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" : "AdverseEvent",
"id" : "FAERSExampleEvent",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-faers-adverseevent"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>AgeAtTimeOfOnset</b>: 1 a</p><p><b>actuality</b>: actual</p><p><b>event</b>: <span title=\"Codes: {http://meddra.org 10066173}\">Allergic transfusion reaction</span></p><p><b>subject</b>: <a href=\"Patient-BESTPatient.html\">Generated Summary: id: 123456789; CM ; gender: female; birthDate: 1999-06-24</a></p><p><b>date</b>: 2000-01-01</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"Procedure-FAERSExampleTransfusion.html\">Generated Summary: status: completed; <span title=\"Codes: {http://www.ama-assn.org/go/cpt 36430}\">36430</span>; performed: 2002-01-09</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-FAERSEpinephrine.html\">Generated Summary: status: completed; <span title=\"Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 3992}\">Epinephrine</span>; effective: 2002-01-09</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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-FAERSDiphenhydramine.html\">Generated Summary: status: completed; <span title=\"Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 3498}\">Diphenhydramine</span>; effective: 2002-01-09</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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageattimeofonset",
"valueAge" : {
"value" : 1,
"system" : "http://unitsofmeasure.org",
"code" : "a"
}
}
],
"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "http://meddra.org",
"code" : "10066173",
"display" : "Allergic transfusion reaction"
}
]
},
"subject" : {
"reference" : "Patient/BESTPatient"
},
"date" : "2000-01-01",
"_date" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventenddate",
"valueDateTime" : "2019-01-20"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventduration",
"valueDuration" : {
"value" : 19.05,
"system" : "http://unitsofmeasure.org",
"code" : "a"
}
}
]
},
"suspectEntity" : [
{
"instance" : {
"reference" : "Procedure/FAERSExampleTransfusion"
},
"causality" : [
{
"productRelatedness" : "Suspect"
}
]
},
{
"instance" : {
"reference" : "MedicationAdministration/FAERSEpinephrine"
},
"causality" : [
{
"productRelatedness" : "Concomitant"
}
]
},
{
"instance" : {
"reference" : "MedicationAdministration/FAERSDiphenhydramine"
},
"causality" : [
{
"productRelatedness" : "Concomitant"
}
]
}
]
}