ChanjoKE Immunization Implementation Guide
0.1.0 - ci-build

ChanjoKE Immunization Implementation Guide, published by Intellisoft Consulting Ltd. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IntelliSOFT-Consulting/ChanjoKe-FHIR-IG/ and changes regularly. See the Directory of published versions

Resource Profile: AdverseEventProfile - Detailed Descriptions

Draft as of 2024-11-08

Definitions for the AdverseEventProfile resource profile.

Guidance on how to interpret the contents of this table can be found here

0. AdverseEvent
2. AdverseEvent.extension
Control2..?
SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. AdverseEvent.extension:types-of-aefi
    Slice Nametypes-of-aefi
    Control0..1
    TypeExtension(Extension for types of AEFI) (Extension Type: code)
    Must Supporttrue
    6. AdverseEvent.extension:eventDetails
    Slice NameeventDetails
    Control0..1
    TypeExtension(Extension for Event Details) (Extension Type: string)
    Must Supporttrue
    8. AdverseEvent.extension:actionTaken
    Slice NameactionTaken
    Control0..1
    TypeExtension(Extension for Action Taken) (Extension Type: code)
    Must Supporttrue
    10. AdverseEvent.extension:facility-reported
    Slice Namefacility-reported
    Control0..1
    TypeExtension(Extension for Facility Reported) (Extension Type: string)
    Must Supporttrue
    12. AdverseEvent.extension:treatmentGiven
    Slice NametreatmentGiven
    Control0..1
    TypeExtension(Extension for Treatment Given) (Extension Type: string)
    Must Supporttrue
    14. AdverseEvent.extension:treatmentDetails
    Slice NametreatmentDetails
    Control0..1
    TypeExtension(Extension for Treatment Details) (Extension Type: string)
    Must Supporttrue
    16. AdverseEvent.extension:specimenCollected
    Slice NamespecimenCollected
    Control0..1
    TypeExtension(Extension for Specimen collected for investigation) (Extension Type: string)
    Must Supporttrue
    18. AdverseEvent.extension:specimenDetails
    Slice NamespecimenDetails
    Control0..1
    TypeExtension(Extension for Specimen Details) (Extension Type: string)
    Must Supporttrue
    20. AdverseEvent.extension:reactionSeverity
    Slice NamereactionSeverity
    Control1..1
    TypeExtension(ReactionSeverityExtension) (Extension Type: code)
    Must Supporttrue
    22. AdverseEvent.extension:reactionSeverity.value[x]
    ShortLife Threatening | Mild | Moderate | Severe | Fatal
    BindingThe codes SHALL be taken from Reaction Severity
    (required to https://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVS)
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    24. AdverseEvent.extension:aefiOutcome
    Slice NameaefiOutcome
    Control1..1
    TypeExtension(AefiOutcomeExtension) (Extension Type: code)
    Must Supporttrue
    26. AdverseEvent.extension:aefiOutcome.value[x]
    ShortRecovered | Recovering | Not Recovered | Unknown | Died
    BindingThe codes SHALL be taken from AEFI Outcome
    (required to https://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVS)
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    28. AdverseEvent.identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control1..?
    Must Supporttrue
    30. AdverseEvent.actuality
    Must Supporttrue
    32. AdverseEvent.subject
    TypeReference(KenyanImmunizationRegistryPatient)
    34. AdverseEvent.date
    Control1..?
    Must Supporttrue
    36. AdverseEvent.recordedDate
    Control1..?
    Must Supporttrue
    38. AdverseEvent.suspectEntity
    Control0..1
    Must Supporttrue
    40. AdverseEvent.suspectEntity.instance
    TypeReference(Substance)
    Must Supporttrue
    42. AdverseEvent.subjectMedicalHistory
    Control1..1
    TypeReference(Condition, Observation, Immunization, DocumentReference)
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles

    Guidance on how to interpret the contents of this table can be found here

    0. AdverseEvent
    Definition

    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.

    ShortMedical care, research study or other healthcare event causing physical injury
    Control0..*
    Is Modifierfalse
    Summaryfalse
    Alternate NamesAE
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
    dom-6: A resource should have narrative for robust management (text.`div`.exists())
    2. AdverseEvent.implicitRules
    Definition

    A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

    ShortA set of rules under which this content was created
    Comments

    Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

    Control0..1
    Typeuri
    Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    4. AdverseEvent.extension
    Definition

    An Extension


    May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortExtensionAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control20..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 6. AdverseEvent.extension:types-of-aefi
      Slice Nametypes-of-aefi
      Definition

      Extension for types of AEFI

      ShortExtension for types of AEFI
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for types of AEFI) (Extension Type: code)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      8. AdverseEvent.extension:eventDetails
      Slice NameeventDetails
      Definition

      Brief details on the event

      ShortExtension for Event Details
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for Event Details) (Extension Type: string)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      10. AdverseEvent.extension:actionTaken
      Slice NameactionTaken
      Definition

      Action Taken

      ShortExtension for Action Taken
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for Action Taken) (Extension Type: code)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      12. AdverseEvent.extension:facility-reported
      Slice Namefacility-reported
      Definition

      Facility Reported

      ShortExtension for Facility Reported
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for Facility Reported) (Extension Type: string)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      14. AdverseEvent.extension:treatmentGiven
      Slice NametreatmentGiven
      Definition

      Treatment Given

      ShortExtension for Treatment Given
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for Treatment Given) (Extension Type: string)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      16. AdverseEvent.extension:treatmentDetails
      Slice NametreatmentDetails
      Definition

      Treatment Details

      ShortExtension for Treatment Details
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for Treatment Details) (Extension Type: string)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      18. AdverseEvent.extension:specimenCollected
      Slice NamespecimenCollected
      Definition

      Specimen collected for investigation

      ShortExtension for Specimen collected for investigation
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for Specimen collected for investigation) (Extension Type: string)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      20. AdverseEvent.extension:specimenDetails
      Slice NamespecimenDetails
      Definition

      Specimen Details

      ShortExtension for Specimen Details
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Extension for Specimen Details) (Extension Type: string)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      22. AdverseEvent.extension:reactionSeverity
      Slice NamereactionSeverity
      Definition

      ReactionSeverityExtension

      ShortReactionSeverityExtension
      Control1..1
      This element is affected by the following invariants: ele-1
      TypeExtension(ReactionSeverityExtension) (Extension Type: code)
      Is Modifierfalse
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      24. AdverseEvent.extension:reactionSeverity.extension
      Definition

      An Extension


      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortExtensionAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..0*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on AdverseEvent.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 26. AdverseEvent.extension:reactionSeverity.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valuehttps://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity
        28. AdverseEvent.extension:reactionSeverity.value[x]
        Definition

        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

        ShortLife Threatening | Mild | Moderate | Severe | Fatal Value of extension
        Control0..1
        BindingThe codes SHALL be taken from For codes, see Reaction Severity
        (required to https://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVS)
        Typecode, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. AdverseEvent.extension:aefiOutcome
        Slice NameaefiOutcome
        Definition

        AefiOutcomeExtension

        ShortAefiOutcomeExtension
        Control1..1
        This element is affected by the following invariants: ele-1
        TypeExtension(AefiOutcomeExtension) (Extension Type: code)
        Is Modifierfalse
        Must Supporttrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        32. AdverseEvent.extension:aefiOutcome.extension
        Definition

        An Extension


        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortExtensionAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..0*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on AdverseEvent.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 34. AdverseEvent.extension:aefiOutcome.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Valuehttps://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome
          36. AdverseEvent.extension:aefiOutcome.value[x]
          Definition

          Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

          ShortRecovered | Recovering | Not Recovered | Unknown | Died Value of extension
          Control0..1
          BindingThe codes SHALL be taken from For codes, see AEFI Outcome
          (required to https://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVS)
          Typecode, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. AdverseEvent.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
          Summaryfalse
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          40. AdverseEvent.identifier
          Definition

          Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.

          ShortBusiness identifier for the event
          Comments

          This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control10..1
          TypeIdentifier
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Requirements

          Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          42. AdverseEvent.actuality
          Definition

          Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

          Shortactual | potential
          Control1..1
          BindingThe codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
          (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

          Overall nature of the adverse event, e.g. real or potential.

          Typecode
          Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. AdverseEvent.subject
          Definition

          This subject or group impacted by the event.

          ShortSubject impacted by event
          Comments

          If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

          Control1..1
          TypeReference(KenyanImmunizationRegistryPatient, Patient, Group, Practitioner, RelatedPerson)
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

          Alternate Namespatient
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          46. AdverseEvent.date
          Definition

          The date (and perhaps time) when the adverse event occurred.

          ShortWhen the event occurred
          Control10..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. AdverseEvent.recordedDate
          Definition

          The date on which the existence of the AdverseEvent was first recorded.

          ShortWhen the event was recorded
          Comments

          The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.

          Control10..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. AdverseEvent.suspectEntity
          Definition

          Describes the entity that is suspected to have caused the adverse event.

          ShortThe suspected agent causing the adverse event
          Control0..1*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. AdverseEvent.suspectEntity.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          54. AdverseEvent.suspectEntity.instance
          Definition

          Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

          ShortRefers to the specific entity that caused the adverse event
          Control1..1
          TypeReference(Substance, Immunization, Procedure, Medication, MedicationAdministration, MedicationStatement, Device)
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Alternate NamesSubstance or Medication or Device
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. AdverseEvent.subjectMedicalHistory
          Definition

          AdverseEvent.subjectMedicalHistory.

          ShortAdverseEvent.subjectMedicalHistory
          Control10..1*
          TypeReference(Condition, Observation, Immunization, DocumentReference, AllergyIntolerance, FamilyMemberHistory, Procedure, Media)
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

          Guidance on how to interpret the contents of this table can be found here

          0. AdverseEvent
          Definition

          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.

          ShortMedical care, research study or other healthcare event causing physical injury
          Control0..*
          Is Modifierfalse
          Summaryfalse
          Alternate NamesAE
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
          dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
          dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          2. AdverseEvent.id
          Definition

          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

          ShortLogical id of this artifact
          Comments

          The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

          Control0..1
          Typeid
          Is Modifierfalse
          Summarytrue
          4. AdverseEvent.meta
          Definition

          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

          ShortMetadata about the resource
          Control0..1
          TypeMeta
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. AdverseEvent.implicitRules
          Definition

          A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

          ShortA set of rules under which this content was created
          Comments

          Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

          Control0..1
          Typeuri
          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          8. AdverseEvent.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

          Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

          Control0..1
          BindingThe codes SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages)

          A human language.

          Additional BindingsPurpose
          AllLanguagesMax Binding
          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. AdverseEvent.text
          Definition

          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

          Control0..1
          TypeNarrative
          Is Modifierfalse
          Summaryfalse
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. AdverseEvent.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

          ShortContained, inline Resources
          Comments

          This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

          Control0..*
          TypeResource
          Is Modifierfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          14. AdverseEvent.extension
          Definition

          An Extension

          ShortExtension
          Control2..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 16. AdverseEvent.extension:types-of-aefi
            Slice Nametypes-of-aefi
            Definition

            Extension for types of AEFI

            ShortExtension for types of AEFI
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for types of AEFI) (Extension Type: code)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            18. AdverseEvent.extension:eventDetails
            Slice NameeventDetails
            Definition

            Brief details on the event

            ShortExtension for Event Details
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for Event Details) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            20. AdverseEvent.extension:actionTaken
            Slice NameactionTaken
            Definition

            Action Taken

            ShortExtension for Action Taken
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for Action Taken) (Extension Type: code)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            22. AdverseEvent.extension:facility-reported
            Slice Namefacility-reported
            Definition

            Facility Reported

            ShortExtension for Facility Reported
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for Facility Reported) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            24. AdverseEvent.extension:treatmentGiven
            Slice NametreatmentGiven
            Definition

            Treatment Given

            ShortExtension for Treatment Given
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for Treatment Given) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            26. AdverseEvent.extension:treatmentDetails
            Slice NametreatmentDetails
            Definition

            Treatment Details

            ShortExtension for Treatment Details
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for Treatment Details) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            28. AdverseEvent.extension:specimenCollected
            Slice NamespecimenCollected
            Definition

            Specimen collected for investigation

            ShortExtension for Specimen collected for investigation
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for Specimen collected for investigation) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            30. AdverseEvent.extension:specimenDetails
            Slice NamespecimenDetails
            Definition

            Specimen Details

            ShortExtension for Specimen Details
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Extension for Specimen Details) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            32. AdverseEvent.extension:reactionSeverity
            Slice NamereactionSeverity
            Definition

            ReactionSeverityExtension

            ShortReactionSeverityExtension
            Control1..1
            This element is affected by the following invariants: ele-1
            TypeExtension(ReactionSeverityExtension) (Extension Type: code)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            34. AdverseEvent.extension:reactionSeverity.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            Typestring
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            36. AdverseEvent.extension:reactionSeverity.extension
            Definition

            An Extension

            ShortExtension
            Control0..0
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on AdverseEvent.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 38. AdverseEvent.extension:reactionSeverity.url
              Definition

              Source of the definition for the extension code - a logical name or a URL.

              Shortidentifies the meaning of the extension
              Comments

              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

              Control1..1
              Typeuri
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              Fixed Valuehttps://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/reaction-severity
              40. AdverseEvent.extension:reactionSeverity.value[x]
              Definition

              Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

              ShortLife Threatening | Mild | Moderate | Severe | Fatal
              Control0..1
              BindingThe codes SHALL be taken from Reaction Severity
              (required to https://chanjoke.intellisoftkenya.com/fhir/ValueSet/reactionSeverityVS)
              Typecode
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. AdverseEvent.extension:aefiOutcome
              Slice NameaefiOutcome
              Definition

              AefiOutcomeExtension

              ShortAefiOutcomeExtension
              Control1..1
              This element is affected by the following invariants: ele-1
              TypeExtension(AefiOutcomeExtension) (Extension Type: code)
              Is Modifierfalse
              Must Supporttrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              44. AdverseEvent.extension:aefiOutcome.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              46. AdverseEvent.extension:aefiOutcome.extension
              Definition

              An Extension

              ShortExtension
              Control0..0
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on AdverseEvent.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 48. AdverseEvent.extension:aefiOutcome.url
                Definition

                Source of the definition for the extension code - a logical name or a URL.

                Shortidentifies the meaning of the extension
                Comments

                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                Control1..1
                Typeuri
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                Fixed Valuehttps://chanjoke.intellisoftkenya.com/fhir/StructureDefinition/aefi-outcome
                50. AdverseEvent.extension:aefiOutcome.value[x]
                Definition

                Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                ShortRecovered | Recovering | Not Recovered | Unknown | Died
                Control0..1
                BindingThe codes SHALL be taken from AEFI Outcome
                (required to https://chanjoke.intellisoftkenya.com/fhir/ValueSet/aefiOutcomeVS)
                Typecode
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                52. AdverseEvent.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                Summaryfalse
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                54. AdverseEvent.identifier
                Definition

                Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.

                ShortBusiness identifier for the event
                Comments

                This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control1..1
                TypeIdentifier
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                56. AdverseEvent.actuality
                Definition

                Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

                Shortactual | potential
                Control1..1
                BindingThe codes SHALL be taken from AdverseEventActuality
                (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

                Overall nature of the adverse event, e.g. real or potential.

                Typecode
                Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                58. AdverseEvent.category
                Definition

                The overall type of event, intended for search and filtering purposes.

                Shortproduct-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
                Control0..*
                BindingUnless not suitable, these codes SHALL be taken from AdverseEventCategory
                (extensible to http://hl7.org/fhir/ValueSet/adverse-event-category)

                Overall categorization of the event, e.g. product-related or situational.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                60. AdverseEvent.event
                Definition

                This element defines the specific type of event that occurred or that was prevented from occurring.

                ShortType of the event itself in relation to the subject
                Control0..1
                BindingFor example codes, see SNOMEDCTClinicalFindings
                (example to http://hl7.org/fhir/ValueSet/adverse-event-type)

                Detailed type of event.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                62. AdverseEvent.subject
                Definition

                This subject or group impacted by the event.

                ShortSubject impacted by event
                Comments

                If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

                Control1..1
                TypeReference(KenyanImmunizationRegistryPatient)
                Is Modifierfalse
                Summarytrue
                Requirements

                Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

                Alternate Namespatient
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                64. AdverseEvent.encounter
                Definition

                The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

                ShortEncounter created as part of
                Comments

                This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.

                Control0..1
                TypeReference(Encounter)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                66. AdverseEvent.date
                Definition

                The date (and perhaps time) when the adverse event occurred.

                ShortWhen the event occurred
                Control1..1
                TypedateTime
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                68. AdverseEvent.detected
                Definition

                Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

                ShortWhen the event was detected
                Control0..1
                TypedateTime
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. AdverseEvent.recordedDate
                Definition

                The date on which the existence of the AdverseEvent was first recorded.

                ShortWhen the event was recorded
                Comments

                The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.

                Control1..1
                TypedateTime
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                72. AdverseEvent.resultingCondition
                Definition

                Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

                ShortEffect on the subject due to this event
                Control0..*
                TypeReference(Condition)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                74. AdverseEvent.location
                Definition

                The information about where the adverse event occurred.

                ShortLocation where adverse event occurred
                Control0..1
                TypeReference(Location)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                76. AdverseEvent.seriousness
                Definition

                Assessment whether this event was of real importance.

                ShortSeriousness of the event
                Control0..1
                BindingFor example codes, see AdverseEventSeriousness
                (example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness)

                Overall seriousness of this event for the patient.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                78. AdverseEvent.severity
                Definition

                Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.

                Shortmild | moderate | severe
                Control0..1
                BindingThe codes SHALL be taken from AdverseEventSeverity
                (required to http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1)

                The severity of the adverse event itself, in direct relation to the subject.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                80. AdverseEvent.outcome
                Definition

                Describes the type of outcome from the adverse event.

                Shortresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
                Control0..1
                BindingThe codes SHALL be taken from AdverseEventOutcome
                (required to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1)

                TODO (and should this be required?).

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                82. AdverseEvent.recorder
                Definition

                Information on who recorded the adverse event. May be the patient or a practitioner.

                ShortWho recorded the adverse event
                Control0..1
                TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                84. AdverseEvent.contributor
                Definition

                Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).

                ShortWho was involved in the adverse event or the potential adverse event
                Control0..*
                TypeReference(Practitioner, PractitionerRole, Device)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                86. AdverseEvent.suspectEntity
                Definition

                Describes the entity that is suspected to have caused the adverse event.

                ShortThe suspected agent causing the adverse event
                Control0..1
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                88. AdverseEvent.suspectEntity.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                90. AdverseEvent.suspectEntity.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                92. AdverseEvent.suspectEntity.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                94. AdverseEvent.suspectEntity.instance
                Definition

                Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

                ShortRefers to the specific entity that caused the adverse event
                Control1..1
                TypeReference(Substance)
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Alternate NamesSubstance or Medication or Device
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                96. AdverseEvent.suspectEntity.causality
                Definition

                Information on the possible cause of the event.

                ShortInformation on the possible cause of the event
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                98. AdverseEvent.suspectEntity.causality.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                100. AdverseEvent.suspectEntity.causality.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                102. AdverseEvent.suspectEntity.causality.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                104. AdverseEvent.suspectEntity.causality.assessment
                Definition

                Assessment of if the entity caused the event.

                ShortAssessment of if the entity caused the event
                Control0..1
                BindingFor example codes, see AdverseEventCausalityAssessment
                (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-assess)

                Codes for the assessment of whether the entity caused the event.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                106. AdverseEvent.suspectEntity.causality.productRelatedness
                Definition

                AdverseEvent.suspectEntity.causalityProductRelatedness.

                ShortAdverseEvent.suspectEntity.causalityProductRelatedness
                Control0..1
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                108. AdverseEvent.suspectEntity.causality.author
                Definition

                AdverseEvent.suspectEntity.causalityAuthor.

                ShortAdverseEvent.suspectEntity.causalityAuthor
                Control0..1
                TypeReference(Practitioner, PractitionerRole)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                110. AdverseEvent.suspectEntity.causality.method
                Definition

                ProbabilityScale | Bayesian | Checklist.

                ShortProbabilityScale | Bayesian | Checklist
                Control0..1
                BindingFor example codes, see AdverseEventCausalityMethod
                (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)

                TODO.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                112. AdverseEvent.subjectMedicalHistory
                Definition

                AdverseEvent.subjectMedicalHistory.

                ShortAdverseEvent.subjectMedicalHistory
                Control1..1
                TypeReference(Condition, Observation, Immunization, DocumentReference)
                Is Modifierfalse
                Must Supporttrue
                Must Support TypesNo must-support rules about the choice of types/profiles
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                114. AdverseEvent.referenceDocument
                Definition

                AdverseEvent.referenceDocument.

                ShortAdverseEvent.referenceDocument
                Control0..*
                TypeReference(DocumentReference)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                116. AdverseEvent.study
                Definition

                AdverseEvent.study.

                ShortAdverseEvent.study
                Control0..*
                TypeReference(ResearchStudy)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))