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 
{
"resourceType" : "Bundle",
"id" : "ConnectathonFAERSBundle",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle"
]
},
"type" : "message",
"entry" : [
{
"fullUrl" : "MessageHeader/beafb541-3eab-eb9e-1bf1-5fa477d56e77",
"resource" : {
"resourceType" : "MessageHeader",
"id" : "beafb541-3eab-eb9e-1bf1-5fa477d56e77",
"meta" : {
"lastUpdated" : "2021-01-05T14:14:39+06:00",
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader"
]
},
"text" : {
"status" : "extensions",
"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 \"beafb541-3eab-eb9e-1bf1-5fa477d56e77\" Updated \"2021-01-05T08:14:39Z\" </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>-</td><td><b>Endpoint</b></td><td><b>Receiver</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/ZZFDA\">http://example.org/ZZFDA</a></td><td><a href=\"#Organization_FDA\">See above (Organization/FDA)</a></td></tr></table><p><b>sender</b>: <a href=\"#Organization_BESTPrototype\">See above (Organization/BESTPrototype)</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>: 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_FAERSExample\">See above (Composition/FAERSExample)</a></p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory",
"valueCode" : "notification"
}
],
"eventCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v3-ActCode",
"code" : "PAT_ADV_EVNT",
"display" : "Patient Adverse Event"
},
"destination" : [
{
"endpoint" : "http://example.org/ZZFDA",
"receiver" : {
"reference" : "Organization/FDA"
}
}
],
"sender" : {
"reference" : "Organization/BESTPrototype"
},
"source" : {
"endpoint" : "http://example.org/BEST-Pilot"
},
"reason" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents",
"code" : "received-public-health-report"
}
]
},
"focus" : [
{
"reference" : "Composition/FAERSExample"
}
]
}
},
{
"fullUrl" : "Composition/FAERSExample",
"resource" : {
"resourceType" : "Composition",
"id" : "FAERSExample",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"
]
},
"text" : {
"status" : "extensions",
"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 \"FAERSExample\" </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>: Other <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</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: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</p><p><b>identifier</b>: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</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</p><p><b>author</b>: <a href=\"#PractitionerRole_BESTAuthorRole\">See above (PractitionerRole/BESTAuthorRole)</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/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" : "2",
"display" : "Non-Expedited AE"
}
]
}
}
],
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/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/icsr-ext-combinationproductreport",
"valueBoolean" : false
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate",
"valueDateTime" : "2021-01-05"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate",
"valueDateTime" : "2021-01-05"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier",
"valueIdentifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.2",
"value" : "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"
}
}
],
"identifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
"value" : "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"
},
"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/BESTPatient"
},
"date" : "2021-01-05",
"author" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource",
"valueBoolean" : true
}
],
"reference" : "PractitionerRole/BESTAuthorRole"
}
],
"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\">Allergic transfusion reaction</div>"
},
"entry" : [
{
"reference" : "AdverseEvent/FAERSExampleEvent"
}
]
},
{
"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\">Description code for blood products: E7003, Blood group and type: N/A Blood processing type: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:&lt;5E6|2nd container</div>"
},
"entry" : [
{
"reference" : "Procedure/FAERSExampleTransfusion"
},
{
"reference" : "MedicationAdministration/FAERSEpinephrine"
},
{
"reference" : "MedicationAdministration/FAERSDiphenhydramine"
}
]
},
{
"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\">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: Phenotype link: rules-cd BEST Certainty: Definite BEST Severity: Non-Severe BEST Imputability: Probable Form Type: 3500 Contact Method: Email Adverse Event: 1 Center to which the case is being routed to: CBER Whether the case is being sent to DQRS: false Whether the report is related to drugs or food/cosmetics: 1 Whether the blood report is of type Transfusion or Collection: 2 Patient Race Code: 2f, Blood group of patient: N/A, Onset location for reaction: MedStar Location Description code for blood products: N/A, Blood group and type: N/A Blood processing type: N/A Product available for evaluation: 2 Volume of transfusion: NI NHSN Workup: NI Preliminary investigation results: Developed rash &#38; stridor following transfusion prbc for anemia. Tx with benadryl &#38; epinephrine &#38; sx improved., Adverse Event Type Imputability: Blood Transfusion - Certainty: Definite; Notes: 1. notes, Eval+Plan Note, For admission to Hosp with Dx Anemia. Transfuse PRBC now., Date 20020109; 2. notes, Eval+Plan Note, Patient has developed a new maculopapular rash following transfusion. Will give Benadryl 25 mg., Date 20020109; 3. notes, Eval+Plan Note, New onset Stridor following transfusion. Will give Epinephrine .5mg, and do transfusion Rxn workup, Date 20020109; 4. notes, Eval+Plan Note, RN note - Administered Benadryl 25mg IV for skin sx. After 30 min pt. reports some improvement in skin symptoms, Date 20020109 Labs, Vitals, and Tests: 1. labs, Diastolic Blood Pressure, 75.918 mm[Hg], Date 20020109; 2. labs, Systolic Blood Pressure, 123.08 mm[Hg], Date 20020109; 3. labs, Physical findings of Skin, generalized rash, Date 20020109; 4. labs, Respiratory status finding, Stridor, Date 20020109; Illness at Time of Vaccination: 1. illness, Problem, Anemia, Date 20020109;</div>"
}
},
{
"title" : "Patient Information",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "PatientInformation"
}
]
},
"entry" : [
{
"reference" : "Observation/BESTPatientAgeGroup"
}
]
},
{
"title" : "Relevant Medical History",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "RelevantMedicalHistory"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">NI</div>"
}
}
]
}
},
{
"fullUrl" : "Organization/FDA",
"resource" : {
"resourceType" : "Organization",
"id" : "FDA",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageorganization"
]
},
"text" : {
"status" : "extensions",
"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 \"FDA\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-messageorganization.html\">MessageHeader Organization</a></p></div><p><b>DepartmentName</b>: Office of Surveillance and Epidemiology</p><p><b>active</b>: true</p><p><b>type</b>: Regulatory Authority <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</span></p><p><b>name</b>: FDA</p><p><b>telecom</b>: <a href=\"mailto:faersesub@fda.hhs.gov\">faersesub@fda.hhs.gov</a></p><p><b>address</b>: 10903 New Hampshire Avenue Silver Spring MD 20993 US </p><h3>Contacts</h3><table class=\"grid\"><tr><td>-</td><td><b>Name</b></td></tr><tr><td>*</td><td>FAERS </td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-departmentname",
"valueString" : "Office of Surveillance and Epidemiology"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.7",
"code" : "2",
"display" : "Regulatory Authority"
}
]
}
],
"name" : "FDA",
"telecom" : [
{
"system" : "email",
"value" : "faersesub@fda.hhs.gov"
}
],
"address" : [
{
"line" : [
"10903 New Hampshire Avenue"
],
"city" : "Silver Spring",
"state" : "MD",
"postalCode" : "20993",
"country" : "US"
}
],
"contact" : [
{
"name" : {
"given" : [
"FAERS"
]
}
}
]
}
},
{
"fullUrl" : "Organization/BESTPrototype",
"resource" : {
"resourceType" : "Organization",
"id" : "BESTPrototype",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageorganization"
]
},
"text" : {
"status" : "generated",
"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 \"BESTPrototype\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-messageorganization.html\">MessageHeader Organization</a></p></div><p><b>active</b>: true</p><p><b>name</b>: BEST-Prototype</p></div>"
},
"active" : true,
"name" : "BEST-Prototype"
}
},
{
"fullUrl" : "PractitionerRole/BESTAuthorRole",
"resource" : {
"resourceType" : "PractitionerRole",
"id" : "BESTAuthorRole",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitionerrole"
]
},
"text" : {
"status" : "generated",
"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 \"BESTAuthorRole\" </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_BESTAuthor\">See above (Practitioner/BESTAuthor)</a></p><p><b>organization</b>: <a href=\"#Organization_BESTPrototype\">See above (Organization/BESTPrototype)</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></p></div>"
},
"practitioner" : {
"reference" : "Practitioner/BESTAuthor"
},
"organization" : {
"reference" : "Organization/BESTPrototype"
},
"code" : [
{
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.6",
"code" : "1",
"display" : "Physician"
}
]
}
],
"telecom" : [
{
"system" : "email",
"value" : "admin@admin.com"
}
]
}
},
{
"fullUrl" : "Practitioner/BESTAuthor",
"resource" : {
"resourceType" : "Practitioner",
"id" : "BESTAuthor",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner"
]
},
"text" : {
"status" : "generated",
"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 \"BESTAuthor\" </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>: NI </p></div>"
},
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/us-npi",
"value" : "NI"
}
],
"name" : [
{
"family" : "NI"
}
]
}
},
{
"fullUrl" : "Patient/BESTPatient",
"resource" : {
"resourceType" : "Patient",
"id" : "BESTPatient",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient"
]
},
"text" : {
"status" : "generated",
"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 \"BESTPatient\" </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>: CM </p><p><b>gender</b>: female</p><p><b>birthDate</b>: 1999-06-24</p></div>"
},
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/us-ssn",
"value" : "123456789"
}
],
"name" : [
{
"family" : "CM"
}
],
"gender" : "female",
"birthDate" : "1999-06-24"
}
},
{
"fullUrl" : "Observation/BESTPatientAgeGroup",
"resource" : {
"resourceType" : "Observation",
"id" : "BESTPatientAgeGroup",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patientagegroup"
]
},
"text" : {
"status" : "generated",
"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 \"BESTPatientAgeGroup\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-patientagegroup.html\">Descriptive Age Group for the Patient</a></p></div><p><b>status</b>: final</p><p><b>code</b>: Age group <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#46251-5)</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>value</b>: Adult <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#5)</span></p></div>"
},
"status" : "final",
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "46251-5",
"display" : "Age group"
}
]
},
"subject" : {
"reference" : "Patient/BESTPatient"
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.9",
"code" : "5",
"display" : "Adult"
}
]
}
}
},
{
"fullUrl" : "AdverseEvent/FAERSExampleEvent",
"resource" : {
"resourceType" : "AdverseEvent",
"id" : "FAERSExampleEvent",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/faers-adverseevent"
]
},
"text" : {
"status" : "extensions",
"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 \"FAERSExampleEvent\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-faers-adverseevent.html\">FAERS Adverse Event</a></p></div><p><b>AgeAtTimeOfOnset</b>: 1 a<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code a = 'a')</span></p><p><b>actuality</b>: actual</p><p><b>event</b>: Allergic transfusion reaction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (meddra.org#10066173)</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>date</b>: 2000-01-01</p><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/3.0.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#serious)</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#Procedure_FAERSExampleTransfusion\">See above (Procedure/FAERSExampleTransfusion)</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\">See above (MedicationAdministration/FAERSEpinephrine)</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\">See above (MedicationAdministration/FAERSDiphenhydramine)</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/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/icsr-ext-eventenddate",
"valueDateTime" : "2019-01-20"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration",
"valueDuration" : {
"value" : 19.05,
"system" : "http://unitsofmeasure.org",
"code" : "a"
}
}
]
},
"seriousness" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "serious"
}
]
},
"suspectEntity" : [
{
"instance" : {
"reference" : "Procedure/FAERSExampleTransfusion"
},
"causality" : [
{
"productRelatedness" : "Suspect"
}
]
},
{
"instance" : {
"reference" : "MedicationAdministration/FAERSEpinephrine"
},
"causality" : [
{
"productRelatedness" : "Concomitant"
}
]
},
{
"instance" : {
"reference" : "MedicationAdministration/FAERSDiphenhydramine"
},
"causality" : [
{
"productRelatedness" : "Concomitant"
}
]
}
]
}
},
{
"fullUrl" : "Procedure/FAERSExampleTransfusion",
"resource" : {
"resourceType" : "Procedure",
"id" : "FAERSExampleTransfusion",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-transfusion"
]
},
"text" : {
"status" : "extensions",
"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 \"FAERSExampleTransfusion\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-transfusion.html\">ICSR Transfusion</a></p></div><p><b>UsedProductAmount</b>: 1 unit<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code {unit} = '{unit}')</span></p><p><b>status</b>: completed</p><p><b>code</b>: 36430 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/3.0.0/CodeSystem-CPT.html\">Current Procedural Terminology (CPT®)</a>#36430)</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>performed</b>: 2002-01-09</p><p><b>usedReference</b>: <span>: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container</span></p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-usedproductamount",
"valueQuantity" : {
"value" : 1,
"unit" : "unit",
"system" : "http://unitsofmeasure.org",
"code" : "{unit}"
}
}
],
"status" : "completed",
"code" : {
"coding" : [
{
"system" : "http://www.ama-assn.org/go/cpt",
"code" : "36430"
}
]
},
"subject" : {
"reference" : "Patient/BESTPatient"
},
"performedDateTime" : "2002-01-09",
"usedReference" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-usedproduct",
"valueReference" : {
"reference" : "BiologicallyDerivedProduct/FAERSBloodProduct"
}
}
],
"display" : "Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container"
}
]
}
},
{
"fullUrl" : "BiologicallyDerivedProduct/FAERSBloodProduct",
"resource" : {
"resourceType" : "BiologicallyDerivedProduct",
"id" : "FAERSBloodProduct",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bloodproduct"
]
},
"text" : {
"status" : "generated",
"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 \"FAERSBloodProduct\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-bloodproduct.html\">ICSR Blood Product</a></p></div><p><b>productCategory</b>: cells</p><p><b>productCode</b>: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterminology#E7003)</span></p><h3>Collections</h3><table class=\"grid\"><tr><td>-</td><td><b>Extension</b></td></tr><tr><td>*</td><td></td></tr></table></div>"
},
"productCategory" : "cells",
"productCode" : {
"coding" : [
{
"system" : "https://iccbba.org/standardterminology",
"code" : "E7003",
"display" : "Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container"
}
]
},
"collection" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-donationIdentificationNumber",
"valueIdentifier" : {
"system" : "http://example.org/bloodDonationNumber",
"value" : "G101610840386"
}
}
]
}
}
},
{
"fullUrl" : "MedicationAdministration/FAERSEpinephrine",
"resource" : {
"resourceType" : "MedicationAdministration",
"id" : "FAERSEpinephrine",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration"
]
},
"text" : {
"status" : "generated",
"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 \"FAERSEpinephrine\" </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>: Epinephrine <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/3.0.0/CodeSystem-v3-rxNorm.html\">RxNorm</a>#3992)</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>effective</b>: 2002-01-09</p></div>"
},
"status" : "completed",
"medicationCodeableConcept" : {
"coding" : [
{
"system" : "http://www.nlm.nih.gov/research/umls/rxnorm",
"code" : "3992",
"display" : "Epinephrine"
}
]
},
"subject" : {
"reference" : "Patient/BESTPatient"
},
"effectiveDateTime" : "2002-01-09"
}
},
{
"fullUrl" : "MedicationAdministration/FAERSDiphenhydramine",
"resource" : {
"resourceType" : "MedicationAdministration",
"id" : "FAERSDiphenhydramine",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration"
]
},
"text" : {
"status" : "generated",
"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 \"FAERSDiphenhydramine\" </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>: Diphenhydramine <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/3.0.0/CodeSystem-v3-rxNorm.html\">RxNorm</a>#3498)</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>effective</b>: 2002-01-09</p></div>"
},
"status" : "completed",
"medicationCodeableConcept" : {
"coding" : [
{
"system" : "http://www.nlm.nih.gov/research/umls/rxnorm",
"code" : "3498",
"display" : "Diphenhydramine"
}
]
},
"subject" : {
"reference" : "Patient/BESTPatient"
},
"effectiveDateTime" : "2002-01-09"
}
}
]
}
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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