HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
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 
<Bundle xmlns="http://hl7.org/fhir">
<id value="MinimumFAERSBundle"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-bundle"/>
</meta>
<type value="message"/>
<entry>
<fullUrl value="Bundle/SampleFAERSMessageHeader"/>
<resource>
<MessageHeader>
<id value="US-IBM-FAERS-fad94c04-29e7-5b37-e535-a8aad123cf9a"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-messageheader"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: <span title="{http://terminology.hl7.org/CodeSystem/v3-ActCode PAT_ADV_EVNT}">Patient Adverse Event</span></p><h3>Destinations</h3><table class="grid"><tr><td>-</td><td><b>Endpoint</b></td><td><b>Receiver</b></td></tr><tr><td>*</td><td><a href="http://example.org/CBERFAERS">http://example.org/CBERFAERS</a></td><td><a href="Organization-ReceiverOrganization.html">Generated Summary: active; <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 2}">Regulatory Authority</span>; name: FDA; faersedub@fda.hhs.gov</a></td></tr></table><p><b>sender</b>: <a href="Organization-SenderOrganization.html">Generated Summary: active; <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 1}">Pharmaceutical Company</span>; name: sender organization; Phone: +01 123 456 78, Fax: +01 123 456 89, email@city.us</a></p><h3>Sources</h3><table class="grid"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href="http://example.org/SENDER-IDENTIFIER">http://example.org/SENDER-IDENTIFIER</a></td></tr></table><p><b>reason</b>: <span title="Codes: {http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents received-public-health-report}">Indicates receipt of a public health report</span></p><p><b>focus</b>: <a href="#Composition_SampleFAERSReport">See above (Composition/SampleFAERSReport)</a></p></div>
</text>
<extension
url="http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory">
<valueCode value="notification"/>
</extension>
<eventCoding>
<system value="http://terminology.hl7.org/CodeSystem/v3-ActCode"/>
<code value="PAT_ADV_EVNT"/>
<display value="Patient Adverse Event"/>
</eventCoding>
<destination>
<endpoint value="http://example.org/CBERFAERS"/>
<receiver>
<reference value="Organization/ReceiverOrganization"/>
</receiver>
</destination>
<sender>
<reference value="Organization/SenderOrganization"/>
</sender>
<source>
<endpoint value="http://example.org/SENDER-IDENTIFIER"/>
</source>
<reason>
<coding>
<system
value="http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents"/>
<code value="received-public-health-report"/>
</coding>
</reason>
<focus>
<reference value="Composition/SampleFAERSReport"/>
</focus>
</MessageHeader>
</resource>
</entry>
<entry>
<fullUrl value="Composition/SampleFAERSReport"/>
<resource>
<Composition>
<id value="SampleFAERSReport"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><blockquote><p><b>AdditionalDocumentInformation</b></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><p><b>value</b>: false</p><p><b>value</b>: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.1003 C53578}">Non-Expedited AE</span></p></blockquote><p><b>FirstSenderType</b>: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.3 2}">Other</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: Feb 10, 2020 10:18:00 PM</p><p><b>MostRecentDate</b>: Feb 10, 2020 10:18:00 PM</p><p><b>CaseIdentifier</b>: id: US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee</p><p><b>PreviousCaseIdentifier</b>: id: Other-case-identifier</p><blockquote><p><b>ReportAmendment</b></p><p><b>value</b>: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.5 2}">2</span></p><p><b>value</b>: Fixed some identifiers</p></blockquote><p><b>identifier</b>: id: US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a</p><p><b>status</b>: final</p><p><b>type</b>: <span title="Codes: {http://loinc.org 85893-6}">Adverse event note</span></p><p><b>category</b>: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.2 1}">Spontaneous report</span></p><p><b>date</b>: Feb 10, 2020 10:18:00 PM</p><p><b>author</b>: <a href="PractitionerRole-SampleAuthorRole.html">Generated Summary: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}">Physician</span>; joe@anywhere.com</a></p><p><b>title</b>: ICSR Submission</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation">
<extension url="availableFlag">
<valueBoolean value="false"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport">
<extension url="localCriteriaFlag">
<valueBoolean value="false"/>
</extension>
<extension url="localCriteriaReportType">
<valueCodeableConcept>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.1003"/>
<code value="C53578"/>
<display value="Non-Expedited AE"/>
</coding>
</valueCodeableConcept>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype">
<valueCodeableConcept>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.3"/>
<code value="2"/>
<display value="Other"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport">
<valueBoolean value="false"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate">
<valueDateTime value="2020-02-10T17:18:00-05:00"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate">
<valueDateTime value="2020-02-10T17:18:00-05:00"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier">
<valueIdentifier>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.2"/>
<value value="US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee"/>
</valueIdentifier>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-previouscaseidentifier">
<valueIdentifier>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.3"/>
<value value="Other-case-identifier"/>
<assigner>
<display value="Case identifier source name"/>
</assigner>
</valueIdentifier>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-reportamendment">
<extension url="amendmentType">
<valueCodeableConcept>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.5"/>
<code value="2"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="amendmentReason">
<valueString value="Fixed some identifiers"/>
</extension>
</extension>
<identifier>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.1"/>
<value value="US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="http://loinc.org"/>
<code value="85893-6"/>
<display value="Adverse event note"/>
</coding>
</type>
<category>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.2"/>
<code value="1"/>
<display value="Spontaneous report"/>
</coding>
</category>
<subject>
<reference value="Patient/SampleICSRPatient"/>
</subject>
<date value="2020-02-10T17:18:00-05:00"/>
<author>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource">
<valueBoolean value="true"/>
</extension>
<reference value="PractitionerRole/SampleAuthorRole"/>
</author>
<title value="ICSR Submission"/>
<section>
<title value="Reaction/Event"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="ReactionEvent"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">No events</div>
</text>
</section>
<section>
<title value="Drug Information"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="DrugInformation"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">No drugs taken</div>
</text>
</section>
<section>
<title value="Case Summary Narrative"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="CaseSummaryNarrative"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div>No adverse event happened. Not sure why I'm sending this report.</div><div lang="fr">il n'y a eu aucun événement indésirable</div></div>
</text>
</section>
<section>
<title value="Information about the Data Source of the AE information"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="DataSourceInformation"/>
</coding>
</code>
<entry>
<reference value="Observation/SampleAECountObservation"/>
</entry>
<entry>
<reference value="Observation/SampleExposureCountObservation"/>
</entry>
</section>
</Composition>
</resource>
</entry>
</Bundle>
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#0.1.0 based on FHIR 4.0.1. Generated 2021-08-05
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