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Vaccines for Children Program

The Vaccine Adverse Event Reporting System (VAERS) is a national program, which collects information about adverse events associated with vaccinations. This information is used to monitor the safety of vaccines that are administered in the United States. The National Childhood Vaccine Injury Act (NCVIA) of 1986 mandated reporting of certain adverse events. The Department of Health and Human Services created VAERS in 1990. 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. They watch for associations between vaccines and rare events that were not found during clinical trials.

Who should report?
Anyone can report to VAERS. Public health departments, private health care providers, vaccine manufacturers, and vaccine recipients (or their parent/guardian) usually submit reports. Vaccine recipients (or their parent/guardian) are encouraged to seek help from their health care provider when reporting to VAERS.

What should be reported?
VAERS encourages reporting of any clinically significant adverse event that occurs after the administration of any vaccine licensed in the United States, even if is not certain that the vaccine caused the event. Required reports include any event listed in the NCVIA reportable event table and any event listed in the package insert as a contraindication to subsequent doses.

How do I report?
Reports should be made on a VAERS form. All requested information should be recorded. Report forms may be obtained by calling the Immunization program at 538-9450. They can also be downloaded from the Internet.

Completed forms from public providers must be submitted to the Immunization Program.
Utah Department of Health Immunization Program
PO Box 142001
SLC, UT 84114-2001
FAX (801) 538-9440

Completed forms from private providers should be submitted directly to VAERS.
VAERS
PO Box 1100
Rockville, MD 20849-1100
FAX (877) 721-0366

Why should I report?
Registries of disease or injury work best when reporting is complete. Complete reporting of post-vaccination events supplies public health professionals with the information they need to ensure the safest strategies of vaccine administration. All vaccine providers can contribute to the success of this system by reporting any adverse event that might be related to vaccination in children and adults. This system works because you make it work.

More information may be obtained from these sources:

Vaccine Adverse Event Reporting System (VAERS)
National Immunization Program
FDA VAERS
Utah Department of Health, Immunization Program (801)538-9450