This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. 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 | Trial Use | Security Category: Patient | Compartments: Patient, Practitioner, RelatedPerson |
Detailed Descriptions for the elements in the AdverseEvent resource.
AdverseEvent | |
Element Id | 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. |
Cardinality | 0..* |
Type | DomainResource |
Alternate Names | AE |
Summary | false |
AdverseEvent.identifier | |
Element Id | AdverseEvent.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. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..1 |
Type | Identifier |
Requirements | Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers. |
Summary | true |
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.actuality | |
Element Id | 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. |
Cardinality | 1..1 |
Terminology Binding | AdverseEventActuality (Required) |
Type | code |
Is Modifier | true (Reason: This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.) |
Summary | true |
AdverseEvent.category | |
Element Id | AdverseEvent.category |
Definition | The overall type of event, intended for search and filtering purposes. |
Cardinality | 0..* |
Terminology Binding | AdverseEventCategory (Extensible) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.event | |
Element Id | AdverseEvent.event |
Definition | This element defines the specific type of event that occurred or that was prevented from occurring. |
Cardinality | 0..1 |
Terminology Binding | SNOMED CT Clinical Findings (Example) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.subject | |
Element Id | AdverseEvent.subject |
Definition | This subject or group impacted by the event. |
Cardinality | 1..1 |
Type | Reference(Patient | Group | Practitioner | RelatedPerson) |
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital. |
Alternate Names | patient |
Summary | true |
Comments | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject. |
AdverseEvent.encounter | |
Element Id | AdverseEvent.encounter |
Definition | The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated. |
Cardinality | 0..1 |
Type | Reference(Encounter) |
Summary | true |
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.date | |
Element Id | AdverseEvent.date |
Definition | The date (and perhaps time) when the adverse event occurred. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
AdverseEvent.detected | |
Element Id | AdverseEvent.detected |
Definition | Estimated or actual date the AdverseEvent began, in the opinion of the reporter. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
AdverseEvent.recordedDate | |
Element Id | AdverseEvent.recordedDate |
Definition | The date on which the existence of the AdverseEvent was first recorded. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
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 Id | 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). |
Cardinality | 0..* |
Type | Reference(Condition) |
Summary | true |
AdverseEvent.location | |
Element Id | AdverseEvent.location |
Definition | The information about where the adverse event occurred. |
Cardinality | 0..1 |
Type | Reference(Location) |
Summary | true |
AdverseEvent.seriousness | |
Element Id | AdverseEvent.seriousness |
Definition | Assessment whether this event was of real importance. |
Cardinality | 0..1 |
Terminology Binding | AdverseEventSeriousness (Example) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.severity | |
Element Id | AdverseEvent.severity |
Definition | Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is. |
Cardinality | 0..1 |
Terminology Binding | AdverseEventSeverity (Required) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.outcome | |
Element Id | AdverseEvent.outcome |
Definition | Describes the type of outcome from the adverse event. |
Cardinality | 0..1 |
Terminology Binding | AdverseEventOutcome (Required) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.recorder | |
Element Id | AdverseEvent.recorder |
Definition | Information on who recorded the adverse event. May be the patient or a practitioner. |
Cardinality | 0..1 |
Type | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) |
Summary | true |
AdverseEvent.contributor | |
Element Id | AdverseEvent.contributor |
Definition | Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness). |
Cardinality | 0..* |
Type | Reference(Practitioner | PractitionerRole | Device) |
Summary | true |
AdverseEvent.suspectEntity | |
Element Id | AdverseEvent.suspectEntity |
Definition | Describes the entity that is suspected to have caused the adverse event. |
Cardinality | 0..* |
Summary | true |
AdverseEvent.suspectEntity.instance | |
Element Id | 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. |
Cardinality | 1..1 |
Type | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) |
Alternate Names | Substance or Medication or Device |
Summary | true |
AdverseEvent.suspectEntity.causality | |
Element Id | AdverseEvent.suspectEntity.causality |
Definition | Information on the possible cause of the event. |
Cardinality | 0..* |
Summary | true |
To Do | is this meant to be a backbone element? |
AdverseEvent.suspectEntity.causality.assessment | |
Element Id | AdverseEvent.suspectEntity.causality.assessment |
Definition | Assessment of if the entity caused the event. |
Cardinality | 0..1 |
Terminology Binding | AdverseEventCausalityAssessment (Example) |
Type | CodeableConcept |
Summary | true |
To Do | what is difference between assessment and result? |
AdverseEvent.suspectEntity.causality.productRelatedness | |
Element Id | AdverseEvent.suspectEntity.causality.productRelatedness |
Definition | AdverseEvent.suspectEntity.causalityProductRelatedness. |
Cardinality | 0..1 |
Type | string |
Summary | true |
AdverseEvent.suspectEntity.causality.author | |
Element Id | AdverseEvent.suspectEntity.causality.author |
Definition | AdverseEvent.suspectEntity.causalityAuthor. |
Cardinality | 0..1 |
Type | Reference(Practitioner | PractitionerRole) |
Summary | true |
AdverseEvent.suspectEntity.causality.method | |
Element Id | AdverseEvent.suspectEntity.causality.method |
Definition | ProbabilityScale | Bayesian | Checklist. |
Cardinality | 0..1 |
Terminology Binding | AdverseEventCausalityMethod (Example) |
Type | CodeableConcept |
Summary | true |
AdverseEvent.subjectMedicalHistory | |
Element Id | AdverseEvent.subjectMedicalHistory |
Definition | AdverseEvent.subjectMedicalHistory. |
Cardinality | 0..* |
Type | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) |
Summary | true |
AdverseEvent.referenceDocument | |
Element Id | AdverseEvent.referenceDocument |
Definition | AdverseEvent.referenceDocument. |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
AdverseEvent.study | |
Element Id | AdverseEvent.study |
Definition | AdverseEvent.study. |
Cardinality | 0..* |
Type | Reference(ResearchStudy) |
Summary | true |