{ "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": "

Generated Narrative

Message Processing Category: notification

event: Patient Adverse Event

Destinations

-Endpoint
*http://example.org/CBERVAERS

sender: See above (Organization/VAERSSender)

Sources

-Endpoint
*http://example.org/BEST-Pilot

reason: Indicates receipt of a public health report

focus: See above (Composition/VAERSExample)

" }, "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": "

Generated Narrative

AdditionalDocumentInformation

value: false

ExpeditedReport

value: false

value: Non-Expedited AE

FirstSenderType: Regulator

CombinationProductReport: false

FirstReceiveDate: 2021-01-05

MostRecentDate: 2021-01-05

CaseIdentifier: id: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495

identifier: id: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495

status: final

type: Adverse event note

category: Spontaneous report

date: Jan 5, 2021 9:24:44 AM

author: See above (PractitionerRole/VAERSAuthorRole)

title: ICSR Submission

" }, "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": "
Developed acute facial nerve paralysis after ED administration of influenza vaccine
" }, "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": "
ED administration of influenza vaccine
" }, "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": "
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;
" } }, { "title": "Relevant Medical History", "code": { "coding": [ { "system": "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS", "code": "RelevantMedicalHistory" } ] }, "text": { "status": "generated", "div": "
Long term (current) use of anticoagulants
" } } ] } }, { "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": "

Generated Narrative

DepartmentName: sender department

active: true

type: Pharmaceutical Company

name: sender organization

telecom: +01 123 456 78, fax: +01 123 456 89, email@city.us

address: street city CA postcode US

Contacts

-Name
*sender gname sender fname
" }, "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": "

Generated Narrative

practitioner: See above (Practitioner/VAERSAuthor)

organization: See above (Organization/VAERSSender)

code: Physician

telecom: admin@admin.com, ph: 3333333333

" }, "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": "

Generated Narrative

identifier: id: NI

name: asdhj Admin

address: US

" }, "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": "

Generated Narrative

identifier: id: 123456789

name: FNAME LNAME

gender: male

birthDate: 1955-07-22

" }, "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": "

Generated Narrative

actuality: actual

event: Bell's Palsy

subject: See above (Patient/VAERSPatient)

date: 2017-04-23

seriousness: 26

outcome: Recovering

suspectEntity

instance: See above (Immunization/VAERSExampleImmunization)

Causalities

-ProductRelatedness
*Suspect

suspectEntity

instance: See above (MedicationAdministration/VAERSHydrocortisoneAdministration)

Causalities

-ProductRelatedness
*Concomitant
" }, "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": "

Generated Narrative

AgeAtVaccination: 12 years

status: completed

vaccineCode: 7046101903

patient: See above (Patient/VAERSPatient)

occurrence: 2017-04-23

primarySource: false

" }, "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": "

Generated Narrative

status: completed

medication: hydrocortisone 10 MG Oral Tablet

subject: See above (Patient/VAERSPatient)

effective: 2017-04-23

" }, "status": "completed", "medicationCodeableConcept": { "coding": [ { "system": "http://www.nlm.nih.gov/research/umls/rxnorm", "code": "197782" } ] }, "subject": { "reference": "Patient/VAERSPatient" }, "effectiveDateTime": "2017-04-23" } } ] }