Communicable Disease Service

The Vaccine Adverse Event Reporting System (VAERS) is a national program managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) to monitor the safety of all vaccines licensed in the United States. VAERS collects and reviews reports of adverse events that occur after vaccination. An “adverse event” is any health problem or “side effect” that happens after a vaccination. VAERS cannot determine if a vaccine caused an adverse event but can determine if further investigation is needed.

Anyone can submit a report to VAERS, including patients, family members, health care providers, vaccine manufacturers and the general public. CDC and FDA encourage anyone who experiences an adverse event after receiving a vaccine to report to VAERS.

Any clinically significant adverse event occurring after administration of any vaccine licensed in the U.S. should be reported. The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine or any adverse event listed in the Reportable Event Table. Health care providers also are encouraged to report any clinically significant adverse event that occurs in a patient following a vaccination, even if they are unsure whether a vaccine caused the event.

Specific to COVID-19 vaccination, providers are required to report the following adverse events to VAERS:

• Vaccine administration errors (whether associated with an adverse event or not)
• Serious adverse events
• Cases of multisystem inflammatory syndrome
• Cases of COVID-19 that result in hospitalization or death after the recipient has received COVID-19 vaccine

Healthcare providers are encouraged to report any clinically significant adverse events that occur after vaccination.