HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1
HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "VAERSExample" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-composition.html">ICSR Composition</a></p></div><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>: 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>: 2021-01-05T14:24:44+05:00</p><p><b>author</b>: <a href="PractitionerRole-VAERSAuthorRole.html">PractitionerRole/VAERSAuthorRole</a></p><p><b>title</b>: ICSR Submission</p></div>
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<extension
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<extension url="localCriteriaFlag">
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<extension url="localCriteriaReportType">
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<display value="Regulator"/>
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url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport">
<valueBoolean value="false"/>
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<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate">
<valueDateTime value="2021-01-05"/>
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<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate">
<valueDateTime value="2021-01-05"/>
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<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"/>
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<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"/>
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<status value="final"/>
<type>
<coding>
<system value="http://loinc.org"/>
<code value="85893-6"/>
<display value="Adverse event note"/>
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<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"/>
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<date value="2021-01-05T14:24:44+05:00"/>
<author>
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url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource">
<valueBoolean value="true"/>
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<reference value="PractitionerRole/VAERSAuthorRole"/>
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<title value="ICSR Submission"/>
<section>
<title value="Reaction/Event"/>
<code>
<coding>
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<code value="ReactionEvent"/>
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<div xmlns="http://www.w3.org/1999/xhtml">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>
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<entry>
<reference value="AdverseEvent/VAERSExampleEvent"/>
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<section>
<title value="Drug Information"/>
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<coding>
<system
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<code value="DrugInformation"/>
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<div xmlns="http://www.w3.org/1999/xhtml">ED administration of influenza vaccine</div>
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<entry>
<reference value="Immunization/VAERSExampleImmunization"/>
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<entry>
<reference
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<section>
<title value="Case Summary Narrative"/>
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<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>
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<section>
<title value="Relevant Medical History"/>
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<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="RelevantMedicalHistory"/>
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">Long term (current) use of anticoagulants</div>
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IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.0 based on FHIR 4.0.1. Generated 2022-01-19
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