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.
NameFlagsCardTypeDescription & Constraints
AdverseEvent
0..*Medical care, research study or other healthcare event causing physical injury
 
identifier
Σ
0..1IdentifierBusiness identifier for the event
 
actuality *
?!Σ
1..1codeactual | potential AdverseEventActuality (required)
 
category
Σ
0..*CodeableConceptproduct-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)
 
event
Σ
0..1CodeableConceptType of the event itself in relation to the subject AdverseEventType (example)
 
subject *
Σ
1..1ReferenceSubject impacted by event
 
encounter
Σ
0..1ReferenceEncounter created as part of
 
date
Σ
0..1dateTimeWhen the event occurred
 
detected
Σ
0..1dateTimeWhen the event was detected
 
recordedDate
Σ
0..1dateTimeWhen the event was recorded
 
resultingCondition
Σ
0..*ReferenceEffect on the subject due to this event
 
location
Σ
0..1ReferenceLocation where adverse event occurred
 
seriousness
Σ
0..1CodeableConceptSeriousness of the event AdverseEventSeriousness (example)
 
severity
Σ
0..1CodeableConceptmild | moderate | severe AdverseEventSeverity (required)
 
outcome
Σ
0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown AdverseEventOutcome (required)
 
recorder
Σ
0..1ReferenceWho recorded the adverse event
 
contributor
Σ
0..*ReferenceWho was involved in the adverse event or the potential adverse event
 
suspectEntity
Σ
0..*BackboneElementThe suspected agent causing the adverse event
 
 
instance *
Σ
1..1ReferenceRefers to the specific entity that caused the adverse event
 
 
causality
Σ
0..*BackboneElementInformation on the possible cause of the event
 
 
 
assessment
Σ
0..1CodeableConceptAssessment of if the entity caused the event AdverseEventCausalityAssessment (example)
 
 
 
productRelatedness
Σ
0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
 
 
 
author
Σ
0..1ReferenceAdverseEvent.suspectEntity.causalityAuthor
 
 
 
method
Σ
0..1CodeableConceptProbabilityScale | Bayesian | Checklist AdverseEventCausalityMethod (example)
 
subjectMedicalHistory
Σ
0..*ReferenceAdverseEvent.subjectMedicalHistory
 
referenceDocument
Σ
0..*ReferenceAdverseEvent.referenceDocument
 
study
Σ
0..*ReferenceAdverseEvent.study