HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Example Bundle: Minimum FAERS Bundle

Bundle MinimumFAERSBundle of type message

Entry 1 - Full URL = Bundle/SampleFAERSMessageHeader

Resource MessageHeader:

Generated Narrative

Resource "US-IBM-FAERS-fad94c04-29e7-5b37-e535-a8aad123cf9a"

Profile: ICSR MessageHeader

Message Processing Category: notification

event: Patient Adverse Event (Details: http://terminology.hl7.org/CodeSystem/v3-ActCode code PAT_ADV_EVNT = 'patient adverse event', stated as 'Patient Adverse Event')

Destinations

-EndpointReceiver
*http://example.org/CBERFAERSOrganization/ReceiverOrganization "FDA"

sender: Organization/SenderOrganization "sender organization"

Sources

-Endpoint
*http://example.org/SENDER-IDENTIFIER

reason: Indicates receipt of a public health report (US Public Health TriggerDefinition Named Events#received-public-health-report)

focus: Composition/SampleFAERSReport

Entry 2 - Full URL = Composition/SampleFAERSReport

Resource Composition:

Generated Narrative

Resource "SampleFAERSReport"

Profile: ICSR Composition

AdditionalDocumentInformation

value: false

ExpeditedReport

value: false

value: Non-Expedited AE (unknown#C53578)

FirstSenderType: Other (unknown#2)

CombinationProductReport: false

FirstReceiveDate: 2020-02-10T17:18:00-05:00

MostRecentDate: 2020-02-10T17:18:00-05:00

CaseIdentifier: id: US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee

PreviousCaseIdentifier: id: Other-case-identifier

ReportAmendment

value: 2 (unknown#2)

value: Fixed some identifiers

identifier: id: US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a

status: FINAL

type: Adverse event note (LOINC#85893-6)

category: Spontaneous report (unknown#1)

date: 2020-02-10T17:18:00-05:00

author: PractitionerRole/SampleAuthorRole

title: ICSR Submission