HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1
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 
<Composition xmlns="http://hl7.org/fhir">
<id value="SampleFAERSReport"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource "SampleFAERSReport" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-composition.html">ICSR Composition</a></p></div><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>: Non-Expedited AE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#C53578)</span></p></blockquote><p><b>FirstSenderType</b>: Other <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#2)</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: 2020-02-10T17:18:00-05:00</p><p><b>MostRecentDate</b>: 2020-02-10T17:18:00-05:00</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>: 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#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>: Adverse event note <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#85893-6)</span></p><p><b>category</b>: Spontaneous report <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#1)</span></p><p><b>date</b>: 2020-02-10T17:18:00-05:00</p><p><b>author</b>: <a href="PractitionerRole-SampleAuthorRole.html">PractitionerRole/SampleAuthorRole</a></p><p><b>title</b>: ICSR Submission</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation">
<extension url="availableFlag">
<valueBoolean value="false"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/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/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/icsr-ext-combinationproductreport">
<valueBoolean value="false"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate">
<valueDateTime value="2020-02-10T17:18:00-05:00"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate">
<valueDateTime value="2020-02-10T17:18:00-05:00"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/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/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/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/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>
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.0 based on FHIR 4.0.1. Generated 2022-01-19
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