U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Vaccines
  4. CBER Vaccine ICSR (Legacy) Implementation
  1. Vaccines

CBER Vaccine ICSR (Legacy) Implementation



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:

Back to Top