Case Investigation Form

(for COVID-19 Vaccine AEFI)

Philippine Integrated Disease Version 2021.03.04
Surveillance and Response 1/4
Name of Disease Reporting Unit: Type: ¨RHU ¨CHO ¨Gov’t Hospital ¨Private Hospital ¨Clinic
Address: ¨Gov’t Laboratory ¨Private Laboratory ¨Airport/Seaport
I. PATIENT Initials Patient’s First Name Middle Name Last Name
INFORMATION
Complete Address: Region Province City/Municipality HOUSE/BLK/LOT/APT # PUROK/BRGY/SUBD. Inter-Local Health Zone

Sex: Date of Birth: MM/DD/YYYY Age in years: Height: Weight: Date Admitted/ MM /DD /YYYY
¨ Male Seen/Consult :
¨ Female
__ __ / __ __/ __ __ __ __ ______cm ______kg
¨ Pregnant
¨ Lactating

Name of hospital/health facility: Address : Admitted?

¨ Yes ¨ No ¨ Unknown
Date onset of AEFI/ MM/ DD/ YYYY TIME (hh:min)
Date next higher Date of
present illness __ __ / __ __/ __ __ __ __ __ __ :__ __ __ __ / __ __/ __ __ __ __ Investigation __ __ / __ __/ __ __ __ __
AM / PM level notified
Name & Designa- Contact #/email:
Institution:
tion of Reporter
Name & Contact #/email:
Designation of Institution:
Investigator
II. VACCINE ADMINISTERED

Name of Date of Time of Dose Brand Name Expiry

Site of Batch/ Name of Profession of
Vaccine/s Vaccinati Vaccinati No. and Name of
Injection Lot No. Date Vaccinator Vaccinator
(Please indicate on on (e.g.1st, (Indicate Manufacturer
Generic and Brand 2nd, 3rd) left or right)
Name)

Date of Time of Batch/Lot

Diluent Expiry Date Name of Vaccinator
Reconstitution Reconstitution No.

Vaccination Center/Facility:
Vaccination Session: ¨ Routine session ¨ Clinic ¨ Mass Campaign ¨ School – based ¨ Others, ____________________________

III. TYPE OF AEFI:

* Adverse event(s): check as appropriate

Abdominal Pain Joint Pain ¨ Anaphylaxis ¨ Severe local reaction

Body Malaise Local site pain ¨ Injection site abscess  Pain, redness and/or swelling of >3 days
Colds Loss of appetite ¨ Seizures  swelling beyond nearest joint
Cough Muscle Pain febrile
Diarrhea Nausea / Vomiting afebrile
Fainting Numbness
¨ Sepsis
Fatigue Rash / Itch
¨ Encephalopathy
Fever Redness
¨ Thrombocytopenia
Headache Retroorbital Pain
¨ Toxic shock syndrome
Swelling
¨ Fever >38oC
Other (specify) .......................................
Date & Time AEFI started (MM/DD/YYYY):

__ __ / __ __/ __ __ __ __ __ __ : __ __ AM / PM

Serious: ○ Yes ○ No; If Yes ¨ Death ¨ Life Threatening ¨ Disability ¨ Hospitalization  Congenital anomaly
 Other important medical event (Specify ______________________________________)
Current Status: ¨ Currently under treatment in facility ¨ Treated and sent home
For Serious AEFIs, notify immediately the Local Epidemiology Surveillance Unit (ESU), Regional ESU, and Epidemiology Bureau.
For Serious AEFIs, please fill up pages 2 to 4. For Non-serious AEFIs, page 1 is enough.
Version 2021.03.04

AEFI Case Investigation Form 2/4

IV. EXAMINATION** DETAILS

Source of Information ¨ Attending physician ¨ Nurse ¨ Midwife ¨ Parent/Guardian ¨ Other

Mode of examination ¨ Interview ¨ Medical records ¨ Physical Examination ¨ Verbal autopsy ¨ Laboratory Result
¨ Other
If from Verbal autopsy, please mention the source:

Name & Designation of person who first examined the patient: Date & time:

__ __ / __ __/ __ __ __ __ __ __ :__ __:__ __

Name & Designation of other person/s who treated the patient: Date & time:
__ __ / __ __/ __ __ __ __ __ __ :__ __:__ __
Other sources who provided information (specify):

Signs & Symptoms in Chronological Order:

Name & Designation of person completing these clinical details: Contact Information: Date & time:
__ __ / __ __/ __ __ __ __ __ __ :__ __:__ __

**Instructions – Attach copies of ALL available documents (including case sheet, health screening form, discharge summary, case notes, lab and autopsy
reports, prescriptions for concomitant medication) and then complete additional information NOT AVAILABLE in existing documents.
If patient has taken medical care - Attach copies of all available documents (including case sheet, discharge summary, laboratory reports and post mortem
reports - if available) and write only information unavailable in the attached documents below.
If patient has not taken medical care – obtain history, examine the patient and write down your findings below (use additional sheets if necessary)

Working/Final Diagnosis:

Condition at Investigation: ¨ Alive : ○ Recovering ○ Fully recovered ○With Permanent Disability, Specify: _____________________
¨ Died, Date: __ __ / __ __/ __ __ __ __
V. Relevant patient information prior to immunization YES/NO Remarks
Past history of similar event?
Adverse event after previous vaccination(s)?

History of allergy (ex. Vaccine, drug, or food)

Pre-existing comorbidity / illness / congenital disorder

Has the patient tested COVID-19 positive prior to vaccination?

History of hospitalization in last 30 days (indicate the cause)

Recent history of trauma (indicate date, time and site)

For adult women

Currently pregnant? (If YES, indicate AOG)
Currently breastfeeding ?

Was the patient on any concurrent medication for any illness?

(If YES, indicate name of drug, indication, doses & date in the remarks)

Family History of similar event

Did the patient receive any previous vaccination and experienced the similar event? ¨ NO ¨YES (If YES, complete the table below)

Vaccine Date of Vaccination Time of Vaccination Batch / Lot No. Brand Name and Expiry Date Name of Vaccinator
Name of
Manufacturer
Version 2021.03.04
AEFI Case Investigation Form 3/4

VI. IMMUNIZATION PRACTICES

(Fill up this section by asking and observing immunization practices at the place (s) where concerned vaccine was used)
Syringes and Needles Used YES/NO/NA* Remarks
Are auto-disable syringes used for immunization?

If NO, specify the type: ¨ Glass ¨ Disposable ¨ Recycled disposable ¨ Pre-filled syringes ¨ Other
Specific key findings/additional observations and comments:

Reconstitution procedure (complete only if applicable) * Not applicable

Same reconstitution syringe used for multiple vials of same vaccine?
Same reconstitution syringe used for reconstituting different vaccines?
Separate reconstitution syringe for each vaccine vial?
Separate reconstitution syringe for each vaccination?
Are the vaccines and diluents used as recommended by the manufacturer
Specific key findings/additional observations and comments:

Injection technique of vaccinator (s): (Observe another session in the same locality –same or different place)
Correct dose and route?
Time of reconstitution mentioned on the vial (in case of freeze dried vaccines)?
Non-touch technique followed?
Contraindication screened prior to vaccination?
How many AEFI reported from the center that distributed the vaccine in the last 30 days?
Training received by the vaccinator: (Title) If YES, specify date of last training
__ __ / __ __/ __ __ __ __
Specific key findings/additional observations and comments:

VII. COLD CHAIN AND TRANSPORT (Fill up this section by asking and observing practice)
Last vaccine storage point: YES/NO Remarks
Type of vaccine storage: ¨Freezer ¨ Refrigerator ¨ Dry Store ¨ Other, specify: __________________________
Temperature: Body of refrigerator _______ ⁰C Freezer: _______⁰C

Correct procedure of storing vaccines, diluents and syringes followed?

Any other item (other than vaccines and diluents) in the refrigerator or freezer?

Partially used reconstituted vaccines in the refrigerator?

Unusable vaccines in the refrigerator?
If YES, check all that apply: ¨ expired ¨ no label ¨ VVM Stage 3/4 ¨ Frozen
Unusable diluents in the storage area?
If YES, check all that apply: ¨ expired ¨ manufacturer not matched ¨ cracked ¨ dirty ampule
Specific key findings/additional observations and comments:

Vaccine transportation:
Vaccine carrier used: ¨ Polyurethane Foam Insulation ¨ Insulated Plastic Container ¨ Styrofoam ¨ Other, specify
Vaccine carrier sent to the site on the same day of vaccination?
Vaccination carrier returned from the site on the same day of vaccination?
Condition of the vaccine carrier: Was ice-pack used?
Specific key findings/additional observations and comments:
Version 2021.03.04
AEFI Case Investigation Form 4/4

VIII.VACCINE DETAILS (Indicate vaccines provided at the site linked to AEFI on the corresponding day)
Number of recipients Vaccine
immunized for each
antigen at the session Given
site. Attach record if
available Total Doses
Given
NOTE: Provide explanation for each YES answers on the following: YES/NO/#

a) When was the patient immunized? (Tick box below)

Within the first vaccinations of the session ¨ Within the last vaccinations of the session ¨ Unknown

Within the first few doses of the vial administered ¨ Within the last doses of the vial administered ¨ Unknown

b) Was the recommendation for use of this vaccine not followed?

c) Based on the investigation, does the vaccine (ingredients) administered could have been unsterile?
d) Based on the investigation, does the vaccine's physical condition (e.g. color, turbidity, foreign substances etc.) was
abnormal at the time of administration?
e) Based on the investigation was there an error in vaccine reconstitution/preparation by the vaccinator (e.g., wrong
product, wrong diluent, improper mixing, improper syringe filling etc.)?
f) Based on the investigation, was there an error in vaccine handling? (e.g. Break in cold chain during transport
storage and/or immunization session etc.)?

g) Based on the investigation, was the vaccine administered incorrectly (e.g. wrong dose, site or route of
administration, wrong needle size, not following good injection practice etc.)?
h) Number of OTHER recipients immunized from the concerned vaccine vial/ampule
i) Number of OTHER recipients immunized with the concerned vaccine in the same session:
j) Number of OTHER recipients immunized with the concerned vaccine having the same batch number in other
locations: _________________ Specify locations: _________________________________________________
k) Is it possible for the vaccine given to this patient have a quality defect or is substandard or falsified?

l) Is it possible for this event be a stress response related to immunization (e.g. acute stress response,
vasovagal reaction, hyperventilation, dissociative neurological symptom reaction etc.)?
m) Is this case a part of a cluster?
If yes, how many other cases have been detected in the cluster?
a. Did all the cases in the cluster receive vaccine from the same vial?

b. If no, number of vials used in the cluster (enter details separately)

IX. COMMUNITY INVESTIGATION

Any known similar events reported recently in the locality/community? YES NO UNKNOWN
a. If YES, Describe: ___________________________________________________________________________________
b. How many events/episodes? __________________________________________________________________________
Of those affected, how many are: Vaccinated _______ Not vaccinated _______ ¨Unknown
Other significant findings in the community

X. CAUSALITY ASSESSMENT ¨ NAEFIC ¨ RAEFIC Date Classified: __ __ / __ __/ __ __ __ __

¨ [A1] Vaccine product-related reaction ¨ [A4] Immunization anxiety-related reaction

¨ [A2] Vaccine quality defect-related reaction ¨ [B1] Consistent temporal relationship but insufficient
¨ [A3] Immunization error-related reaction ¨ [B2] Conflicting trends of consistency and
¨ error in vaccine handling inconsistency with causality
¨ error in vaccine prescribing or non-adherence ¨ [C1] Co-incidental - Underlying emerging condition(s)
to recommendations for use or exposure to external factors/something other
¨ error in administration than vaccine
¨ Other, specify: ______ ¨ [D] Unclassifiable/Inadequate information