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Pharmacovigilance Glossary

VAERS (Vaccine Adverse Event Reporting System)

What is it?

VAERS is the US national early-warning system for possible vaccine safety problems, jointly run by the CDC and FDA. Anyone, healthcare providers, manufacturers, or the public, can submit a report of a health event that occurred after vaccination, whether or not they believe the vaccine caused it.

That openness is deliberate. VAERS exists to generate hypotheses, catching a potential signal early enough to investigate it properly, not to serve as a confirmed record of vaccine-caused harm on its own.

Common Misconceptions

Myth

"If something is logged in VAERS as happening after a vaccine, doesn't that mean the vaccine caused it?"

Truth

No. Anyone can submit a VAERS report, and it's accepted regardless of how plausible the link is. Raw VAERS counts are a starting point for signal detection, exactly like any other spontaneous reporting database, not evidence of causation by themselves.