Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
suspectEntity:procedure	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(Procedure: Imaging Acquisition)	Refers to the specific entity that caused the adverse event
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.status	Base	required	Adverse Event Status	📍5.0.0	FHIR Std.
AdverseEvent.actuality	Base	required	Adverse Event Actuality	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor:allergy.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
Slices for suspectEntity		0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:procedure		0..*	BackboneElement	The suspected agent causing the adverse event
Slices for instance[x]		1..1	CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)	Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instance[x]:instanceReference		0..1	Reference(Procedure: Imaging Acquisition)	Refers to the specific entity that caused the adverse event
Slices for contributingFactor		0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor:allergy		0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event
Slices for item[x]		1..1	Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement), CodeableConcept	Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this
item[x]:itemReference		0..1	Reference(AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	Σ	0..*	CodeableConcept	wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.
code	Σ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	Σ	0..1		When the event occurred
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingEffect	Σ	0..*	Reference(Condition | Observation)	Effect on the subject due to this event
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness or gravity of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: AdverseEventOutcome (example): Codes describing the type of outcome from the adverse event.
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
participant	Σ	0..*	BackboneElement	Who was involved in the adverse event or the potential adverse event and what they did
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
function	Σ	0..1	CodeableConcept	Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)	Who was involved in the adverse event or the potential adverse event
study	Σ	0..*	Reference(ResearchStudy)	Research study that the subject is enrolled in
expectedInResearchStudy		0..1	boolean	Considered likely or probable or anticipated in the research study
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
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[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
causality	Σ	0..1	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
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
suspectEntity:procedure	Σ	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
Slices for instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(Procedure: Imaging Acquisition)	Refers to the specific entity that caused the adverse event
causality	Σ	0..1	BackboneElement	Information on the possible cause of the event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor:All Slices				Content/Rules for all slices
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
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of 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
Slices for item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
preventiveAction	Σ	0..*	BackboneElement	Preventive actions that contributed to avoiding 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
item[x]	Σ	1..1		Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event.
itemReference			Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
mitigatingAction	Σ	0..*	BackboneElement	Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
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
item[x]	Σ	1..1		Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.
itemReference			Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to 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
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.language	Base	required	All Languages	📍5.0.0	FHIR Std.
AdverseEvent.status	Base	required	Adverse Event Status	📍5.0.0	FHIR Std.
AdverseEvent.actuality	Base	required	Adverse Event Actuality	📍5.0.0	FHIR Std.
AdverseEvent.category	Base	example	Adverse Event Category	📍5.0.0	FHIR Std.
AdverseEvent.code	Base	example	AdverseEvent Type	📍5.0.0	FHIR Std.
AdverseEvent.seriousness	Base	example	Adverse Event Seriousness	📍5.0.0	FHIR Std.
AdverseEvent.outcome	Base	example	AdverseEvent Outcome	📍5.0.0	FHIR Std.
AdverseEvent.participant.​function	Base	example	AdverseEvent Participant Function	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity.​causality.assessmentMethod	Base	example	Adverse Event Causality Method	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity.​causality.entityRelatedness	Base	example	Adverse Event Causality Assessment	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity:procedure.​causality.assessmentMethod	Base	example	Adverse Event Causality Method	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity:procedure.​causality.entityRelatedness	Base	example	Adverse Event Causality Assessment	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor:allergy.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	FHIR Std.
AdverseEvent.preventiveAction.​item[x]	Base	example	AdverseEvent Preventive Action	📍5.0.0	FHIR Std.
AdverseEvent.mitigatingAction.​item[x]	Base	example	AdverseEvent Mitigating Action	📍5.0.0	FHIR Std.
AdverseEvent.supportingInfo.​item[x]	Base	example	AdverseEvent Supporting Information	📍5.0.0	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()

Summary

Structures

This structure refers to these other structures:

• Procedure: Imaging Acquisition (http://hl7.eu/fhir/imaging-r5/StructureDefinition/ProcedureEuImaging)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of AdverseEvent.suspectEntity
• The element 1 is sliced based on the value of AdverseEvent.suspectEntity.instance[x]
• The element 1 is sliced based on the value of AdverseEvent.contributingFactor
• The element 1 is sliced based on the value of AdverseEvent.contributingFactor.item[x]

Maturity: 1

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
suspectEntity:procedure	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(Procedure: Imaging Acquisition)	Refers to the specific entity that caused the adverse event
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.status	Base	required	Adverse Event Status	📍5.0.0	FHIR Std.
AdverseEvent.actuality	Base	required	Adverse Event Actuality	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor:allergy.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
Slices for suspectEntity		0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:procedure		0..*	BackboneElement	The suspected agent causing the adverse event
Slices for instance[x]		1..1	CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)	Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instance[x]:instanceReference		0..1	Reference(Procedure: Imaging Acquisition)	Refers to the specific entity that caused the adverse event
Slices for contributingFactor		0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor:allergy		0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event
Slices for item[x]		1..1	Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement), CodeableConcept	Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this
item[x]:itemReference		0..1	Reference(AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	Σ	0..*	CodeableConcept	wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.
code	Σ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	Σ	0..1		When the event occurred
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingEffect	Σ	0..*	Reference(Condition | Observation)	Effect on the subject due to this event
location	Σ	0..1	Reference(Location)	Location where adverse event occurred
seriousness	Σ	0..1	CodeableConcept	Seriousness or gravity of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: AdverseEventOutcome (example): Codes describing the type of outcome from the adverse event.
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
participant	Σ	0..*	BackboneElement	Who was involved in the adverse event or the potential adverse event and what they did
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
function	Σ	0..1	CodeableConcept	Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)	Who was involved in the adverse event or the potential adverse event
study	Σ	0..*	Reference(ResearchStudy)	Research study that the subject is enrolled in
expectedInResearchStudy		0..1	boolean	Considered likely or probable or anticipated in the research study
Slices for suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices				Content/Rules for all slices
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[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
causality	Σ	0..1	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
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
suspectEntity:procedure	Σ	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
Slices for instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event Slice: Unordered, Open by type:$this
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
instance[x]:instanceReference	Σ	0..1	Reference(Procedure: Imaging Acquisition)	Refers to the specific entity that caused the adverse event
causality	Σ	0..1	BackboneElement	Information on the possible cause of the event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessmentMethod	Σ	0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
Slices for contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by profile:$this
contributingFactor:All Slices				Content/Rules for all slices
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
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
contributingFactor:allergy	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of 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
Slices for item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Slice: Unordered, Open by type:$this Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
item[x]:itemReference	Σ	0..1	Reference(AllergyIntolerance)	Item suspected to have increased the probability or severity of the adverse event
preventiveAction	Σ	0..*	BackboneElement	Preventive actions that contributed to avoiding 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
item[x]	Σ	1..1		Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event.
itemReference			Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
mitigatingAction	Σ	0..*	BackboneElement	Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
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
item[x]	Σ	1..1		Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.
itemReference			Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to 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
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.language	Base	required	All Languages	📍5.0.0	FHIR Std.
AdverseEvent.status	Base	required	Adverse Event Status	📍5.0.0	FHIR Std.
AdverseEvent.actuality	Base	required	Adverse Event Actuality	📍5.0.0	FHIR Std.
AdverseEvent.category	Base	example	Adverse Event Category	📍5.0.0	FHIR Std.
AdverseEvent.code	Base	example	AdverseEvent Type	📍5.0.0	FHIR Std.
AdverseEvent.seriousness	Base	example	Adverse Event Seriousness	📍5.0.0	FHIR Std.
AdverseEvent.outcome	Base	example	AdverseEvent Outcome	📍5.0.0	FHIR Std.
AdverseEvent.participant.​function	Base	example	AdverseEvent Participant Function	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity.​causality.assessmentMethod	Base	example	Adverse Event Causality Method	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity.​causality.entityRelatedness	Base	example	Adverse Event Causality Assessment	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity:procedure.​causality.assessmentMethod	Base	example	Adverse Event Causality Method	📍5.0.0	FHIR Std.
AdverseEvent.suspectEntity:procedure.​causality.entityRelatedness	Base	example	Adverse Event Causality Assessment	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	FHIR Std.
AdverseEvent.contributingFactor:allergy.​item[x]	Base	example	AdverseEvent Contributing Factor	📍5.0.0	FHIR Std.
AdverseEvent.preventiveAction.​item[x]	Base	example	AdverseEvent Preventive Action	📍5.0.0	FHIR Std.
AdverseEvent.mitigatingAction.​item[x]	Base	example	AdverseEvent Mitigating Action	📍5.0.0	FHIR Std.
AdverseEvent.supportingInfo.​item[x]	Base	example	AdverseEvent Supporting Information	📍5.0.0	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()

Summary

Structures

This structure refers to these other structures:

• Procedure: Imaging Acquisition (http://hl7.eu/fhir/imaging-r5/StructureDefinition/ProcedureEuImaging)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of AdverseEvent.suspectEntity
• The element 1 is sliced based on the value of AdverseEvent.suspectEntity.instance[x]
• The element 1 is sliced based on the value of AdverseEvent.contributingFactor
• The element 1 is sliced based on the value of AdverseEvent.contributingFactor.item[x]

Maturity: 1