May 2021: Vaccine Adverse Event Reporting System (VAERS)

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Written by Kylee Taavola, PharmD Candidate, and Julie Earby, PharmD, BCACP

Key Points

  • 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

Important

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

Ways to report

  1. Report online to VAERS:
    1. Submit a VAERS report online: https://vaers.hhs.gov/esub/index.jsp
    2. Must be submitted in one sitting and cannot be saved to return to later
  2. Report using a writable PDF:
    1. Download the PDF form to a computer: https://vaers.hhs.gov/uploadFile/index.jsp
    2. May complete the report offline then save and upload the completed PDF form
  3. Reporting specific to COVID-19 vaccination
    1. 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)

Contact information for VAERS

References

  1. Health Resources & Services Administration. 2021. Vaccine Injury Table. Available at: https://www.hrsa.gov/sites/default/files/vaccinecompensation/vaccineinjurytable.pdf.
  2. Centers for Disease Control and Prevention. 2021. V-safe. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html