reporting as required because pt died 7 days later. Narrative: Reporting this event because
patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was
60-64
3347 TERMINAL STATE PFIZER\BIONTECH Death 964629-1 administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine
years
or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as
monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to
underlying terminal illness.
3348 THALAMIC INFARCTION PFIZER\BIONTECH 941401-1
3349 THIRST MODERNA 917784-1
40-49 Life
3350 THROAT CLEARING MODERNA 932614-1 Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing Hoarse voice
years Threatening
Vaccine Event
3351 THROAT CLEARING PFIZER\BIONTECH 938868-1
3352 THROAT CLEARING PFIZER\BIONTECH 939190-1
50-59 Life
3353 THROAT CLEARING PFIZER\BIONTECH 916790-1 The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea
years Threatening
3354 THROAT IRRITATION MODERNA 915199-1
30-39 Life
3355 THROAT IRRITATION MODERNA 924524-1 FOLLOWED UP WITH PATIENT, SHE REPORTED HER AIRWAY STARTED TO CLOSE AND SHE RECEIVED EPINEPHRINE, AFTER 5
years Threatening
40-49 Life
3356 THROAT IRRITATION MODERNA 932614-1 Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing Hoarse voice
years Threatening
18-29 Life
3357 THROAT IRRITATION PFIZER\BIONTECH 935180-1 Scratchy throat, dizziness and eventually feeling like her throat is closing in
years Threatening
30-39 Life
3358 THROAT IRRITATION PFIZER\BIONTECH 903324-1 Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn?t
years Threatening
3359 THROAT IRRITATION PFIZER\BIONTECH 909147-1
30-39 Life
3360 THROAT IRRITATION PFIZER\BIONTECH 914103-1 that time. Epi pen given via L thigh IM. PIV started and benadryl and solumedrol given. Relief of symptoms noted very shortly
years Threatening
30-39 Life
3361 THROAT IRRITATION PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
40-49 Life
3365 THROAT IRRITATION PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
40-49 Life
3367 THROAT IRRITATION PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
50-59 Life
3368 THROAT IRRITATION PFIZER\BIONTECH 913238-1 of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied
years Threatening
50-59 Life
3369 THROAT IRRITATION PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
Vaccine Event
18-29 Life
3370 THROAT TIGHTNESS MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
3371 THROAT TIGHTNESS MODERNA 916859-1
not recurred.
30-39 Life
3372 THROAT TIGHTNESS MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
30-39 Life
3373 THROAT TIGHTNESS MODERNA 947019-1 was administered and 50 mg Benadryl given p.o., EMS transport to ED after administration of solumedrol 125 mg - received
years Threatening
30-39 Life
3374 THROAT TIGHTNESS MODERNA 959996-1 nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in
years Threatening
40-49 Life
3375 THROAT TIGHTNESS MODERNA 932614-1 Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing Hoarse voice
years Threatening
50-59 Life
3378 THROAT TIGHTNESS MODERNA 929418-1 Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
years Threatening
65+ Life
3379 THROAT TIGHTNESS MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
18-29 Life
3380 THROAT TIGHTNESS PFIZER\BIONTECH 916742-1 anaphylactic and had several doses of epinephrine to help calm this. I continued to have rashes and the feeling of my throat
years Threatening
18-29 Life
3381 THROAT TIGHTNESS PFIZER\BIONTECH 917712-1 nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under
years Threatening
quick and prepared.
18-29 Life
3382 THROAT TIGHTNESS PFIZER\BIONTECH 935180-1 Scratchy throat, dizziness and eventually feeling like her throat is closing in
years Threatening
18-29 Life
3383 THROAT TIGHTNESS PFIZER\BIONTECH 951689-1 assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min
years Threatening
30-39 Life
3384 THROAT TIGHTNESS PFIZER\BIONTECH 903324-1 Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn?t
years Threatening
30-39 Life
3385 THROAT TIGHTNESS PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
30-39 Life
3386 THROAT TIGHTNESS PFIZER\BIONTECH 909278-1 Rapid onset of hoarseness, throat tingling and tightness
years Threatening
30-39 Life
3387 THROAT TIGHTNESS PFIZER\BIONTECH 916890-1 HIVES, SOB, THROAT CLOSING UP, WHEEZING
years Threatening
30-39 Life
3388 THROAT TIGHTNESS PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
years Threatening
30-39 Life
3389 THROAT TIGHTNESS PFIZER\BIONTECH 936026-1 1600 to home with instructions to return if needed. Patient returned to ER Sunday January 10 at 1300 complaining of throat
years Threatening
3390 THROAT TIGHTNESS PFIZER\BIONTECH 938868-1
Vaccine Event
40 year female received Pfizer-BioNTech COVID-19 Vaccine today Patient reported prior h/o severe allergic reaction to influenza
vaccine with eggs preservative. She has received flu vaccine w/o egg w/o problem. Due to her prior history of severe allergic
reaction/ anaphylaxis to another vaccine, in this case flu vaccine with eggs, we should proceed with caution. She was told we
40-49 Life could defer vaccination until more information becomes available. She opted to proceed with receiving Pfizer-BioNTech COVID-
years Threatening 19 Vaccine and be observed for 30 minute observation period. Patient developed throat tightening approximately 20 minutes
after vaccination. She received EpiPen within 1 minute of symptoms and was sent to ER immediately in wheelchair by nursing
staff. Patient was evaluated in ED and was hemodynamically stable. She was given IV benadryl and was stable throughout
observation
40-49 Life
3393 THROAT TIGHTNESS PFIZER\BIONTECH 908003-1 ANAPHLACTIC REACTION, SOB, CHEST PRESSURE, TIGHTNESS IN THROAT, TACHYCARDIA
years Threatening
40-49 Life
3394 THROAT TIGHTNESS PFIZER\BIONTECH 910035-1 in the past without problems. Taken to ED via W/C was talking all the way not SOB admitted to ED. 12-28 States she was
years Threatening
40-49 Life
3395 THROAT TIGHTNESS PFIZER\BIONTECH 938829-1 and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I
years Threatening
40-49 Life
3397 THROAT TIGHTNESS PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old
female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer
EL 3302), via an unspecified route of administration on 09Jan2021 07:30 am at single dose at left arm for covid-19
immunization. Medical history included diabetes, high blood pressure, allergies. The patient's concomitant medications were not
reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed
40-49 Life
3398 THROAT TIGHTNESS PFIZER\BIONTECH 946098-1 with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 10Jan2021 14:30,
years Threatening
patient woke up with throat closing up and struggled the breath. Patient immediately drank a dose of diphenhydramine
hydrochloride (BENADRYL). Patient did that two more time in the evening of 10Jan2021. Patient called the doctor in the
morning. Events were considered serious per life-threatening. The adverse events resulted in doctor or other healthcare
professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient received treatment liquid
diphenhydramine hydrochloride, epinephrine (EPI-PEN) for events. Outcome of events was recovered in Jan2021.
40-49 Life
3399 THROAT TIGHTNESS PFIZER\BIONTECH 953402-1 Was feeling anxious right after vaccine given. Laid in cot for a short time, then stated her throat felt like it was closing.
years Threatening
50-59 Life
3400 THROAT TIGHTNESS PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
3402 THROMBECTOMY MODERNA 955565-1
18-29 Life
3403 THROMBOCYTOPENIA MODERNA 932915-1 Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
years Threatening
40-49 Life
3404 THROMBOCYTOPENIA MODERNA 933935-1 Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine. Clinically suspicious for ITP.
years Threatening
3405 THROMBOCYTOPENIA PFIZER\BIONTECH Unknown Death 940950-1
Vaccine Event
3406 THROMBOCYTOPENIA PFIZER\BIONTECH Unknown Death 960437-1
3407 THROMBOLYSIS MODERNA 946978-1
40-49 Life
3408 THROMBOSIS MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
30-39 Life
3409 THROMBOSIS PFIZER\BIONTECH 957555-1 upper lobe pulmonary artery consistent with pulmonary embolus). I was discharged on Xarelto and advised to follow up with a
years Threatening
3410 THROMBOSIS PFIZER\BIONTECH 934745-1
3411 THROMBOTIC STROKE MODERNA 919546-1
30-39 Life
3412 TONGUE DISCOMFORT PFIZER\BIONTECH 903324-1 Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn?t
years Threatening
30-39 Life
3413 TONGUE DISCOMFORT PFIZER\BIONTECH 903592-1 swallow, throat tightness, shortness of breath, tachycardia, tachypnea, pressure, tingling, and numbness from head to toe,
years Threatening
3414 TONGUE DRY PFIZER\BIONTECH 915464-1
40-49 Life
3415 TONGUE PRURITUS MODERNA 907075-1 Patient experienced bronchospasm with coughing and tongue itching approximately 10 minutes after the injection.
years Threatening
40-49 Life
3416 TONGUE PRURITUS MODERNA 932614-1 Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing Hoarse voice
years Threatening
65+ Life
3417 TONGUE PRURITUS MODERNA 924657-1 hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the
years Threatening
3418 TONGUE PRURITUS PFIZER\BIONTECH 938868-1
3419 TONGUE PRURITUS PFIZER\BIONTECH 907042-1
40-49 Life
3420 TONGUE PRURITUS PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
40-49 Life
3421 TONGUE PRURITUS PFIZER\BIONTECH 947992-1 just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth
years Threatening
3422 TOXIC ENCEPHALOPATHY MODERNA 958235-1
65+
3423 TOXICOLOGIC TEST MODERNA Death 934539-1 approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January
years
9, 2021
50-59 Life
3424 TRANSCUTANEOUS PACING PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
50-59 Life
3425 TRANSPLANT EVALUATION PFIZER\BIONTECH 955096-1 Acute liver injury requiring transplant evaluation and acute kidney injury
years Threatening
Vaccine Event
30-39 Life
3426 TREMOR MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
3427 TREMOR MODERNA 956527-1
40-49 Life
3428 TREMOR MODERNA 953630-1 airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my
years Threatening
40-49 Life
3429 TREMOR MODERNA 958509-1 Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
years Threatening
3430 TREMOR MODERNA 926787-1
were made.
50-59 Life
3431 TREMOR MODERNA 929418-1 Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
years Threatening
3432 TREMOR MODERNA Death 950073-1
30-39 Life
3433 TREMOR PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
40-49 Life
3434 TREMOR PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
40-49 Life
3435 TREMOR PFIZER\BIONTECH 932420-1 morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx
years Threatening
3436 TREMOR PFIZER\BIONTECH 952803-1
3437 TREMOR PFIZER\BIONTECH 905544-1
50-59 Life
3438 TREMOR PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
3439 TREMOR PFIZER\BIONTECH Death 942085-1
60-64
3440 TREMOR PFIZER\BIONTECH Death 958322-1 Shaking and then became unresponsive
years
65+
3441 TREMOR PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
years
3442 TREMOR PFIZER\BIONTECH Unknown Death 944155-1
Vaccine Event
TREPONEMA TEST 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
encephalopathy."
50-59 Life
3444 TROPONIN MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
3445 TROPONIN MODERNA 917784-1
3446 TROPONIN PFIZER\BIONTECH 947687-1
3447 TROPONIN PFIZER\BIONTECH Death 928062-1
40-49 Life
3448 TROPONIN I INCREASED PFIZER\BIONTECH 949611-1 Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed
years Threatening
30-39 Life
3449 TROPONIN I NORMAL MODERNA 916538-1 contacted and transported to the emergency room. She arrived at the ER, was monitored for 2 hours, was started on pepcid and
years Threatening
18-29 Life
3450 TROPONIN INCREASED MODERNA 917835-1 and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on
years Threatening
3451 TROPONIN INCREASED MODERNA 952782-1
3452 TROPONIN INCREASED MODERNA 954442-1
65+ Life
3453 TROPONIN INCREASED MODERNA 916497-1 sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying emotional or physical
years Threatening
65+ Life
3454 TROPONIN INCREASED MODERNA 924201-1 back pain, presented to Med Center where he was found to have an Acute Coronary Syndrome. Transferred to Medical Center
years Threatening
3455 TROPONIN INCREASED PFIZER\BIONTECH 937932-1
up.
50-59 Life
3456 TROPONIN INCREASED PFIZER\BIONTECH 909130-1 Acute NSTEMI with symptom onset 4 days after vaccination
years Threatening
50-59 Life
3457 TROPONIN INCREASED PFIZER\BIONTECH 914798-1 she was given Morphine, Oxygen, Nitroglycerine and Aspirin. IM had an EKG which showed Sinus Bradycardia with a Right
years Threatening
3458 TROPONIN INCREASED PFIZER\BIONTECH Death 951101-1
3459 TROPONIN INCREASED PFIZER\BIONTECH Death 959179-1
65+
3460 TROPONIN INCREASED PFIZER\BIONTECH Death 961010-1 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro
years
30-39 Life
3461 TROPONIN NORMAL MODERNA 919604-1 continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She
years Threatening
Racepinephrine x 1.
3462 TROPONIN NORMAL MODERNA Death 957799-1
years resuscitated
40-49 Life
3463 TROPONIN NORMAL PFIZER\BIONTECH 914730-1 admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-
years Threatening
3464 TROPONIN T INCREASED PFIZER\BIONTECH 919087-1
60-64 Life
3465 TROPONIN T INCREASED PFIZER\BIONTECH 931417-1 that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the
years Threatening
3466 TROPONIN T NORMAL PFIZER\BIONTECH 903123-1
ULTRASOUND ANTENATAL 40-49 Life
SCREEN NORMAL years Threatening
Vaccine Event
3468 ULTRASOUND DOPPLER PFIZER\BIONTECH 959401-1
ULTRASOUND DOPPLER 40-49 Life respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed
3469 MODERNA 946978-1
ABNORMAL years Threatening multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered
50-59 Life
3470 ULTRASOUND JOINT PFIZER\BIONTECH 934676-1 Chills Hip pain
years Threatening
40-49 Life
3471 ULTRASOUND SCAN MODERNA 954804-1 warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in
years Threatening
the hospital now.
60-64 Life
3472 ULTRASOUND SCAN MODERNA 952677-1 and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for
years Threatening
2/5/2021 at 7:15am
ULTRASOUND SCAN 30-39 Life
ULTRASOUND SCAN 40-49 Life
3474 PFIZER\BIONTECH 956642-1 Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now
65+ Life
3475 UNEVALUABLE EVENT MODERNA 957091-1 COVID-19 Vaccine
years Threatening
UNRESPONSIVE TO 18-29 Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive
STIMULI years and subsequently expired at home on 1/11/21.
UNRESPONSIVE TO 18-29 Life was laying on the floor when i arrived. Patient reported she felt like she was ""floating"" and she did not want to ""fall"". She was
3477 MODERNA 912930-1
STIMULI years Threatening also nausea and wanted to vomit and did not end up vomiting anything up. Patient fainted several more times. Her BP was
UNRESPONSIVE TO 50-59
3478 MODERNA Death 959001-1 back to bed. When staff went to wake patient apx 0530, he was unresponsive and had no pulse. Chest compressions were
STIMULI years
UNRESPONSIVE TO 50-59 Life Pt found unresponsive at home, respiratory distress. Had reported nausea and vointing for two days prior to admit which started
3479 MODERNA 958235-1
STIMULI years Threatening 1/15. Acute metabolic encephalopathy and acute renal failure Currently at time of this report still in critical care
3480 MODERNA Death 918065-1 1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm
STIMULI years
UNRESPONSIVE TO 60-64 Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and
STIMULI years started CPR. 911 arrived and pronounced resident dead at 1:01 am.
UNRESPONSIVE TO 60-64 Life
3482 MODERNA 934156-1 01/08/21 at SPO@ less then 60% on room air, non responsive to verbal tactile stimuli. Responsive to sternal rub only. Was sent
UNRESPONSIVE TO 65+
3483 MODERNA Death 909095-1 medication for his legs at 250PM. At 255AM on 12/25/2020 the resident was observed in bed lying still, pale, eyes half open and
STIMULI years
UNRESPONSIVE TO 65+
3484 MODERNA Death 921572-1 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again.
STIMULI years
UNRESPONSIVE TO 65+ This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER,
STIMULI years CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the
UNRESPONSIVE TO 65+ breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse
STIMULI years was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple
UNRESPONSIVE TO 65+
3487 MODERNA Death 934050-1 they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of
STIMULI years
requested.
UNRESPONSIVE TO 65+
3488 MODERNA Death 934539-1 approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January
STIMULI years
9, 2021
UNRESPONSIVE TO 65+
3489 MODERNA Death 935350-1 Patient was found unresponsive at home with SpO2 20% 1/2/2021
STIMULI years
UNRESPONSIVE TO 65+ RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM, RESIDENT FOUND UNRESPONSIVE
STIMULI years ON 01/05/2021.
UNRESPONSIVE TO 65+
3491 MODERNA Death 941607-1 vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went
STIMULI years
UNRESPONSIVE TO 65+
3492 MODERNA Death 944732-1 Resident found unresponsive and without pulse at 05:45am.
STIMULI years
UNRESPONSIVE TO 65+
3493 MODERNA Death 953129-1 stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went
STIMULI years
UNRESPONSIVE TO 65+
3494 MODERNA Death 956811-1 resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm
STIMULI years
1/18/21
UNRESPONSIVE TO 65+
3495 MODERNA Death 958745-1 Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found
STIMULI years
UNRESPONSIVE TO 65+
3496 MODERNA Death 959568-1 Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by
STIMULI years
3497 PFIZER\BIONTECH Death 943397-1 was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was
STIMULI years
UNRESPONSIVE TO 50-59 The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services
STIMULI years were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to
Vaccine Event
3499 PFIZER\BIONTECH Death 944595-1 and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the
STIMULI years
UNRESPONSIVE TO 50-59 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT
STIMULI years 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode
UNRESPONSIVE TO 50-59 Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD
STIMULI years and EMS arrived, resident pronounced at 12:51am.
UNRESPONSIVE TO 50-59 Life diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to
STIMULI years Threatening provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to
encephalopathy."
UNRESPONSIVE TO 60-64 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary
STIMULI years physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At
STIMULI years
testing.
3505 PFIZER\BIONTECH Death 958322-1 Shaking and then became unresponsive
STIMULI years
UNRESPONSIVE TO 60-64 Life
status
UNRESPONSIVE TO 65+
3507 PFIZER\BIONTECH Death 915682-1 contacted. Upon EMS arrival at facility, resident went into cardiac arrest, code initiated by EMS and transported to hospital.
STIMULI years
UNRESPONSIVE TO 65+
3508 PFIZER\BIONTECH Death 918388-1 Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
STIMULI years
UNRESPONSIVE TO 65+ nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's
STIMULI years COVID-19 specimen collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to the room to check on
UNRESPONSIVE TO 65+
3510 PFIZER\BIONTECH Death 926269-1 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first
STIMULI years
UNRESPONSIVE TO 65+
STIMULI years
UNRESPONSIVE TO 65+ little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient
STIMULI years was found unresponsive and pronounced dead later that day.
UNRESPONSIVE TO 65+ 95% (trach w/O2). At 11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test
STIMULI years and assessment (the facility is experiencing an outbreak), and found the patient unresponsive on the bathroom floor. CPR was
UNRESPONSIVE TO 65+
3514 PFIZER\BIONTECH Death 945253-1 asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient
STIMULI years
UNRESPONSIVE TO 65+ "The patient stated "" I just feel Blah"". vital signs obtained. 156/75 p-84 spo2 94% via NC 2L. T-96.7, c/o feeling restless, c/o
STIMULI years nausea with no vomiting. Patient observed at 0600 nonresponsive, CPR initiated, and EMS notified Patient expired"
UNRESPONSIVE TO 65+
3516 PFIZER\BIONTECH Death 949657-1 Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired
STIMULI years
UNRESPONSIVE TO 65+
STIMULI years
soon as discovered.
UNRESPONSIVE TO 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
STIMULI years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
UNRESPONSIVE TO 65+
STIMULI years
UNRESPONSIVE TO 65+
3520 PFIZER\BIONTECH Death 955390-1 January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away
STIMULI years
later that day.
UNRESPONSIVE TO 65+ Systemic: Pt monitored by nursing for 30min after inj,pt was stable/no reaction.At ~1hr post inj pt was unresponsive.Pt was a
STIMULI years hospice/dnr per director
At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team
would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can
help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and
maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and
proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the
day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop
occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in
and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a
thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we
got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the
patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes
ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and
had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I
UNRESPONSIVE TO 65+ then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all
STIMULI years the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for
Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was
monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to
announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After
speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the
vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing
her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to
vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At
approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually
not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021,
they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the
consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating
state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the
clinic.
UNRESPONSIVE TO 65+
3523 PFIZER\BIONTECH Death 961741-1 Theápatientáreceivedáhisávaccineáináthe.ámorningáofá1/20/2021,áwhileágettingáintoácarátoágoáseeáhisápulmonologist,áaboutá2áhoursáafter,áco
STIMULI years
Vaccine Event
UNRESPONSIVE TO 65+
3524 PFIZER\BIONTECH Death 961776-1 appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08:
STIMULI years
UNRESPONSIVE TO 65+ ""dissipated after a few minutes"" followed by a headache which ""dissipated after a few minutes"" as well. Then patient
STIMULI years complained of nausea, no vomiting and ""couldn't relax."" Per wife, from around 1400/1500, patient stayed on his recliner while
UNRESPONSIVE TO 65+ Life
3526 PFIZER\BIONTECH 924658-1 Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.
UNRESPONSIVE TO 65+ Life Congestion Shortness of breath Tachycardia Transferred out 911. Per hospital, patient had a myocardial infarction, is
STIMULI years Threatening unresponsive, and on hospice services.
UNRESPONSIVE TO 65+ Life of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and
STIMULI years Threatening white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low
she was dying as her blood pressure dropped to 70/40 and to come for a last visit; This is a spontaneous report from a
contactable consumer. A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. Medical history included COVID in
Dec2020, urinary tract infection (UTI), dehydration and Covid sickness (vomiting) (was treated earlier in month for UTI and
dehydration from the Covid sickness (vomiting)). Known allergies: no. The patient's concomitant medications were not reported.
After testing positive in mid December to COVID and being declared Covid free on 30Dec by the nursing staff and in good health,
with normal vitals and oxygen levels, the patient was given a vaccination on 02Jan2021. In the early evening the patient's blood
pressure dropped to 70/40 and the reporter was told to come for a last visit. The patient was sleeping comfortably. She did not
UNRESPONSIVE TO 65+ Life wake up when spoke with her. No one expected her to make it through the night. The next morning she work up, ate breakfast,
STIMULI years Threatening watched TV, got IVs and oxygen and her vitals improved significantly. Lab tests and procedures included blood pressure: 70/40
on 02Jan2021, oxygen levels: normal, COVID test: positive in Dec2020 (testing positive in mid December to COVID and being
declare Covid free on 30Dec), vitals: normal; improved significantly. Facility where the most recent COVID-19 vaccine was
administered: Nursing Home/Senior Living Facility. If the patient received any other vaccines within 4 weeks prior to the COVID
vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been
tested for COVID-19: No. AE resulted in: Life threatening illness (immediate risk of death from the event). Serious: Yes.
Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged
hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Information about lot/batch number has been requested.
UNRESPONSIVE TO
3530 PFIZER\BIONTECH Unknown Death 923219-1 death was unknown. It was reported that an autopsy would be performed in the next days; the results were not yet available. The
STIMULI
UNRESPONSIVE TO
STIMULI
hypoglycaem
UPPER
3532 GASTROINTESTINAL PFIZER\BIONTECH Death 961848-1
HAEMORRHAGE
3533 URINARY INCONTINENCE PFIZER\BIONTECH 953333-1
3534 URINARY RETENTION MODERNA 955565-1
URINARY TRACT 65+
INFECTION years
report
50-59 Life
3536 URINE ANALYSIS PFIZER\BIONTECH 923015-1 Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
years Threatening
65+
3537 URINE ANALYSIS PFIZER\BIONTECH Death 919108-1 Fever, Malaise
years
URINE ANALYSIS 65+
ABNORMAL years
report
3539 URINE ANALYSIS NORMAL PFIZER\BIONTECH 929689-1
cultures.
3540 URINE ANALYSIS NORMAL PFIZER\BIONTECH 953333-1
URINE LEUKOCYTE 50-59
ESTERASE POSITIVE years
URINE LEUKOCYTE 50-59 Life
ESTERASE POSITIVE years Threatening
3543 URINE OUTPUT DECREASED PFIZER\BIONTECH Death 963057-1
3544 UROSEPSIS PFIZER\BIONTECH 929689-1
cultures.
Vaccine Event
18-29 Life
3545 URTICARIA MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
3546 URTICARIA MODERNA 913445-1
18-29 Life
3547 URTICARIA MODERNA 930079-1 Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
years Threatening
18-29 Life
3548 URTICARIA MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
to local er.
30-39 Life
3551 URTICARIA MODERNA 952707-1 episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV,
years Threatening
40-49 Life
3552 URTICARIA MODERNA 933142-1 immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling,
years Threatening
dizziness.
18-29 Life
3553 URTICARIA PFIZER\BIONTECH 904334-1 Angioedema, hives, tachycardia, shortness of breath
years Threatening
3554 URTICARIA PFIZER\BIONTECH 944450-1
on monitor.
18-29 Life
3555 URTICARIA PFIZER\BIONTECH 954265-1 chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until
years Threatening
30-39 Life
3556 URTICARIA PFIZER\BIONTECH 904029-1 and Pepcid STAT. Rash/hives and SOB improved, but legs weakness/tingling, cramping did not and noted purple feet with
years Threatening
30-39 Life
3557 URTICARIA PFIZER\BIONTECH 916890-1 HIVES, SOB, THROAT CLOSING UP, WHEEZING
years Threatening
30-39 Life
3560 URTICARIA PFIZER\BIONTECH 955374-1 face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling
years Threatening
30-39 Life
3561 URTICARIA PFIZER\BIONTECH 955966-1 tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids,
years Threatening
40-49 Life
3562 URTICARIA PFIZER\BIONTECH 928209-1 Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
years Threatening
40-49 Life
3565 URTICARIA PFIZER\BIONTECH 938524-1 trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv
years Threatening
Vaccine Event
40-49 Life
3566 URTICARIA PFIZER\BIONTECH 942808-1 receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with
years Threatening
50-59 Life
3568 URTICARIA PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
50-59 Life
3569 URTICARIA PFIZER\BIONTECH 954723-1 itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
years Threatening
USE OF ACCESSORY 30-39 Life
3570 PFIZER\BIONTECH 935939-1 Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions,
RESPIRATORY MUSCLES years Threatening
VACCINATION 50-59 The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services
COMPLICATION years were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to
VACCINATION 65+
3572 PFIZER\BIONTECH Death 952704-1 diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse
COMPLICATION years
40-49 Life
3573 VAGINAL HAEMORRHAGE MODERNA 958885-1 immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and
years Threatening
40-49 Life
3574 VAGINAL HAEMORRHAGE PFIZER\BIONTECH 958755-1 that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently
years Threatening
3575 VASCULAR TEST MODERNA 955565-1
3576 VENOGRAM MODERNA 955565-1
3577 VENOUS STENT INSERTION MODERNA 955565-1
VENTRICULAR 60-64 Life
3578 MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
ARRHYTHMIA years Threatening
VENTRICULAR 30-39 Life PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath,
EXTRASYSTOLES years Threatening dizziness and blurry vision
VENTRICULAR 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
FIBRILLATION years continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He
VENTRICULAR 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
FIBRILLATION years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
Vaccine Event
VENTRICULAR 65+ Life
HYPOKINESIA years Threatening
VENTRICULAR 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
HYPOKINESIA years of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021.
VENTRICULAR 60-64 Life
3584 MODERNA 941834-1 fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of
VENTRICULAR 40-49 Life Ventricular tachycardia. Defibrillator paced me out of rhythm. I have had my ICD for 3 years. This is the first abnormal rhythm I
TACHYCARDIA years Threatening have had where it delivered a therapy to abort it.
18-29 Life
3586 VERTIGO MODERNA 944831-1 home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts
years Threatening
65+
3587 VIRAL TEST PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
65+
3588 VIRAL TEST NEGATIVE PFIZER\BIONTECH Death 949965-1 No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner
years
soon as discovered.
3589 VIRAL TEST NEGATIVE PFIZER\BIONTECH Unknown Death 934782-1 within 5 days of receiving Covid vaccine, had been on antibiotics for LRTI for 2 days and had appeared to be improving,
tract infection
3590 VISION BLURRED MODERNA 939216-1
30-39 Life
3591 VISION BLURRED PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
3592 VISION BLURRED PFIZER\BIONTECH 953888-1
3593 VISION BLURRED PFIZER\BIONTECH 952803-1
3594 VISUAL FIELD DEFECT PFIZER\BIONTECH 932366-1
30-39 Life
3595 VISUAL IMPAIRMENT MODERNA 912511-1 take zinc gluconate 50 mg last night and this morning. Has never taken zinc 50 mg, but has taken zinc as component of
years Threatening
40-49 Life
3596 VISUAL IMPAIRMENT PFIZER\BIONTECH 904260-1 became difficult to swallow and my tongue was feeling fat. A Rapid Response Team was alerted, they started and IV, and took
years Threatening
3597 VISUAL IMPAIRMENT PFIZER\BIONTECH 959746-1
VITAL FUNCTIONS 60-64 T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening.
ABNORMAL years Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T
VITAL FUNCTIONS 65+
ABNORMAL years
VITAL FUNCTIONS 65+ little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient
ABNORMAL years was found unresponsive and pronounced dead later that day.
VITAL FUNCTIONS 65+
ABNORMAL years
18-29 Life
3602 VOMITING MODERNA 909481-1 medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had
years Threatening
18-29 Life
3603 VOMITING MODERNA 946553-1 anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips
years Threatening
Vaccine Event
30-39 Life
3604 VOMITING MODERNA 929391-1 vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for
years Threatening
40-49 Life
3605 VOMITING MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
50-59 Life
3606 VOMITING MODERNA 951799-1 patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the
years Threatening
3607 VOMITING MODERNA 958235-1
60-64 Life
3608 VOMITING MODERNA 955968-1 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and
years Threatening
3609 VOMITING MODERNA Death 949474-1
3610 VOMITING MODERNA Death 954780-1
65+ Life
3611 VOMITING MODERNA 952235-1 nausea and vomiting possible cause of diabetic ketoacidosis and svt
years Threatening
65+ Life
3612 VOMITING MODERNA 956597-1 Pulmonary Edema, fever, nausea, vomiting
years Threatening
18-29 Life
3613 VOMITING PFIZER\BIONTECH 917712-1 nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under
years Threatening
quick and prepared.
18-29 Life
3614 VOMITING PFIZER\BIONTECH 936715-1 difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee
years Threatening
40-49 Life
3615 VOMITING PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
3616 VOMITING PFIZER\BIONTECH Death 934968-1
50-59 Life
3617 VOMITING PFIZER\BIONTECH 952483-1 went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement.
years Threatening
65+
3618 VOMITING PFIZER\BIONTECH Death 915562-1 staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night. Pt had
years
65+
3621 VOMITING PFIZER\BIONTECH Death 942290-1 resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the
years
65+
3622 VOMITING PFIZER\BIONTECH Death 943266-1 drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial
years
symptoms.
65+
3623 VOMITING PFIZER\BIONTECH Death 944998-1 On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.
years
3626 VOMITING PFIZER\BIONTECH 953333-1
Vaccine Event
3627 VOMITING PFIZER\BIONTECH Unknown Death 929016-1
3629 VOMITING PFIZER\BIONTECH Unknown Death 939332-1 deterioration (patient known to be declining); all from an unknown date and unknown if ongoing. Concomitant medications were
05Jan2021 at 12:51, the patient experienced vomiting (non-serious); 25 minutes post vaccine (had further vomiting episodes).
On 07Jan2021 at 01:00, the patient experienced death; which caused death, and was medically significant. The patient had not
Death: Death
Life
3631 VOMITING PFIZER\BIONTECH Unknown 959417-1 minutes later developed symptoms of chest tightness shortness of breath wheezing. Arrived to ED at 1156 and discharged at
Threatening
60-64 approximately 3 hours prior to expiring the patient was experiencing forceful emesis. later was found to have expired, patient
3632 VOMITING PROJECTILE PFIZER\BIONTECH Death 961705-1
years was comfort care only.
WEIGHT BEARING 30-39 Life
DIFFICULTY years Threatening
3634 WEIGHT DECREASED MODERNA Death 941561-1
40 year female received Pfizer-BioNTech COVID-19 Vaccine today Patient reported prior h/o severe allergic reaction to influenza
vaccine with eggs preservative. She has received flu vaccine w/o egg w/o problem. Due to her prior history of severe allergic
reaction/ anaphylaxis to another vaccine, in this case flu vaccine with eggs, we should proceed with caution. She was told we
40-49 Life could defer vaccination until more information becomes available. She opted to proceed with receiving Pfizer-BioNTech COVID-
3635 WHEELCHAIR USER PFIZER\BIONTECH 903132-1
years Threatening 19 Vaccine and be observed for 30 minute observation period. Patient developed throat tightening approximately 20 minutes
after vaccination. She received EpiPen within 1 minute of symptoms and was sent to ER immediately in wheelchair by nursing
staff. Patient was evaluated in ED and was hemodynamically stable. She was given IV benadryl and was stable throughout
observation
30-39 Life
3636 WHEEZING MODERNA 959996-1 nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in
years Threatening
3637 WHEEZING MODERNA 945596-1
40-49 Life
3638 WHEEZING MODERNA 956897-1 respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was
years Threatening
30-39 Life
3639 WHEEZING PFIZER\BIONTECH 915928-1 HCL 50 mg Sumatriptan 6mg , Discharge from ED at 1902 ----------------------------------------------------------------------------------------------------------------
years Threatening
------------------------------------------------------RN
30-39 Life
3640 WHEEZING PFIZER\BIONTECH 916890-1 HIVES, SOB, THROAT CLOSING UP, WHEEZING
years Threatening
3641 WHEEZING PFIZER\BIONTECH 934749-1
40-49 Life
3643 WHEEZING PFIZER\BIONTECH 908157-1 min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth. Sent to ER, received IM Epi, IV: Steroids,
years Threatening
Vaccine Event
40-49 Life
3644 WHEEZING PFIZER\BIONTECH 943220-1 developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and
years Threatening
50-59 Life
3645 WHEEZING PFIZER\BIONTECH 903400-1 saturation and a normal blood pressure. She had taken another dose of her EpiPen IM and diphenhydramine 50 mg by mouth
years Threatening
ACHES, SORE THROAT.
50-59 Life
3648 WHEEZING PFIZER\BIONTECH 936612-1 on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely
years Threatening
Life
3650 WHEEZING PFIZER\BIONTECH Unknown 959417-1 minutes later developed symptoms of chest tightness shortness of breath wheezing. Arrived to ED at 1156 and discharged at
Threatening
WHITE BLOOD CELL COUNT 50-59 Life
WHITE BLOOD CELL COUNT 60-64
DECREASED years
testing.
WHITE BLOOD CELL COUNT 18-29 Life Acute appendicitis, onset morning of 1/1/2021 (Reporting this because Pfizer covid vaccine had 3-4x higher risk of appendicitis,
3653 MODERNA 916710-1
INCREASED years Threatening although data not reported for Moderna covid vaccine)
WHITE BLOOD CELL COUNT 65+
INCREASED years
WHITE BLOOD CELL COUNT 65+ breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse
INCREASED years was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple
WHITE BLOOD CELL COUNT 65+ Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital
INCREASED years and treated for worsening AKI and hypotension.
WHITE BLOOD CELL COUNT 65+ Life stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose
3658 MODERNA 917784-1
INCREASED years Threatening Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and
WHITE BLOOD CELL COUNT 30-39 Life visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy)
Vaccine Event
WHITE BLOOD CELL COUNT 40-49 Life developed AF. He came to the hospital where he was tachycardia to 200 bpm and hypotensive to SBP70s. He received
INCREASED years Threatening aggressive fluid resuscitation (4L), IV metoprolol and was started on empiric Abx. Within several hours, the HR lowered, BP
3662 PFIZER\BIONTECH 923000-1 and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from
12/26/20-12/28/20.
WHITE BLOOD CELL COUNT 65+ CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A
INCREASED years STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE
WHITE BLOOD CELL COUNT 65+ suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF
WHITE BLOOD CELL COUNT 65+ Life Patient presented with signs and symptoms of sepsis, developing over 12 to 24 hours 6 days after vaccination. was hypotensive
WHITE BLOOD CELL COUNT 65+ Life patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was
INCREASED years Threatening hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.
Racepinephrine x 1.
WHITE BLOOD CELL COUNT 50-59
NORMAL years
WHITE BLOOD CELL COUNT 60-64 Life Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of
3672 MODERNA 958913-1
WHITE BLOOD CELL COUNT 65+ Life
WHITE BLOOD CELL COUNT 30-39 Life Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring. Released after about 4 hours and continue
WHITE BLOOD CELL COUNT 65+ medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and
WHITE BLOOD CELL COUNT 65+ issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees
NORMAL years and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-
WHITE BLOOD CELL COUNT 65+ Life Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for
NORMAL years Threatening hypertensive emergency Received surgical evacuation admitted in Intensive care,
WHITE BLOOD CELL COUNT
NORMAL
hypoglycaem
WHITE BLOOD CELLS URINE 50-59
POSITIVE years
WHITE BLOOD CELLS URINE 50-59 Life
WITHDRAWAL OF LIFE 50-59 placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine
SUPPORT years that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the
WITHDRAWAL OF LIFE 60-64 The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on
SUPPORT years 12/30/20. He had known cardiac disease.
50-59 Life
3683 X-RAY PFIZER\BIONTECH 959549-1 hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.
years Threatening
of the thrombosis.
Vaccine Event
3684 X-RAY ABNORMAL MODERNA Death 924664-1
65+
3685 X-RAY WITH CONTRAST MODERNA Death 930876-1 Death
years
Note: Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the
adverse event (possible side effect).
Notes:
Caveats: VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine
manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports
alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain
information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they
are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports
should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a
vaccine. As part of CDC and FDA's multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to
rapidly detect unusual or unexpected patterns of adverse events, also known as "safety signals." If a safety signal is found in
VAERS, further studies can be done in safety systems such as the CDC's Vaccine Safety Datalink (VSD) or the Clinical
Immunization Safety Assessment (CISA) project. These systems do not have the same limitations as VAERS, and can better
assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or
not they believe the vaccine was the cause.
Reports may include incomplete, inaccurate, coincidental and unverified information.
The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates
of problems associated with vaccines.
VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date for which data are
available.
VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other
scientific information.
Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers,
and Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the
total number of unique events. If percentages are shown, then the associated percentage of total unique event reports will
exceed 100% in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported,
because many reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report, then the percentage
of Symptoms to unique events is more than 100%. More information. (/wonder/help/vaers.html#Suppress)
Data contains VAERS reports processed as of the previous Friday. The VAERS data in WONDER are updated weekly, yet the
VAERS system receives continuous updates including revisions and new reports for preceding time periods. More information.
(/wonder/help/vaers.html#Reporting)
Values of Event Category field vary in their availability over time due to changes in the reporting form. The "Emergency
Room/Office Visit" value was avaliable only for events reported using the VAERS-1 form, active 07/01/1990 to 06/29/2017. The
"Congenital Anomaly/Birth Defect", "Emergency Room", and "Office Visit" values are available only for events reported using the
VAERS 2.0 form, active 06/30/2017 to present. These changes must be considered when evaluating count of events for these
categories.
Help: See The Vaccine Adverse Event Reporting System (VAERS) Documentation (/wonder/help/vaers.html) for more information.
Query Date: Feb 1, 2021 3:55:58 AM
Suggested Citation:
United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control
(CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - Previous Friday, CDC
WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on Feb 1, 2021 3:55:58 AM
Query Criteria:
Event Category: Death; Life Threatening
Vaccine Products: COVID19 VACCINE (COVID19)
VAERS ID: All
Group By: Symptoms; Vaccine Manufacturer; Age; Event Category; VAERS ID
Show Totals: False
Show Zero Values: Disabled

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The Vaccine Adverse Event Reporting System

Key considerations and limitations of VAERS data:

Query Date: Feb 1, 2021 3:55:58 AM

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