| identifier | No | Identifier | Business identifier for the event |
| actuality | Yes | code | actual / potential |
| category | No | CodeableConcept[] | product-problem / product-quality / product-use-error / wrong-dose / incorrect-prescribing-information / wrong-technique / wrong-route-of-administration / wrong-rate / wrong-duration / wrong-time / expired-drug / medical-device-use-error / problem-different-manufacturer / unsafe-physical-environment |
| event | No | CodeableConcept | Type of the event itself in relation to the subject |
| subject | Yes | Reference<Patient / Group / Practitioner / RelatedPerson> | Subject impacted by event |
| encounter | No | Reference<Encounter> | Encounter created as part of |
| date | No | dateTime | When the event occurred |
| detected | No | dateTime | When the event was detected |
| recordedDate | No | dateTime | When the event was recorded |
| resultingCondition | No | Reference<Condition>[] | Effect on the subject due to this event |
| location | No | Reference<Location> | Location where adverse event occurred |
| seriousness | No | CodeableConcept | Seriousness of the event |
| severity | No | CodeableConcept | mild / moderate / severe |
| outcome | No | CodeableConcept | resolved / recovering / ongoing / resolvedWithSequelae / fatal / unknown |
| recorder | No | Reference<Patient / Practitioner / PractitionerRole / RelatedPerson> | Who recorded the adverse event |
| contributor | No | Reference<Practitioner / PractitionerRole / Device>[] | Who was involved in the adverse event or the potential adverse event |
| suspectEntity | No | AdverseEventSuspectEntity | The suspected agent causing the adverse event |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - instance | Yes | Reference<Immunization / Procedure / Substance / Medication / MedicationAdministration / MedicationStatement / Device> | Refers to the specific entity that caused the adverse event |
| - causality | No | AdverseEventSuspectEntityCausality | Information on the possible cause of the event |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - assessment | No | CodeableConcept | Assessment of if the entity caused the event |
| - productRelatedness | No | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| - author | No | Reference<Practitioner / PractitionerRole> | AdverseEvent.suspectEntity.causalityAuthor |
| - method | No | CodeableConcept | ProbabilityScale / Bayesian / Checklist |
| subjectMedicalHistory | No | Reference<Condition / Observation / AllergyIntolerance / FamilyMemberHistory / Immunization / Procedure / Media / DocumentReference>[] | AdverseEvent.subjectMedicalHistory |
| referenceDocument | No | Reference<DocumentReference>[] | AdverseEvent.referenceDocument |
| study | No | Reference<ResearchStudy>[] | AdverseEvent.study |
