What is the Vaccine Adverse Event Reporting System (VAERS)?
VAERS is a passive reporting system established in 1990 as a national early warning system to detect possible safety concerns in U.S.-licensed vaccines. The program, co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), accepts and analyzes reports of adverse events or possible side effects after an individual receives a vaccination. Anyone can report to VAERS.
Health care providers are required to report all adverse events they become aware of, but anyone can make report of their experiences with vaccine side effects. The system is not designed to determine if a vaccine caused a health problem, but is very useful in detecting patterns or unusual occurrences that might indicate a possible safety problem with a vaccine.
The primary objectives of VAERS are to:
- Detect new, unusual, or rare vaccine adverse events;
- Monitor increases in known vaccine adverse events;
- Identify potential patient risk factors for particular types of vaccine adverse events;
- Assess the safety of newly licensed vaccines;
- Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
- Recognize persistent safe-use problems (such as vaccines not handled and stored properly), administration errors; and
- Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.
Reporting an adverse event to VAERS. Reports are welcome from all concerned individuals: patients, parents, health care providers, pharmacists and vaccine manufacturers.
Health care providers are required by law to report to VAERS:
- Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccinations.
- An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.
Health care providers are strongly encouraged to report to VAERS:
- Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it is or is not clear that a vaccine caused the adverse event.
- Vaccine administration errors, such as wrong vaccine, wrong route, wrong dosage, wrong patient, etc.
Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.
Online reporting is strongly encouraged. It is important to report clinically important adverse events that occur after vaccination of adults and children, even if unsure whether or not the vaccine caused the adverse event. Colorado Immunization Information System (CIIS) has the ability to assist providers with completing a VAERS report. Contact CIIS (303-692-2437, option 2) for more information on this feature.
The Vaccine Adverse Event Reporting System (VAERS) accepts all reports, including reports of vaccination errors. Of importance to note, knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.
Occasionally, CDC and FDA may ask for more information than is available on the form. VAERS is covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) so patient consent is not necessary to release any requested information.
For more information on the Vaccine Adverse Event Reporting System or to make a report visit: www.vaers.hhs.gov.