The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
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).
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