What is VAERS?

Established in 1990 as a joint venture between CDC and FDA , the Vaccine Adverse Event Reporting System (VAERS) serves as the nation’s early warning system to collect reports of adverse events after vaccination. VAERS depends on reports made by the public and health care providers. It provides scientists with valuable information to assess possible safety concerns related to vaccines.

What VAERS is NOT: While VAERS is a robust, nationwide reporting system, it is also subject to several important limitations. Because VAERS is not designed to assess cause and effect, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event (AE) or illness. Some reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they are subject to bias. Data from VAERS reports should be interpreted with these limitations in mind.

When to submit a report to VAERS:
Note: Knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) and punishable by fine and imprisonment.

• VAERS reporting required by law for COVID-19 vaccines:
  • Vaccine administration errors, whether or not associated with an adverse event (AE).
    • These may include variations related to site/route, age, formulation and dosage, storage and handling, and interval. See CDC’s COVID-19 Vaccine Administration Errors and Deviations document.
  • Serious adverse events (as defined by federal law), regardless of cause.
• VAERS reporting required by law for ALL vaccines:
  • Serious AEs regardless of cause, as defined by the FDA.
  • Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination.
  • An adverse event listed by the vaccine manufacturer as a contraindication to further doses of a specific vaccine.
• VAERS reporting is strongly encouraged for:
  • Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event.
  • All other vaccine administration errors.
• VAERS reporting can be done by anyone:
  • Vaccine providers, other health care professionals, local public health agencies, vaccine recipients, patients, and/or family members of people who have received a vaccine are encouraged to submit a VAERS report when an adverse event occurs after vaccination.
• Follow up by CDC and FDA:
  • Occasionally, these agencies contact the reporting person to request more information. VAERS is covered by HIPAA, so patient consent is not necessary to release the requested information to CDC or FDA.

Completion of the VAERS report does not require that all demographic information be completed. However, complete reports have become more important when COVID-19 vaccines are administered. This is due to COVID infections being reported at higher rates in people and communities of color. For information on health equity considerations, visit CDC’s webpage Health Equity Considerations and Racial and Ethnic Minority Groups.

Please review the brochure that includes 10 things health care providers need to know about the Vaccine Adverse Event Reporting System. For more information on VAERS or to make a report, visit vaers.hhs.gov.

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