vaersVaccine Adverse Event Reporting System (VAERS)

The Vaccine Adverse Event Reporting System is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of US licensed vaccines.

This Web site provides a nationwide mechanism by which adverse events following immunization (AEFI) may be reported, analyzed and made available to the public. The VAERS Web site also provides a vehicle for disseminating vaccine safety-related information to parents/guardians, healthcare providers, vaccine manufacturers, state vaccine programs, and other constituencies.

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse events following immunization. Since 1990, VAERS has received over 123,000 reports, most of which describe mild side effects such as fever. Very rarely, people experience serious adverse events following immunization. By monitoring such events, VAERS helps to identify any important new safety concerns and thereby assists in ensuring that the benefits of vaccines continue to be far greater than the risks.

Anyone can report to VAERS. The majority of VAERS reports are sent in by vaccine manufacturers (42%) and health care providers (30%). The remaining reports are obtained from state immunization programs (12%), vaccine recipients (or their parent/guardians, 7%) and other sources (9%). Vaccine recipients or their parents or guardians are encouraged to seek the help of their health care professional in filling out the VAERS form.

Each report provides valuable information that is added to the VAERS database. Accurate and complete reporting of post-vaccination events supplies the information needed for evaluation of vaccine safety. The CDC and FDA use VAERS information to ensure the safest strategies of vaccine use and to further reduce the rare risks associated with vaccines.

You should use a VAERS report form to report any adverse event. You can obtain pre-addressed postage paid report forms by calling VAERS at
1-800-822-7967. You may use photocopies of the form to submit reports. You may also download printable copies of the VAERS form as well as other information about the VAERS Program from the following Internet sites: