Reporting vaccine adverse events
The Vaccine Adverse Event Reporting System (VAERS) is a national program which collects information about adverse events associated with vaccinations for the purpose of monitoring 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 Louisiana Immunization Program is not part of the reporting system and does not analyze or utilize any of the information submitted to VAERS.
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. Vaccine providers are required to report any event listed in NCVIA reportable event table and any event listed in the package insert as a contraindication to subsequent doses. The Reportable Event Table (PDF) specifically outlines the reportable post-vaccination events and the time frames of events that are reportable by law. A report is not documentation that a vaccine caused the event.
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)
How do you report?
Reports should be made on the CDC VAERS Website or contact (800) 822-7967. All requested information should be recorded.
Why report to VAERS?
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. If you are a vaccine manufacturer or a professional who administers vaccines, you are required by law to report certain adverse events found in the Reportable Event Table (PDF) .
Note: A report submitted to VAERS does not initiate a report or claim wiith the National Vaccine Compensation Program VICP). To file a claim with VICP click here.