{ "resourceType": "Bundle", "id": "ConnectathonFAERSBundle", "meta": { "profile": [ "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-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/ibm-fda-icsr-faers-messageheader" ] }, "text": { "status": "extensions", "div": "

Generated Narrative

Message Processing Category: notification

event: Patient Adverse Event

Destinations

-EndpointReceiver
*http://example.org/ZZFDASee above (Organization/FDA)

sender: See above (Organization/BESTPrototype)

Sources

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

reason: Indicates receipt of a public health report

focus: See above (Composition/FAERSExample)

" }, "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/ibm-fda-icsr-composition" ] }, "text": { "status": "extensions", "div": "

Generated Narrative

AdditionalDocumentInformation

value: false

ExpeditedReport

value: false

value: Non-Expedited AE

FirstSenderType: Other

CombinationProductReport: false

FirstReceiveDate: 2021-01-05

MostRecentDate: 2021-01-05

CaseIdentifier: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77

identifier: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77

status: final

type: Adverse event note

category: Spontaneous report

date: 2021-01-05

author: See above (PractitionerRole/BESTAuthorRole)

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": "2", "display": "Other" } ] } }, { "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": "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/ibm-fda-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": "
Allergic transfusion reaction
" }, "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": "
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:<5E6|2nd container
" }, "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": "
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 & stridor following transfusion prbc for anemia. Tx with benadryl & epinephrine & 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;
" } }, { "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": "
NI
" } } ] } }, { "fullUrl": "Organization/FDA", "resource": { "resourceType": "Organization", "id": "FDA", "meta": { "profile": [ "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization" ] }, "text": { "status": "extensions", "div": "

Generated Narrative

DepartmentName: Office of Surveillance and Epidemiology

active: true

type: Regulatory Authority

name: FDA

telecom: faersesub@fda.hhs.gov

address: 10903 New Hampshire Avenue Silver Spring MD 20993 US

Contacts

-Name
*FAERS
" }, "extension": [ { "url": "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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/ibm-fda-icsr-messageorganization" ] }, "text": { "status": "generated", "div": "

Generated Narrative

active: true

name: BEST-Prototype

" }, "active": true, "name": "BEST-Prototype" } }, { "fullUrl": "PractitionerRole/BESTAuthorRole", "resource": { "resourceType": "PractitionerRole", "id": "BESTAuthorRole", "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/BESTAuthor)

organization: See above (Organization/BESTPrototype)

code: Physician

telecom: admin@admin.com

" }, "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/ibm-fda-icsr-authorpractitioner" ] }, "text": { "status": "generated", "div": "

Generated Narrative

identifier: id: NI

name: NI

" }, "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/ibm-fda-icsr-patient" ] }, "text": { "status": "generated", "div": "

Generated Narrative

identifier: id: 123456789

name: CM

gender: female

birthDate: 1999-06-24

" }, "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/ibm-fda-icsr-patientagegroup" ] }, "text": { "status": "generated", "div": "

Generated Narrative

code: Age group

subject: See above (Patient/BESTPatient)

value: Adult

" }, "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/ibm-fda-faers-adverseevent" ] }, "text": { "status": "extensions", "div": "

Generated Narrative

AgeAtTimeOfOnset: 1 a

actuality: actual

event: Allergic transfusion reaction

subject: See above (Patient/BESTPatient)

date: 2000-01-01

suspectEntity

instance: See above (Procedure/FAERSExampleTransfusion)

Causalities

-ProductRelatedness
*Suspect

suspectEntity

instance: See above (MedicationAdministration/FAERSEpinephrine)

Causalities

-ProductRelatedness
*Concomitant

suspectEntity

instance: See above (MedicationAdministration/FAERSDiphenhydramine)

Causalities

-ProductRelatedness
*Concomitant
" }, "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" } ] } ] } }, { "fullUrl": "Procedure/FAERSExampleTransfusion", "resource": { "resourceType": "Procedure", "id": "FAERSExampleTransfusion", "meta": { "profile": [ "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-transfusion" ] }, "text": { "status": "extensions", "div": "

Generated Narrative

UsedProductAmount: 1 unit

status: completed

code: 36430

subject: See above (Patient/BESTPatient)

performed: 2002-01-09

usedReference: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container

" }, "extension": [ { "url": "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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/ibm-fda-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/ibm-fda-icsr-bloodproduct" ] }, "text": { "status": "generated", "div": "

Generated Narrative

productCategory: cells

productCode: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container

Collections

-Extension
*
" }, "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/ibm-fda-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/ibm-fda-icsr-medicationadministration" ] }, "text": { "status": "generated", "div": "

Generated Narrative

status: completed

medication: Epinephrine

subject: See above (Patient/BESTPatient)

effective: 2002-01-09

" }, "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/ibm-fda-icsr-medicationadministration" ] }, "text": { "status": "generated", "div": "

Generated Narrative

status: completed

medication: Diphenhydramine

subject: See above (Patient/BESTPatient)

effective: 2002-01-09

" }, "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" } } ] }