AdverseEvent
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.
Metadata
hl7.org/fhir- Canonical URL
- http://hl7.org/fhir/StructureDefinition/AdverseEvent
- ID
- AdverseEvent
- Type
- Base Definition
- Derivation
- specialization
- Publisher
- Health Level Seven International (Patient Care)
- Version
- 5.0.0
| Path | Card. | Type | Description |
|---|---|---|---|
AdverseEvent | 0..* | An event that may be related to unintended effects on a patient or research participant | |
id | 0..1 | string | Logical id of this artifact |
meta | 0..1 | Metadata about the resource | |
implicitRules | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource contentrequired: all-languages |
text | 0..1 | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources |
extension | 0..* | Additional content defined by implementations | |
modifierExtension | 0..* | Extensions that cannot be ignored | |
identifier | 0..* | Business identifier for the event | |
status | 1..1 | code | in-progress | completed | entered-in-error | unknownrequired: adverse-event-status |
actuality | 1..1 | code | actual | potentialrequired: adverse-event-actuality |
category | 0..* | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-siteexample: adverse-event-category | |
code | 0..1 | Event or incident that occurred or was avertedexample: adverse-event-type | |
subject | 1..1 | Subject impacted by event | |
encounter | 0..1 | The Encounter associated with the start of the AdverseEvent | |
occurrence[x] | 0..1 | When the event occurred | |
detected | 0..1 | dateTime | When the event was detected |
recordedDate | 0..1 | dateTime | When the event was recorded |
resultingEffect | 0..* | Effect on the subject due to this event | |
location | 0..1 | Location where adverse event occurred | |
seriousness | 0..1 | Seriousness or gravity of the eventexample: adverse-event-seriousness | |
outcome | 0..* | Type of outcome from the adverse eventexample: adverse-event-outcome | |
recorder | 0..1 | Who recorded the adverse event | |
participant | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did |
study | 0..* | Research study that the subject is enrolled in | |
expectedInResearchStudy | 0..1 | boolean | Considered likely or probable or anticipated in the research study |
suspectEntity | 0..* | BackboneElement | The suspected agent causing the adverse event |
contributingFactor | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event |
preventiveAction | 0..* | BackboneElement | Preventive actions that contributed to avoiding the adverse event |
mitigatingAction | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm |
supportingInfo | 0..* | BackboneElement | Supporting information relevant to the event |
note | 0..* | Comment on adverse event |