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Written by Kylee Taavola, PharmD Candidate, and Julie Earby, PharmD, BCACP
The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect potential safety concerns in vaccines. It is co-managed by the CDC and FDA.
VAERS accepts and analyzes reports of adverse events after a person has received a vaccination.
VAERS is not designed to determine whether a vaccine caused a health problem, but it is useful for detecting unusual or unexpected patterns of adverse events.
Who can report to VAERS?
Anyone can submit a report to VAERS, including parents, patients, and healthcare providers.
What to report
It is appropriate to report any clinically important medical event or health problem that occurs after vaccination. Reporting in a timely manner provides important information to improve vaccine safety and research.
Adverse events can occur immediately or up to 42 days after vaccine administration. The time period is dependent on the injury that occurs. Most adverse events occur within 48 hours.1
Knowingly filing a false VAERS report is a violation of Federal law punishable by fine/imprisonment
Healthcare provider requirements
*Serious adverse events = death, life-threatening illness, hospitalization, a substantial disruption in the ability to conduct normal life functions, a birth defect, or an important medical event that may require medical/surgical intervention
May complete the report offline then save and upload the completed PDF form
Reporting specific to COVID-19 vaccination
There is a smart-phone based tool, V-safe, that utilizes text messages and surveys to help report adverse events specifically related to COVID-19 vaccination. The tool also helps to remind recipients of when their second dose will be due if applicable.2 More information and instructions on how to register can be found at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html
Information needed for VAERS
Patient information (name, date of birth, sex)
Information identifying the patient or reporter is not available to the public
Vaccine information (brand name, dosage)
Date, time, and location administered
Date and time when adverse event(s) started
Symptoms and outcome of the adverse event(s)
Patient history: medications, allergies, illness up to one month prior to vaccine, previous vaccines within the month prior, and chronic health conditions (if applicable)
Medical test and laboratory results (if applicable)