HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
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 
<Composition xmlns="http://hl7.org/fhir">
<id value="VAERSExample"/>
<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 2}">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 1}">Regulator</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>: <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>: Jan 5, 2021 9:24:44 AM</p><p><b>author</b>: <a href="PractitionerRole-VAERSAuthorRole.html">Generated Summary: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}">Physician</span>; admin@admin.com, Phone: 3333333333</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="2"/>
<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="1"/>
<display value="Regulator"/>
</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="2021-01-05"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate">
<valueDateTime value="2021-01-05"/>
</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-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/VAERSPatient"/>
</subject>
<date value="2021-01-05T14:24:44+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/VAERSAuthorRole"/>
</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/VAERSExampleEvent"/>
</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/VAERSExampleImmunization"/>
</entry>
<entry>
<reference
value="MedicationAdministration/VAERSHydrocortisoneAdministration"/>
</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>
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#0.1.0 based on FHIR 4.0.1. Generated 2021-08-05
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