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
@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 "VaccinationExample" </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>" ]
] ) . #
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.1 based on FHIR 4.0.1. Generated 2023-08-29
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