CBER Vaccine ICSR (Legacy) Implementation
ATTENTION:
A new version (Version 2.1) of VAERS Data elements and corresponding Technical Specifications and Business Rules have been posted. Current specifications (Version 2.1) for vaccine reporting are provided at
CBER Vaccine ICSR Implementation
ICSRs formatted in the original version (Version 1.0) may still be submitted for the foreseeable future. The historical (i.e., legacy) information below, including the Version 1.0 Technical Specifications and Business Rules continue to be available on this page, while manufacturers and FDA transition to the new version.
CBER is implementing the updated International Council on Harmonisation’s (ICH) E2B(R3) Individual Case Safety Report (ICSR) specification to support electronic reporting of vaccine postmarketing safety reports as specified in the Electronic Safety Reporting Rule published June 10, 2014. Information about ICSR specifications supported by CBER is available at: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-biologics/electronic-submission-postmarket-safety-reports.
VAERS Electronic Reporting Resources:
- FDA E2B(R3) Guidance to Industry:
- Electronic Vaccine Adverse Event Reporting System (eVAERS) Guidance:
- FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting:
- Appendix A to the FDA ICH E2B(R3) Technical Specifications Document is provided in XML format to demonstrate how FDA regional data elements are accommodated in the XML schema:
- Appendix B: Consolidated Business Rules Document - Appendix B has been added to provide more information about eVAERS field lengths and datatypes for FDA regional data elements. XLS Format:
- Appendix C: Test cases scenarios recommended for the Pilot Test.