Did the anonymous "whistleblower" in a July 19, 2021, lawsuit against the Secretary of Health and Human Services document her claim that 45,000 people died within three days of receiving a COVID vaccination? No, that's not true: It's her "opinion" that a five-fold multiplier of a list of unverified reports is warranted. The Food & Drug Administration (FDA) has repeatedly said that informal list of vaccine injury reports cannot be used to precisely tally vaccine effects. Declaring herself an expert in data analytics, the witness says -- without providing her statistical model -- that it is her opinion the number of deaths (about 9,000) reported to the Vaccine Adverse Event Reporting System (VAERS) should be multiplied by five. To access VAERS data, users must confirm that they understand the data is subject to several statistical limitations. This is because health issues and deaths that, chronologically, occur after vaccination may be caused by underlying illnesses or other factors unrelated to a vaccination, none of which is known until each report is authenticated and each cause of death is investigated.
The claim was being cited widely on social media, including in a video published on the 3AM Lowdown BitChute account on July 19, 2021, titled "45,000 dead from vaccination in 3 days, lawyer Thomas Renz sues federal government - [07/18/2021]" (archived here) which opened:
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45,000 dead from vaccination in 3 days, lawyer Thomas Renz sues federal government - [07/18/2021]
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The lawsuit by America's Frontline Doctors, an organization of anti-vaccine activists, describes the anonymous witness as follows:
Plaintiffs' expert Jane Doe45 is a computer programmer with subject matter expertise in the healthcare data analytics field ... In her expert opinion, VAERS under-reports deaths caused by the Vaccines by a conservative factor of at least 5.
A copy of the witness' statement, found online in pdf form, explains her opinion as follows:
I am a computer programmer with subject matter expertise in the healthcare data analytics field ... I earned a B.S. degree in Mathematics...It is my professional estimate that VAERS (the Vaccine Adverse Event Reporting System) database, while extremely useful, is under-reported by a conservative factor of at least 5 ... This would indicate the true number of vaccine-related deaths was at least 45,000.
The witness does not provide her analytical model and there are not 45,000 COVID vaccine death reports in the government vaccine safety system. She does not explain how or if she has adjusted for the multiple limitations on the accuracy and authenticity of VAERS data. And, she does not warn the court about the limitations the VAERS operators emphasize, which is that VAERS' mission is to collect a wide-open, likely repetitive, messy and incomplete list of anyone's anecdotal, amateur, professional and even malicious reports of post-vaccination problems. The VAERS site repeatedly notes the list cannot be used to determine causation of deaths or injuries. Even her starting-point number of 9,000 is only a tally of reports of people who got vaccinated against COVID and later died, regardless of what their health condition was or what they died of.
But in the video repeating the claim, Attorney Thomas Renz says, at the 2:50 mark:
We know, based on what she has said, that there have been at least 45,000 deaths from this vaccine.
Neither Renz nor his witness make it clear the VAERS list is not a precision instrument of measure. It is a warning system. Monitoring it, the FDA and the Centers for Disease Control and Prevention hope to spot patterns in the reports, which can be added to the list by anyone with an internet connection. A pattern is not itself evidence, since the reports that make up a pattern have to be checked for authenticity.
For instance, a March report to VAERS by a 59-year-old Michigan man mocked VAERS misusers by reporting marital strife as an adverse event, writing:
To demonstrate my point I am filling a report and the adverse event and outcome of receiving the covid vaccine was an extremely angry wife who thinks the vaccine is going to A kill me and B cause me to spread covid and C may result in divorce.
Even when an authentic post-vaccination health event is reported, the CDC and FDA have to then seek medical records and interview caregivers to find out if it was coincidental or vaccine-caused, which is why they caution against using VAERS data to declare causes of death or injury.
Prominent on the VAERS webpage is this disclaimer, to which Lead Stories has added underline emphasis to save readers time:
VAERS accepts reports of adverse events and reactions that occur following vaccination ... 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 ...
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 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.