HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions

ICSR Mappings

Mappings from ICSR Specifications to FHIR

Two sets of mappings were created from the FDA ICSR Specifications. The FAERS mappings were done using FDA's FAERS R2 Implementation Guide and mapping the specified elements to the FHIR Profiles in this guide. The VAERS mappings where done using both the ICH ICSR R3 Implementation Guide and FDA's VAERS Regional Guide.

The mappings were expressed in an Excel spreadsheet.

Samples used at the January 2021 Connectathon provide the FAERS and VAERS XML formats as well as the converted FHIR Bundles that correspond to those samples (Transfusion FHIR Bundle and Vaccination FHIR Bundle).