Reporting Adverse Events Following Vaccination

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 health problems that may occur following vaccination. VAERS is a passive surveillance system, and relies on people sending in reports of their experiences.  As the frontline system for vaccine safety monitoring, VAERS depends on healthcare professionals to report any health problems of clinical significance that may occur after vaccination.

What to Report

Healthcare providers are required by law to report to VAERS:

• Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination  pdf icon[PDF – 5 pages]external icon that occurs within the specified time period after vaccination
• Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine

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

Online reporting is strongly encouraged. Please report clinically important adverse events that occur after vaccination of adults or children, even if you are not sure whether the vaccine caused the adverse event.

VAERS accepts all reports, including reports of vaccination errors. Guidance on reporting vaccination errorsexternal icon is available if you have additional questions.

How to Report an Adverse Event

There are 2 ways to submit a report to VAERS:

Option 1: Submit a VAERS Report onlineexternal icon (Preferred)
The online VAERS Report must be completed and submitted in the same session; it cannot be saved and edited at a later time.
Note: sessions time out after 20 minutes of inactivity; no information is saved.

Option 2: Download a Writable PDF Form and upload when readyexternal icon
The Writable PDF Form can be downloaded and completed electronically on your own time. When ready, return to the VAERS Writable PDF web page (use link above) and follow Step 2 instructions to upload the form.

More information on reporting an adverse event to VAERSexternal icon. If you need further assistance, please email info@VAERS.org or call 1-800-822-7967.