http://hl7.org/fhir/StructureDefinition/AdverseEvent|5.0.0
An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.
description: An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints. derivation: specialization name: AdverseEvent type: AdverseEvent elements: category: isModifier: false short: wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site mustSupport: false array: true binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-category'} isSummary: true index: 3 actuality: isModifier: true short: actual | potential mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0'} isModifierReason: This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen. isSummary: true index: 2 study: {isModifier: false, short: Research study that the subject is enrolled in, mustSupport: false, array: true, isSummary: true, index: 19} supportingInfo: isModifier: false short: Supporting information relevant to the event mustSupport: false array: true isSummary: true index: 37 elements: item: isModifier: false short: Subject medical history or document relevant to this adverse event mustSupport: false choices: [] isSummary: true index: 39 required: [item] encounter: {isModifier: false, short: The Encounter associated with the start of the AdverseEvent, mustSupport: false, isSummary: true, index: 6} suspectEntity: isModifier: false short: The suspected agent causing the adverse event mustSupport: false array: true isSummary: true index: 21 elements: instance: isModifier: false short: Refers to the specific entity that caused the adverse event mustSupport: false choices: [] isSummary: true index: 23 causality: isModifier: false short: Information on the possible cause of the event mustSupport: false isSummary: true index: 24 elements: assessmentMethod: isModifier: false short: Method of evaluating the relatedness of the suspected entity to the event mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-causality-method'} isSummary: true index: 25 entityRelatedness: isModifier: false short: Result of the assessment regarding the relatedness of the suspected entity to the event mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-causality-assess'} isSummary: true index: 26 author: {isModifier: false, short: Author of the information on the possible cause of the event, mustSupport: false, isSummary: true, index: 27} required: [instance] expectedInResearchStudy: {isModifier: false, short: Considered likely or probable or anticipated in the research study, mustSupport: false, isSummary: false, index: 20} outcome: isModifier: false short: Type of outcome from the adverse event mustSupport: false array: true binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-outcome'} isSummary: true index: 14 participant: isModifier: false short: Who was involved in the adverse event or the potential adverse event and what they did mustSupport: false array: true isSummary: true index: 16 elements: function: isModifier: false short: Type of involvement mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-participant-function'} isSummary: true index: 17 actor: {isModifier: false, short: Who was involved in the adverse event or the potential adverse event, mustSupport: false, isSummary: true, index: 18} required: [actor] note: {isModifier: false, short: Comment on adverse event, mustSupport: false, array: true, isSummary: true, index: 40} recordedDate: {isModifier: false, short: When the event was recorded, mustSupport: false, isSummary: true, index: 10} contributingFactor: isModifier: false short: Contributing factors suspected to have increased the probability or severity of the adverse event mustSupport: false array: true isSummary: true index: 28 elements: item: isModifier: false short: Item suspected to have increased the probability or severity of the adverse event mustSupport: false choices: [] isSummary: true index: 30 required: [item] status: isModifier: true short: in-progress | completed | entered-in-error | unknown mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0'} isModifierReason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid isSummary: true index: 1 recorder: {isModifier: false, short: Who recorded the adverse event, mustSupport: false, isSummary: true, index: 15} seriousness: isModifier: false short: Seriousness or gravity of the event mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-seriousness'} isSummary: true index: 13 mitigatingAction: isModifier: false short: Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm mustSupport: false array: true isSummary: true index: 34 elements: item: isModifier: false short: Ameliorating action taken after the adverse event occured in order to reduce the extent of harm mustSupport: false choices: [] isSummary: true index: 36 required: [item] code: isModifier: false short: Event or incident that occurred or was averted mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-type'} isSummary: true index: 4 identifier: {isModifier: false, short: Business identifier for the event, mustSupport: false, array: true, isSummary: true, index: 0} detected: {isModifier: false, short: When the event was detected, mustSupport: false, isSummary: true, index: 9} resultingEffect: {isModifier: false, short: Effect on the subject due to this event, mustSupport: false, array: true, isSummary: true, index: 11} preventiveAction: isModifier: false short: Preventive actions that contributed to avoiding the adverse event mustSupport: false array: true isSummary: true index: 31 elements: item: isModifier: false short: Action that contributed to avoiding the adverse event mustSupport: false choices: [] isSummary: true index: 33 required: [item] location: {isModifier: false, short: Location where adverse event occurred, mustSupport: false, isSummary: true, index: 12} subject: {isModifier: false, short: Subject impacted by event, mustSupport: false, isSummary: true, index: 5} occurrence: isModifier: false short: When the event occurred mustSupport: false choices: [] isSummary: true index: 8 class: resource kind: resource url: http://hl7.org/fhir/StructureDefinition/AdverseEvent base: http://hl7.org/fhir/StructureDefinition/DomainResource version: 5.0.0 required: [status, subject, actuality]