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 
{
"resourceType" : "Composition",
"id" : "SampleVAERSReport",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition"
]
},
"text" : {
"status" : "extensions",
"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 C53578}\">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 2}\">Other</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: Feb 10, 2020 10:18:00 PM</p><p><b>MostRecentDate</b>: Feb 10, 2020 10:18:00 PM</p><p><b>CaseIdentifier</b>: id: US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee</p><p><b>PreviousCaseIdentifier</b>: id: Other-case-identifier</p><blockquote><p><b>ReportAmendment</b></p><p><b>value</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.5 2}\">2</span></p><p><b>value</b>: Fixed some identifiers</p></blockquote><p><b>identifier</b>: id: US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a</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>: Feb 10, 2020 10:18:00 PM</p><p><b>author</b>: <a href=\"PractitionerRole-SampleAuthorRole.html\">Generated Summary: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span>; joe@anywhere.com</a></p><p><b>title</b>: ICSR Submission</p></div>"
},
"extension" : [
{
"extension" : [
{
"url" : "availableFlag",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation"
},
{
"extension" : [
{
"url" : "localCriteriaFlag",
"valueBoolean" : false
},
{
"url" : "localCriteriaReportType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003",
"code" : "C53578",
"display" : "Non-Expedited AE"
}
]
}
}
],
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.3",
"code" : "2",
"display" : "Other"
}
]
}
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport",
"valueBoolean" : false
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate",
"valueDateTime" : "2020-02-10T17:18:00-05:00"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate",
"valueDateTime" : "2020-02-10T17:18:00-05:00"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier",
"valueIdentifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.2",
"value" : "US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee"
}
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-previouscaseidentifier",
"valueIdentifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.3",
"value" : "Other-case-identifier",
"assigner" : {
"display" : "Case identifier source name"
}
}
},
{
"extension" : [
{
"url" : "amendmentType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.5",
"code" : "2"
}
]
}
},
{
"url" : "amendmentReason",
"valueString" : "Fixed some identifiers"
}
],
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-reportamendment"
}
],
"identifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
"value" : "US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a"
},
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "85893-6",
"display" : "Adverse event note"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.2",
"code" : "1",
"display" : "Spontaneous report"
}
]
}
],
"subject" : {
"reference" : "Patient/SampleICSRPatient"
},
"date" : "2020-02-10T17:18:00-05:00",
"author" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource",
"valueBoolean" : true
}
],
"reference" : "PractitionerRole/SampleAuthorRole"
}
],
"title" : "ICSR Submission",
"section" : [
{
"title" : "Reaction/Event",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "ReactionEvent"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No events</div>"
}
},
{
"title" : "Drug Information",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "DrugInformation"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No drugs taken</div>"
}
},
{
"title" : "Case Summary Narrative",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "CaseSummaryNarrative"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div>No adverse event happened. Not sure why I'm sending this report.</div><div lang=\"fr\">il n'y a eu aucun événement indésirable</div></div>"
}
}
]
}
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