VAERS is the nation's early warning system that monitors the safety of vaccines after they are authorized or licensed for use by the U.S. Food and Drug Administration (FDA). VAERS is part of the larger vaccine safety system in the United States that helps make sure vaccines are safe. The system is co-managed by CDC and FDA.
VAERS accepts and analyzes reports of possible health problems- also called "adverse events"- after vaccination. As an early warning system, VAERS cannot prove that vaccine caused a problem. Specifically, a report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed.
Anyone can submit a report to VAERS- healthcare professionals, vaccine manufacturers, and the general public. VAERS welcomes all reports, regardless of seriousness, and regardless of how likely the vaccine may have been to have caused the adverse event.