description: Actual 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.
package_name: hl7.fhir.core
derivation: specialization
name: AdverseEvent
type: AdverseEvent
elements:
  category:
    short: 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
    type: CodeableConcept
    array: true
    binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-category'}
    isSummary: true
    index: 2
  actuality:
    isModifier: true
    short: actual | potential
    type: code
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-actuality'}
    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: 1
  date: {short: When the event occurred, type: dateTime, isSummary: true, index: 6}
  study:
    short: AdverseEvent.study
    refers: ['http://hl7.org/fhir/StructureDefinition/ResearchStudy']
    type: Reference
    array: true
    isSummary: true
    index: 25
  suspectEntity:
    type: BackboneElement
    short: The suspected agent causing the adverse event
    isSummary: true
    array: true
    index: 16
    elements:
      instance:
        short: Refers to the specific entity that caused the adverse event
        refers: ['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/Substance']
        type: Reference
        isSummary: true
        index: 17
      causality:
        type: BackboneElement
        short: Information on the possible cause of the event
        isSummary: true
        array: true
        index: 18
        elements:
          assessment:
            short: Assessment of if the entity caused the event
            type: CodeableConcept
            binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-causality-assess'}
            isSummary: true
            index: 19
          productRelatedness: {type: string, short: AdverseEvent.suspectEntity.causalityProductRelatedness, isSummary: true, index: 20}
          author:
            short: AdverseEvent.suspectEntity.causalityAuthor
            refers: ['http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/PractitionerRole']
            type: Reference
            isSummary: true
            index: 21
          method:
            short: ProbabilityScale | Bayesian | Checklist
            type: CodeableConcept
            binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-causality-method'}
            isSummary: true
            index: 22
    required: [instance]
  referenceDocument:
    short: AdverseEvent.referenceDocument
    refers: ['http://hl7.org/fhir/StructureDefinition/DocumentReference']
    type: Reference
    array: true
    isSummary: true
    index: 24
  outcome:
    short: resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
    type: CodeableConcept
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-outcome'}
    isSummary: true
    index: 13
  recordedDate: {short: When the event was recorded, type: dateTime, isSummary: true, index: 8}
  event:
    short: Type of the event itself in relation to the subject
    type: CodeableConcept
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-type'}
    isSummary: true
    index: 3
  contributor:
    short: Who  was involved in the adverse event or the potential adverse event
    refers: ['http://hl7.org/fhir/StructureDefinition/Device', 'http://hl7.org/fhir/StructureDefinition/Practitioner']
    type: Reference
    array: true
    isSummary: true
    index: 15
  subjectMedicalHistory:
    short: AdverseEvent.subjectMedicalHistory
    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/Media', 'http://hl7.org/fhir/StructureDefinition/Observation', 'http://hl7.org/fhir/StructureDefinition/Procedure']
    type: Reference
    array: true
    isSummary: true
    index: 23
  recorder:
    short: Who recorded the adverse event
    refers: ['http://hl7.org/fhir/StructureDefinition/Patient', 'http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/RelatedPerson']
    type: Reference
    isSummary: true
    index: 14
  seriousness:
    short: Seriousness of the event
    type: CodeableConcept
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-seriousness'}
    isSummary: true
    index: 11
  severity:
    short: mild | moderate | severe
    type: CodeableConcept
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-severity'}
    isSummary: true
    index: 12
  identifier: {short: Business identifier for the event, type: Identifier, isSummary: true, index: 0}
  context:
    short: Encounter or episode of care that establishes the context for this AdverseEvent
    refers: ['http://hl7.org/fhir/StructureDefinition/Encounter', 'http://hl7.org/fhir/StructureDefinition/EpisodeOfCare']
    type: Reference
    isSummary: true
    index: 5
  detected: {type: dateTime, short: When the event was detected, isSummary: true, index: 7}
  location:
    short: Location where adverse event occurred
    refers: ['http://hl7.org/fhir/StructureDefinition/Location']
    type: Reference
    isSummary: true
    index: 10
  subject:
    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']
    type: Reference
    isSummary: true
    index: 4
  resultingCondition:
    short: Effect on the subject due to this event
    refers: ['http://hl7.org/fhir/StructureDefinition/Condition']
    type: Reference
    array: true
    isSummary: true
    index: 9
package_version: 3.5.0
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/AdverseEvent
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: null
required: [subject, actuality]