HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
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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

Resource Profile: ICSRAdverseEvent - Detailed Descriptions

Draft as of 2023-08-30

Definitions for the icsr-adverseevent resource profile.

Guidance on how to interpret the contents of this table can be found here

0. AdverseEvent
2. AdverseEvent.extension
SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
4. AdverseEvent.extension:ageAtTimeOfOnset
Slice NameageAtTimeOfOnset
Control0..1
TypeExtension(AgeAtTimeOfOnset) (Extension Type: Age)
6. AdverseEvent.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Must Supporttrue
8. AdverseEvent.actuality
Must Supporttrue
Fixed Valueactual
10. AdverseEvent.category
Must Supporttrue
12. AdverseEvent.event
Control1..?
Must Supporttrue
14. AdverseEvent.event.coding
16. AdverseEvent.event.coding.system
Fixed Valuehttp://meddra.org
18. AdverseEvent.subject
TypeReference(ICSR Patient)
Must Supporttrue
20. AdverseEvent.encounter
TypeReference(US Core Encounter Profile)
Must Supporttrue
22. AdverseEvent.date
Must Supporttrue
24. AdverseEvent.date.extension
SlicingThis element introduces a set of slices on AdverseEvent.date.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
26. AdverseEvent.date.extension:eventDuration
Slice NameeventDuration
Control0..1
TypeExtension(EventDuration) (Extension Type: Duration)
Must Supporttrue
28. AdverseEvent.date.extension:endDate
Slice NameendDate
Control0..1
TypeExtension(EventEndDate) (Extension Type: dateTime)
Must Supporttrue
30. AdverseEvent.location
TypeReference(US Core Location Profile)
Must Supporttrue
32. AdverseEvent.seriousness
Control1..?
BindingThe codes SHALL be taken from ICSR Top-Level Seriousness
Must Supporttrue
34. AdverseEvent.seriousness.extension:seriousness
Slice Nameseriousness
Control0..1
TypeExtension(EventSeriousness) (Extension Type: CodeableConcept)
Must Supporttrue
36. AdverseEvent.outcome
Must Supporttrue
38. AdverseEvent.recorder
TypeReference(Practitioner Author)
Must Supporttrue
40. AdverseEvent.suspectEntity
Control1..?
Must Supporttrue
42. AdverseEvent.suspectEntity.instance
TypeReference(ICSR Immunization, ICSR MedicationAdministration, ICSR Transfusion)
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
44. AdverseEvent.suspectEntity.causality
Control1..1
Must Supporttrue
46. AdverseEvent.suspectEntity.causality.productRelatedness
Control1..?
Must Supporttrue