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

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

Example Bundle: Minimum FAERS Bundle

Bundle MinimumFAERSBundle of type message

Entry 1 - Full URL = Bundle/SampleFAERSMessageHeader

Resource MessageHeader:

Generated Narrative

Message Processing Category: notification

event: Patient Adverse Event

Destinations

-EndpointReceiver
*http://example.org/CBERFAERSGenerated Summary: active; Regulatory Authority; name: FDA; faersedub@fda.hhs.gov

sender: Generated Summary: active; Pharmaceutical Company; name: sender organization; Phone: +01 123 456 78, Fax: +01 123 456 89, email@city.us

Sources

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

reason: Indicates receipt of a public health report

focus: Generated Summary: id: US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a; status: final; Adverse event note; Spontaneous report; date: Feb 10, 2020 10:18:00 PM; title: ICSR Submission

Entry 2 - Full URL = Composition/SampleFAERSReport

Resource Composition:

Generated Narrative

AdditionalDocumentInformation

value: false

ExpeditedReport

value: false

value: Non-Expedited AE

FirstSenderType: Other

CombinationProductReport: false

FirstReceiveDate: Feb 10, 2020 10:18:00 PM

MostRecentDate: Feb 10, 2020 10:18:00 PM

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

PreviousCaseIdentifier: id: Other-case-identifier

ReportAmendment

value: 2

value: Fixed some identifiers

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

status: FINAL

type: Adverse event note

category: Spontaneous report

date: Feb 10, 2020 10:18:00 PM

author: Generated Summary: Physician; joe@anywhere.com

title: ICSR Submission