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.

AdverseEvent
identifier
Business identifier for the event
actuality
actual | potential
category
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
event
Type of the event itself in relation to the subject
subject
Subject impacted by event
encounter
Encounter created as part of
date
When the event occurred
detected
When the event was detected
recordedDate
When the event was recorded
resultingCondition
Effect on the subject due to this event
location
Location where adverse event occurred
seriousness
Seriousness of the event
severity
mild | moderate | severe
outcome
resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
recorder
Who recorded the adverse event
contributor
Who was involved in the adverse event or the potential adverse event
suspectEntity
The suspected agent causing the adverse event
instance
Refers to the specific entity that caused the adverse event
causality
Information on the possible cause of the event
assessment
Assessment of if the entity caused the event
productRelatedness
AdverseEvent.suspectEntity.causalityProductRelatedness
author
AdverseEvent.suspectEntity.causalityAuthor
method
ProbabilityScale | Bayesian | Checklist
subjectMedicalHistory
AdverseEvent.subjectMedicalHistory
referenceDocument
AdverseEvent.referenceDocument
study
AdverseEvent.study