HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction United States of America flag

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.1: STU 1 Update) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

: Vaccination Bundle for Connectathon Sample - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="ConnectathonVaccinationBundle"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle"/>
  </meta>
  <identifier>
    <system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.22"/>
    <value
           value="BATCH20210105142444-0500533f2636-a404-13c5-10e3-7d293893227a"/>
  </identifier>
  <type value="message"/>
  <timestamp value="2021-01-05T14:24:44-05:00"/>
  <entry>
    <fullUrl
             value="MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
    <resource>
      <MessageHeader>
        <id value="US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
        <meta>
          <lastUpdated value="2021-01-05T14:24:44+05:00"/>
          <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-e380bc14-2a03-7b64-c3f5-22daea2aa495"> </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-e380bc14-2a03-7b64-c3f5-22daea2aa495&quot; Updated &quot;2021-01-05 14:24:44+0500&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_VaccinationSender">See above (Organization/VaccinationSender)</a></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/BEST-Pilot">http://example.org/BEST-Pilot</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_VaccinationExample">See above (Composition/VaccinationExample)</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/VaccinationSender"/>
        </sender>
        <source>
          <endpoint value="http://example.org/BEST-Pilot"/>
        </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/VaccinationExample"/>
        </focus>
      </MessageHeader>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Composition/VaccinationExample"/>
    <resource>
      <Composition>
        <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">See above (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>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Organization/VaccinationSender"/>
    <resource>
      <Organization>
        <id value="VaccinationSender"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageorganization"/>
        </meta>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="VaccinationSender"> </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 Organization &quot;VaccinationSender&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-messageorganization.html">MessageHeader Organization</a></p></div><p><b>DepartmentName</b>: sender department</p><p><b>active</b>: true</p><p><b>type</b>: Pharmaceutical Company <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#1)</span></p><p><b>name</b>: sender organization</p><p><b>telecom</b>: <a href="tel:+0112345678">+01 123 456 78</a>, fax: +01 123 456 89, <a href="mailto:email@city.us">email@city.us</a></p><p><b>address</b>: street city CA postcode US </p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>sender gname sender fname </td></tr></table></div>
        </text>
        <extension
                   url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-departmentname">
          <valueString value="sender department"/>
        </extension>
        <active value="true"/>
        <type>
          <coding>
            <system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.7"/>
            <code value="1"/>
            <display value="Pharmaceutical Company"/>
          </coding>
        </type>
        <name value="sender organization"/>
        <telecom>
          <system value="phone"/>
          <value value="+01 123 456 78"/>
        </telecom>
        <telecom>
          <system value="fax"/>
          <value value="+01 123 456 89"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="email@city.us"/>
        </telecom>
        <address>
          <line value="street"/>
          <city value="city"/>
          <state value="CA"/>
          <postalCode value="postcode"/>
          <country value="US"/>
        </address>
        <contact>
          <name>
            <family value="sender fname"/>
            <given value="sender gname"/>
            <prefix value="sender title"/>
          </name>
        </contact>
      </Organization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="PractitionerRole/VaccinationAuthorRole"/>
    <resource>
      <PractitionerRole>
        <id value="VaccinationAuthorRole"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitionerrole"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PractitionerRole</b><a name="VaccinationAuthorRole"> </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 PractitionerRole &quot;VaccinationAuthorRole&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-authorpractitionerrole.html">PractitionerRole Author</a></p></div><p><b>practitioner</b>: <a href="#Practitioner_VaccinationAuthor">See above (Practitioner/VaccinationAuthor)</a></p><p><b>organization</b>: <a href="#Organization_VaccinationSender">See above (Organization/VaccinationSender)</a></p><p><b>code</b>: Physician <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#1)</span></p><p><b>telecom</b>: <a href="mailto:admin@admin.com">admin@admin.com</a>, ph: 3333333333</p></div>
        </text>
        <practitioner>
          <reference value="Practitioner/VaccinationAuthor"/>
        </practitioner>
        <organization>
          <reference value="Organization/VaccinationSender"/>
        </organization>
        <code>
          <coding>
            <system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.6"/>
            <code value="1"/>
            <display value="Physician"/>
          </coding>
        </code>
        <telecom>
          <system value="email"/>
          <value value="admin@admin.com"/>
        </telecom>
        <telecom>
          <system value="phone"/>
          <value value="3333333333"/>
        </telecom>
      </PractitionerRole>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Practitioner/VaccinationAuthor"/>
    <resource>
      <Practitioner>
        <id value="VaccinationAuthor"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Practitioner</b><a name="VaccinationAuthor"> </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 Practitioner &quot;VaccinationAuthor&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-authorpractitioner.html">Practitioner Author</a></p></div><p><b>identifier</b>: id: NI</p><p><b>name</b>: asdhj Admin </p><p><b>address</b>: US </p></div>
        </text>
        <identifier>
          <system value="http://hl7.org/fhir/sid/us-npi"/>
          <value value="NI"/>
        </identifier>
        <name>
          <family value="Admin"/>
          <given value="asdhj"/>
        </name>
        <address>
          <country value="US"/>
        </address>
      </Practitioner>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Patient/VaccinationPatient"/>
    <resource>
      <Patient>
        <id value="VaccinationPatient"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Patient</b><a name="VaccinationPatient"> </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 Patient &quot;VaccinationPatient&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-patient.html">ICSR Patient</a></p></div><p><b>identifier</b>: id: 123456789</p><p><b>name</b>: FNAME LNAME </p><p><b>gender</b>: male</p><p><b>birthDate</b>: 1955-07-22</p></div>
        </text>
        <identifier>
          <system value="http://hl7.org/fhir/sid/us-ssn"/>
          <value value="123456789"/>
        </identifier>
        <name>
          <family value="LNAME"/>
          <given value="FNAME"/>
        </name>
        <gender value="male"/>
        <birthDate value="1955-07-22"/>
      </Patient>
    </resource>
  </entry>
  <entry>
    <fullUrl value="AdverseEvent/VaccinationExampleEvent"/>
    <resource>
      <AdverseEvent>
        <id value="VaccinationExampleEvent"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/vaccination-adverseevent"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdverseEvent</b><a name="VaccinationExampleEvent"> </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 AdverseEvent &quot;VaccinationExampleEvent&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-vaccination-adverseevent.html">Vaccination Adverse Event</a></p></div><p><b>actuality</b>: actual</p><p><b>event</b>: Bell's Palsy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (meddra.org#10004223)</span></p><p><b>subject</b>: <a href="#Patient_VaccinationPatient">See above (Patient/VaccinationPatient)</a></p><p><b>date</b>: 2017-04-23</p><p><b>seriousness</b>: Serious <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: Recovering <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R4/codesystem-adverse-event-outcome.html">AdverseEventOutcome</a>#recovering)</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#Immunization_VaccinationExampleImmunization">See above (Immunization/VaccinationExampleImmunization)</a></p><h3>Causalities</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductRelatedness</b></td></tr><tr><td style="display: none">*</td><td>Suspect</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#MedicationAdministration_VaccinationHydrocortisoneAdministration">See above (MedicationAdministration/VaccinationHydrocortisoneAdministration)</a></p><h3>Causalities</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductRelatedness</b></td></tr><tr><td style="display: none">*</td><td>Concomitant</td></tr></table></blockquote></div>
        </text>
        <actuality value="actual"/>
        <event>
          <coding>
            <system value="http://meddra.org"/>
            <code value="10004223"/>
            <display value="Bell's Palsy"/>
          </coding>
        </event>
        <subject>
          <reference value="Patient/VaccinationPatient"/>
        </subject>
        <date value="2017-04-23"/>
        <seriousness>
          <extension
                     url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness">
            <valueCodeableConcept>
              <coding>
                <system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.19"/>
                <code value="26"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
            <code value="serious"/>
          </coding>
        </seriousness>
        <outcome>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/adverse-event-outcome"/>
            <code value="recovering"/>
          </coding>
        </outcome>
        <suspectEntity>
          <instance>
            <reference value="Immunization/VaccinationExampleImmunization"/>
          </instance>
          <causality>
            <productRelatedness value="Suspect"/>
          </causality>
        </suspectEntity>
        <suspectEntity>
          <instance>
            <reference
                       value="MedicationAdministration/VaccinationHydrocortisoneAdministration"/>
          </instance>
          <causality>
            <productRelatedness value="Concomitant"/>
          </causality>
        </suspectEntity>
      </AdverseEvent>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Immunization/VaccinationExampleImmunization"/>
    <resource>
      <Immunization>
        <id value="VaccinationExampleImmunization"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization"/>
        </meta>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Immunization</b><a name="VaccinationExampleImmunization"> </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 Immunization &quot;VaccinationExampleImmunization&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-immunization.html">ICSR Immunization</a></p></div><p><b>AgeAtVaccination</b>: 12 years<span style="background: LightGoldenRodYellow"> (Details: UCUM code y = 'y')</span></p><p><b>status</b>: completed</p><p><b>vaccineCode</b>: 7046101903 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-ndc.html">National drug codes</a>#7046101903)</span></p><p><b>patient</b>: <a href="#Patient_VaccinationPatient">See above (Patient/VaccinationPatient)</a></p><p><b>occurrence</b>: 2017-04-23</p><p><b>primarySource</b>: false</p></div>
        </text>
        <extension
                   url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination">
          <valueAge>
            <value value="12"/>
            <unit value="years"/>
            <system value="http://unitsofmeasure.org"/>
            <code value="y"/>
          </valueAge>
        </extension>
        <status value="completed"/>
        <vaccineCode>
          <coding>
            <system value="http://hl7.org/fhir/sid/ndc"/>
            <code value="7046101903"/>
          </coding>
        </vaccineCode>
        <patient>
          <reference value="Patient/VaccinationPatient"/>
        </patient>
        <occurrenceDateTime value="2017-04-23"/>
        <primarySource value="false"/>
      </Immunization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="MedicationAdministration/VaccinationHydrocortisoneAdministration"/>
    <resource>
      <MedicationAdministration>
        <id value="VaccinationHydrocortisoneAdministration"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicationAdministration</b><a name="VaccinationHydrocortisoneAdministration"> </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 MedicationAdministration &quot;VaccinationHydrocortisoneAdministration&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-medicationadministration.html">ICSR MedicationAdministration</a></p></div><p><b>status</b>: completed</p><p><b>medication</b>: 197782 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-rxNorm.html">RxNorm</a>#197782)</span></p><p><b>subject</b>: <a href="#Patient_VaccinationPatient">See above (Patient/VaccinationPatient)</a></p><p><b>effective</b>: 2017-04-23</p></div>
        </text>
        <status value="completed"/>
        <medicationCodeableConcept>
          <coding>
            <system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
            <code value="197782"/>
          </coding>
        </medicationCodeableConcept>
        <subject>
          <reference value="Patient/VaccinationPatient"/>
        </subject>
        <effectiveDateTime value="2017-04-23"/>
      </MedicationAdministration>
    </resource>
  </entry>
</Bundle>