Name Flags Card. Type Description & Constraints doco
. . AdverseEvent Σ DomainResource Medical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
. . . identifier Σ 0..1 Identifier Business identifier for the event
. . . category Σ 0..1 code AE | PAE An adverse event is an event that caused harm to a patient, an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
AdverseEventCategory ( Required)
. . . type Σ 0..1 CodeableConcept actual | potential
SNOMED CT Clinical Findings ( Example)
. . . subject Σ 0..1 Reference( Patient | ResearchSubject | Medication | Device) Subject or group impacted by event
. . . date Σ 0..1 dateTime When the event occurred
. . . reaction Σ 0..* Reference( Condition) Adverse Reaction Events linked to exposure to substance
. . . location Σ 0..1 Reference( Location) Location where adverse event occurred
. . . seriousness Σ 0..1 CodeableConcept Mild | Moderate | Severe
AdverseEventSeriousness ( Example)
. . . outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
AdverseEventOutcome ( Required)
. . . recorder Σ 0..1 Reference( Patient | Practitioner | RelatedPerson) Who recorded the adverse event
. . . eventParticipant Σ 0..1 Reference( Practitioner | Device) Who was involved in the adverse event or the potential adverse event
. . . description Σ 0..1 string Description of the adverse event
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . . instance Σ 1..1 Reference( Substance | Medication | MedicationAdministration | MedicationStatement | Device) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..1 code causality1 | causality2
AdverseEventCausality ( Required)
. . . . causalityAssessment Σ 0..1 CodeableConcept assess1 | assess2
AdverseEventCausalityAssessment ( Example)
. . . . causalityProductRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
. . . . causalityMethod Σ 0..1 CodeableConcept method1 | method2
AdverseEventCausalityMethod ( Example)
. . . . causalityAuthor Σ 0..1 Reference( Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
. . . . causalityResult Σ 0..1 CodeableConcept result1 | result2
AdverseEventCausalityResult ( Example)
. . . subjectMedicalHistory Σ 0..* Reference( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure) AdverseEvent.subjectMedicalHistory
. . . referenceDocument Σ 0..* Reference( DocumentReference) AdverseEvent.referenceDocument
. . . study Σ 0..* Reference( ResearchStudy) AdverseEvent.study

doco Documentation for this format