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What the CDC’s VAERS system is — and isn’t — good for

Experts say drawing a direct line between VAERS reports and vaccines mischaracterizes the database and what it’s designed to do. The reports contained in VAERS are open source, anecdotal and largely unverified, and while they may indicate symptoms that occurred post-vaccine, they do not link those symptoms to vaccines in any meaningful way...

VAERS is also not the be-all, end-all of vaccine safety monitoring in the U.S. There are other databases, including Vaccine Safety Datalink, which monitors electronic health records, and the FDA’s Sentinel program, which looks at insurance claims, that track these kinds of things, and that VAERS can be checked against.

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  VAERS

VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of US licensed vaccines.

 Unverified reports of vaccine side effects in VAERS aren’t the smoking guns portrayed by right-wing media outlets – they can offer insight into vaccine hesitancy

Because VAERS claims are self-reported, they tell us something about what ordinary people, as opposed to doctors and medical researchers, think about vaccine safety. In other words, people who feel that a vaccine is responsible for a side effect they might be experiencing can log that concern with the federal government, whether or not those claims would stand scrutiny in rigorous clinical testing.

Articles of Interest

Vaccine Safety Datalink (VSD)

The VSD has a long history of monitoring and evaluating the safety of vaccines. Since 1990, investigators from the VSD have published many studies to address vaccine safety concerns.

Anti-Vaxxers Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous

VAERS, a database of reports of vaccine side effects, is being abused by people trying to sow fear. It's not the first time.

Don’t Fall for the ‘VAERS Scare’ Tactic

Anti-vaxxers show how a precious vaccine adverse event reporting database can be used to scare the public.

Federal VAERS database is a critical tool for researchers, but a breeding ground for misinformation

For 30 years, VAERS has been critically important for the two health agencies and researchers to collect and analyze data on vaccine after-effects and to detect patterns that may warrant a closer look. But VAERS is unlike other official government data sources. Numbers from other agencies, like the Bureau of Labor Statistics or the Census Bureau, flow through consistent reporting channels and get screened by statisticians and analysts before they are made available to the public. VAERS, on the other hand, is an open-access system.

Healthcare Practitioner’s Vaccine Error Reporting Form

Use the form below to report an error or hazard to the ISMP National Vaccine Errors Reporting Program.

How the Vaccine Adverse Event Reporting System Works

VAERS operates as a passive reporting system, meaning that it relies on reporting from individuals to track adverse events that may be related to vaccines. These reports can come from anyone, including healthcare providers, vaccine manufacturers, vaccine recipients, and family members of individuals who have received vaccines. Because it is a passive reporting system, even those who are not vaccinated or who are opposed to vaccinations can submit reports, sometimes resulting in reports based on hearsay or intentionally false reports.

Top 6 Things to Know About VAERS

While VAERS is an extremely helpful tool used by experts to track adverse reactions and safety concerns associated with vaccinations (not just COVID-19, but all vaccines!), it is important to know a few things about the system before digging in too deeply. Scientists and health experts consider VARES to be a starting point in the search for rare but potentially serious vaccine side effects. It is by no means the only system in place to track this data.

What VAERS Is (And Isn’t)

The public database of reported post-vaccination health issues is often misused to sow misinformation.

Resources

Sentinel Initiative

Monitoring the safety of its regulated products is a major part of the FDA’s mission to protect public health. Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. In response to the FDA Amendments Act (FDAAA) of 2007, in May 2008 the FDA launched the Sentinel Initiative.