FHIR Implementation Guide for Transfusion and Vaccination Adverse Event Reporting (PSS in Confluence)

The FHIR Implementation Guide provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations. There are two sets of profiles with the first set intended to enable the detection, validation, and recording of conditions and observations on a patient’s record that would indicate the occurrence of an Adverse Event. The second set of profiles provides mappings to the ICH Individual Care Study Report (ICSR) specifications, specifically FDA’s FAERS (FDA Adverse Event Reporting System) and VAERS (Vaccine Adverse Event Reporting System) implementations of those specifications, for the purposes of allowing the submission of Adverse Event Case Reports to FDA using the FHIR profiles after they have been transformed into the current XML specifications.

This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.