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Patient Care icon 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, 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. 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.

Short DisplayAn event that may be related to unintended effects on a patient or research subject
Cardinality0..*
TypeDomainResource
Alternate NamesAE
Summaryfalse
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.

Short DisplayBusiness identifier for the event
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 adverse event or potential adverse event.

Short Displayin-progress | completed | entered-in-error | unknown
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. This is not the outcome of the patient's condition.

AdverseEvent.actuality
Element IdAdverseEvent.actuality
Definition

Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

Short Displayactual | potential
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
Comments

AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.

AdverseEvent.category
Element IdAdverseEvent.category
Definition

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

Short Displaywrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
Cardinality0..*
Terminology BindingAdverseEventCategory (Example)
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.

Short DisplayEvent or incident that occurred or was averted
Cardinality0..1
Terminology BindingAdverseEvent Type (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.subject
Element IdAdverseEvent.subject
Definition

This subject or group impacted by the event.

Short DisplaySubject impacted by event
Cardinality1..1
TypeReference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)
Requirements

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

Alternate Namespatient
Summarytrue
Comments

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

AdverseEvent.encounter
Element IdAdverseEvent.encounter
Definition

The Encounter associated with the start of the AdverseEvent.

Short DisplayThe Encounter associated with the start of the AdverseEvent
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 associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter.

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

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

Short DisplayWhen the event occurred
Cardinality0..1
TypedateTime|Period|Timing
[x] NoteSee Choice of Datatypes 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.

Short DisplayWhen the event was detected
Cardinality0..1
TypedateTime
Summarytrue
AdverseEvent.recordedDate
Element IdAdverseEvent.recordedDate
Definition

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

Short DisplayWhen the event was 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.resultingEffect
Element IdAdverseEvent.resultingEffect
Definition

Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall.

Short DisplayEffect on the subject due to this event
Cardinality0..*
TypeReference(Condition | Observation)
Summarytrue
AdverseEvent.location
Element IdAdverseEvent.location
Definition

The information about where the adverse event occurred.

Short DisplayLocation where 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.

Short DisplaySeriousness or gravity of the event
Cardinality0..1
Terminology BindingAdverseEventSeriousness (Example)
TypeCodeableConcept
Summarytrue
Comments

Using an example, a rash can have an AdverseEvent.resultingEffect.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.resultingEffect.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.resultingEffect.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.

Short DisplayType of outcome from the adverse event
Cardinality0..*
Terminology BindingAdverseEvent Outcome (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.recorder
Element IdAdverseEvent.recorder
Definition

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

Short DisplayWho recorded the adverse event
Cardinality0..1
TypeReference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)
Summarytrue
AdverseEvent.participant
Element IdAdverseEvent.participant
Definition

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

Short DisplayWho was involved in the adverse event or the potential adverse event and what they did
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.

Short DisplayType of involvement
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.

Short DisplayWho was involved in the adverse event or the potential adverse event
Cardinality1..1
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)
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.study
Element IdAdverseEvent.study
Definition

The research study that the subject is enrolled in.

Short DisplayResearch study that the subject is enrolled in
Cardinality0..*
TypeReference(ResearchStudy)
Summarytrue
AdverseEvent.expectedInResearchStudy
Element IdAdverseEvent.expectedInResearchStudy
Definition

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Short DisplayConsidered likely or probable or anticipated in the research study
Cardinality0..1
Typeboolean
Summaryfalse
AdverseEvent.suspectEntity
Element IdAdverseEvent.suspectEntity
Definition

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

Short DisplayThe suspected agent causing 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.

Short DisplayRefers to the specific entity that caused the adverse event
Cardinality1..1
TypeCodeableConcept|Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationUsage | Device | BiologicallyDerivedProduct | ResearchStudy)
[x] NoteSee Choice of Datatypes 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.

Short DisplayInformation 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.

Short DisplayMethod 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.

Short DisplayResult 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.

Short DisplayAuthor of the information on the possible cause of the event
Cardinality0..1
TypeReference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)
Summarytrue
AdverseEvent.contributingFactor
Element IdAdverseEvent.contributingFactor
Definition

The contributing factors suspected to have increased the probability or severity of the adverse event.

Short DisplayContributing factors suspected to have increased the probability or severity of the adverse event
Cardinality0..*
Summarytrue
AdverseEvent.contributingFactor.item[x]
Element IdAdverseEvent.contributingFactor.item[x]
Definition

The item that is suspected to have increased the probability or severity of the adverse event.

Short DisplayItem suspected to have increased the probability or severity of the adverse event
Cardinality1..1
Terminology BindingAdverseEvent Contributing Factor (Example)
TypeReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DocumentReference | MedicationAdministration | MedicationUsage)|CodeableConcept
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
AdverseEvent.preventiveAction
Element IdAdverseEvent.preventiveAction
Definition

Preventive actions that contributed to avoiding the adverse event.

Short DisplayPreventive actions that contributed to avoiding the adverse event
Cardinality0..*
Summarytrue
AdverseEvent.preventiveAction.item[x]
Element IdAdverseEvent.preventiveAction.item[x]
Definition

The action that contributed to avoiding the adverse event.

Short DisplayAction that contributed to avoiding the adverse event
Cardinality1..1
Terminology BindingAdverseEvent Preventive Action (Example)
TypeReference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)|CodeableConcept
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
AdverseEvent.mitigatingAction
Element IdAdverseEvent.mitigatingAction
Definition

The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.

Short DisplayAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm
Cardinality0..*
Summarytrue
AdverseEvent.mitigatingAction.item[x]
Element IdAdverseEvent.mitigatingAction.item[x]
Definition

The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.

Short DisplayAmeliorating action taken after the adverse event occured in order to reduce the extent of harm
Cardinality1..1
Terminology BindingAdverseEvent Mitigating Action (Example)
TypeReference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)|CodeableConcept
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
AdverseEvent.supportingInfo
Element IdAdverseEvent.supportingInfo
Definition

Supporting information relevant to the event.

Short DisplaySupporting information relevant to the event
Cardinality0..*
Summarytrue
AdverseEvent.supportingInfo.item[x]
Element IdAdverseEvent.supportingInfo.item[x]
Definition

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin 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). Supporting information is not a contributing factor, preventive action, or mitigating action.

Short DisplaySubject medical history or document relevant to this adverse event
Cardinality1..1
Terminology BindingAdverseEvent Supporting Information (Example)
TypeReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationUsage)|CodeableConcept
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
AdverseEvent.note
Element IdAdverseEvent.note
Definition

Comments made about the adverse event by the performer, subject or other participants.

Short DisplayComment on adverse event
Cardinality0..*
TypeAnnotation
Summarytrue