HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
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HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions

: Vaccination Sample ICSR Report - XML Representation

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<Composition xmlns="http://hl7.org/fhir">
  <id value="VaccinationExample"/>
  <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: Composition</b><a name="VaccinationExample"> </a></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 Composition &quot;VaccinationExample&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-composition.html">ICSR Composition</a></p></div><blockquote><p><b>AdditionalDocumentInformation</b></p><blockquote><p><b>url</b></p><code>availableFlag</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><blockquote><p><b>url</b></p><code>localCriteriaFlag</code></blockquote><p><b>value</b>: false</p><blockquote><p><b>url</b></p><code>localCriteriaReportType</code></blockquote><p><b>value</b>: Non-Expedited AE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#2)</span></p></blockquote><p><b>FirstSenderType</b>: Regulator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#1)</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: 2021-01-05</p><p><b>MostRecentDate</b>: 2021-01-05</p><p><b>CaseIdentifier</b>: id: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495</p><p><b>identifier</b>: id: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495</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>: 2021-01-05 14:24:44+0500</p><p><b>author</b>: <a href="PractitionerRole-VaccinationAuthorRole.html">PractitionerRole/VaccinationAuthorRole</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="2"/>
          <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="1"/>
        <display value="Regulator"/>
      </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="2021-01-05"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate">
    <valueDateTime value="2021-01-05"/>
  </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-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
    </valueIdentifier>
  </extension>
  <identifier>
    <system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.1"/>
    <value value="US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
  </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/VaccinationPatient"/>
  </subject>
  <date value="2021-01-05T14:24:44+05:00"/>
  <author>
    <extension
               url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource">
      <valueBoolean value="true"/>
    </extension>
    <reference value="PractitionerRole/VaccinationAuthorRole"/>
  </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">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>
    </text>
    <entry>
      <reference value="AdverseEvent/VaccinationExampleEvent"/>
    </entry>
  </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">ED administration of influenza vaccine</div>
    </text>
    <entry>
      <reference value="Immunization/VaccinationExampleImmunization"/>
    </entry>
    <entry>
      <reference
                 value="MedicationAdministration/VaccinationHydrocortisoneAdministration"/>
    </entry>
  </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">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: sharepoint link BEST Certainty: Definite BEST Severity: Non-Severe BEST Causality: Probable Onset location for reaction: Preliminary investigation results: Developed acute facial nerve paralysis after ED administration of influenza vaccine; Reaction Type: vax_bells_palsy; Illness at Time of Vaccination: 1. illness, Problem, Chronic systolic (congestive) heart failure, Date 20170430; Notes: 1. notes, Progress Note - Nurse, Patient Care Documentation, Progress Note : Patient suffered face weakness from unknown cause. Patient had idiopathic facial nerve palsy and showed rapid progression. Palsy improved lot facial paralysis identified., Date 20170423;</div>
    </text>
  </section>
  <section>
    <title value="Relevant Medical History"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
        <code value="RelevantMedicalHistory"/>
      </coding>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">Long term (current) use of anticoagulants</div>
    </text>
  </section>
</Composition>