This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3
Patient Care Work Group | Maturity Level: 0 | Draft | Compartments: Patient, Practitioner, RelatedPerson |
Detailed Descriptions for the elements in the AdverseEvent resource.
AdverseEvent | |
Definition | Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death. |
Control | 1..1 |
Alternate Names | AE |
Summary | true |
AdverseEvent.identifier | |
Definition | The identifier(s) of this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate. |
Note | This is a business identifer, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier |
Summary | true |
AdverseEvent.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. |
Control | 1..1 |
Terminology Binding | AdverseEventActuality (Required) |
Type | code |
Is Modifier | true |
Summary | true |
AdverseEvent.category | |
Definition | The overall type of event, intended for search and filtering purposes. |
Control | 0..* |
Terminology Binding | AdverseEventCategory (Extensible) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.event | |
Definition | This element defines the specific type of event that occurred or that was prevented from occurring. |
Control | 0..1 |
Terminology Binding | SNOMED CT Clinical Findings (Example) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.subject | |
Definition | This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented. |
Control | 0..1 |
Type | Reference(Patient | Group | Practitioner | RelatedPerson) |
Alternate Names | patient |
Summary | true |
Comments | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject. |
AdverseEvent.date | |
Definition | The date (and perhaps time) when the adverse event occurred. |
Control | 0..1 |
Type | dateTime |
Summary | true |
AdverseEvent.resultingCondition | |
Definition | Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical). |
Control | 0..* |
Type | Reference(Condition) |
Summary | true |
AdverseEvent.location | |
Definition | The information about where the adverse event occurred. |
Control | 0..1 |
Type | Reference(Location) |
Summary | true |
AdverseEvent.seriousness | |
Definition | Assessment whether this event was of real importance. |
Control | 0..1 |
Terminology Binding | AdverseEventSeriousness (Example) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.severity | |
Definition | Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.serious - a severe rash might not be serious, but a mild heart problem is. |
Control | 0..1 |
Terminology Binding | AdverseEventSeverity (Required) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.outcome | |
Definition | Describes the type of outcome from the adverse event. |
Control | 0..1 |
Terminology Binding | AdverseEventOutcome (Required) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.recorder | |
Definition | Information on who recorded the adverse event. May be the patient or a practitioner. |
Control | 0..1 |
Type | Reference(Patient | Practitioner | RelatedPerson) |
Summary | true |
AdverseEvent.eventParticipant | |
Definition | Parties that may or should contribute or have contributed information to the Act. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness). |
Control | 0..1 |
Type | Reference(Practitioner | Device) |
Summary | true |
AdverseEvent.description | |
Definition | Describes the adverse event in text. |
Control | 0..1 |
Type | string |
Summary | true |
AdverseEvent.suspectEntity | |
Definition | Describes the entity that is suspected to have caused the adverse event. |
Control | 0..* |
Summary | true |
AdverseEvent.suspectEntity.instance | |
Definition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device. |
Control | 1..1 |
Type | Reference(Substance | Medication | MedicationAdministration | MedicationStatement | Device) |
Alternate Names | Substance or Medication or Device |
Summary | true |
AdverseEvent.suspectEntity.causality | |
Definition | Information on the possible cause of the event. |
Control | 0..* |
Summary | true |
To Do | is this meant to be a backbone element? |
AdverseEvent.suspectEntity.causality.assessment | |
Definition | Assessment of if the entity caused the event. |
Control | 0..1 |
Terminology Binding | AdverseEventCausalityAssessment (Example) |
Type | CodeableConcept |
Summary | true |
To Do | what is difference between assessment and result? |
AdverseEvent.suspectEntity.causality.productRelatedness | |
Definition | AdverseEvent.suspectEntity.causalityProductRelatedness. |
Control | 0..1 |
Type | string |
Summary | true |
AdverseEvent.suspectEntity.causality.author | |
Definition | AdverseEvent.suspectEntity.causalityAuthor. |
Control | 0..1 |
Type | Reference(Practitioner | PractitionerRole) |
Summary | true |
AdverseEvent.suspectEntity.causality.method | |
Definition | ProbabilityScale | Bayesian | Checklist. |
Control | 0..1 |
Terminology Binding | AdverseEventCausalityMethod (Example) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.subjectMedicalHistory | |
Definition | AdverseEvent.subjectMedicalHistory. |
Control | 0..* |
Type | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure) |
Summary | true |
AdverseEvent.referenceDocument | |
Definition | AdverseEvent.referenceDocument. |
Control | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
AdverseEvent.study | |
Definition | AdverseEvent.study. |
Control | 0..* |
Type | Reference(ResearchStudy) |
Summary | true |