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. package_name: hl7.fhir.r5.examples 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 type: CodeableConcept 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 index: 2 type: code mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0-draft-final'} 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 study: isModifier: false short: Research study that the subject is enrolled in refers: ['http://hl7.org/fhir/StructureDefinition/ResearchStudy'] type: Reference mustSupport: false array: true isSummary: true index: 22 supportingInfo: isModifier: false short: Supporting information relevant to the event index: 48 type: BackboneElement mustSupport: false array: true elements: item: isModifier: false short: Subject medical history or document relevant to this adverse event mustSupport: false choices: [itemReference, itemCodeableConcept] isSummary: true index: 50 itemReference: isModifier: false short: Subject medical history or document relevant to this adverse event index: 51 refers: ['http://hl7.org/fhir/StructureDefinition/AllergyIntolerance', 'http://hl7.org/fhir/StructureDefinition/Condition', 'http://hl7.org/fhir/StructureDefinition/DocumentReference', 'http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory', 'http://hl7.org/fhir/StructureDefinition/Immunization', 'http://hl7.org/fhir/StructureDefinition/MedicationAdministration', 'http://hl7.org/fhir/StructureDefinition/MedicationStatement', 'http://hl7.org/fhir/StructureDefinition/Observation', 'http://hl7.org/fhir/StructureDefinition/Procedure', 'http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse'] type: Reference mustSupport: false choiceOf: item isSummary: true itemCodeableConcept: {isModifier: false, short: Subject medical history or document relevant to this adverse event, type: CodeableConcept, mustSupport: false, choiceOf: item, isSummary: true, index: 52} required: [itemReference, item, itemCodeableConcept] isSummary: true encounter: isModifier: false short: The Encounter associated with the start of the AdverseEvent refers: ['http://hl7.org/fhir/StructureDefinition/Encounter'] type: Reference mustSupport: false isSummary: true index: 6 suspectEntity: isModifier: false short: The suspected agent causing the adverse event index: 24 type: BackboneElement mustSupport: false array: true elements: instance: isModifier: false short: Refers to the specific entity that caused the adverse event mustSupport: false choices: [instanceCodeableConcept, instanceReference] isSummary: true index: 26 instanceCodeableConcept: {isModifier: false, short: Refers to the specific entity that caused the adverse event, type: CodeableConcept, mustSupport: false, choiceOf: instance, isSummary: true, index: 27} instanceReference: isModifier: false short: Refers to the specific entity that caused the adverse event index: 28 refers: ['http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct', 'http://hl7.org/fhir/StructureDefinition/Device', 'http://hl7.org/fhir/StructureDefinition/Immunization', 'http://hl7.org/fhir/StructureDefinition/Medication', 'http://hl7.org/fhir/StructureDefinition/MedicationAdministration', 'http://hl7.org/fhir/StructureDefinition/MedicationStatement', 'http://hl7.org/fhir/StructureDefinition/Procedure', 'http://hl7.org/fhir/StructureDefinition/ResearchStudy', 'http://hl7.org/fhir/StructureDefinition/Substance'] type: Reference mustSupport: false choiceOf: instance isSummary: true causality: isModifier: false short: Information on the possible cause of the event type: BackboneElement mustSupport: false isSummary: true index: 29 elements: assessmentMethod: isModifier: false short: Method of evaluating the relatedness of the suspected entity to the event type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-causality-method'} isSummary: true index: 30 entityRelatedness: isModifier: false short: Result of the assessment regarding the relatedness of the suspected entity to the event type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-causality-assess'} isSummary: true index: 31 author: isModifier: false short: Author of the information on the possible cause of the event refers: ['http://hl7.org/fhir/StructureDefinition/Patient', 'http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/PractitionerRole', 'http://hl7.org/fhir/StructureDefinition/RelatedPerson', 'http://hl7.org/fhir/StructureDefinition/ResearchSubject'] type: Reference mustSupport: false isSummary: true index: 32 required: [instance, instanceCodeableConcept, instanceReference] isSummary: true expectedInResearchStudy: {isModifier: false, short: Considered likely or probable or anticipated in the research study, type: boolean, mustSupport: false, isSummary: false, index: 23} outcome: isModifier: false short: Type of outcome from the adverse event type: CodeableConcept mustSupport: false array: true binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-outcome'} isSummary: true index: 17 participant: isModifier: false short: Who was involved in the adverse event or the potential adverse event and what they did index: 19 type: BackboneElement mustSupport: false array: true elements: function: isModifier: false short: Type of involvement type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-participant-function'} isSummary: true index: 20 actor: isModifier: false short: Who was involved in the adverse event or the potential adverse event refers: ['http://hl7.org/fhir/StructureDefinition/CareTeam', 'http://hl7.org/fhir/StructureDefinition/Device', 'http://hl7.org/fhir/StructureDefinition/Organization', 'http://hl7.org/fhir/StructureDefinition/Patient', 'http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/PractitionerRole', 'http://hl7.org/fhir/StructureDefinition/RelatedPerson', 'http://hl7.org/fhir/StructureDefinition/ResearchSubject'] type: Reference mustSupport: false isSummary: true index: 21 required: [actor] isSummary: true occurrenceTiming: {isModifier: false, short: When the event occurred, type: Timing, mustSupport: false, choiceOf: occurrence, isSummary: true, index: 11} note: {isModifier: false, short: Comment on adverse event, type: Annotation, mustSupport: false, array: true, isSummary: true, index: 53} recordedDate: {isModifier: false, short: When the event was recorded, type: dateTime, mustSupport: false, isSummary: true, index: 13} contributingFactor: isModifier: false short: Contributing factors suspected to have increased the probability or severity of the adverse event index: 33 type: BackboneElement mustSupport: false array: true elements: item: isModifier: false short: Item suspected to have increased the probability or severity of the adverse event mustSupport: false choices: [itemReference, itemCodeableConcept] isSummary: true index: 35 itemReference: isModifier: false short: Item suspected to have increased the probability or severity of the adverse event index: 36 refers: ['http://hl7.org/fhir/StructureDefinition/AllergyIntolerance', 'http://hl7.org/fhir/StructureDefinition/Condition', 'http://hl7.org/fhir/StructureDefinition/Device', 'http://hl7.org/fhir/StructureDefinition/DeviceUsage', 'http://hl7.org/fhir/StructureDefinition/DocumentReference', 'http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory', 'http://hl7.org/fhir/StructureDefinition/Immunization', 'http://hl7.org/fhir/StructureDefinition/MedicationAdministration', 'http://hl7.org/fhir/StructureDefinition/MedicationStatement', 'http://hl7.org/fhir/StructureDefinition/Observation', 'http://hl7.org/fhir/StructureDefinition/Procedure'] type: Reference mustSupport: false choiceOf: item isSummary: true itemCodeableConcept: {isModifier: false, short: Item suspected to have increased the probability or severity of the adverse event, type: CodeableConcept, mustSupport: false, choiceOf: item, isSummary: true, index: 37} required: [itemReference, item, itemCodeableConcept] isSummary: true occurrencePeriod: {isModifier: false, short: When the event occurred, type: Period, mustSupport: false, choiceOf: occurrence, isSummary: true, index: 10} status: isModifier: true short: in-progress | completed | entered-in-error | unknown index: 1 type: code mustSupport: false binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0-draft-final'} 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 recorder: isModifier: false short: Who recorded the adverse event refers: ['http://hl7.org/fhir/StructureDefinition/Patient', 'http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/PractitionerRole', 'http://hl7.org/fhir/StructureDefinition/RelatedPerson', 'http://hl7.org/fhir/StructureDefinition/ResearchSubject'] type: Reference mustSupport: false isSummary: true index: 18 seriousness: isModifier: false short: Seriousness or gravity of the event type: CodeableConcept mustSupport: false binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-seriousness'} isSummary: true index: 16 mitigatingAction: isModifier: false short: Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm index: 43 type: BackboneElement mustSupport: false array: true elements: item: isModifier: false short: Ameliorating action taken after the adverse event occured in order to reduce the extent of harm mustSupport: false choices: [itemReference, itemCodeableConcept] isSummary: true index: 45 itemReference: isModifier: false short: Ameliorating action taken after the adverse event occured in order to reduce the extent of harm index: 46 refers: ['http://hl7.org/fhir/StructureDefinition/DocumentReference', 'http://hl7.org/fhir/StructureDefinition/MedicationAdministration', 'http://hl7.org/fhir/StructureDefinition/MedicationRequest', 'http://hl7.org/fhir/StructureDefinition/Procedure'] type: Reference mustSupport: false choiceOf: item isSummary: true itemCodeableConcept: {isModifier: false, short: Ameliorating action taken after the adverse event occured in order to reduce the extent of harm, type: CodeableConcept, mustSupport: false, choiceOf: item, isSummary: true, index: 47} required: [itemReference, item, itemCodeableConcept] isSummary: true code: isModifier: false short: Event or incident that occurred or was averted type: CodeableConcept 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, type: Identifier, mustSupport: false, array: true, isSummary: true, index: 0} detected: {isModifier: false, short: When the event was detected, type: dateTime, mustSupport: false, isSummary: true, index: 12} resultingEffect: isModifier: false short: Effect on the subject due to this event refers: ['http://hl7.org/fhir/StructureDefinition/Condition', 'http://hl7.org/fhir/StructureDefinition/Observation'] type: Reference mustSupport: false array: true isSummary: true index: 14 preventiveAction: isModifier: false short: Preventive actions that contributed to avoiding the adverse event index: 38 type: BackboneElement mustSupport: false array: true elements: item: isModifier: false short: Action that contributed to avoiding the adverse event mustSupport: false choices: [itemReference, itemCodeableConcept] isSummary: true index: 40 itemReference: isModifier: false short: Action that contributed to avoiding the adverse event index: 41 refers: ['http://hl7.org/fhir/StructureDefinition/DocumentReference', 'http://hl7.org/fhir/StructureDefinition/Immunization', 'http://hl7.org/fhir/StructureDefinition/MedicationAdministration', 'http://hl7.org/fhir/StructureDefinition/MedicationRequest', 'http://hl7.org/fhir/StructureDefinition/Procedure'] type: Reference mustSupport: false choiceOf: item isSummary: true itemCodeableConcept: {isModifier: false, short: Action that contributed to avoiding the adverse event, type: CodeableConcept, mustSupport: false, choiceOf: item, isSummary: true, index: 42} required: [itemReference, item, itemCodeableConcept] isSummary: true location: isModifier: false short: Location where adverse event occurred refers: ['http://hl7.org/fhir/StructureDefinition/Location'] type: Reference mustSupport: false isSummary: true index: 15 occurrenceDateTime: {isModifier: false, short: When the event occurred, type: dateTime, mustSupport: false, choiceOf: occurrence, isSummary: true, index: 9} subject: isModifier: false short: Subject impacted by event refers: ['http://hl7.org/fhir/StructureDefinition/Group', 'http://hl7.org/fhir/StructureDefinition/Patient', 'http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/RelatedPerson', 'http://hl7.org/fhir/StructureDefinition/ResearchSubject'] type: Reference mustSupport: false isSummary: true index: 5 occurrence: isModifier: false short: When the event occurred mustSupport: false choices: [occurrenceDateTime, occurrencePeriod, occurrenceTiming] isSummary: true index: 8 package_version: 5.0.0-draft-final class: resource kind: resource url: http://hl7.org/fhir/StructureDefinition/AdverseEvent base: http://hl7.org/fhir/StructureDefinition/DomainResource version: 5.0.0-draft-final required: [status, subject, actuality]