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

: Sample ICSR FAERS Report - XML Representation

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<Composition xmlns="http://hl7.org/fhir">
  <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>