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 Sample ICSR Report - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "VaccinationExample"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<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>"
  ] ; # 
  fhir:extension ( [
    ( fhir:extension [
fhir:url [ fhir:v "availableFlag"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "localCriteriaFlag"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] [
fhir:url [ fhir:v "localCriteriaReportType"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2" ] ;
fhir:display [ fhir:v "Non-Expedited AE" ]         ] )       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport"^^xsd:anyURI ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.3"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1" ] ;
fhir:display [ fhir:v "Regulator" ]       ] )     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-05"^^xsd:date ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-05"^^xsd:date ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier"^^xsd:anyURI ] ;
fhir:value [
a fhir:Identifier ;
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.3.2"^^xsd:anyURI ] ;
fhir:value [ fhir:v "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" ]     ]
  ] ) ; # 
  fhir:identifier [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.3.1"^^xsd:anyURI ] ;
fhir:value [ fhir:v "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" ]
  ] ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
a loinc:85893-6 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "85893-6" ] ;
fhir:display [ fhir:v "Adverse event note" ]     ] )
  ] ; # 
  fhir:category ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.2"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1" ] ;
fhir:display [ fhir:v "Spontaneous report" ]     ] )
  ] ) ; # 
  fhir:subject [
fhir:reference [ fhir:v "Patient/VaccinationPatient" ]
  ] ; # 
  fhir:date [ fhir:v "2021-01-05T14:24:44+05:00"^^xsd:dateTime] ; # 
  fhir:author ( [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]     ] ) ;
fhir:reference [ fhir:v "PractitionerRole/VaccinationAuthorRole" ]
  ] ) ; # 
  fhir:title [ fhir:v "ICSR Submission"] ; # 
  fhir:section ( [
fhir:title [ fhir:v "Reaction/Event" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ReactionEvent" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>"     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "AdverseEvent/VaccinationExampleEvent" ]     ] )
  ] [
fhir:title [ fhir:v "Drug Information" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "DrugInformation" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">ED administration of influenza vaccine</div>"     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "Immunization/VaccinationExampleImmunization" ]     ] [
fhir:reference [ fhir:v "MedicationAdministration/VaccinationHydrocortisoneAdministration" ]     ] )
  ] [
fhir:title [ fhir:v "Case Summary Narrative" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "CaseSummaryNarrative" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<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>"     ]
  ] [
fhir:title [ fhir:v "Relevant Medical History" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "RelevantMedicalHistory" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Long term (current) use of anticoagulants</div>"     ]
  ] ) . #