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
{
"resourceType" : "Bundle",
"id" : "ConnectathonVaccinationBundle",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle"
]
},
"identifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.22",
"value" : "BATCH20210105142444-0500533f2636-a404-13c5-10e3-7d293893227a"
},
"type" : "message",
"timestamp" : "2021-01-05T14:24:44-05:00",
"entry" : [
{
"fullUrl" : "MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495",
"resource" : {
"resourceType" : "MessageHeader",
"id" : "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495",
"meta" : {
"lastUpdated" : "2021-01-05T14:24:44+05:00",
"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: 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>"
},
"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/CBERVaccination"
}
],
"sender" : {
"reference" : "Organization/VaccinationSender"
},
"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/VaccinationExample"
}
]
}
},
{
"fullUrl" : "Composition/VaccinationExample",
"resource" : {
"resourceType" : "Composition",
"id" : "VaccinationExample",
"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: 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:\u00a0US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495</p><p><b>identifier</b>: id:\u00a0US-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>"
},
"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" : "1",
"display" : "Regulator"
}
]
}
},
{
"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" : "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"
}
}
],
"identifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
"value" : "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"
},
"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/VaccinationPatient"
},
"date" : "2021-01-05T14:24:44+05:00",
"author" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource",
"valueBoolean" : true
}
],
"reference" : "PractitionerRole/VaccinationAuthorRole"
}
],
"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\">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>"
},
"entry" : [
{
"reference" : "AdverseEvent/VaccinationExampleEvent"
}
]
},
{
"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\">ED administration of influenza vaccine</div>"
},
"entry" : [
{
"reference" : "Immunization/VaccinationExampleImmunization"
},
{
"reference" : "MedicationAdministration/VaccinationHydrocortisoneAdministration"
}
]
},
{
"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: 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>"
}
},
{
"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\">Long term (current) use of anticoagulants</div>"
}
}
]
}
},
{
"fullUrl" : "Organization/VaccinationSender",
"resource" : {
"resourceType" : "Organization",
"id" : "VaccinationSender",
"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: 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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-departmentname",
"valueString" : "sender department"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.7",
"code" : "1",
"display" : "Pharmaceutical Company"
}
]
}
],
"name" : "sender organization",
"telecom" : [
{
"system" : "phone",
"value" : "+01 123 456 78"
},
{
"system" : "fax",
"value" : "+01 123 456 89"
},
{
"system" : "email",
"value" : "email@city.us"
}
],
"address" : [
{
"line" : [
"street"
],
"city" : "city",
"state" : "CA",
"postalCode" : "postcode",
"country" : "US"
}
],
"contact" : [
{
"name" : {
"family" : "sender fname",
"given" : [
"sender gname"
],
"prefix" : [
"sender title"
]
}
}
]
}
},
{
"fullUrl" : "PractitionerRole/VaccinationAuthorRole",
"resource" : {
"resourceType" : "PractitionerRole",
"id" : "VaccinationAuthorRole",
"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: 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>"
},
"practitioner" : {
"reference" : "Practitioner/VaccinationAuthor"
},
"organization" : {
"reference" : "Organization/VaccinationSender"
},
"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"
},
{
"system" : "phone",
"value" : "3333333333"
}
]
}
},
{
"fullUrl" : "Practitioner/VaccinationAuthor",
"resource" : {
"resourceType" : "Practitioner",
"id" : "VaccinationAuthor",
"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: 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:\u00a0NI</p><p><b>name</b>: asdhj Admin </p><p><b>address</b>: US </p></div>"
},
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/us-npi",
"value" : "NI"
}
],
"name" : [
{
"family" : "Admin",
"given" : [
"asdhj"
]
}
],
"address" : [
{
"country" : "US"
}
]
}
},
{
"fullUrl" : "Patient/VaccinationPatient",
"resource" : {
"resourceType" : "Patient",
"id" : "VaccinationPatient",
"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: 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:\u00a0123456789</p><p><b>name</b>: FNAME LNAME </p><p><b>gender</b>: male</p><p><b>birthDate</b>: 1955-07-22</p></div>"
},
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/us-ssn",
"value" : "123456789"
}
],
"name" : [
{
"family" : "LNAME",
"given" : [
"FNAME"
]
}
],
"gender" : "male",
"birthDate" : "1955-07-22"
}
},
{
"fullUrl" : "AdverseEvent/VaccinationExampleEvent",
"resource" : {
"resourceType" : "AdverseEvent",
"id" : "VaccinationExampleEvent",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/vaccination-adverseevent"
]
},
"text" : {
"status" : "generated",
"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>"
},
"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "http://meddra.org",
"code" : "10004223",
"display" : "Bell's Palsy"
}
]
},
"subject" : {
"reference" : "Patient/VaccinationPatient"
},
"date" : "2017-04-23",
"seriousness" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.19",
"code" : "26"
}
]
}
}
],
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "serious"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-outcome",
"code" : "recovering"
}
]
},
"suspectEntity" : [
{
"instance" : {
"reference" : "Immunization/VaccinationExampleImmunization"
},
"causality" : [
{
"productRelatedness" : "Suspect"
}
]
},
{
"instance" : {
"reference" : "MedicationAdministration/VaccinationHydrocortisoneAdministration"
},
"causality" : [
{
"productRelatedness" : "Concomitant"
}
]
}
]
}
},
{
"fullUrl" : "Immunization/VaccinationExampleImmunization",
"resource" : {
"resourceType" : "Immunization",
"id" : "VaccinationExampleImmunization",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization"
]
},
"text" : {
"status" : "extensions",
"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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination",
"valueAge" : {
"value" : 12,
"unit" : "years",
"system" : "http://unitsofmeasure.org",
"code" : "y"
}
}
],
"status" : "completed",
"vaccineCode" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/sid/ndc",
"code" : "7046101903"
}
]
},
"patient" : {
"reference" : "Patient/VaccinationPatient"
},
"occurrenceDateTime" : "2017-04-23",
"primarySource" : false
}
},
{
"fullUrl" : "MedicationAdministration/VaccinationHydrocortisoneAdministration",
"resource" : {
"resourceType" : "MedicationAdministration",
"id" : "VaccinationHydrocortisoneAdministration",
"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: 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>"
},
"status" : "completed",
"medicationCodeableConcept" : {
"coding" : [
{
"system" : "http://www.nlm.nih.gov/research/umls/rxnorm",
"code" : "197782"
}
]
},
"subject" : {
"reference" : "Patient/VaccinationPatient"
},
"effectiveDateTime" : "2017-04-23"
}
}
]
}
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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