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 
@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <http://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:Resource.id [ fhir:value "VAERSExample"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "extensions" ];
fhir:Narrative.div "<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>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "availableFlag" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ] ];
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation" ]
], [
fhir:index 1;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "localCriteriaFlag" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ] ], [
fhir:index 1;
fhir:Extension.url [ fhir:value "localCriteriaReportType" ];
fhir:Extension.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003" ];
fhir:Coding.code [ fhir:value "2" ];
fhir:Coding.display [ fhir:value "Non-Expedited AE" ] ] ] ];
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport" ]
], [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype" ];
fhir:Extension.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.3" ];
fhir:Coding.code [ fhir:value "1" ];
fhir:Coding.display [ fhir:value "Regulator" ] ] ]
], [
fhir:index 3;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ]
], [
fhir:index 4;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate" ];
fhir:Extension.valueDateTime [ fhir:value "2021-01-05"^^xsd:date ]
], [
fhir:index 5;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate" ];
fhir:Extension.valueDateTime [ fhir:value "2021-01-05"^^xsd:date ]
], [
fhir:index 6;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier" ];
fhir:Extension.valueIdentifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.2" ];
fhir:Identifier.value [ fhir:value "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" ] ]
];
fhir:Composition.identifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.1" ];
fhir:Identifier.value [ fhir:value "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" ]
];
fhir:Composition.status [ fhir:value "final"];
fhir:Composition.type [
fhir:CodeableConcept.coding [
fhir:index 0;
a loinc:85893-6;
fhir:Coding.system [ fhir:value "http://loinc.org" ];
fhir:Coding.code [ fhir:value "85893-6" ];
fhir:Coding.display [ fhir:value "Adverse event note" ] ]
];
fhir:Composition.category [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.2" ];
fhir:Coding.code [ fhir:value "1" ];
fhir:Coding.display [ fhir:value "Spontaneous report" ] ]
];
fhir:Composition.subject [
fhir:Reference.reference [ fhir:value "Patient/VAERSPatient" ]
];
fhir:Composition.date [ fhir:value "2021-01-05T14:24:44+05:00"^^xsd:dateTime];
fhir:Composition.author [
fhir:index 0;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource" ];
fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ] ];
fhir:Reference.reference [ fhir:value "PractitionerRole/VAERSAuthorRole" ]
];
fhir:Composition.title [ fhir:value "ICSR Submission"];
fhir:Composition.section [
fhir:index 0;
fhir:Composition.section.title [ fhir:value "Reaction/Event" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "ReactionEvent" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>" ];
fhir:Composition.section.entry [
fhir:index 0;
fhir:Reference.reference [ fhir:value "AdverseEvent/VAERSExampleEvent" ] ]
], [
fhir:index 1;
fhir:Composition.section.title [ fhir:value "Drug Information" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "DrugInformation" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">ED administration of influenza vaccine</div>" ];
fhir:Composition.section.entry [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Immunization/VAERSExampleImmunization" ] ], [
fhir:index 1;
fhir:Reference.reference [ fhir:value "MedicationAdministration/VAERSHydrocortisoneAdministration" ] ]
], [
fhir:index 2;
fhir:Composition.section.title [ fhir:value "Case Summary Narrative" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "CaseSummaryNarrative" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.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:index 3;
fhir:Composition.section.title [ fhir:value "Relevant Medical History" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "RelevantMedicalHistory" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Long term (current) use of anticoagulants</div>" ]
].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.
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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