Source: VAERS.HHS.GOV

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. 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. In large part, 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 scientific 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 is 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.

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.

VAERS, The Database, The Export, and What’s Missing

Published on

29 August 2022

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For the purposes of clarity this article will use VAERS to describe the agency that collects the injury data (which is actually not an agency but more a collaborative project co-managed by CDC and FDA lacking a head or any clearly delineated structure), the Database as the repository for that data, and the Export as the data that the public has access to.

From the beginning of our work with the VAERS Export it was clear that these were files pushed from a larger and more complete Database. For example, when we analyzed the ‘VAERS_ID’s’ we could see that over 100,000 were missing from the Export. Additionally there have been times over the years where VAERS exported incorrectly, reports appeared and disappeared, sometimes within the space of an hour. We didn’t realize the extent of the missing information until an individual (who prefers to remain anonymous) brought to our attention the process of submitting a report. The screen shots they provided unintentionally highlighted all the data being collected that we did not see in the Export. The fields can also be seen in the downloadable PDF VAERS provides for making reports.

The Export does not contain the data collected by the Database on Race, Ethnicity, Pregnancy at time of vaccination, or Author. The live data on Wonder is also clearly not the full Database as it does not allow querying these fields, nor does it allow querying on other information like the ‘SPLTYPE’ which contains whether or not, for example, the report came from V-Safe (the new app set up for Covid injury tracking).

We know that VAERS is collecting the data. We know from the work of the CDC that they have access to and are viewing the data because they sometimes include race data in their reports — proof the data exists in a larger Database.[1, 2]

Finally, the article by Oster et al. [1] and the slide deck by John Su [2] give us a hint as to why the Race based data is being hidden. In both articles the reports of injuries to Black Americans and Asians is roughly equivalent. However, we learn from the CDC MMWR [3] that the rates of uptake of the COVID vaccine are very different. From Table 1 of the report, Blacks have 12.7% lower vaccination rates than whites and Asians have 10.6% higher vaccination rates. If that is the case then the overall rate of vaccine injury in the Black population is much higher than in the White or Asian population. This would be consistent with a large body of research that shows a different immune response by race (and sex) for some vaccines.[4-7] OpenVAERS calls upon the CDC to release all VAERS data to the public so that independent scholars can conduct their own research on race and sex effects from Covid-19 and other shots.

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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.

VAERS CDC Disclaimer

VAERS, The Database, The Export, and What’s Missing

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