Name | Flags | Card. | Type |
Description & Constraints
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TU | DomainResource | An event that may be related to unintended effects on a patient or research participant
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension |
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Σ | 0..* | Identifier | Business identifier for the event
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?! Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown
Binding: Adverse Event Status ( Required) |
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?! Σ | 1..1 | code | actual | potential
Binding: Adverse Event Actuality ( Required) |
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Σ | 0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
Binding: Adverse Event Category ( Example) |
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Σ | 0..1 | CodeableConcept | Event or incident that occurred or was averted
Binding: AdverseEvent Type ( Example) |
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Σ | 1..1 | Reference( Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject impacted by event
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Σ | 0..1 | Reference( Encounter) | The Encounter associated with the start of the AdverseEvent
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Σ | 0..1 | When the event occurred
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dateTime | |||
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Period | |||
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Timing | |||
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Σ | 0..1 | dateTime | When the event was detected
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Σ | 0..1 | dateTime | When the event was recorded
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Σ | 0..* | Reference( Condition | Observation) | Effect on the subject due to this event
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Σ | 0..1 | Reference( Location) | Location where adverse event occurred
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Σ | 0..1 | CodeableConcept | Seriousness or gravity of the event
Binding: Adverse Event Seriousness ( Example) |
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Σ | 0..* | CodeableConcept | Type of outcome from the adverse event
Binding: AdverseEvent Outcome ( Example) |
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Σ | 0..1 | Reference( Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event
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Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did
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Σ | 0..1 | CodeableConcept | Type of involvement
Binding: AdverseEvent Participant Function ( Example) |
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Σ | 1..1 | Reference( Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event
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Σ | 0..* | Reference( ResearchStudy) | Research study that the subject is enrolled in
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0..1 | boolean | Considered likely or probable or anticipated in the research study
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Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
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Σ | 1..1 | Refers to the specific entity that caused the adverse event
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CodeableConcept | |||
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Reference( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
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Σ | 0..1 | BackboneElement | Information on the possible cause of the event
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Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Method ( Example) |
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Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Assessment ( Example) |
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Σ | 0..1 | Reference( Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event
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Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event
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Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event
Binding: AdverseEvent Contributing Factor ( Example) |
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Reference( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement) | |||
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CodeableConcept | |||
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Σ | 0..* | BackboneElement | Preventive actions that contributed to avoiding the adverse event
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Σ | 1..1 | Action that contributed to avoiding the adverse event
Binding: AdverseEvent Preventive Action ( Example) |
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Reference( Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
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CodeableConcept | |||
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Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
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Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
Binding: AdverseEvent Mitigating Action ( Example) |
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Reference( Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
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CodeableConcept | |||
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Σ | 0..* | BackboneElement | Supporting information relevant to the event
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Σ | 1..1 | Subject medical history or document relevant to this adverse event
Binding: AdverseEvent Supporting Information ( Example) |
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Reference( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) | |||
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CodeableConcept | |||
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Σ | 0..* | Annotation | Comment on adverse event
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