HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento, published by HL7 Portugal. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-pt/adr-ig/ and changes regularly. See the Directory of published versions

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Resource Profile: Perfil para notificação de RAM

Perfil para notificação de RAM

Usage:

• Examples for this Resource Profile: AdverseEvent/Notifi-1 and AdverseEvent/Notifi-2

Formal Views of Profile Content

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

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

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
identifier	S	0..*	Identifier	Identificação da reacção
code	S	1..1	CodeableConcept	Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred)
subject	S	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Doente sobre o qual existiu uma potencial reacção
occurrence[x]	S	0..1	dateTime, Period, Timing	Data inicio e duração reacção
seriousness	S	0..1	CodeableConcept	Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required)
outcome	S	0..*	CodeableConcept	Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required)
recorder	S	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Notificador
suspectEntity	S	1..1	BackboneElement	The suspected agent causing the adverse event
instance[x]	S	1..1	CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)	Medicamento suspeito da reaação adversa
causality
assessmentMethod	S	0..1	CodeableConcept	Método de imputação de causalidade
entityRelatedness	S	0..1	CodeableConcept	Grau de causalidade Binding: Causalidade ValueSet (required)
preventiveAction	S	0..*	BackboneElement	Medida Tomada
mitigatingAction	S	0..*	BackboneElement	Medida Tomada
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdverseEvent.code	preferred	MeddraVS https://hl7.pt/fhir/ADR/ValueSet/meddra-vs from this IG
AdverseEvent.seriousness	required	GravidadeVS (a valid code from Gravidade RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs from this IG
AdverseEvent.outcome	required	EvolucaoVS (a valid code from Evolução de uma RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs from this IG
AdverseEvent.suspectEntity.causality.entityRelatedness	required	CausalidadeVS (a valid code from Causalidade CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs from this IG

Name	Flags	Card.	Type	Description & Constraints
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
identifier	SΣ	0..*	Identifier	Identificação da reacção
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.
code	SΣ	1..1	CodeableConcept	Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred)
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Doente sobre o qual existiu uma potencial reacção
occurrence[x]	SΣ	0..1		Data inicio e duração reacção
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
seriousness	SΣ	0..1	CodeableConcept	Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required)
outcome	SΣ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required)
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Notificador
suspectEntity	SΣ	1..1	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	SΣ	1..1		Medicamento suspeito da reaação adversa
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessmentMethod	SΣ	0..1	CodeableConcept	Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	SΣ	0..1	CodeableConcept	Grau de causalidade Binding: Causalidade ValueSet (required)
preventiveAction	SΣ	0..*	BackboneElement	Medida Tomada
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	SΣ	0..*	BackboneElement	Medida Tomada
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.code	preferred	MeddraVS https://hl7.pt/fhir/ADR/ValueSet/meddra-vs from this IG
AdverseEvent.seriousness	required	GravidadeVS (a valid code from Gravidade RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs from this IG
AdverseEvent.outcome	required	EvolucaoVS (a valid code from Evolução de uma RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs from this IG
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	required	CausalidadeVS (a valid code from Causalidade CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs from this IG
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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 Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Identificação da reacção
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	SΣ	1..1	CodeableConcept	Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred)
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Doente sobre o qual existiu uma potencial reacção
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	SΣ	0..1		Data inicio e duração reacção
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	SΣ	0..1	CodeableConcept	Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required)
outcome	SΣ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required)
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Notificador
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
suspectEntity	SΣ	1..1	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[x]	SΣ	1..1		Medicamento suspeito da reaação adversa
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	SΣ	0..1	CodeableConcept	Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	SΣ	0..1	CodeableConcept	Grau de causalidade Binding: Causalidade ValueSet (required)
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
contributingFactor	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
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
preventiveAction	SΣ	0..*	BackboneElement	Medida Tomada
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	SΣ	0..*	BackboneElement	Medida Tomada
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	Conformance	ValueSet	URI
AdverseEvent.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.category	example	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.code	preferred	MeddraVS https://hl7.pt/fhir/ADR/ValueSet/meddra-vs from this IG
AdverseEvent.seriousness	required	GravidadeVS (a valid code from Gravidade RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs from this IG
AdverseEvent.outcome	required	EvolucaoVS (a valid code from Evolução de uma RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs from this IG
AdverseEvent.participant.function	example	AdverseEventParticipantFunction http://hl7.org/fhir/ValueSet/adverse-event-participant-function from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	required	CausalidadeVS (a valid code from Causalidade CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs from this IG
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation http://hl7.org/fhir/ValueSet/adverse-event-supporting-info from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 13 elements

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
identifier	S	0..*	Identifier	Identificação da reacção
code	S	1..1	CodeableConcept	Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred)
subject	S	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Doente sobre o qual existiu uma potencial reacção
occurrence[x]	S	0..1	dateTime, Period, Timing	Data inicio e duração reacção
seriousness	S	0..1	CodeableConcept	Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required)
outcome	S	0..*	CodeableConcept	Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required)
recorder	S	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Notificador
suspectEntity	S	1..1	BackboneElement	The suspected agent causing the adverse event
instance[x]	S	1..1	CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)	Medicamento suspeito da reaação adversa
causality
assessmentMethod	S	0..1	CodeableConcept	Método de imputação de causalidade
entityRelatedness	S	0..1	CodeableConcept	Grau de causalidade Binding: Causalidade ValueSet (required)
preventiveAction	S	0..*	BackboneElement	Medida Tomada
mitigatingAction	S	0..*	BackboneElement	Medida Tomada
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdverseEvent.code	preferred	MeddraVS https://hl7.pt/fhir/ADR/ValueSet/meddra-vs from this IG
AdverseEvent.seriousness	required	GravidadeVS (a valid code from Gravidade RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs from this IG
AdverseEvent.outcome	required	EvolucaoVS (a valid code from Evolução de uma RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs from this IG
AdverseEvent.suspectEntity.causality.entityRelatedness	required	CausalidadeVS (a valid code from Causalidade CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
identifier	SΣ	0..*	Identifier	Identificação da reacção
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.
code	SΣ	1..1	CodeableConcept	Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred)
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Doente sobre o qual existiu uma potencial reacção
occurrence[x]	SΣ	0..1		Data inicio e duração reacção
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
seriousness	SΣ	0..1	CodeableConcept	Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required)
outcome	SΣ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required)
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Notificador
suspectEntity	SΣ	1..1	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	SΣ	1..1		Medicamento suspeito da reaação adversa
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
assessmentMethod	SΣ	0..1	CodeableConcept	Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	SΣ	0..1	CodeableConcept	Grau de causalidade Binding: Causalidade ValueSet (required)
preventiveAction	SΣ	0..*	BackboneElement	Medida Tomada
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	SΣ	0..*	BackboneElement	Medida Tomada
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.code	preferred	MeddraVS https://hl7.pt/fhir/ADR/ValueSet/meddra-vs from this IG
AdverseEvent.seriousness	required	GravidadeVS (a valid code from Gravidade RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs from this IG
AdverseEvent.outcome	required	EvolucaoVS (a valid code from Evolução de uma RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs from this IG
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	required	CausalidadeVS (a valid code from Causalidade CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs from this IG
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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 Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Identificação da reacção
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	SΣ	1..1	CodeableConcept	Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred)
subject	SΣ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Doente sobre o qual existiu uma potencial reacção
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	SΣ	0..1		Data inicio e duração reacção
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	SΣ	0..1	CodeableConcept	Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required)
outcome	SΣ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required)
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Notificador
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
suspectEntity	SΣ	1..1	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[x]	SΣ	1..1		Medicamento suspeito da reaação adversa
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	SΣ	0..1	CodeableConcept	Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO.
entityRelatedness	SΣ	0..1	CodeableConcept	Grau de causalidade Binding: Causalidade ValueSet (required)
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event
contributingFactor	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
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
preventiveAction	SΣ	0..*	BackboneElement	Medida Tomada
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	SΣ	0..*	BackboneElement	Medida Tomada
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	Conformance	ValueSet	URI
AdverseEvent.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.category	example	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.code	preferred	MeddraVS https://hl7.pt/fhir/ADR/ValueSet/meddra-vs from this IG
AdverseEvent.seriousness	required	GravidadeVS (a valid code from Gravidade RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs from this IG
AdverseEvent.outcome	required	EvolucaoVS (a valid code from Evolução de uma RAM CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs from this IG
AdverseEvent.participant.function	example	AdverseEventParticipantFunction http://hl7.org/fhir/ValueSet/adverse-event-participant-function from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	required	CausalidadeVS (a valid code from Causalidade CodeSystem) https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs from this IG
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation http://hl7.org/fhir/ValueSet/adverse-event-supporting-info from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 13 elements

Other representations of profile: CSV, Excel, Schematron