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" : "Bundle",
"id" : "ConnectathonVAERSBundle",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-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/ibm-fda-icsr-vaers-messageheader"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ActCode PAT_ADV_EVNT}\">Patient Adverse Event</span></p><h3>Destinations</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/CBERVAERS\">http://example.org/CBERVAERS</a></td></tr></table><p><b>sender</b>: <a href=\"#Organization_VAERSSender\">See above (Organization/VAERSSender)</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>: <span title=\"Codes: {http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents received-public-health-report}\">Indicates receipt of a public health report</span></p><p><b>focus</b>: <a href=\"#Composition_VAERSExample\">See above (Composition/VAERSExample)</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/CBERVAERS"
}
],
"sender" : {
"reference" : "Organization/VAERSSender"
},
"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/VAERSExample"
}
]
}
},
{
"fullUrl" : "Composition/VAERSExample",
"resource" : {
"resourceType" : "Composition",
"id" : "VAERSExample",
"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 2}\">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 1}\">Regulator</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>: <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>: Jan 5, 2021 9:24:44 AM</p><p><b>author</b>: <a href=\"#PractitionerRole_VAERSAuthorRole\">See above (PractitionerRole/VAERSAuthorRole)</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" : "2",
"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" : "1",
"display" : "Regulator"
}
]
}
},
{
"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" : "2021-01-05"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate",
"valueDateTime" : "2021-01-05"
},
{
"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-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/VAERSPatient"
},
"date" : "2021-01-05T14:24:44+05:00",
"author" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource",
"valueBoolean" : true
}
],
"reference" : "PractitionerRole/VAERSAuthorRole"
}
],
"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/VAERSExampleEvent"
}
]
},
{
"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/VAERSExampleImmunization"
},
{
"reference" : "MedicationAdministration/VAERSHydrocortisoneAdministration"
}
]
},
{
"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/VAERSSender",
"resource" : {
"resourceType" : "Organization",
"id" : "VAERSSender",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>DepartmentName</b>: sender department</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 1}\">Pharmaceutical Company</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>-</td><td><b>Name</b></td></tr><tr><td>*</td><td>sender gname sender fname </td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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/VAERSAuthorRole",
"resource" : {
"resourceType" : "PractitionerRole",
"id" : "VAERSAuthorRole",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitionerrole"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>practitioner</b>: <a href=\"#Practitioner_VAERSAuthor\">See above (Practitioner/VAERSAuthor)</a></p><p><b>organization</b>: <a href=\"#Organization_VAERSSender\">See above (Organization/VAERSSender)</a></p><p><b>code</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span></p><p><b>telecom</b>: <a href=\"mailto:admin@admin.com\">admin@admin.com</a>, ph: 3333333333</p></div>"
},
"practitioner" : {
"reference" : "Practitioner/VAERSAuthor"
},
"organization" : {
"reference" : "Organization/VAERSSender"
},
"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/VAERSAuthor",
"resource" : {
"resourceType" : "Practitioner",
"id" : "VAERSAuthor",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitioner"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: NI</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/VAERSPatient",
"resource" : {
"resourceType" : "Patient",
"id" : "VAERSPatient",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><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>"
},
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/us-ssn",
"value" : "123456789"
}
],
"name" : [
{
"family" : "LNAME",
"given" : [
"FNAME"
]
}
],
"gender" : "male",
"birthDate" : "1955-07-22"
}
},
{
"fullUrl" : "AdverseEvent/VAERSExampleEvent",
"resource" : {
"resourceType" : "AdverseEvent",
"id" : "VAERSExampleEvent",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-vaers-adverseevent"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>actuality</b>: actual</p><p><b>event</b>: <span title=\"Codes: {http://meddra.org 10004223}\">Bell's Palsy</span></p><p><b>subject</b>: <a href=\"#Patient_VAERSPatient\">See above (Patient/VAERSPatient)</a></p><p><b>date</b>: 2017-04-23</p><p><b>seriousness</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.19 26}\">26</span></p><p><b>outcome</b>: <span title=\"Codes: {http://terminology.hl7.org/CodeSystem/adverse-event-outcome recovering}\">Recovering</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#Immunization_VAERSExampleImmunization\">See above (Immunization/VAERSExampleImmunization)</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_VAERSHydrocortisoneAdministration\">See above (MedicationAdministration/VAERSHydrocortisoneAdministration)</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>"
},
"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "http://meddra.org",
"code" : "10004223",
"display" : "Bell's Palsy"
}
]
},
"subject" : {
"reference" : "Patient/VAERSPatient"
},
"date" : "2017-04-23",
"seriousness" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.19",
"code" : "26"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-outcome",
"code" : "recovering"
}
]
},
"suspectEntity" : [
{
"instance" : {
"reference" : "Immunization/VAERSExampleImmunization"
},
"causality" : [
{
"productRelatedness" : "Suspect"
}
]
},
{
"instance" : {
"reference" : "MedicationAdministration/VAERSHydrocortisoneAdministration"
},
"causality" : [
{
"productRelatedness" : "Concomitant"
}
]
}
]
}
},
{
"fullUrl" : "Immunization/VAERSExampleImmunization",
"resource" : {
"resourceType" : "Immunization",
"id" : "VAERSExampleImmunization",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-immunization"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>AgeAtVaccination</b>: 12 years</p><p><b>status</b>: completed</p><p><b>vaccineCode</b>: <span title=\"Codes: {http://hl7.org/fhir/sid/ndc 7046101903}\">7046101903</span></p><p><b>patient</b>: <a href=\"#Patient_VAERSPatient\">See above (Patient/VAERSPatient)</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/ibm-fda-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/VAERSPatient"
},
"occurrenceDateTime" : "2017-04-23",
"primarySource" : false
}
},
{
"fullUrl" : "MedicationAdministration/VAERSHydrocortisoneAdministration",
"resource" : {
"resourceType" : "MedicationAdministration",
"id" : "VAERSHydrocortisoneAdministration",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>status</b>: completed</p><p><b>medication</b>: <span title=\"Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 197782}\">hydrocortisone 10 MG Oral Tablet</span></p><p><b>subject</b>: <a href=\"#Patient_VAERSPatient\">See above (Patient/VAERSPatient)</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/VAERSPatient"
},
"effectiveDateTime" : "2017-04-23"
}
}
]
}
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
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