React19 Research: VAERS Audit

03 December 2022

November 29, 2022 React19, a patient advocacy organization representing more than 20,000 Covid vaccine-injured individuals, reviewed 126 VAERS report numbers filed by 103 independent Covid vaccine-injured individuals. We conducted this audit due to concerns raised by members that they never received permanent VAERS report Identification Numbers, they could not find their VAERS reports after published on the website, and/or their reports had been altered, combined with previous reports, or removed. The scope of the audit was to understand how CDC and FDA are following up with VAERS reports filed by those who continually suffer after their Covid vaccine injury. We recruited React19 members to the audit between October 17 and November 7, 2022. We advertised this through a support group. React19 individuals who agreed to the audit provided their name and report number(s). The audit (conducted by Alberto Benavides, Brianne Dressen, Joel Wallskog, MD, Linda Wastila, PhD) captured the following information: Temporary ID, Link to the live VAERS report, VAERS permanent ID, State, Age, Gender, Vaccination Date, Symptom on-set date, Date entered, date published, date deleted, and any commentary by injured who filed the report.

Our audit found the following:

Of 126 verified true VAERS reports of Covid-19 vaccine injury or death:

61% of the reports were logged and published in the VAERS system correctly (provided a permanent ID#);
22% of the reports do not have a permanent ID and, therefore, are not publicly visible;
12% of the reports have been outright deleted and, therefore, not publicly visible;
5% could not file a report or their report number remains unknown.

Medical status of the 15 deleted reports:

53% are Reports of Permanent Disability
27% are Reports of ER/Hospital
20% are “Other”

Medical status of the 79 reports currently visible in the VAERS system:

23% are Reports of Permanent Disability
38% are Reports of ER/Hospital Visits
39% are “Other”

Individuals who received only temporary IDs (their reports are not visible to the public) reported that they were not aware that their report was not officially in the system, nor were they aware VAERS would need to issue a 2^nd permanent ID. During the audit, these individuals were encouraged to call the VAERS office to inquire about the status of their report. Examples of the responses follow. Individuals whose reports were deleted called the VAERS office as well.

Sample responses of calls to the VAERS system:

Call log from individuals asking VAERS about their temporary reports:

"Basically, she didn't have an answer why some of us are stuck in temporary mode. She said when we filed originally, we should have gotten an email as an acknowledgment letter with a permanent ID. Seems it's up to us to know that, look out for the email and if we don't get one, we are to call them to figure it out. As of now she says two of my temp IDs will be merged into one and I should get an email from them in the next week that will have my permanent ID.”

“I called VAERS and they were cagey when I said I heard my report was deleted. After being placed on hold while she checked, I was told they had my info. Neither denied or confirmed my report was deleted. Told me they would contact me if they need anything. Basic response each time I dug for more details.”

Example of investigation of 2 reports, with one deleted:

Report 1 not updated: “I called, emailed, and faxed updates as they instructed when I repeatedly reached out to update the lot# and medical diagnostics. Nothing was ever updated. I tried every possible avenue even though my hands didn't work. Months later I got the standard automated updated request from them which I always filled out and again, no update to anything. I called again and they said you cannot update any reports at all ever, I must put in a new report.”

“Report 2 deleted: They instructed me to file this report when refusing to do updates to report #1. My report #2 has my medical proof of SFN (small fiber neuropathy), bilateral ulnar neuropathy on EMG, brain spots on MRI, and the lot #. The second report is clearly more important and shows specific medical findings. Yet they silently deleted it, and never updated the misleading and weak first report which was too early for diagnostics.”

Example of death report NOT listed as a death report: (2 reports filed)

- 1^st Report after HLH diagnosis classified as “life threatening” - 2^nd Report filed after his death classified as “hospitalized” Family called to request a correction to the 2^nd report to be fatality and was instructed to file another report, and was sent a form condolence letter from the CDC. (fatality was May 2021, form letter received December 2022. After their initial complaint inquiring about why his report is not indicated as a death, they subsequently received the following email:

"Good afternoon, Thank you for contacting the Vaccine Adverse Event Reporting System (VAERS) program. Thank you for taking the time to file the report. VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public. You can find the above information on our website at https://vaers.hhs.gov/data.html. Should you require assistance in the future please visit our website or contact us. Sincerely, VAERS Staff”

Example of death report not followed up on:

“My condolence letters from the cdc. Despite claims of safety monitoring they never contacted me, never asked for death certificate, autopsy report, medical records. They were not looking for any “signals”. I called several times to ask why no one had contacted me to investigate why a young healthy 34 year old passed 2 weeks after Pfizer vaccine and the only thing I got was those insulting letters.”

Summary

Our audit found that 1 in 3 reports are either not processed through the system for the public to review due to lack of assignment of a permanent ID and/or deletion after original publication. This lack of public visibility is psychologically hurtful and disrespectful to the injured and their families who filed the reports. A ratio of 1 in 3 reports not being visible to the public due to being deleted or incorrectly processed in the VAERS system is far above the margin of error anyone would expect. It also suggests problems of omission, data, and under-reporting of VAERS reports may be even greater than estimated.(1-3) In sum, our audit illustrates a wide-spread issue with reports not being processed by the CDC appropriately. The VAERS system insists they have the information for each report, but when asked they do not provide the information, only stating that they can see it on the private side and that it is combined with the original report. This makes it impossible for submitters to verify and/or validate their reports. The original report in public-facing VAERS does not reflect any updates given. This also illustrates the lack of transparency of the VAERS system, co-managed by the FDA and CDC.

We are requesting the immediate release of the non-public VAERS reports that the CDC has combined, and a comprehensive audit of the VAERS system by external reviewers.

We also request answers to the following questions:

How many VAERS reports have been “combined” in the non-public facing VAERS system?
How many VAERS reports have been deleted?
1. What are the criteria for VAERS reports to be deleted?
Why are follow-up reports with more specific findings and specific diagnoses and more likely to show permanent disability NOT visible to the public, despite the CDC’s encouragement that individuals file these subsequent reports whenever possible?
How many of these follow-up reports with more specific findings and diagnoses are only visible internally and not to the public?
Why is there an existence of a public VAERS system and a non-public VAERS system?
What communication is provided to the individual who filed the report when their VAERS report is deleted or not given a permanent ID designation?

References

Rose J. Critical appraisal of VAERS pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a functioning pharmacovigilance system? Science, Public Health Policy, and the Law. October 2021;3:100-129. https://61ee839e4c3e409708bac62c--i-do-not-consent.netlify.app/media/Pharmacovigilance%20VAERS%20paper%20FINAL_OCT_1_2021.pdf
Kirsch S, Rose J, Crawford M. Estimating the number of COVID vaccine deaths in America. https://www.skirsch.com/covid/Deaths.pdf
OpenVaers Newsletter. How to calculate the URF in V-Safe and VAERS. November 15, 2022. https://openvaers.com/faq/how-to-calculate-the-urf-using-v-safe-and-vaers

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