Reporting Adverse Events (VAERS)
Background Information on VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a national program which collects information about adverse events associated with vaccinations to monitor the safety of vaccines used in the United States. The National Childhood Vaccine Injury Act (NCVIA) of 1986 mandated reporting of certain adverse events by vaccine manufacturers and medical professionals who administer vaccines. VAERS was created in 1990 by the Department of Health and Human Services. VAERS provides a database management system for the collection and analysis of these reports. It is operated jointly by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). These agencies monitor VAERS reports to determine if any vaccine or vaccine lot has a higher than expected rate of events and the types of events reported for each vaccine. These agencies also watch for associations between vaccines and rare events that were not found during clinical trials. The Texas Department of State Health Services (DSHS) is not part of the reporting system but is available to assist with questions about vaccine safety or adverse event reporting by email to firstname.lastname@example.org.
- U.S. Food & Drug Administration - VAERS Page
- Centers for Disease Control and Prevention (CDC) - VAERS Page
- The Vaccine Adverse Event Reporting System
- Vaccine Adverse Event Reporting System Brochure
Who Should Report?
Anyone can report to VAERS. Reports are usually submitted by health care providers, vaccine manufacturers, and vaccine recipients (or their parents or guardians). Patients, parents, and guardians are encouraged to seek the help of the vaccine provider in reporting adverse events.
What Should be Reported?
Any clinically significant adverse event occurring after administration of any vaccine licensed in the U.S. should be reported to VAERS. Vaccine providers are required to report any event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine, and certain events listed in the VAERS Table of Reportable Events Following Vaccination that happens within a specific time period after vaccination. Making a VAERS report does not necessarily mean the vaccine caused the event. Healthcare providers are also encouraged to report vaccine administration errors through VAERS.
How do you Report?
Reports should be made on the CDC VAERS Website or contact (800) 822-7967. All requested information should be recorded.
To fill out a report, you will need:
- Patient information (date of birth, age, sex)
- Vaccine information (brand name, dosage)
- Date, time, and location where the vaccine was administered
- Date and time when adverse event(s) started
- Symptoms and outcome of the adverse event(s)
- Medical tests and laboratory results (if applicable)
- Physician’s contact information (if applicable)
Why Should I Report to VAERS?
Each report of an adverse event provides valuable information that is added to the VAERS database. VAERS serves as an early warning system to detect possible safety problems in U.S. licensed vaccines. Accurate, complete, and timely reporting of post-vaccination health issues provides important information for vaccine safety monitoring and research.
Registries of disease or injury work best when reporting is complete. Complete reporting of post-vaccination events provides public health professionals with the information they need to ensure the safest strategies of vaccine administration.
PLEASE NOTE THAT A REPORT TO VAERS DOES NOT INITIATE A REPORT TO OR FILE A CLAIM WITH THE NATIONAL VACCINE INJURY COMPENSATION PROGRAM (VICP). To file a report with the NVICP, please visit the VICP website.