Integrated Campaign Registry (ICR) Implementation Guide
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Integrated Campaign Registry (ICR) Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ICR Adverse Event

Official URL: https://icr.healthcampaigns.org/StructureDefinition/ICRAdverseEvent Version: 0.1.0
Draft as of 2026-08-07 Computable Name: ICRAdverseEvent

An adverse event following a campaign intervention — vaccine (AEFI) or MDA drug (pharmacovigilance) alike. The suspected product/event is referenced via suspectEntity; causality uses the WHO/CIOMS classification; seriousness/severity carry the minor-vs-serious distinction the field forms collect. Carries the required campaign-vs-routine record origin. Intervention-neutral so it serves both the immunization and MDA arms (working doc §17.2 C1).

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:recordOrigin S 1..1 code Record Origin
URL: https://icr.healthcampaigns.org/StructureDefinition/record-origin
Binding: ICR Record Origin (required)
.... extension:seriousCriteria S 0..* CodeableConcept Why it is serious — WHO/CIOMS criteria (death, life-threatening, hospitalization…); present when seriousness = serious (v0.20.0)
URL: https://icr.healthcampaigns.org/StructureDefinition/serious-criteria
Binding: ICR Serious-Event Criteria (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... category SΣ 0..* CodeableConcept product-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 SΣ 0..1 CodeableConcept What happened (fever, abscess, abdominal pain, anaphylaxis…) — code from a clinical terminology
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
... subject SΣ 1..1 Reference(Patient | ICR Delivery Unit (Household / Community)) The affected person, or the community/household delivery-unit Group for aggregate pharmacovigilance counts
... date SΣ 0..1 dateTime When the event occurred
... seriousness SΣ 0..1 CodeableConcept Serious vs non-serious — the ESPEN minor/serious side-effect distinction
Binding: ICR Adverse Event Seriousness (extensible)
... severity SΣ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... suspectEntity SΣ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(ICR Immunization Event | ICR Medication Administration | Medication | Substance) The suspected product or delivery event — the campaign vaccine dose or MDA administration (or the Medication/Substance itself)
.... causality SΣ 0..* BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept WHO/CIOMS causality category (A/B/C/D); immunization may use IMMZ finer A1–A4 subtypes
Binding: ICR Adverse Event Causality (extensible)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.seriousness Base extensible ICR Adverse Event Seriousness 📦0.1.0 This IG
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base extensible ICR Adverse Event Causality 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:recordOrigin S 1..1 code Record Origin
URL: https://icr.healthcampaigns.org/StructureDefinition/record-origin
Binding: ICR Record Origin (required)
.... extension:seriousCriteria S 0..* CodeableConcept Why it is serious — WHO/CIOMS criteria (death, life-threatening, hospitalization…); present when seriousness = serious (v0.20.0)
URL: https://icr.healthcampaigns.org/StructureDefinition/serious-criteria
Binding: ICR Serious-Event Criteria (extensible)
... actuality S 1..1 code actual | potential
... category S 0..* CodeableConcept product-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
... subject S 1..1 Reference(Patient | ICR Delivery Unit (Household / Community)) The affected person, or the community/household delivery-unit Group for aggregate pharmacovigilance counts
... date S 0..1 dateTime When the event occurred
... seriousness S 0..1 CodeableConcept Serious vs non-serious — the ESPEN minor/serious side-effect distinction
Binding: ICR Adverse Event Seriousness (extensible)
... severity S 0..1 CodeableConcept mild | moderate | severe
... suspectEntity S 0..* BackboneElement The suspected agent causing the adverse event
.... instance S 1..1 Reference(ICR Immunization Event | ICR Medication Administration | Medication | Substance) The suspected product or delivery event — the campaign vaccine dose or MDA administration (or the Medication/Substance itself)
.... causality S 0..* BackboneElement Information on the possible cause of the event
..... assessment 0..1 CodeableConcept WHO/CIOMS causality category (A/B/C/D); immunization may use IMMZ finer A1–A4 subtypes
Binding: ICR Adverse Event Causality (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.seriousness Base extensible ICR Adverse Event Seriousness 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.assessment Base extensible ICR Adverse Event Causality 📦0.1.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:recordOrigin S 1..1 code Record Origin
URL: https://icr.healthcampaigns.org/StructureDefinition/record-origin
Binding: ICR Record Origin (required)
.... extension:seriousCriteria S 0..* CodeableConcept Why it is serious — WHO/CIOMS criteria (death, life-threatening, hospitalization…); present when seriousness = serious (v0.20.0)
URL: https://icr.healthcampaigns.org/StructureDefinition/serious-criteria
Binding: ICR Serious-Event Criteria (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... category SΣ 0..* CodeableConcept product-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 SΣ 0..1 CodeableConcept What happened (fever, abscess, abdominal pain, anaphylaxis…) — code from a clinical terminology
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
... subject SΣ 1..1 Reference(Patient | ICR Delivery Unit (Household / Community)) The affected person, or the community/household delivery-unit Group for aggregate pharmacovigilance counts
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness SΣ 0..1 CodeableConcept Serious vs non-serious — the ESPEN minor/serious side-effect distinction
Binding: ICR Adverse Event Seriousness (extensible)
... severity SΣ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ 0..* BackboneElement The suspected agent causing the adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(ICR Immunization Event | ICR Medication Administration | Medication | Substance) The suspected product or delivery event — the campaign vaccine dose or MDA administration (or the Medication/Substance itself)
.... causality SΣ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept WHO/CIOMS causality category (A/B/C/D); immunization may use IMMZ finer A1–A4 subtypes
Binding: ICR Adverse Event Causality (extensible)
..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.seriousness Base extensible ICR Adverse Event Seriousness 📦0.1.0 This IG
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base extensible ICR Adverse Event Causality 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:recordOrigin S 1..1 code Record Origin
URL: https://icr.healthcampaigns.org/StructureDefinition/record-origin
Binding: ICR Record Origin (required)
.... extension:seriousCriteria S 0..* CodeableConcept Why it is serious — WHO/CIOMS criteria (death, life-threatening, hospitalization…); present when seriousness = serious (v0.20.0)
URL: https://icr.healthcampaigns.org/StructureDefinition/serious-criteria
Binding: ICR Serious-Event Criteria (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... category SΣ 0..* CodeableConcept product-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 SΣ 0..1 CodeableConcept What happened (fever, abscess, abdominal pain, anaphylaxis…) — code from a clinical terminology
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
... subject SΣ 1..1 Reference(Patient | ICR Delivery Unit (Household / Community)) The affected person, or the community/household delivery-unit Group for aggregate pharmacovigilance counts
... date SΣ 0..1 dateTime When the event occurred
... seriousness SΣ 0..1 CodeableConcept Serious vs non-serious — the ESPEN minor/serious side-effect distinction
Binding: ICR Adverse Event Seriousness (extensible)
... severity SΣ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... suspectEntity SΣ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(ICR Immunization Event | ICR Medication Administration | Medication | Substance) The suspected product or delivery event — the campaign vaccine dose or MDA administration (or the Medication/Substance itself)
.... causality SΣ 0..* BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept WHO/CIOMS causality category (A/B/C/D); immunization may use IMMZ finer A1–A4 subtypes
Binding: ICR Adverse Event Causality (extensible)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.seriousness Base extensible ICR Adverse Event Seriousness 📦0.1.0 This IG
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base extensible ICR Adverse Event Causality 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:recordOrigin S 1..1 code Record Origin
URL: https://icr.healthcampaigns.org/StructureDefinition/record-origin
Binding: ICR Record Origin (required)
.... extension:seriousCriteria S 0..* CodeableConcept Why it is serious — WHO/CIOMS criteria (death, life-threatening, hospitalization…); present when seriousness = serious (v0.20.0)
URL: https://icr.healthcampaigns.org/StructureDefinition/serious-criteria
Binding: ICR Serious-Event Criteria (extensible)
... actuality S 1..1 code actual | potential
... category S 0..* CodeableConcept product-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
... subject S 1..1 Reference(Patient | ICR Delivery Unit (Household / Community)) The affected person, or the community/household delivery-unit Group for aggregate pharmacovigilance counts
... date S 0..1 dateTime When the event occurred
... seriousness S 0..1 CodeableConcept Serious vs non-serious — the ESPEN minor/serious side-effect distinction
Binding: ICR Adverse Event Seriousness (extensible)
... severity S 0..1 CodeableConcept mild | moderate | severe
... suspectEntity S 0..* BackboneElement The suspected agent causing the adverse event
.... instance S 1..1 Reference(ICR Immunization Event | ICR Medication Administration | Medication | Substance) The suspected product or delivery event — the campaign vaccine dose or MDA administration (or the Medication/Substance itself)
.... causality S 0..* BackboneElement Information on the possible cause of the event
..... assessment 0..1 CodeableConcept WHO/CIOMS causality category (A/B/C/D); immunization may use IMMZ finer A1–A4 subtypes
Binding: ICR Adverse Event Causality (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.seriousness Base extensible ICR Adverse Event Seriousness 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.assessment Base extensible ICR Adverse Event Causality 📦0.1.0 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:recordOrigin S 1..1 code Record Origin
URL: https://icr.healthcampaigns.org/StructureDefinition/record-origin
Binding: ICR Record Origin (required)
.... extension:seriousCriteria S 0..* CodeableConcept Why it is serious — WHO/CIOMS criteria (death, life-threatening, hospitalization…); present when seriousness = serious (v0.20.0)
URL: https://icr.healthcampaigns.org/StructureDefinition/serious-criteria
Binding: ICR Serious-Event Criteria (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... category SΣ 0..* CodeableConcept product-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 SΣ 0..1 CodeableConcept What happened (fever, abscess, abdominal pain, anaphylaxis…) — code from a clinical terminology
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
... subject SΣ 1..1 Reference(Patient | ICR Delivery Unit (Household / Community)) The affected person, or the community/household delivery-unit Group for aggregate pharmacovigilance counts
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness SΣ 0..1 CodeableConcept Serious vs non-serious — the ESPEN minor/serious side-effect distinction
Binding: ICR Adverse Event Seriousness (extensible)
... severity SΣ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ 0..* BackboneElement The suspected agent causing the adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(ICR Immunization Event | ICR Medication Administration | Medication | Substance) The suspected product or delivery event — the campaign vaccine dose or MDA administration (or the Medication/Substance itself)
.... causality SΣ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept WHO/CIOMS causality category (A/B/C/D); immunization may use IMMZ finer A1–A4 subtypes
Binding: ICR Adverse Event Causality (extensible)
..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.seriousness Base extensible ICR Adverse Event Seriousness 📦0.1.0 This IG
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base extensible ICR Adverse Event Causality 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

 

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