About the VAERS Program
- Background and Public Health Importance
- Number of Reports VAERS Receives
- Objectives of VAERS
- Frequently Asked Questions (FAQs)
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 is a post-marketing safety surveillance program that collects information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.
The National Childhood Vaccine Injury Act (NCVIA) of 1986 requires health professionals and vaccine manufacturers to report to the U.S. Department of Health and Human Services (HHS) specific adverse events that occur after the administration of routinely recommended vaccines. In response to NCVIA, CDC and FDA established VAERS in 1990 (Chen, Vaccine, 1994).
VAERS has demonstrated its public health importance by providing health scientists with signals about possible adverse events following immunization. In one instance, VAERS detected reports for intussusception over that what would be expected to occur by chance alone after the RotaShield rotavirus vaccine in 1999. Epidemiologic studies confirmed an increased risk, and these data contributed to the product's removal from the US market. In another example, VAERS determined that there may be a potential for a small increase in risk for Guillain-Barre' syndrome (GBS) after the meningococcal conjugate vaccine, Menactra. As a result of this finding, a history of GBS became a contraindication to the vaccine and further controlled studies are currently underway to research this issue.
VAERS receives around 30,000 reports annually, with 13% classified as serious (e.g., associated with disability, hospitalization, life-threatening illness or death) (CDC VAERS Master Search Tool, April 2, 2008). Since 1990, VAERS has received over 200,000 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.
Many different types of adverse events occur after vaccination. About 85-90% of the reports describe mild adverse events such as fever, local reactions, and episodes of crying or mild irritability. The remaining reports reflect serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been caused by a vaccine.
The primary objectives of VAERS are to:
Detect new, unusual, or rare vaccine adverse events (VAEs);
Monitor increases in known adverse events;
Identify potential patient risk factors for particular types of adverse events;
Identify vaccine lots with increased numbers or types of reported adverse events; and
Assess the safety of newly licensed vaccines.
Visit our Frequently Asked Questions (FAQs) page.