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

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-0487
• Issued by: 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. 

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

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