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Patient Care Work GroupMaturity Level: 0 Trial UseSecurity Category: Patient Compartments: Patient, Practitioner, RelatedPerson

Detailed Descriptions for the elements in the AdverseEvent resource.

AdverseEvent
Element IdAdverseEvent
Definition

An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research subject. The unintended effects may require additional monitoring, treatment or hospitalization or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects.

Cardinality0..*
TypeDomainResource
Alternate NamesAE
Summarytrue
AdverseEvent.identifier
Element IdAdverseEvent.identifier
Definition

Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Requirements

Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

Summarytrue
Comments

This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

AdverseEvent.status
Element IdAdverseEvent.status
Definition

The current state of the data entry of the adverse event or potential adverse event.

Cardinality1..1
Terminology BindingAdverse Event Status (Required)
Typecode
Is Modifiertrue (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)
Summarytrue
Comments

This is not the reporting of the event to any regulatory or quality organization.

AdverseEvent.actuality
Element IdAdverseEvent.actuality
Definition

Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

Cardinality1..1
Terminology BindingAdverseEventActuality (Required)
Typecode
Is Modifiertrue (Reason: This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.)
Summarytrue
AdverseEvent.category
Element IdAdverseEvent.category
Definition

The overall type of event, intended for search and filtering purposes.

Cardinality0..*
Terminology BindingAdverseEventCategory (Extensible)
TypeCodeableConcept
Summarytrue
AdverseEvent.code
Element IdAdverseEvent.code
Definition

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

Cardinality0..1
Terminology BindingAdverseEvent Type (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.subject
Element IdAdverseEvent.subject
Definition

This subject or group impacted by the event.

Cardinality1..1
TypeReference(Patient | Group | Practitioner | RelatedPerson)
PatternsReference(Patient,Group,Practitioner,RelatedPerson): Common patterns = Participant
Requirements

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

Alternate Namespatient
Summarytrue
Comments

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

AdverseEvent.encounter
Element IdAdverseEvent.encounter
Definition

The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

Cardinality0..1
TypeReference(Encounter)
Summarytrue
Comments

This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.

AdverseEvent.occurrence[x]
Element IdAdverseEvent.occurrence[x]
Definition

The date (and perhaps time) when the adverse event occurred.

Cardinality0..1
TypedateTime|Period|Timing
[x] NoteSee Choice of Data Types for further information about how to use [x]
Alternate Namestiming
Summarytrue
AdverseEvent.detected
Element IdAdverseEvent.detected
Definition

Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

Cardinality0..1
TypedateTime
Summarytrue
AdverseEvent.recordedDate
Element IdAdverseEvent.recordedDate
Definition

The date on which the existence of the AdverseEvent was first recorded.

Cardinality0..1
TypedateTime
Summarytrue
Comments

The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.

AdverseEvent.resultingCondition
Element IdAdverseEvent.resultingCondition
Definition

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

Cardinality0..*
TypeReference(Condition)
Summarytrue
AdverseEvent.location
Element IdAdverseEvent.location
Definition

The information about where the adverse event occurred.

Cardinality0..1
TypeReference(Location)
Summarytrue
AdverseEvent.seriousness
Element IdAdverseEvent.seriousness
Definition

Assessment whether this event, or averted event, was of clinical importance.

Cardinality0..1
Terminology BindingAdverseEventSeriousness (Example)
TypeCodeableConcept
Summarytrue
Comments

Using an example, a rash can have an AdverseEvent.resultingCondition.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingCondition.severity = mild, yet a AdverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingCondition.severity = mild, yet a AdverseEvent.seriousness = serious.

AdverseEvent.outcome
Element IdAdverseEvent.outcome
Definition

Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.

Cardinality0..1
Terminology BindingAdverseEvent Outcome (Preferred)
TypeCodeableConcept
Summarytrue
AdverseEvent.recorder
Element IdAdverseEvent.recorder
Definition

Information on who recorded the adverse event. May be the patient or a practitioner.

Cardinality0..1
TypeReference(Patient | Practitioner | PractitionerRole | RelatedPerson)
PatternsReference(Patient,Practitioner,PractitionerRole,RelatedPerson): Common patterns = Participant
Summarytrue
AdverseEvent.participant
Element IdAdverseEvent.participant
Definition

Indicates who or what participated in the adverse event and how they were involved.

Cardinality0..*
Summarytrue
AdverseEvent.participant.function
Element IdAdverseEvent.participant.function
Definition

Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant.

Cardinality0..1
Terminology BindingAdverseEvent Participant Function (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.participant.actor
Element IdAdverseEvent.participant.actor
Definition

Indicates who or what participated in the event.

Cardinality1..1
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)
PatternsReference(Practitioner,PractitionerRole,Organization,CareTeam,Patient,Device,RelatedPerson): Common patterns = Participant
Summarytrue
Comments

For example, the physician prescribing a drug, a nurse administering the drug, a device that administered the drug, a witness to the event, or an informant of clinical history.

AdverseEvent.suspectEntity
Element IdAdverseEvent.suspectEntity
Definition

Describes the entity that is suspected to have caused the adverse event.

Cardinality0..*
Summarytrue
AdverseEvent.suspectEntity.instance[x]
Element IdAdverseEvent.suspectEntity.instance[x]
Definition

Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

Cardinality1..1
TypeCodeableConcept|Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationUsage | Device)
PatternsReference(Immunization,Procedure,Substance,Medication,MedicationAdministration,MedicationUsage,Device): No common pattern
[x] NoteSee Choice of Data Types for further information about how to use [x]
Alternate NamesSubstance or Medication or Device
Summarytrue
AdverseEvent.suspectEntity.causality
Element IdAdverseEvent.suspectEntity.causality
Definition

Information on the possible cause of the event.

Cardinality0..1
Summarytrue
AdverseEvent.suspectEntity.causality.assessmentMethod
Element IdAdverseEvent.suspectEntity.causality.assessmentMethod
Definition

The method of evaluating the relatedness of the suspected entity to the event.

Cardinality0..1
Terminology BindingAdverseEventCausalityMethod (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.suspectEntity.causality.entityRelatedness
Element IdAdverseEvent.suspectEntity.causality.entityRelatedness
Definition

The result of the assessment regarding the relatedness of the suspected entity to the event.

Cardinality0..1
Terminology BindingAdverseEventCausalityAssessment (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.suspectEntity.causality.author
Element IdAdverseEvent.suspectEntity.causality.author
Definition

The author of the information on the possible cause of the event.

Cardinality0..1
TypeReference(Practitioner | PractitionerRole | Patient | RelatedPerson)
PatternsReference(Practitioner,PractitionerRole,Patient,RelatedPerson): Common patterns = Participant
Summarytrue
AdverseEvent.supportingInfo
Element IdAdverseEvent.supportingInfo
Definition

Supporting information relevant to the event.

Cardinality0..*
Summarytrue
AdverseEvent.supportingInfo.item
Element IdAdverseEvent.supportingInfo.item
Definition

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penciliin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS).

Cardinality1..1
TypeReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference)
PatternsReference(Condition,Observation,AllergyIntolerance,FamilyMemberHistory,Immunization,Procedure,DocumentReference): No common pattern
Summarytrue
AdverseEvent.supportingInfo.contributingFactor
Element IdAdverseEvent.supportingInfo.contributingFactor
Definition

If true, the item has been assessed to be a contributing factor of the adverse event.

Cardinality0..1
Typeboolean
Summarytrue
AdverseEvent.study
Element IdAdverseEvent.study
Definition

The research study that the subject is enrolled in.

Cardinality0..*
TypeReference(ResearchStudy)
Summarytrue