AdverseEvent
ClinicalActual 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.
| Path | Card. | Type | Description & Constraints |
|---|---|---|---|
| AdverseEvent | 0..* | — | Medical care, research study or other healthcare event causing physical injury |
| .idΣ | 0..1 | String | Logical id of this artifact |
| .metaΣ | 0..1 | Meta | Metadata about the resource |
| .implicitRules?!Σ | 0..1 | uri | A set of rules under which this content was created |
| .language | 0..1 | code | Language of the resource content Bindinglanguages(preferred) |
| .text | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| .contained | 0..* | Resource | Contained, inline Resources |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?! | 0..* | Extension | Extensions that cannot be ignored |
| .identifierΣ | 0..1 | Identifier | Business identifier for the event |
| .actuality?!Σ | 1..1 | code | actual | potential Bindingadverse-event-actuality(required) |
| .categoryΣ | 0..* | 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 Bindingadverse-event-category(extensible) |
| .eventΣ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Bindingadverse-event-type(example) |
| .subjectΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
| .encounterΣ | 0..1 | Reference(Encounter) | Encounter created as part of |
| .dateΣ | 0..1 | dateTime | When the event occurred |
| .detectedΣ | 0..1 | dateTime | When the event was detected |
| .recordedDateΣ | 0..1 | dateTime | When the event was recorded |
| .resultingConditionΣ | 0..* | Reference(Condition) | Effect on the subject due to this event |
| .locationΣ | 0..1 | Reference(Location) | Location where adverse event occurred |
| .seriousnessΣ | 0..1 | CodeableConcept | Seriousness of the event Bindingadverse-event-seriousness(example) |
| .severityΣ | 0..1 | CodeableConcept | mild | moderate | severe Bindingadverse-event-severity(required) |
| .outcomeΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Bindingadverse-event-outcome(required) |
| .recorderΣ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event |
| .contributorΣ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
| .suspectEntityΣ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .instanceΣ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
| .causalityΣ | 0..* | BackboneElement | Information on the possible cause of the event |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .assessmentΣ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Bindingadverse-event-causality-assess(example) |
| .productRelatednessΣ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
| .authorΣ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
| .methodΣ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Bindingadverse-event-causality-method(example) |
| .subjectMedicalHistoryΣ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory |
| .referenceDocumentΣ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument |
| .studyΣ | 0..* | Reference(ResearchStudy) | AdverseEvent.study |