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.

AdverseEvent
identifier
Business identifier for the event
status
in-progress | completed | entered-in-error | unknown
actuality
actual | potential
category
wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
code
Event or incident that occurred or was averted
subject
Subject impacted by event
encounter
The Encounter associated with the start of the AdverseEvent
occurrence[x]
When the event occurred
detected
When the event was detected
recordedDate
When the event was recorded
resultingEffect
Effect on the subject due to this event
location
Location where adverse event occurred
seriousness
Seriousness or gravity of the event
outcome
Type of outcome from the adverse event
recorder
Who recorded the adverse event
participant
Who was involved in the adverse event or the potential adverse event and what they did
function
Type of involvement
actor
Who was involved in the adverse event or the potential adverse event
study
Research study that the subject is enrolled in
expectedInResearchStudy
Considered likely or probable or anticipated in the research study
suspectEntity
The suspected agent causing the adverse event
instance[x]
Refers to the specific entity that caused the adverse event
causality
Information on the possible cause of the event
assessmentMethod
Method of evaluating the relatedness of the suspected entity to the event
entityRelatedness
Result of the assessment regarding the relatedness of the suspected entity to the event
author
Author of the information on the possible cause of the event
contributingFactor
Contributing factors suspected to have increased the probability or severity of the adverse event
item[x]
Item suspected to have increased the probability or severity of the adverse event
preventiveAction
Preventive actions that contributed to avoiding the adverse event
item[x]
Action that contributed to avoiding the adverse event
mitigatingAction
Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
item[x]
Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
supportingInfo
Supporting information relevant to the event
item[x]
Subject medical history or document relevant to this adverse event
note
Comment on adverse event