FR Document Core (FHIR), published by Agence du Numérique en Santé (ANS) - 2-10 Rue d'Oradour-sur-Glane, 75015 Paris. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/ansforge/interop-IG-fhir-document-core/ and changes regularly. See the Directory of published versions

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Resource Profile: AdverseEvent - FR adverse event Document

FRAdverseEventDocument permet de décrire un effet indésirable prévisible lié à un médicament

Usages:

• This Profile is not used by any profiles in this Specification

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent(4.0.1)	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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	SΣ	1..1	CodeableConcept	Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson)	Subject impacted by event
date	SΣ	1..1	dateTime	Date de début de l'effet indésirable
detected	SΣ	1..1	dateTime	Date de détection de l'effet indésirable
resultingCondition	SΣ	0..*	Reference(Condition - FR Condition Document(0.1.0))	Réaction observée
severity	SΣ	1..1	CodeableConcept	Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome	SΣ	0..1	CodeableConcept	Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity	SΣ	1..*	BackboneElement	Agent soupçonné d’être à l’origine de l’événement indésirable
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance	SΣ	1..1	Reference(MedicationAdministration - FR Medication Administration Document(0.1.0))	Médicament, substance incriminée, posologie
causality	SΣ	0..1	BackboneElement	Imputabilité
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment	SΣ	1..1	CodeableConcept	Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
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	required	JDV Origine Effet Indesirable CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.severity	Base	required	JDV Gravite CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.outcome	Base	required	JDV Evolution CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment	Base	required	JDV Imputabilite CISIS	📍20260619134042	Terminologies de Santé v1.11

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	AdverseEvent.implicitRules, AdverseEvent.modifierExtension, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.subject, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.resultingCondition, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury
category	S	1..1	CodeableConcept	Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
date	S	1..1	dateTime	Date de début de l'effet indésirable
detected	S	1..1	dateTime	Date de détection de l'effet indésirable
resultingCondition	S	0..*	Reference(Condition - FR Condition Document(0.1.0))	Réaction observée
severity	S	1..1	CodeableConcept	Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome	S	0..1	CodeableConcept	Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity	S	1..*	BackboneElement	Agent soupçonné d’être à l’origine de l’événement indésirable
instance	S	1..1	Reference(MedicationAdministration - FR Medication Administration Document(0.1.0))	Médicament, substance incriminée, posologie
causality	S	0..1	BackboneElement	Imputabilité
assessment	S	1..1	CodeableConcept	Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.category	Base	required	JDV Origine Effet Indesirable CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.severity	Base	required	JDV Gravite CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.outcome	Base	required	JDV Evolution CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment	Base	required	JDV Imputabilite CISIS	📍20260619134042	Terminologies de Santé v1.11

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent(4.0.1)	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 Bindings Purpose 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
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	SΣ	1..1	CodeableConcept	Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	SΣ	1..1	dateTime	Date de début de l'effet indésirable
detected	SΣ	1..1	dateTime	Date de détection de l'effet indésirable
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingCondition	SΣ	0..*	Reference(Condition - FR Condition Document(0.1.0))	Réaction observée
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	SΣ	1..1	CodeableConcept	Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome	SΣ	0..1	CodeableConcept	Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (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	1..*	BackboneElement	Agent soupçonné d’être à l’origine de l’événement indésirable
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance	SΣ	1..1	Reference(MedicationAdministration - FR Medication Administration Document(0.1.0))	Médicament, substance incriminée, posologie
causality	SΣ	0..1	BackboneElement	Imputabilité
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment	SΣ	1..1	CodeableConcept	Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
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
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	required	JDV Origine Effet Indesirable CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.event	Base	example	SNOMED CT Clinical Findings	📍4.0.1	FHIR Std.
AdverseEvent.seriousness	Base	example	AdverseEventSeriousness	📍4.0.1	FHIR Std.
AdverseEvent.severity	Base	required	JDV Gravite CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.outcome	Base	required	JDV Evolution CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment	Base	required	JDV Imputabilite CISIS	📍20260619134042	Terminologies de Santé v1.11
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	AdverseEvent.meta, AdverseEvent.implicitRules, AdverseEvent.language, AdverseEvent.text, AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.identifier, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment, AdverseEvent.suspectEntity.causality.productRelatedness, AdverseEvent.suspectEntity.causality.author, AdverseEvent.suspectEntity.causality.method, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Summary

Mandatory: 5 elements(1 nested mandatory element)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

• Condition - FR Condition Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-condition-document|0.1.0)
• MedicationAdministration - FR Medication Administration Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-medication-administration-document|0.1.0)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent(4.0.1)	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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	SΣ	1..1	CodeableConcept	Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson)	Subject impacted by event
date	SΣ	1..1	dateTime	Date de début de l'effet indésirable
detected	SΣ	1..1	dateTime	Date de détection de l'effet indésirable
resultingCondition	SΣ	0..*	Reference(Condition - FR Condition Document(0.1.0))	Réaction observée
severity	SΣ	1..1	CodeableConcept	Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome	SΣ	0..1	CodeableConcept	Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity	SΣ	1..*	BackboneElement	Agent soupçonné d’être à l’origine de l’événement indésirable
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance	SΣ	1..1	Reference(MedicationAdministration - FR Medication Administration Document(0.1.0))	Médicament, substance incriminée, posologie
causality	SΣ	0..1	BackboneElement	Imputabilité
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment	SΣ	1..1	CodeableConcept	Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
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	required	JDV Origine Effet Indesirable CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.severity	Base	required	JDV Gravite CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.outcome	Base	required	JDV Evolution CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment	Base	required	JDV Imputabilite CISIS	📍20260619134042	Terminologies de Santé v1.11

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	AdverseEvent.implicitRules, AdverseEvent.modifierExtension, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.subject, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.resultingCondition, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Differential View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury
category	S	1..1	CodeableConcept	Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
date	S	1..1	dateTime	Date de début de l'effet indésirable
detected	S	1..1	dateTime	Date de détection de l'effet indésirable
resultingCondition	S	0..*	Reference(Condition - FR Condition Document(0.1.0))	Réaction observée
severity	S	1..1	CodeableConcept	Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome	S	0..1	CodeableConcept	Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (required)
suspectEntity	S	1..*	BackboneElement	Agent soupçonné d’être à l’origine de l’événement indésirable
instance	S	1..1	Reference(MedicationAdministration - FR Medication Administration Document(0.1.0))	Médicament, substance incriminée, posologie
causality	S	0..1	BackboneElement	Imputabilité
assessment	S	1..1	CodeableConcept	Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.category	Base	required	JDV Origine Effet Indesirable CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.severity	Base	required	JDV Gravite CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.outcome	Base	required	JDV Evolution CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment	Base	required	JDV Imputabilite CISIS	📍20260619134042	Terminologies de Santé v1.11

Snapshot ViewView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent(4.0.1)	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 Bindings Purpose 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
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	SΣ	1..1	CodeableConcept	Type d'effet indésirable Binding: JdvOrigineEffetIndesirableCisis (20260619134042) (required)
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	SΣ	1..1	dateTime	Date de début de l'effet indésirable
detected	SΣ	1..1	dateTime	Date de détection de l'effet indésirable
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingCondition	SΣ	0..*	Reference(Condition - FR Condition Document(0.1.0))	Réaction observée
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	SΣ	1..1	CodeableConcept	Gravité de l'effet indésirable Binding: JdvGraviteCisis (20260619134042) (required)
outcome	SΣ	0..1	CodeableConcept	Évolution de l'effet indésirable Binding: JdvEvolutionCisis (20260619134042) (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	1..*	BackboneElement	Agent soupçonné d’être à l’origine de l’événement indésirable
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance	SΣ	1..1	Reference(MedicationAdministration - FR Medication Administration Document(0.1.0))	Médicament, substance incriminée, posologie
causality	SΣ	0..1	BackboneElement	Imputabilité
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
assessment	SΣ	1..1	CodeableConcept	Niveau d'imputabilité Binding: JdvImputabiliteCisis (20260619134042) (required)
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
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	required	JDV Origine Effet Indesirable CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.event	Base	example	SNOMED CT Clinical Findings	📍4.0.1	FHIR Std.
AdverseEvent.seriousness	Base	example	AdverseEventSeriousness	📍4.0.1	FHIR Std.
AdverseEvent.severity	Base	required	JDV Gravite CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.outcome	Base	required	JDV Evolution CISIS	📍20260619134042	Terminologies de Santé v1.11
AdverseEvent.suspectEntity.​causality.assessment	Base	required	JDV Imputabilite CISIS	📍20260619134042	Terminologies de Santé v1.11
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	AdverseEvent.meta, AdverseEvent.implicitRules, AdverseEvent.language, AdverseEvent.text, AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.identifier, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment, AdverseEvent.suspectEntity.causality.productRelatedness, AdverseEvent.suspectEntity.causality.author, AdverseEvent.suspectEntity.causality.method, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.extension, AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Summary

Mandatory: 5 elements(1 nested mandatory element)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

• Condition - FR Condition Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-condition-document|0.1.0)
• MedicationAdministration - FR Medication Administration Document (https://interop.esante.gouv.fr/ig/fhir/document-core/StructureDefinition/fr-medication-administration-document|0.1.0)

Other representations of profile: CSV, Excel, Schematron