HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. 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:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "ConnectathonVaccinationBundle"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle> ] ) ] ; # fhir:identifier [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.3.22"^^xsd:anyURI ] ; fhir:value [ fhir:v "BATCH20210105142444-0500533f2636-a404-13c5-10e3-7d293893227a" ] ] ; # fhir:type [ fhir:v "message"] ; # fhir:timestamp [ fhir:v "2021-01-05T14:24:44-05:00"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"^^xsd:anyURI ] ; ( fhir:resource <MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495> ) ] [ fhir:fullUrl [ fhir:v "Composition/VaccinationExample"^^xsd:anyURI ] ; ( fhir:resource <Composition/VaccinationExample> ) ] [ fhir:fullUrl [ fhir:v "Organization/VaccinationSender"^^xsd:anyURI ] ; ( fhir:resource <Organization/VaccinationSender> ) ] [ fhir:fullUrl [ fhir:v "PractitionerRole/VaccinationAuthorRole"^^xsd:anyURI ] ; ( fhir:resource <PractitionerRole/VaccinationAuthorRole> ) ] [ fhir:fullUrl [ fhir:v "Practitioner/VaccinationAuthor"^^xsd:anyURI ] ; ( fhir:resource <Practitioner/VaccinationAuthor> ) ] [ fhir:fullUrl [ fhir:v "Patient/VaccinationPatient"^^xsd:anyURI ] ; ( fhir:resource <Patient/VaccinationPatient> ) ] [ fhir:fullUrl [ fhir:v "AdverseEvent/VaccinationExampleEvent"^^xsd:anyURI ] ; ( fhir:resource <AdverseEvent/VaccinationExampleEvent> ) ] [ fhir:fullUrl [ fhir:v "Immunization/VaccinationExampleImmunization"^^xsd:anyURI ] ; ( fhir:resource <Immunization/VaccinationExampleImmunization> ) ] [ fhir:fullUrl [ fhir:v "MedicationAdministration/VaccinationHydrocortisoneAdministration"^^xsd:anyURI ] ; ( fhir:resource <MedicationAdministration/VaccinationHydrocortisoneAdministration> ) ] ) . # <MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495> a fhir:MessageHeader ; fhir:id [ fhir:v "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"] ; # fhir:meta [ fhir:lastUpdated [ fhir:v "2021-01-05T14:24:44+05:00"^^xsd:dateTime ] ; ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MessageHeader</b><a name=\"US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495\"> </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 MessageHeader "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" Updated "2021-01-05 14:24:44+0500" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-messageheader.html\">ICSR MessageHeader</a></p></div><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: Patient Adverse Event (Details: http://terminology.hl7.org/CodeSystem/v3-ActCode code PAT_ADV_EVNT = 'patient adverse event', stated as 'Patient Adverse Event')</p><h3>Destinations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Endpoint</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"http://example.org/CBERVaccination\">http://example.org/CBERVaccination</a></td></tr></table><p><b>sender</b>: <a href=\"#Organization_VaccinationSender\">See above (Organization/VaccinationSender)</a></p><h3>Sources</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Endpoint</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"http://example.org/BEST-Pilot\">http://example.org/BEST-Pilot</a></td></tr></table><p><b>reason</b>: Indicates receipt of a public health report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/us/medmorph/2021Jan/CodeSystem-us-ph-triggerdefinition-namedevents.html\">US Public Health TriggerDefinition Named Events</a>#received-public-health-report)</span></p><p><b>focus</b>: <a href=\"#Composition_VaccinationExample\">See above (Composition/VaccinationExample)</a></p></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory"^^xsd:anyURI ] ; fhir:value [ fhir:v "notification" ] ] ) ; # fhir:event [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-ActCode"^^xsd:anyURI ] ; fhir:code [ fhir:v "PAT_ADV_EVNT" ] ; fhir:display [ fhir:v "Patient Adverse Event" ] ] ; # fhir:destination ( [ fhir:endpoint [ fhir:v "http://example.org/CBERVaccination"^^xsd:anyURI ] ] ) ; # fhir:sender [ fhir:reference [ fhir:v "Organization/VaccinationSender" ] ] ; # fhir:source [ fhir:endpoint [ fhir:v "http://example.org/BEST-Pilot"^^xsd:anyURI ] ] ; # fhir:reason [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents"^^xsd:anyURI ] ; fhir:code [ fhir:v "received-public-health-report" ] ] ) ] ; # fhir:focus ( [ fhir:reference [ fhir:v "Composition/VaccinationExample" ] ] ) . # <Composition/VaccinationExample> a fhir:Composition ; 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\">See above (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>" ] ] ) . # <Organization/VaccinationSender> a fhir:Organization ; fhir:id [ fhir:v "VaccinationSender"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageorganization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageorganization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"VaccinationSender\"> </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 Organization "VaccinationSender" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-messageorganization.html\">MessageHeader Organization</a></p></div><p><b>DepartmentName</b>: sender department</p><p><b>active</b>: true</p><p><b>type</b>: Pharmaceutical Company <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#1)</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 style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>sender gname sender fname </td></tr></table></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-departmentname"^^xsd:anyURI ] ; fhir:value [ fhir:v "sender department" ] ] ) ; # fhir:active [ fhir:v "true"^^xsd:boolean] ; # fhir:type ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.7"^^xsd:anyURI ] ; fhir:code [ fhir:v "1" ] ; fhir:display [ fhir:v "Pharmaceutical Company" ] ] ) ] ) ; # fhir:name [ fhir:v "sender organization"] ; # fhir:telecom ( [ fhir:system [ fhir:v "phone" ] ; fhir:value [ fhir:v "+01 123 456 78" ] ] [ fhir:system [ fhir:v "fax" ] ; fhir:value [ fhir:v "+01 123 456 89" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "email@city.us" ] ] ) ; # fhir:address ( [ ( fhir:line [ fhir:v "street" ] ) ; fhir:city [ fhir:v "city" ] ; fhir:state [ fhir:v "CA" ] ; fhir:postalCode [ fhir:v "postcode" ] ; fhir:country [ fhir:v "US" ] ] ) ; # fhir:contact ( [ fhir:name [ fhir:family [ fhir:v "sender fname" ] ; ( fhir:given [ fhir:v "sender gname" ] ) ; ( fhir:prefix [ fhir:v "sender title" ] ) ] ] ) . # <PractitionerRole/VaccinationAuthorRole> a fhir:PractitionerRole ; fhir:id [ fhir:v "VaccinationAuthorRole"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitionerrole"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitionerrole> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PractitionerRole</b><a name=\"VaccinationAuthorRole\"> </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 PractitionerRole "VaccinationAuthorRole" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-authorpractitionerrole.html\">PractitionerRole Author</a></p></div><p><b>practitioner</b>: <a href=\"#Practitioner_VaccinationAuthor\">See above (Practitioner/VaccinationAuthor)</a></p><p><b>organization</b>: <a href=\"#Organization_VaccinationSender\">See above (Organization/VaccinationSender)</a></p><p><b>code</b>: Physician <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#1)</span></p><p><b>telecom</b>: <a href=\"mailto:admin@admin.com\">admin@admin.com</a>, ph: 3333333333</p></div>" ] ; # fhir:practitioner [ fhir:reference [ fhir:v "Practitioner/VaccinationAuthor" ] ] ; # fhir:organization [ fhir:reference [ fhir:v "Organization/VaccinationSender" ] ] ; # fhir:code ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.6"^^xsd:anyURI ] ; fhir:code [ fhir:v "1" ] ; fhir:display [ fhir:v "Physician" ] ] ) ] ) ; # fhir:telecom ( [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "admin@admin.com" ] ] [ fhir:system [ fhir:v "phone" ] ; fhir:value [ fhir:v "3333333333" ] ] ) . # <Practitioner/VaccinationAuthor> a fhir:Practitioner ; fhir:id [ fhir:v "VaccinationAuthor"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Practitioner</b><a name=\"VaccinationAuthor\"> </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 Practitioner "VaccinationAuthor" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-authorpractitioner.html\">Practitioner Author</a></p></div><p><b>identifier</b>: id: NI</p><p><b>name</b>: asdhj Admin </p><p><b>address</b>: US </p></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://hl7.org/fhir/sid/us-npi"^^xsd:anyURI ] ; fhir:value [ fhir:v "NI" ] ] ) ; # fhir:name ( [ fhir:family [ fhir:v "Admin" ] ; ( fhir:given [ fhir:v "asdhj" ] ) ] ) ; # fhir:address ( [ fhir:country [ fhir:v "US" ] ] ) . # <Patient/VaccinationPatient> a fhir:Patient ; fhir:id [ fhir:v "VaccinationPatient"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Patient</b><a name=\"VaccinationPatient\"> </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 Patient "VaccinationPatient" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-patient.html\">ICSR Patient</a></p></div><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:identifier ( [ fhir:system [ fhir:v "http://hl7.org/fhir/sid/us-ssn"^^xsd:anyURI ] ; fhir:value [ fhir:v "123456789" ] ] ) ; # fhir:name ( [ fhir:family [ fhir:v "LNAME" ] ; ( fhir:given [ fhir:v "FNAME" ] ) ] ) ; # fhir:gender [ fhir:v "male"] ; # fhir:birthDate [ fhir:v "1955-07-22"^^xsd:date] . # <AdverseEvent/VaccinationExampleEvent> a fhir:AdverseEvent ; fhir:id [ fhir:v "VaccinationExampleEvent"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/vaccination-adverseevent"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/vaccination-adverseevent> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"VaccinationExampleEvent\"> </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 AdverseEvent "VaccinationExampleEvent" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-vaccination-adverseevent.html\">Vaccination Adverse Event</a></p></div><p><b>actuality</b>: actual</p><p><b>event</b>: Bell's Palsy <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (meddra.org#10004223)</span></p><p><b>subject</b>: <a href=\"#Patient_VaccinationPatient\">See above (Patient/VaccinationPatient)</a></p><p><b>date</b>: 2017-04-23</p><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: Recovering <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R4/codesystem-adverse-event-outcome.html\">AdverseEventOutcome</a>#recovering)</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#Immunization_VaccinationExampleImmunization\">See above (Immunization/VaccinationExampleImmunization)</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ProductRelatedness</b></td></tr><tr><td style=\"display: none\">*</td><td>Suspect</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#MedicationAdministration_VaccinationHydrocortisoneAdministration\">See above (MedicationAdministration/VaccinationHydrocortisoneAdministration)</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ProductRelatedness</b></td></tr><tr><td style=\"display: none\">*</td><td>Concomitant</td></tr></table></blockquote></div>" ] ; # fhir:actuality [ fhir:v "actual"] ; # fhir:event [ ( fhir:coding [ fhir:system [ fhir:v "http://meddra.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "10004223" ] ; fhir:display [ fhir:v "Bell's Palsy" ] ] ) ] ; # fhir:subject [ fhir:reference [ fhir:v "Patient/VaccinationPatient" ] ] ; # fhir:date [ fhir:v "2017-04-23"^^xsd:date] ; # fhir:seriousness [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.19"^^xsd:anyURI ] ; fhir:code [ fhir:v "26" ] ] ) ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"^^xsd:anyURI ] ; fhir:code [ fhir:v "serious" ] ] ) ] ; # fhir:outcome [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-outcome"^^xsd:anyURI ] ; fhir:code [ fhir:v "recovering" ] ] ) ] ; # fhir:suspectEntity ( [ fhir:instance [ fhir:reference [ fhir:v "Immunization/VaccinationExampleImmunization" ] ] ; ( fhir:causality [ fhir:productRelatedness [ fhir:v "Suspect" ] ] ) ] [ fhir:instance [ fhir:reference [ fhir:v "MedicationAdministration/VaccinationHydrocortisoneAdministration" ] ] ; ( fhir:causality [ fhir:productRelatedness [ fhir:v "Concomitant" ] ] ) ] ) . # <Immunization/VaccinationExampleImmunization> a fhir:Immunization ; fhir:id [ fhir:v "VaccinationExampleImmunization"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Immunization</b><a name=\"VaccinationExampleImmunization\"> </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 Immunization "VaccinationExampleImmunization" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-immunization.html\">ICSR Immunization</a></p></div><p><b>AgeAtVaccination</b>: 12 years<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code y = 'y')</span></p><p><b>status</b>: completed</p><p><b>vaccineCode</b>: 7046101903 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-ndc.html\">National drug codes</a>#7046101903)</span></p><p><b>patient</b>: <a href=\"#Patient_VaccinationPatient\">See above (Patient/VaccinationPatient)</a></p><p><b>occurrence</b>: 2017-04-23</p><p><b>primarySource</b>: false</p></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination"^^xsd:anyURI ] ; fhir:value [ a fhir:Age ; fhir:value [ fhir:v "12"^^xsd:decimal ] ; fhir:unit [ fhir:v "years" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "y" ] ] ] ) ; # fhir:status [ fhir:v "completed"] ; # fhir:vaccineCode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/sid/ndc"^^xsd:anyURI ] ; fhir:code [ fhir:v "7046101903" ] ] ) ] ; # fhir:patient [ fhir:reference [ fhir:v "Patient/VaccinationPatient" ] ] ; # fhir:occurrence [ fhir:v "2017-04-23"^^xsd:date] ; # fhir:primarySource [ fhir:v "false"^^xsd:boolean] . # <MedicationAdministration/VaccinationHydrocortisoneAdministration> a fhir:MedicationAdministration ; fhir:id [ fhir:v "VaccinationHydrocortisoneAdministration"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicationAdministration</b><a name=\"VaccinationHydrocortisoneAdministration\"> </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 MedicationAdministration "VaccinationHydrocortisoneAdministration" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-medicationadministration.html\">ICSR MedicationAdministration</a></p></div><p><b>status</b>: completed</p><p><b>medication</b>: 197782 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-rxNorm.html\">RxNorm</a>#197782)</span></p><p><b>subject</b>: <a href=\"#Patient_VaccinationPatient\">See above (Patient/VaccinationPatient)</a></p><p><b>effective</b>: 2017-04-23</p></div>" ] ; # fhir:status [ fhir:v "completed"] ; # fhir:medication [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://www.nlm.nih.gov/research/umls/rxnorm"^^xsd:anyURI ] ; fhir:code [ fhir:v "197782" ] ] ) ] ; # fhir:subject [ fhir:reference [ fhir:v "Patient/VaccinationPatient" ] ] ; # fhir:effective [ fhir:v "2017-04-23"^^xsd:date] . #
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.1 based on FHIR 4.0.1. Generated 2023-08-30
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