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 
@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:Bundle;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "ConnectathonVAERSBundle"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-bundle";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-bundle> ]
];
fhir:Bundle.identifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.22" ];
fhir:Identifier.value [ fhir:value "BATCH20210105142444-0500533f2636-a404-13c5-10e3-7d293893227a" ]
];
fhir:Bundle.type [ fhir:value "message"];
fhir:Bundle.timestamp [ fhir:value "2021-01-05T14:24:44-05:00"^^xsd:dateTime];
fhir:Bundle.entry [
fhir:index 0;
fhir:Bundle.entry.fullUrl [ fhir:value "MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" ];
fhir:Bundle.entry.resource <MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495>
], [
fhir:index 1;
fhir:Bundle.entry.fullUrl [ fhir:value "Composition/VAERSExample" ];
fhir:Bundle.entry.resource <Composition/VAERSExample>
], [
fhir:index 2;
fhir:Bundle.entry.fullUrl [ fhir:value "Organization/VAERSSender" ];
fhir:Bundle.entry.resource <Organization/VAERSSender>
], [
fhir:index 3;
fhir:Bundle.entry.fullUrl [ fhir:value "PractitionerRole/VAERSAuthorRole" ];
fhir:Bundle.entry.resource <PractitionerRole/VAERSAuthorRole>
], [
fhir:index 4;
fhir:Bundle.entry.fullUrl [ fhir:value "Practitioner/VAERSAuthor" ];
fhir:Bundle.entry.resource <Practitioner/VAERSAuthor>
], [
fhir:index 5;
fhir:Bundle.entry.fullUrl [ fhir:value "Patient/VAERSPatient" ];
fhir:Bundle.entry.resource <Patient/VAERSPatient>
], [
fhir:index 6;
fhir:Bundle.entry.fullUrl [ fhir:value "AdverseEvent/VAERSExampleEvent" ];
fhir:Bundle.entry.resource <AdverseEvent/VAERSExampleEvent>
], [
fhir:index 7;
fhir:Bundle.entry.fullUrl [ fhir:value "Immunization/VAERSExampleImmunization" ];
fhir:Bundle.entry.resource <Immunization/VAERSExampleImmunization>
], [
fhir:index 8;
fhir:Bundle.entry.fullUrl [ fhir:value "MedicationAdministration/VAERSHydrocortisoneAdministration" ];
fhir:Bundle.entry.resource <MedicationAdministration/VAERSHydrocortisoneAdministration>
].
<MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495> a fhir:MessageHeader;
fhir:Resource.id [ fhir:value "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"];
fhir:Resource.meta [
fhir:Meta.lastUpdated [ fhir:value "2021-01-05T14:24:44+05:00"^^xsd:dateTime ];
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-messageheader";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-messageheader> ]
];
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><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ActCode PAT_ADV_EVNT}\">Patient Adverse Event</span></p><h3>Destinations</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/CBERVAERS\">http://example.org/CBERVAERS</a></td></tr></table><p><b>sender</b>: <a href=\"#Organization_VAERSSender\">See above (Organization/VAERSSender)</a></p><h3>Sources</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/BEST-Pilot\">http://example.org/BEST-Pilot</a></td></tr></table><p><b>reason</b>: <span title=\"Codes: {http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents received-public-health-report}\">Indicates receipt of a public health report</span></p><p><b>focus</b>: <a href=\"#Composition_VAERSExample\">See above (Composition/VAERSExample)</a></p></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory" ];
fhir:Extension.valueCode [ fhir:value "notification" ]
];
fhir:MessageHeader.eventCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-ActCode" ];
fhir:Coding.code [ fhir:value "PAT_ADV_EVNT" ];
fhir:Coding.display [ fhir:value "Patient Adverse Event" ]
];
fhir:MessageHeader.destination [
fhir:index 0;
fhir:MessageHeader.destination.endpoint [ fhir:value "http://example.org/CBERVAERS" ]
];
fhir:MessageHeader.sender [
fhir:Reference.reference [ fhir:value "Organization/VAERSSender" ]
];
fhir:MessageHeader.source [
fhir:MessageHeader.source.endpoint [ fhir:value "http://example.org/BEST-Pilot" ]
];
fhir:MessageHeader.reason [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents" ];
fhir:Coding.code [ fhir:value "received-public-health-report" ] ]
];
fhir:MessageHeader.focus [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Composition/VAERSExample" ]
].
<Composition/VAERSExample> a fhir:Composition;
fhir:Resource.id [ fhir:value "VAERSExample"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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><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\">See above (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/ibm-fda-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/ibm-fda-icsr-ext-expeditedreport" ]
], [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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/ibm-fda-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/ibm-fda-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/ibm-fda-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/ibm-fda-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/ibm-fda-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>" ]
].
<Organization/VAERSSender> a fhir:Organization;
fhir:Resource.id [ fhir:value "VAERSSender"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization> ]
];
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><p><b>DepartmentName</b>: sender department</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 1}\">Pharmaceutical Company</span></p><p><b>name</b>: sender organization</p><p><b>telecom</b>: <a href=\"tel:+0112345678\">+01 123 456 78</a>, fax: +01 123 456 89, <a href=\"mailto:email@city.us\">email@city.us</a></p><p><b>address</b>: street city CA postcode US </p><h3>Contacts</h3><table class=\"grid\"><tr><td>-</td><td><b>Name</b></td></tr><tr><td>*</td><td>sender gname sender fname </td></tr></table></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-departmentname" ];
fhir:Extension.valueString [ fhir:value "sender department" ]
];
fhir:Organization.active [ fhir:value "true"^^xsd:boolean];
fhir:Organization.type [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.7" ];
fhir:Coding.code [ fhir:value "1" ];
fhir:Coding.display [ fhir:value "Pharmaceutical Company" ] ]
];
fhir:Organization.name [ fhir:value "sender organization"];
fhir:Organization.telecom [
fhir:index 0;
fhir:ContactPoint.system [ fhir:value "phone" ];
fhir:ContactPoint.value [ fhir:value "+01 123 456 78" ]
], [
fhir:index 1;
fhir:ContactPoint.system [ fhir:value "fax" ];
fhir:ContactPoint.value [ fhir:value "+01 123 456 89" ]
], [
fhir:index 2;
fhir:ContactPoint.system [ fhir:value "email" ];
fhir:ContactPoint.value [ fhir:value "email@city.us" ]
];
fhir:Organization.address [
fhir:index 0;
fhir:Address.line [
fhir:value "street";
fhir:index 0 ];
fhir:Address.city [ fhir:value "city" ];
fhir:Address.state [ fhir:value "CA" ];
fhir:Address.postalCode [ fhir:value "postcode" ];
fhir:Address.country [ fhir:value "US" ]
];
fhir:Organization.contact [
fhir:index 0;
fhir:Organization.contact.name [
fhir:HumanName.family [ fhir:value "sender fname" ];
fhir:HumanName.given [
fhir:value "sender gname";
fhir:index 0 ];
fhir:HumanName.prefix [
fhir:value "sender title";
fhir:index 0 ] ]
].
<PractitionerRole/VAERSAuthorRole> a fhir:PractitionerRole;
fhir:Resource.id [ fhir:value "VAERSAuthorRole"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitionerrole";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitionerrole> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>practitioner</b>: <a href=\"#Practitioner_VAERSAuthor\">See above (Practitioner/VAERSAuthor)</a></p><p><b>organization</b>: <a href=\"#Organization_VAERSSender\">See above (Organization/VAERSSender)</a></p><p><b>code</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span></p><p><b>telecom</b>: <a href=\"mailto:admin@admin.com\">admin@admin.com</a>, ph: 3333333333</p></div>"
];
fhir:PractitionerRole.practitioner [
fhir:Reference.reference [ fhir:value "Practitioner/VAERSAuthor" ]
];
fhir:PractitionerRole.organization [
fhir:Reference.reference [ fhir:value "Organization/VAERSSender" ]
];
fhir:PractitionerRole.code [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.6" ];
fhir:Coding.code [ fhir:value "1" ];
fhir:Coding.display [ fhir:value "Physician" ] ]
];
fhir:PractitionerRole.telecom [
fhir:index 0;
fhir:ContactPoint.system [ fhir:value "email" ];
fhir:ContactPoint.value [ fhir:value "admin@admin.com" ]
], [
fhir:index 1;
fhir:ContactPoint.system [ fhir:value "phone" ];
fhir:ContactPoint.value [ fhir:value "3333333333" ]
].
<Practitioner/VAERSAuthor> a fhir:Practitioner;
fhir:Resource.id [ fhir:value "VAERSAuthor"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitioner";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitioner> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: NI</p><p><b>name</b>: asdhj Admin </p><p><b>address</b>: US </p></div>"
];
fhir:Practitioner.identifier [
fhir:index 0;
fhir:Identifier.system [ fhir:value "http://hl7.org/fhir/sid/us-npi" ];
fhir:Identifier.value [ fhir:value "NI" ]
];
fhir:Practitioner.name [
fhir:index 0;
fhir:HumanName.family [ fhir:value "Admin" ];
fhir:HumanName.given [
fhir:value "asdhj";
fhir:index 0 ]
];
fhir:Practitioner.address [
fhir:index 0;
fhir:Address.country [ fhir:value "US" ]
].
<Patient/VAERSPatient> a fhir:Patient;
fhir:Resource.id [ fhir:value "VAERSPatient"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patient";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patient> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: 123456789</p><p><b>name</b>: FNAME LNAME </p><p><b>gender</b>: male</p><p><b>birthDate</b>: 1955-07-22</p></div>"
];
fhir:Patient.identifier [
fhir:index 0;
fhir:Identifier.system [ fhir:value "http://hl7.org/fhir/sid/us-ssn" ];
fhir:Identifier.value [ fhir:value "123456789" ]
];
fhir:Patient.name [
fhir:index 0;
fhir:HumanName.family [ fhir:value "LNAME" ];
fhir:HumanName.given [
fhir:value "FNAME";
fhir:index 0 ]
];
fhir:Patient.gender [ fhir:value "male"];
fhir:Patient.birthDate [ fhir:value "1955-07-22"^^xsd:date].
<AdverseEvent/VAERSExampleEvent> a fhir:AdverseEvent;
fhir:Resource.id [ fhir:value "VAERSExampleEvent"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-vaers-adverseevent";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-vaers-adverseevent> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>actuality</b>: actual</p><p><b>event</b>: <span title=\"Codes: {http://meddra.org 10004223}\">Bell's Palsy</span></p><p><b>subject</b>: <a href=\"#Patient_VAERSPatient\">See above (Patient/VAERSPatient)</a></p><p><b>date</b>: 2017-04-23</p><p><b>seriousness</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.19 26}\">26</span></p><p><b>outcome</b>: <span title=\"Codes: {http://terminology.hl7.org/CodeSystem/adverse-event-outcome recovering}\">Recovering</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#Immunization_VAERSExampleImmunization\">See above (Immunization/VAERSExampleImmunization)</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Suspect</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#MedicationAdministration_VAERSHydrocortisoneAdministration\">See above (MedicationAdministration/VAERSHydrocortisoneAdministration)</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Concomitant</td></tr></table></blockquote></div>"
];
fhir:AdverseEvent.actuality [ fhir:value "actual"];
fhir:AdverseEvent.event [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://meddra.org" ];
fhir:Coding.code [ fhir:value "10004223" ];
fhir:Coding.display [ fhir:value "Bell's Palsy" ] ]
];
fhir:AdverseEvent.subject [
fhir:Reference.reference [ fhir:value "Patient/VAERSPatient" ]
];
fhir:AdverseEvent.date [ fhir:value "2017-04-23"^^xsd:date];
fhir:AdverseEvent.seriousness [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.19" ];
fhir:Coding.code [ fhir:value "26" ] ]
];
fhir:AdverseEvent.outcome [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-outcome" ];
fhir:Coding.code [ fhir:value "recovering" ] ]
];
fhir:AdverseEvent.suspectEntity [
fhir:index 0;
fhir:AdverseEvent.suspectEntity.instance [
fhir:Reference.reference [ fhir:value "Immunization/VAERSExampleImmunization" ] ];
fhir:AdverseEvent.suspectEntity.causality [
fhir:index 0;
fhir:AdverseEvent.suspectEntity.causality.productRelatedness [ fhir:value "Suspect" ] ]
], [
fhir:index 1;
fhir:AdverseEvent.suspectEntity.instance [
fhir:Reference.reference [ fhir:value "MedicationAdministration/VAERSHydrocortisoneAdministration" ] ];
fhir:AdverseEvent.suspectEntity.causality [
fhir:index 0;
fhir:AdverseEvent.suspectEntity.causality.productRelatedness [ fhir:value "Concomitant" ] ]
].
<Immunization/VAERSExampleImmunization> a fhir:Immunization;
fhir:Resource.id [ fhir:value "VAERSExampleImmunization"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-immunization";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-immunization> ]
];
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><p><b>AgeAtVaccination</b>: 12 years</p><p><b>status</b>: completed</p><p><b>vaccineCode</b>: <span title=\"Codes: {http://hl7.org/fhir/sid/ndc 7046101903}\">7046101903</span></p><p><b>patient</b>: <a href=\"#Patient_VAERSPatient\">See above (Patient/VAERSPatient)</a></p><p><b>occurrence</b>: 2017-04-23</p><p><b>primarySource</b>: false</p></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageatvaccination" ];
fhir:Extension.valueAge [
fhir:Quantity.value [ fhir:value "12"^^xsd:decimal ];
fhir:Quantity.unit [ fhir:value "years" ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "y" ] ]
];
fhir:Immunization.status [ fhir:value "completed"];
fhir:Immunization.vaccineCode [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/sid/ndc" ];
fhir:Coding.code [ fhir:value "7046101903" ] ]
];
fhir:Immunization.patient [
fhir:Reference.reference [ fhir:value "Patient/VAERSPatient" ]
];
fhir:Immunization.occurrenceDateTime [ fhir:value "2017-04-23"^^xsd:date];
fhir:Immunization.primarySource [ fhir:value "false"^^xsd:boolean].
<MedicationAdministration/VAERSHydrocortisoneAdministration> a fhir:MedicationAdministration;
fhir:Resource.id [ fhir:value "VAERSHydrocortisoneAdministration"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>status</b>: completed</p><p><b>medication</b>: <span title=\"Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 197782}\">hydrocortisone 10 MG Oral Tablet</span></p><p><b>subject</b>: <a href=\"#Patient_VAERSPatient\">See above (Patient/VAERSPatient)</a></p><p><b>effective</b>: 2017-04-23</p></div>"
];
fhir:MedicationAdministration.status [ fhir:value "completed"];
fhir:MedicationAdministration.medicationCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://www.nlm.nih.gov/research/umls/rxnorm" ];
fhir:Coding.code [ fhir:value "197782" ] ]
];
fhir:MedicationAdministration.subject [
fhir:Reference.reference [ fhir:value "Patient/VAERSPatient" ]
];
fhir:MedicationAdministration.effectiveDateTime [ fhir:value "2017-04-23"^^xsd:date].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.
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
Links: Table of Contents |
QA Report
| Version History |
Search |
|
Propose a change