Adverse events due to biological products are underreported to regulatory authorities and the data reported may not always contain adequate information for decision-making. Use of EHR FHIR data could improve reporting of adverse events and minimize the burden of identification on practitioners.  This project will develop a FHIR IG to capture the details where adverse event (AE) individual case safety reports (ICSR) are generated from EHR data.


The ICSR data elements are detailed in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ICSR specifications and are used by the FDA in two systems: the FDA Adverse Event Reporting System (FAERS) and the Vaccine Adverse Event Reporting System (VAERS). In this guide, there are two main components to the generation process: detection and reporting. To support AE detection, this IG includes a set of Clinical Quality Language (CQL) algorithms which can be run on FHIR data. To support AE reporting, this IG includes a set of profiles that enables the creation of a FHIR-based ICSR report and mappings to ICH ICSR specification (FAERS and VAERS implementation of those specifications). This work was developed as part of the FDA’s Center for Biologic Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) initiative. This IG currently focuses on post-vaccination and post-transfusion AE reporting.

Project Status

  • ACTIVE  (Status Date: 10/2022)


IG ProposalFHIR Implementation Guide for Transfusion and Vaccination Adverse Event Reporting

Zulip Chat Stream icsr-on-fhir

FHIR Resources

Last Updated: 10/2022

This Implementation Guide profiles the following FHIR resources:

AdverseEventThe main profile that contains all of the data elements needed to report an adverse event using either the FAERS or VAERS systems.
ImmunizationThe details of an immunization that was the suspected cause of an Adverse Event
ProcedureThe details of a transfusion that was the suspected cause of an Adverse Event
BiologicallyDerivedProductThe information of the blood products that were used in a transfusion
MedicationAdministrationDetails of a reported medication administration that might be relevant to the adverse event
ObservationUsed for a number of structured elements in the ICSR report
MessageHeaderContains information about the sender and receiver of an ICSR report
CompositionThe header information of an ICSR report
Practitioner/PractitionerRole/RelatedPersonThe author of the ICSR report
PatientThe subject of the Adverse Event
OrganizationOrganizations that are the senders and receivers of ICSR reports

  • No labels