FDA Guidance for Industry How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)
Title:
FDA Guidance for Industry
How to Complete the Vaccine
Adverse Event Reporting System
Form (VAERS-1)
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM164319.pdf
Document Type:
Guidance for Industry
Content:
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).