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

: FAERS Sample Event - XML Representation

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<AdverseEvent xmlns="http://hl7.org/fhir">
  <id value="FAERSExampleEvent"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-faers-adverseevent"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>AgeAtTimeOfOnset</b>: 1 a</p><p><b>actuality</b>: actual</p><p><b>event</b>: <span title="Codes: {http://meddra.org 10066173}">Allergic transfusion reaction</span></p><p><b>subject</b>: <a href="Patient-BESTPatient.html">Generated Summary: id: 123456789; CM ; gender: female; birthDate: 1999-06-24</a></p><p><b>date</b>: 2000-01-01</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="Procedure-FAERSExampleTransfusion.html">Generated Summary: status: completed; <span title="Codes: {http://www.ama-assn.org/go/cpt 36430}">36430</span>; performed: 2002-01-09</a></p><h3>Causalities</h3><table class="grid"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Suspect</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-FAERSEpinephrine.html">Generated Summary: status: completed; <span title="Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 3992}">Epinephrine</span>; effective: 2002-01-09</a></p><h3>Causalities</h3><table class="grid"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Concomitant</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-FAERSDiphenhydramine.html">Generated Summary: status: completed; <span title="Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 3498}">Diphenhydramine</span>; effective: 2002-01-09</a></p><h3>Causalities</h3><table class="grid"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Concomitant</td></tr></table></blockquote></div>
  </text>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageattimeofonset">
    <valueAge>
      <value value="1"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="a"/>
    </valueAge>
  </extension>
  <actuality value="actual"/>
  <event>
    <coding>
      <system value="http://meddra.org"/>
      <code value="10066173"/>
      <display value="Allergic transfusion reaction"/>
    </coding>
  </event>
  <subject>
    <reference value="Patient/BESTPatient"/>
  </subject>
  <date value="2000-01-01">
    <extension
               url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventenddate">
      <valueDateTime value="2019-01-20"/>
    </extension>
    <extension
               url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventduration">
      <valueDuration>
        <value value="19.05"/>
        <system value="http://unitsofmeasure.org"/>
        <code value="a"/>
      </valueDuration>
    </extension>
  </date>
  <suspectEntity>
    <instance>
      <reference value="Procedure/FAERSExampleTransfusion"/>
    </instance>
    <causality>
      <productRelatedness value="Suspect"/>
    </causality>
  </suspectEntity>
  <suspectEntity>
    <instance>
      <reference value="MedicationAdministration/FAERSEpinephrine"/>
    </instance>
    <causality>
      <productRelatedness value="Concomitant"/>
    </causality>
  </suspectEntity>
  <suspectEntity>
    <instance>
      <reference value="MedicationAdministration/FAERSDiphenhydramine"/>
    </instance>
    <causality>
      <productRelatedness value="Concomitant"/>
    </causality>
  </suspectEntity>
</AdverseEvent>