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StructureDefinitionsAdverseEvent

http://hl7.org/fhir/StructureDefinition/AdverseEvent|5.0.0

An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.
StructureJSONDependenciesFHIRSchemaOther VersionsDependant (0)ElementsSummary
NameFlagsCardTypeDescription & Constraints
AdverseEvent
0..*An event that may be related to unintended effects on a patient or research participant
 
identifier
Σ
0..*IdentifierBusiness identifier for the event
 
status *
?!Σ
1..1codein-progress | completed | entered-in-error | unknown AdverseEventStatus (required)
 
actuality *
?!Σ
1..1codeactual | potential AdverseEventActuality (required)
 
category
Σ
0..*CodeableConceptwrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site AdverseEventCategory (example)
 
code
Σ
0..1CodeableConceptEvent or incident that occurred or was averted AdverseEventType (example)
 
subject *
Σ
1..1ReferenceSubject impacted by event
 
encounter
Σ
0..1ReferenceThe Encounter associated with the start of the AdverseEvent
 
occurrence[x]
Σ
0..1When the event occurred
 
 
occurrenceDateTime
Σ
0..1dateTime
 
 
occurrencePeriod
Σ
0..1Period
 
 
occurrenceTiming
Σ
0..1Timing
 
detected
Σ
0..1dateTimeWhen the event was detected
 
recordedDate
Σ
0..1dateTimeWhen the event was recorded
 
resultingEffect
Σ
0..*ReferenceEffect on the subject due to this event
 
location
Σ
0..1ReferenceLocation where adverse event occurred
 
seriousness
Σ
0..1CodeableConceptSeriousness or gravity of the event AdverseEventSeriousness (example)
 
outcome
Σ
0..*CodeableConceptType of outcome from the adverse event AdverseEventOutcome (example)
 
recorder
Σ
0..1ReferenceWho recorded the adverse event
 
participant
Σ
0..*BackboneElementWho was involved in the adverse event or the potential adverse event and what they did
 
 
function
Σ
0..1CodeableConceptType of involvement AdverseEventParticipantFunction (example)
 
 
actor *
Σ
1..1ReferenceWho was involved in the adverse event or the potential adverse event
 
study
Σ
0..*ReferenceResearch study that the subject is enrolled in
 
expectedInResearchStudy
0..1booleanConsidered likely or probable or anticipated in the research study
 
suspectEntity
Σ
0..*BackboneElementThe suspected agent causing the adverse event
 
 
instance[x] *
Σ
1..1Refers to the specific entity that caused the adverse event
 
 
 
instanceCodeableConcept *
Σ
1..1CodeableConcept
 
 
 
instanceReference *
Σ
1..1Reference
 
 
causality
Σ
0..1BackboneElementInformation on the possible cause of the event
 
 
 
assessmentMethod
Σ
0..1CodeableConceptMethod of evaluating the relatedness of the suspected entity to the event AdverseEventCausalityMethod (example)
 
 
 
entityRelatedness
Σ
0..1CodeableConceptResult of the assessment regarding the relatedness of the suspected entity to the event AdverseEventCausalityAssessment (example)
 
 
 
author
Σ
0..1ReferenceAuthor of the information on the possible cause of the event
 
contributingFactor
Σ
0..*BackboneElementContributing factors suspected to have increased the probability or severity of the adverse event
 
 
item[x] *
Σ
1..1Item suspected to have increased the probability or severity of the adverse event AdverseEventContributingFactor (example)
 
 
 
itemReference *
Σ
1..1Reference AdverseEventContributingFactor (example)
 
 
 
itemCodeableConcept *
Σ
1..1CodeableConcept AdverseEventContributingFactor (example)
 
preventiveAction
Σ
0..*BackboneElementPreventive actions that contributed to avoiding the adverse event
 
 
item[x] *
Σ
1..1Action that contributed to avoiding the adverse event AdverseEventPreventiveAction (example)
 
 
 
itemReference *
Σ
1..1Reference AdverseEventPreventiveAction (example)
 
 
 
itemCodeableConcept *
Σ
1..1CodeableConcept AdverseEventPreventiveAction (example)
 
mitigatingAction
Σ
0..*BackboneElementAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm
 
 
item[x] *
Σ
1..1Ameliorating action taken after the adverse event occured in order to reduce the extent of harm AdverseEventMitigatingAction (example)
 
 
 
itemReference *
Σ
1..1Reference AdverseEventMitigatingAction (example)
 
 
 
itemCodeableConcept *
Σ
1..1CodeableConcept AdverseEventMitigatingAction (example)
 
supportingInfo
Σ
0..*BackboneElementSupporting information relevant to the event
 
 
item[x] *
Σ
1..1Subject medical history or document relevant to this adverse event AdverseEventSupportingInfo (example)
 
 
 
itemReference *
Σ
1..1Reference AdverseEventSupportingInfo (example)
 
 
 
itemCodeableConcept *
Σ
1..1CodeableConcept AdverseEventSupportingInfo (example)
 
note
Σ
0..*AnnotationComment on adverse event