Reporting Adverse Events
Why Adverse Events Should Be Reported
The Vaccine Adverse Event Reporting System (VAERS) is an early warning system that helps CDC and the Food and Drug Administration (FDA) monitor problems following vaccination. Because it is a passive surveillance system, VAERS relies on receiving reports from healthcare providers in the event that there are any health problems occur after vaccination.
What to Report
Healthcare providers are required by law to report:
- Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine
- Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination Cdc-pdf[PDF – 5 pages]External that occurs within the specified time period after vaccination
Healthcare providers are encouraged to report:
- 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
- Vaccine administration errors
How to Report an Adverse Event
There are three ways to submit a report to VAERS:
Complete a VAERS form online at: http://vaers.hhs.gov/
Fax a completed VAERS Form Cdc-pdf[PDF – 99 KB]External to (877) 721-0366.
Mail a completed VAERS Form Cdc-pdf[PDF – 99 KB]External to VAERS, P.O. Box 1100, Rockville, MD 20849-1100.
For More Information
Answers to common questions about VAERS can be found on the VAERS Frequently Asked QuestionsExternal page.