http://hl7.org/fhir/StructureDefinition/AdverseEvent|4.0.1
Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.
| Name | Flags | Card | Type | Description & Constraints |
|---|---|---|---|---|
AdverseEvent | 0..* | Medical care, research study or other healthcare event causing physical injury | ||
Σ | 0..1 | Identifier | Business identifier for the event | |
?!Σ | 1..1 | code | actual | potential AdverseEventActuality (required) | |
Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment AdverseEventCategory (extensible) | |
Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject AdverseEventType (example) | |
Σ | 1..1 | Reference | Subject impacted by event | |
Σ | 0..1 | Reference | Encounter created as part of | |
Σ | 0..1 | dateTime | When the event occurred | |
Σ | 0..1 | dateTime | When the event was detected | |
Σ | 0..1 | dateTime | When the event was recorded | |
Σ | 0..* | Reference | Effect on the subject due to this event | |
Σ | 0..1 | Reference | Location where adverse event occurred | |
Σ | 0..1 | CodeableConcept | Seriousness of the event AdverseEventSeriousness (example) | |
Σ | 0..1 | CodeableConcept | mild | moderate | severe AdverseEventSeverity (required) | |
Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown AdverseEventOutcome (required) | |
Σ | 0..1 | Reference | Who recorded the adverse event | |
Σ | 0..* | Reference | Who was involved in the adverse event or the potential adverse event | |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | |
Σ | 1..1 | Reference | Refers to the specific entity that caused the adverse event | |
Σ | 0..* | BackboneElement | Information on the possible cause of the event | |
Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event AdverseEventCausalityAssessment (example) | |
Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | |
Σ | 0..1 | Reference | AdverseEvent.suspectEntity.causalityAuthor | |
Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist AdverseEventCausalityMethod (example) | |
Σ | 0..* | Reference | AdverseEvent.subjectMedicalHistory | |
Σ | 0..* | Reference | AdverseEvent.referenceDocument | |
Σ | 0..* | Reference | AdverseEvent.study |