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GUIDANCE DOCUMENT

How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) Guidance for Industry September 1998

Final
Docket Number:
FDA-2022-D-0487
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance for industry has been developed to clarify what information should be obtained before an individual case of an adverse experience after immunization should be submitted to the Vaccine Adverse Event Reporting System (VAERS). The Food and Drug Administration (FDA) believes that the recommendations in this guidance document will improve the quality of postmarketing safety reports and clarify the industry's current safety reporting responsibility to assure public health. 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0487.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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