AdverseEvent

Trial Use 2 Specialized — Public Health & Research

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.

Endpoints

devhttps://api.sandbox.ovok.com/fhir/R5/AdverseEvent

Interaction	Method	Path
Read	GET	/fhir/R5/AdverseEvent/[id]
Vread	GET	/fhir/R5/AdverseEvent/[id]/_history/[vid]
Update	PUT	/fhir/R5/AdverseEvent/[id]
Patch	PATCH	/fhir/R5/AdverseEvent/[id]
Delete	DELETE	/fhir/R5/AdverseEvent/[id]
Create	POST	/fhir/R5/AdverseEvent
Search	GET	/fhir/R5/AdverseEvent?...
History	GET	/fhir/R5/AdverseEvent/[id]/_history
Type-history	GET	/fhir/R5/AdverseEvent/_history

Top-level elements

Element	Type(s)	Cardinality	Description
identifier	Identifier	0..*	Business identifier for the event
status	code	1..1	in-progress
actuality	code	1..1	actual
category	CodeableConcept	0..*	wrong-patient
code	CodeableConcept	0..1	Event or incident that occurred or was averted
subject	Reference	1..1	Subject impacted by event
encounter	Reference	0..1	The Encounter associated with the start of the AdverseEvent
occurrence[x]	dateTime / Period / Timing	0..1	When the event occurred
detected	dateTime	0..1	When the event was detected
recordedDate	dateTime	0..1	When the event was recorded
resultingEffect	Reference	0..*	Effect on the subject due to this event
location	Reference	0..1	Location where adverse event occurred
seriousness	CodeableConcept	0..1	Seriousness or gravity of the event
outcome	CodeableConcept	0..*	Type of outcome from the adverse event
recorder	Reference	0..1	Who recorded the adverse event
participant	BackboneElement	0..*	Who was involved in the adverse event or the potential adverse event and what they did
study	Reference	0..*	Research study that the subject is enrolled in
expectedInResearchStudy	boolean	0..1	Considered likely or probable or anticipated in the research study
suspectEntity	BackboneElement	0..*	The suspected agent causing the adverse event
contributingFactor	BackboneElement	0..*	Contributing factors suspected to have increased the probability or severity of the adverse event
preventiveAction	BackboneElement	0..*	Preventive actions that contributed to avoiding the adverse event
mitigatingAction	BackboneElement	0..*	Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
supportingInfo	BackboneElement	0..*	Supporting information relevant to the event
note	Annotation	0..*	Comment on adverse event

Resource-specific search parameters

Parameter	Type	Description
actuality	token	actual
category	token	wrong-patient
code	token	Event or incident that occurred or was averted
date	date	When the event occurred
identifier	token	Account number
location	reference	Location where adverse event occurred
patient	reference	The entity that caused the expenses
recorder	reference	Who recorded the adverse event
resultingeffect	reference	Effect on the subject due to this event
seriousness	token	Seriousness or gravity of the event
status	token	in-progress
study	reference	Research study that the subject is enrolled in
subject	reference	Subject impacted by event
substance	reference	Refers to the specific entity that caused the adverse event

Reference

• Official FHIR R5 spec: AdverseEvent
• Maturity: Trial Use 2 (FMM 2).