HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento
1.0.0-ballot - CI Build
HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento
1.0.0-ballot - CI Build
HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento, publicado por HL7 Portugal. Este guia não é uma publicação autorizada; é a compilação contínua para a versão 1.0.0-ballot construída pela FHIR (HL7® FHIR® Standard) CI Build. Esta versão é baseada no conteúdo atual de https://github.com/hl7-pt/adr-ig/ e muda regularmente. Veja o Diretório de versões publicadas
| Official URL: https://hl7.pt/fhir/ADR/StructureDefinition/ReacaoAdversa | Version: 1.0.0-ballot | |||
| Active as of 2026-10-20 | Computable Name: ReacaoAdversa | |||
Perfil para notificação de RAM
Usos:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Nome | Bandeiras | Card. | Tipo | Descrição e condicionalismos Filter:  |
|---|---|---|---|---|
  AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |
  implicitRules |
0..1 | uri | A set of rules under which this content was created | |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |
 identifier |
0..* | Identifier | Identificação da reacção | |
| status |
1..1 | code | in-progress | completed | entered-in-error | unknown Vínculo: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. | |
| actuality |
1..1 | code | actual | potential Vínculo: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | |
| code |
1..1 | CodeableConcept | Código da Reacção que aconteceu Vínculo: MedDRA ValueSet (preferred) | |
 subject |
1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção | |
  occurrence[x] |
0..1 | Data inicio e duração reacção | ||
 occurrenceDateTime |
dateTime | |||
| occurrencePeriod |
Period | |||
 occurrenceTiming |
Timing | |||
| seriousness |
0..1 | CodeableConcept | Seriousness or gravity of the event Vínculo: Gravidade RAM ValueSet (required) | |
| outcome |
0..* | CodeableConcept | Type of outcome from the adverse event Vínculo: Evolução de uma RAM ValueSet (required) | |
| recorder |
0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador | |
| suspectEntity |
1..1 | BackboneElement | The suspected agent causing the adverse event | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| instance[x] |
1..1 | Medicamento suspeito da reaação adversa | ||
| instanceCodeableConcept |
CodeableConcept | |||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
 causality |
0..1 | BackboneElement | Information on the possible cause of the event | |
 modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| assessmentMethod |
0..1 | CodeableConcept | Método de imputação de causalidade Vínculo: AdverseEventCausalityMethod (example): TODO. | |
| entityRelatedness |
0..1 | CodeableConcept | Grau de causalidade Vínculo: Causalidade ValueSet (required) | |
| preventiveAction |
0..* | BackboneElement | Medida Tomada | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| item[x] |
1..1 | Action that contributed to avoiding the adverse event Vínculo: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | ||
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept |
CodeableConcept | |||
| mitigatingAction |
0..* | BackboneElement | Medida Tomada | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| item[x] |
1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Vínculo: 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 | |||
| Documentação para este formato | ||||
| Caminho | Estado | Utilização | Conjunto de valores | Versão | Fonte |
| AdverseEvent.status | Base | required | Adverse Event Status | 📍5.0.0 | a norma FHIR |
| AdverseEvent.actuality | Base | required | Adverse Event Actuality | 📍5.0.0 | a norma FHIR |
| AdverseEvent.code | Base | preferred | MedDRA ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.seriousness | Base | required | Gravidade RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.outcome | Base | required | Evolução de uma RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.suspectEntity.causality.assessmentMethod | Base | example | Adverse Event Causality Method | 📍5.0.0 | a norma FHIR |
| AdverseEvent.suspectEntity.causality.entityRelatedness | Base | required | Causalidade ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.preventiveAction.item[x] | Base | example | AdverseEvent Preventive Action | 📍5.0.0 | a norma FHIR |
| AdverseEvent.mitigatingAction.item[x] | Base | example | AdverseEvent Mitigating Action | 📍5.0.0 | a norma FHIR |
| Id | Grau | Caminho(s) | Descrição | Expressão |
| 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
| Caminho | Estado | Utilização | Conjunto de valores | Versão | Fonte |
| AdverseEvent.code | Base | preferred | MedDRA ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.seriousness | Base | required | Gravidade RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.outcome | Base | required | Evolução de uma RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.suspectEntity.causality.entityRelatedness | Base | required | Causalidade ValueSet | 📦1.0.0-ballot | este IG |
| Nome | Bandeiras | Card. | Tipo | Descrição e condicionalismos Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |||||
| id |
0..1 | id | Logical id of this artifact | |||||
| meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |||||
| language |
0..1 | code | Language of the resource content Vínculo: AllLanguages (required): IETF language tag for a human language
| |||||
| 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 |
0..* | Extension | Extensions that cannot be ignored | |||||
| identifier |
0..* | Identifier | Identificação da reacção | |||||
| status |
1..1 | code | in-progress | completed | entered-in-error | unknown Vínculo: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. | |||||
| actuality |
1..1 | code | actual | potential Vínculo: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | |||||
| category |
0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Vínculo: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational. | |||||
| code |
1..1 | CodeableConcept | Código da Reacção que aconteceu Vínculo: MedDRA ValueSet (preferred) | |||||
| subject |
1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção | |||||
| encounter |
0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | |||||
| occurrence[x] |
0..1 | Data inicio e duração reacção | ||||||
| occurrenceDateTime |
dateTime | |||||||
| occurrencePeriod |
Period | |||||||
| occurrenceTiming |
Timing | |||||||
| detected |
0..1 | dateTime | When the event was detected | |||||
| recordedDate |
0..1 | dateTime | When the event was recorded | |||||
| resultingEffect |
0..* | Reference(Condition | Observation) | Effect on the subject due to this event | |||||
| location |
0..1 | Reference(Location) | Location where adverse event occurred | |||||
| seriousness |
0..1 | CodeableConcept | Seriousness or gravity of the event Vínculo: Gravidade RAM ValueSet (required) | |||||
| outcome |
0..* | CodeableConcept | Type of outcome from the adverse event Vínculo: Evolução de uma RAM ValueSet (required) | |||||
| recorder |
0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador | |||||
| participant |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| function |
0..1 | CodeableConcept | Type of involvement Vínculo: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event. | |||||
| actor |
1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | |||||
| study |
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 |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| instance[x] |
1..1 | Medicamento suspeito da reaação adversa | ||||||
| instanceCodeableConcept |
CodeableConcept | |||||||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||||||
| causality |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| assessmentMethod |
0..1 | CodeableConcept | Método de imputação de causalidade Vínculo: AdverseEventCausalityMethod (example): TODO. | |||||
| entityRelatedness |
0..1 | CodeableConcept | Grau de causalidade Vínculo: Causalidade ValueSet (required) | |||||
| author |
0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | |||||
| contributingFactor |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Item suspected to have increased the probability or severity of the adverse event Vínculo: 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 |
0..* | BackboneElement | Medida Tomada | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Action that contributed to avoiding the adverse event Vínculo: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | ||||||
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| mitigatingAction |
0..* | BackboneElement | Medida Tomada | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Vínculo: 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 |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Subject medical history or document relevant to this adverse event Vínculo: 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 |
0..* | Annotation | Comment on adverse event | |||||
| Documentação para este formato | ||||||||
| Caminho | Estado | Utilização | Conjunto de valores | Versão | Fonte |
| AdverseEvent.language | Base | required | All Languages | 📍5.0.0 | a norma FHIR |
| AdverseEvent.status | Base | required | Adverse Event Status | 📍5.0.0 | a norma FHIR |
| AdverseEvent.actuality | Base | required | Adverse Event Actuality | 📍5.0.0 | a norma FHIR |
| AdverseEvent.category | Base | example | Adverse Event Category | 📍5.0.0 | a norma FHIR |
| AdverseEvent.code | Base | preferred | MedDRA ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.seriousness | Base | required | Gravidade RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.outcome | Base | required | Evolução de uma RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.participant.function | Base | example | AdverseEvent Participant Function | 📍5.0.0 | a norma FHIR |
| AdverseEvent.suspectEntity.causality.assessmentMethod | Base | example | Adverse Event Causality Method | 📍5.0.0 | a norma FHIR |
| AdverseEvent.suspectEntity.causality.entityRelatedness | Base | required | Causalidade ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.contributingFactor.item[x] | Base | example | AdverseEvent Contributing Factor | 📍5.0.0 | a norma FHIR |
| AdverseEvent.preventiveAction.item[x] | Base | example | AdverseEvent Preventive Action | 📍5.0.0 | a norma FHIR |
| AdverseEvent.mitigatingAction.item[x] | Base | example | AdverseEvent Mitigating Action | 📍5.0.0 | a norma FHIR |
| AdverseEvent.supportingInfo.item[x] | Base | example | AdverseEvent Supporting Information | 📍5.0.0 | a norma FHIR |
| Id | Grau | Caminho(s) | Descrição | Expressão |
| 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
Key Elements View
| Nome | Bandeiras | Card. | Tipo | Descrição e condicionalismos Filter: |
|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |
| identifier |
0..* | Identifier | Identificação da reacção | |
| status |
1..1 | code | in-progress | completed | entered-in-error | unknown Vínculo: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. | |
| actuality |
1..1 | code | actual | potential Vínculo: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | |
| code |
1..1 | CodeableConcept | Código da Reacção que aconteceu Vínculo: MedDRA ValueSet (preferred) | |
| subject |
1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção | |
| occurrence[x] |
0..1 | Data inicio e duração reacção | ||
| occurrenceDateTime |
dateTime | |||
| occurrencePeriod |
Period | |||
| occurrenceTiming |
Timing | |||
| seriousness |
0..1 | CodeableConcept | Seriousness or gravity of the event Vínculo: Gravidade RAM ValueSet (required) | |
| outcome |
0..* | CodeableConcept | Type of outcome from the adverse event Vínculo: Evolução de uma RAM ValueSet (required) | |
| recorder |
0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador | |
| suspectEntity |
1..1 | BackboneElement | The suspected agent causing the adverse event | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| instance[x] |
1..1 | Medicamento suspeito da reaação adversa | ||
| instanceCodeableConcept |
CodeableConcept | |||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
| causality |
0..1 | BackboneElement | Information on the possible cause of the event | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| assessmentMethod |
0..1 | CodeableConcept | Método de imputação de causalidade Vínculo: AdverseEventCausalityMethod (example): TODO. | |
| entityRelatedness |
0..1 | CodeableConcept | Grau de causalidade Vínculo: Causalidade ValueSet (required) | |
| preventiveAction |
0..* | BackboneElement | Medida Tomada | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| item[x] |
1..1 | Action that contributed to avoiding the adverse event Vínculo: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | ||
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept |
CodeableConcept | |||
| mitigatingAction |
0..* | BackboneElement | Medida Tomada | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |
| item[x] |
1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Vínculo: 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 | |||
| Documentação para este formato | ||||
| Caminho | Estado | Utilização | Conjunto de valores | Versão | Fonte |
| AdverseEvent.status | Base | required | Adverse Event Status | 📍5.0.0 | a norma FHIR |
| AdverseEvent.actuality | Base | required | Adverse Event Actuality | 📍5.0.0 | a norma FHIR |
| AdverseEvent.code | Base | preferred | MedDRA ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.seriousness | Base | required | Gravidade RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.outcome | Base | required | Evolução de uma RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.suspectEntity.causality.assessmentMethod | Base | example | Adverse Event Causality Method | 📍5.0.0 | a norma FHIR |
| AdverseEvent.suspectEntity.causality.entityRelatedness | Base | required | Causalidade ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.preventiveAction.item[x] | Base | example | AdverseEvent Preventive Action | 📍5.0.0 | a norma FHIR |
| AdverseEvent.mitigatingAction.item[x] | Base | example | AdverseEvent Mitigating Action | 📍5.0.0 | a norma FHIR |
| Id | Grau | Caminho(s) | Descrição | Expressão |
| 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()
|
Differential View
This structure is derived from AdverseEvent
| Caminho | Estado | Utilização | Conjunto de valores | Versão | Fonte |
| AdverseEvent.code | Base | preferred | MedDRA ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.seriousness | Base | required | Gravidade RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.outcome | Base | required | Evolução de uma RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.suspectEntity.causality.entityRelatedness | Base | required | Causalidade ValueSet | 📦1.0.0-ballot | este IG |
Snapshot View
| Nome | Bandeiras | Card. | Tipo | Descrição e condicionalismos Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |||||
| id |
0..1 | id | Logical id of this artifact | |||||
| meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |||||
| language |
0..1 | code | Language of the resource content Vínculo: AllLanguages (required): IETF language tag for a human language
| |||||
| 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 |
0..* | Extension | Extensions that cannot be ignored | |||||
| identifier |
0..* | Identifier | Identificação da reacção | |||||
| status |
1..1 | code | in-progress | completed | entered-in-error | unknown Vínculo: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. | |||||
| actuality |
1..1 | code | actual | potential Vínculo: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | |||||
| category |
0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Vínculo: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational. | |||||
| code |
1..1 | CodeableConcept | Código da Reacção que aconteceu Vínculo: MedDRA ValueSet (preferred) | |||||
| subject |
1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção | |||||
| encounter |
0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | |||||
| occurrence[x] |
0..1 | Data inicio e duração reacção | ||||||
| occurrenceDateTime |
dateTime | |||||||
| occurrencePeriod |
Period | |||||||
| occurrenceTiming |
Timing | |||||||
| detected |
0..1 | dateTime | When the event was detected | |||||
| recordedDate |
0..1 | dateTime | When the event was recorded | |||||
| resultingEffect |
0..* | Reference(Condition | Observation) | Effect on the subject due to this event | |||||
| location |
0..1 | Reference(Location) | Location where adverse event occurred | |||||
| seriousness |
0..1 | CodeableConcept | Seriousness or gravity of the event Vínculo: Gravidade RAM ValueSet (required) | |||||
| outcome |
0..* | CodeableConcept | Type of outcome from the adverse event Vínculo: Evolução de uma RAM ValueSet (required) | |||||
| recorder |
0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador | |||||
| participant |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| function |
0..1 | CodeableConcept | Type of involvement Vínculo: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event. | |||||
| actor |
1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | |||||
| study |
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 |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| instance[x] |
1..1 | Medicamento suspeito da reaação adversa | ||||||
| instanceCodeableConcept |
CodeableConcept | |||||||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||||||
| causality |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| assessmentMethod |
0..1 | CodeableConcept | Método de imputação de causalidade Vínculo: AdverseEventCausalityMethod (example): TODO. | |||||
| entityRelatedness |
0..1 | CodeableConcept | Grau de causalidade Vínculo: Causalidade ValueSet (required) | |||||
| author |
0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | |||||
| contributingFactor |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Item suspected to have increased the probability or severity of the adverse event Vínculo: 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 |
0..* | BackboneElement | Medida Tomada | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Action that contributed to avoiding the adverse event Vínculo: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | ||||||
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| mitigatingAction |
0..* | BackboneElement | Medida Tomada | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Vínculo: 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 |
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 |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| item[x] |
1..1 | Subject medical history or document relevant to this adverse event Vínculo: 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 |
0..* | Annotation | Comment on adverse event | |||||
| Documentação para este formato | ||||||||
| Caminho | Estado | Utilização | Conjunto de valores | Versão | Fonte |
| AdverseEvent.language | Base | required | All Languages | 📍5.0.0 | a norma FHIR |
| AdverseEvent.status | Base | required | Adverse Event Status | 📍5.0.0 | a norma FHIR |
| AdverseEvent.actuality | Base | required | Adverse Event Actuality | 📍5.0.0 | a norma FHIR |
| AdverseEvent.category | Base | example | Adverse Event Category | 📍5.0.0 | a norma FHIR |
| AdverseEvent.code | Base | preferred | MedDRA ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.seriousness | Base | required | Gravidade RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.outcome | Base | required | Evolução de uma RAM ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.participant.function | Base | example | AdverseEvent Participant Function | 📍5.0.0 | a norma FHIR |
| AdverseEvent.suspectEntity.causality.assessmentMethod | Base | example | Adverse Event Causality Method | 📍5.0.0 | a norma FHIR |
| AdverseEvent.suspectEntity.causality.entityRelatedness | Base | required | Causalidade ValueSet | 📦1.0.0-ballot | este IG |
| AdverseEvent.contributingFactor.item[x] | Base | example | AdverseEvent Contributing Factor | 📍5.0.0 | a norma FHIR |
| AdverseEvent.preventiveAction.item[x] | Base | example | AdverseEvent Preventive Action | 📍5.0.0 | a norma FHIR |
| AdverseEvent.mitigatingAction.item[x] | Base | example | AdverseEvent Mitigating Action | 📍5.0.0 | a norma FHIR |
| AdverseEvent.supportingInfo.item[x] | Base | example | AdverseEvent Supporting Information | 📍5.0.0 | a norma FHIR |
| Id | Grau | Caminho(s) | Descrição | Expressão |
| 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
Other representations of profile: CSV, Excel, Schematron
