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

: Minimum Vaccination Case Report Bundle - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="MinimumVaccinationReportBundle"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle"/>
  </meta>
  <identifier>
    <value
           value="BATCH20200210171800-05006510d41d-281d-7610-cd0d-4b07dcc8f49d"/>
  </identifier>
  <type value="message"/>
  <timestamp value="2020-02-10T17:18:00.000-05:00"/>
  <entry>
    <fullUrl value="Bundle/SampleVaccinationMessageHeader"/>
    <resource>
      <MessageHeader>
        <id value="US-IBM-Vaccination-fad94c04-29e7-5b37-e535-a8aad123cf9a"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader"/>
        </meta>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MessageHeader</b><a name="US-IBM-Vaccination-fad94c04-29e7-5b37-e535-a8aad123cf9a"> </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 MessageHeader &quot;US-IBM-Vaccination-fad94c04-29e7-5b37-e535-a8aad123cf9a&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-messageheader.html">ICSR MessageHeader</a></p></div><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: Patient Adverse Event (Details: http://terminology.hl7.org/CodeSystem/v3-ActCode code PAT_ADV_EVNT = 'patient adverse event', stated as 'Patient Adverse Event')</p><h3>Destinations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Endpoint</b></td></tr><tr><td style="display: none">*</td><td><a href="http://example.org/CBERVaccination">http://example.org/CBERVaccination</a></td></tr></table><p><b>sender</b>: <a href="Organization-SenderOrganization.html">Organization/SenderOrganization</a> &quot;sender organization&quot;</p><h3>Sources</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Endpoint</b></td></tr><tr><td style="display: none">*</td><td><a href="http://example.org/SENDER-IDENTIFIER">http://example.org/SENDER-IDENTIFIER</a></td></tr></table><p><b>reason</b>: Indicates receipt of a public health report <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/us/medmorph/2021Jan/CodeSystem-us-ph-triggerdefinition-namedevents.html">US Public Health TriggerDefinition Named Events</a>#received-public-health-report)</span></p><p><b>focus</b>: <a href="#Composition_SampleVaccinationReport">See above (Composition/SampleVaccinationReport)</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/CBERVaccination"/>
        </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/SampleVaccinationReport"/>
        </focus>
      </MessageHeader>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Composition/SampleVaccinationReport"/>
    <resource>
      <Composition>
        <id value="SampleVaccinationReport"/>
        <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="SampleVaccinationReport"> </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;SampleVaccinationReport&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#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>: 2020-02-10 17:18:00-0500</p><p><b>MostRecentDate</b>: 2020-02-10 17:18:00-0500</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><blockquote><p><b>url</b></p><code>amendmentType</code></blockquote><p><b>value</b>: 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#2)</span></p><blockquote><p><b>url</b></p><code>amendmentReason</code></blockquote><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>: 2020-02-10 17:18:00-0500</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>
      </Composition>
    </resource>
  </entry>
</Bundle>