Guideline

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Guidance for Industry How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)
Internet:	http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM164319.pdf
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/
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).
Document Type:	Guidance for Industry