Vaccine Adverse Event Reporting System

Vaccine Adverse Event Reporting System (VAERS) is a United States national system for monitoring the safety of vaccines. It is co-managed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes data from reports of adverse events (possible side effects) that occur after the administration of US-licensed vaccines.

History

VAERS was established in 1990 as a national early warning system to detect possible safety concerns in U.S.-licensed vaccines. The program, which is a component of the CDC's Immunization Safety Office, was created in response to the National Childhood Vaccine Injury Act (NCVIA) of 1986.

Function

VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as "safety signals." If a safety signal is found in VAERS, further studies can be done in safety databases managed by the CDC, FDA, and other large linked databases.

Reporting

Healthcare providers are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention. VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can submit a report to VAERS, including parents, patients, and healthcare providers.

Limitations

While VAERS is a valuable tool for monitoring vaccine safety, it has limitations. The data VAERS collects is not enough to determine if a vaccine caused an adverse event. Most reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

See also

• Vaccine safety
• Pharmacovigilance
• Adverse event
• Centers for Disease Control and Prevention
• Food and Drug Administration