Adverse Events Reporting (VAERS)

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.

NEW Vaccine Adverse Event Reporting System (VAERS) Website and Ways to Report to VAERS

VAERS 2.0 includes a new reporting form and a new website that allows you to:

  • Easily submit a VAERS report electronically
  • Access VAERS data
  • Learn more about how CDC and FDA monitor the safety of vaccines

 There are two ways to report an adverse event following vaccination to VAERS:

  1. Use the online reporting tool
  2. Complete a writable VAERS PDF form and upload it onto the new VAERS website

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Updated 7/7/17

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