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

Resource Profile: ICSR Adverse Event

Defining URL:http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-adverseevent
Version:0.1.0
Name:ICSRAdverseEvent
Title:ICSR Adverse Event
Status:Active as of 2021-08-05T14:34:06+00:00
Definition:

The fields needed to submit an AdverseEvent for a ICSR Report.

Publisher:Biomedical Research & Regulation WG
Source Resource:XML / JSON / Turtle

The official URL for this profile is: 

http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-adverseevent

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventThis is an abstract profile
Medical care, research study or other healthcare event causing physical injury
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageattimeofonset 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageattimeofonset
... identifier S0..1IdentifierBusiness identifier for the event
... category S0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
... event S1..1CodeableConceptType of the event itself in relation to the subject
.... coding
..... system 0..1uriIdentity of the terminology system
Fixed Value: http://meddra.org
... subject S1..1Reference(ICSR Patient)Subject impacted by event
... encounter S0..1Reference(US Core Encounter Profile)Encounter created as part of
... date S0..1dateTimeWhen the event occurred
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... ibm-fda-icsr-ext-eventduration 0..1DurationExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventduration
.... ibm-fda-icsr-ext-eventenddate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventenddate
... location S0..1Reference(US Core Location Profile)Location where adverse event occurred
... seriousness S0..1CodeableConceptSeriousness of the event
Binding: ICSR Seriousness Codes (required)
... outcome S0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S0..1Reference(Practitioner Author)Who recorded the adverse event
... suspectEntity S1..*BackboneElementThe suspected agent causing the adverse event
.... instance S1..1Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)Refers to the specific entity that caused the adverse event
.... causality S1..1BackboneElementInformation on the possible cause of the event
..... productRelatedness S1..1stringAdverseEvent.suspectEntity.causalityProductRelatedness

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventThis is an abstract profile
Medical care, research study or other healthcare event causing physical injury
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageattimeofonset 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageattimeofonset
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Fixed Value: actual
... category SΣ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
Fixed Value: http://meddra.org
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... subject SΣ1..1Reference(ICSR Patient)Subject impacted by event
... encounter SΣ0..1Reference(US Core Encounter Profile)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
.... id 0..1stringxml:id (or equivalent in JSON)
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... ibm-fda-icsr-ext-eventduration 0..1DurationExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventduration
.... ibm-fda-icsr-ext-eventenddate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventenddate
.... value 0..1dateTimePrimitive value for dateTime
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location SΣ0..1Reference(US Core Location Profile)Location where adverse event occurred
... seriousness SΣ0..1CodeableConceptSeriousness of the event
Binding: ICSR Seriousness Codes (required)
... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ0..1Reference(Practitioner Author)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ1..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣ1..1Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)Refers to the specific entity that caused the adverse event
.... causality SΣ1..1BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness SΣ1..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventThis is an abstract profile
Medical care, research study or other healthcare event causing physical injury
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!Σ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Fixed Value: actual
... category Σ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... subject Σ1..1Reference(ICSR Patient)Subject impacted by event
... encounter Σ0..1Reference(US Core Encounter Profile)Encounter created as part of
... date Σ0..1dateTimeWhen the event occurred
... location Σ0..1Reference(US Core Location Profile)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
Binding: ICSR Seriousness Codes (required)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder Σ0..1Reference(Practitioner Author)Who recorded the adverse event
... suspectEntity Σ1..*BackboneElementThe suspected agent causing the adverse event
.... instance Σ1..1Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)Refers to the specific entity that caused the adverse event
.... causality Σ1..1BackboneElementInformation on the possible cause of the event
..... productRelatedness Σ1..1stringAdverseEvent.suspectEntity.causalityProductRelatedness

doco Documentation for this format

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventThis is an abstract profile
Medical care, research study or other healthcare event causing physical injury
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageattimeofonset 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageattimeofonset
... identifier S0..1IdentifierBusiness identifier for the event
... category S0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
... event S1..1CodeableConceptType of the event itself in relation to the subject
.... coding
..... system 0..1uriIdentity of the terminology system
Fixed Value: http://meddra.org
... subject S1..1Reference(ICSR Patient)Subject impacted by event
... encounter S0..1Reference(US Core Encounter Profile)Encounter created as part of
... date S0..1dateTimeWhen the event occurred
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... ibm-fda-icsr-ext-eventduration 0..1DurationExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventduration
.... ibm-fda-icsr-ext-eventenddate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventenddate
... location S0..1Reference(US Core Location Profile)Location where adverse event occurred
... seriousness S0..1CodeableConceptSeriousness of the event
Binding: ICSR Seriousness Codes (required)
... outcome S0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S0..1Reference(Practitioner Author)Who recorded the adverse event
... suspectEntity S1..*BackboneElementThe suspected agent causing the adverse event
.... instance S1..1Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)Refers to the specific entity that caused the adverse event
.... causality S1..1BackboneElementInformation on the possible cause of the event
..... productRelatedness S1..1stringAdverseEvent.suspectEntity.causalityProductRelatedness

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventThis is an abstract profile
Medical care, research study or other healthcare event causing physical injury
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageattimeofonset 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageattimeofonset
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Fixed Value: actual
... category SΣ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event SΣ1..1CodeableConceptType of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.

.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
Fixed Value: http://meddra.org
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... subject SΣ1..1Reference(ICSR Patient)Subject impacted by event
... encounter SΣ0..1Reference(US Core Encounter Profile)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
.... id 0..1stringxml:id (or equivalent in JSON)
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... ibm-fda-icsr-ext-eventduration 0..1DurationExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventduration
.... ibm-fda-icsr-ext-eventenddate 0..1dateTimeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventenddate
.... value 0..1dateTimePrimitive value for dateTime
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location SΣ0..1Reference(US Core Location Profile)Location where adverse event occurred
... seriousness SΣ0..1CodeableConceptSeriousness of the event
Binding: ICSR Seriousness Codes (required)
... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ0..1Reference(Practitioner Author)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ1..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣ1..1Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)Refers to the specific entity that caused the adverse event
.... causality SΣ1..1BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness SΣ1..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.languagepreferredCommonLanguages
Max Binding: AllLanguages
AdverseEvent.actualityrequiredFixed Value: actual
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventexampleSNOMEDCTClinicalFindings
AdverseEvent.seriousnessrequiredICSRSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod