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: ICSR Adverse Event ( Abstract )

Official URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-adverseevent Version: 1.0.1
Draft as of 2023-08-30 Computable Name: ICSRAdverseEvent

The fields needed to submit an AdverseEvent for a ICSR Report.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent AdverseEventThis is an abstract profile. Child profiles: AdverseEvent, AdverseEvent
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ageAtTimeOfOnset 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset
... identifier S0..1IdentifierBusiness identifier for the event
... category S0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
... event S1..1CodeableConceptType of the event itself in relation to the subject
.... coding
..... system 0..1uriIdentity of the terminology system
Fixed Value: http://meddra.org
... subject S1..1Reference(ICSR Patient)Subject impacted by event
... encounter S0..1Reference(US Core Encounter Profile)Encounter created as part of
... date S0..1dateTimeWhen the event occurred
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... eventDuration S0..1DurationExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
.... endDate S0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate
... location S0..1Reference(US Core Location Profile)Location where adverse event occurred
... seriousness S1..1CodeableConceptSeriousness of the event
Binding: ICSR Top-Level Seriousness (required)
.... seriousness S0..1CodeableConceptExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness
Binding: ICSR Seriousness Codes (required)
... outcome S0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S0..1Reference(Practitioner Author)Who recorded the adverse event
... suspectEntity S1..*BackboneElementThe suspected agent causing the adverse event
.... instance S1..1Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)Refers to the specific entity that caused the adverse event
.... causality S1..1BackboneElementInformation on the possible cause of the event
..... productRelatedness S1..1stringAdverseEvent.suspectEntity.causalityProductRelatedness

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdverseEvent.seriousnessrequiredICSRAESeriousness

 

Other representations of profile: CSV, Excel, Schematron