This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Profile Descriptions

FHIR ICSR Profiles

This IG specifies two overlapping sets of profiles for formatting an ICSR submission using FHIR resources. The first set is for a VAERS report that represents an ICSR R3 report as a Bundle of MessageHeaders pointing to a Composition. The other set is for a FAERS report that represents an ICSR R2 report as just a MessageHeader pointing to a Composition. Lastly, there is a set of common profiles applicable to both domains.

VAERS Profiles

• VAERS Bundle - representing a set of ICSR report submissions
• VAERS MessageHeader - the specific constraints on a VAERS report submission
• VAERS Adverse Event - the Adverse Event profile with a binding to Vaccination-related event codes
• Immunization

FAERS Profiles

• FAERS MessageHeader - the specific constraints on a FAERS report submission
• FAERS Adverse Event - the Adverse Event profile with a binding to Transfusion-related event codes
• Transfusion - the specific fields needed to represent a transfusion procedure
• Blood Product - information about the blood product that was used in a transfusion

For transfusions, we have three value sets to represent the specific transfusion and the specific blood product:

• Transfusion Procedure Codes
• Blood Product ISBT Codes
• Convalescent Plasma ISBT Codes

Common Profiles

• Composition - the header of an ICSR report
• ICSR Report Author
  • Practitioner
  • PractitionerRole
  • RelatedPerson
• Patient
  • Patient Age Group Observation
  • Patient Height (in cm) Observation
  • Patient Weight (in kg) Observation
  • Patient Last Menstrual Period Start Date Observation
• Report Submission Organization - represents organizations that are senders/receivers of an ICSR report
• Adverse Event - the common fields needed to represent an Adverse Event
• Medication Administration - the specific fields needed to provide the required detail to report a medication administration
• Algorithm Count Observations
  • Adverse Event Count Observation - conveys the number of adverse events detected by the algorithm
  • Exposure Count Observation - conveys the number of exposures detected by the algorithm

Additional Notes

The FHIR profiles conform to the HL7 FHIR US Core Implementation Guide where applicable and is subject to change with subsequent releases. See Relationship to US-Core for more information.

Phenotype Algorithm Value Sets

In order to support the detection adverse event cases for reporting, this IG includes a curated list of value sets. These value sets are comprised of ICD-10-CM and SNOMED codes related to adverse event conditions and symptoms.