Understanding the Vaccine Adverse Event Reporting System (VAERS)

This a document that I participated in developing as a briefing document for the Idaho Legislature from the IMA’s Public Health Committee. Dr. Laura McGeorge from St. Luke’s was the lead author. I thought this would be of interest for followers of my blog.
• The Vaccine Adverse Event Reporting System (VAERS) was developed by the Food and Drug
Administration (FDA) and Centers for Disease Control and Prevention (CDC) in 1990.
• VAERS was developed to get post-vaccine data from across the country to monitor for rare
safety concerns. More common safety concerns are found in clinical trials. However, if a trial
studies 40,000 vaccine doses, for example, and a safety event occurs once every 100,000 doses,
then the event may not occur in the study. Thus, VAERS allows for continued safety oversight of
any vaccine.
• Post-vaccine information may be entered in the VAERS national repository by anyone, including
health care providers, vaccine manufacturers, patients, and their families.
• Often the information entered is incomplete and is usually not validated. Vaccine safety experts
validate the data when there is a serious event reported. To validate the information, the expert
must obtain the medical records and review them to see if the event was likely caused by the
vaccine or an unrelated event.
o For example, if a reported death was from an allergic reaction immediately after
vaccination, that death would be determined to be caused by the vaccine. If the death
was from a car accident following the vaccine, that death would not be attributed to the
vaccine. If a death were from a heart attack, that would be noted for further analysis.
• A common misconception about VAERS is that the high number of reported deaths were caused
by vaccines. Keep in mind that given the U.S. population of 330 million people, thousands of
people are born each day and thousands die every day. In 2017, prior to the pandemic, on
average 7,708 American deaths occurred every day.
• For deaths among those who received the COVID-19 vaccine, it is important to note that those
people tended to be older and were disproportionately people with underlying medical
conditions and their deaths were statistically likely whether vaccinated or not.
• The number of deaths reported to VAERS is less than the number expected and the FDA and
CDC’s review of these deaths has determined that almost all these deaths were unrelated to
COVID-19 vaccines.
• 496 million doses of COVID-19 vaccines were administered in the United States from December
14, 2020, through December 20, 2021. During this time, VAERS received 10,688 reports of death
(0.0022%) among people who received a COVID-19 vaccine.
• In reviewing data from over ten million people, comparing vaccinated versus unvaccinated
mortality rates, those vaccinated had about 30% the mortality rate of those that were
unvaccinated.
Today, the FDA and CDC use several tools to evaluate vaccine safety. VAERS is just one of the tools. The
CDC does not just depend on VAERS to monitor for vaccine safety. V-safe is a new smartphone-based
voluntary health check tool. The v-safe program now also has a pregnancy monitoring registry. In
addition, the Vaccine Safety Datalink has been in place since 1990 and is a collaboration between the
CDC and nine large health care organizations. The CISA project is a collaboration between the CDC and
seven medical research centers.

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