US Veterans Health Administration FHIR Map Set Implementation Guide
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Resource Profile: VAERSAdverseEvent - Detailed Descriptions

Draft as of 2025-06-13

Definitions for the VAERSAdverseEvent resource profile.

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

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.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())
6. 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
Pattern Valueactual
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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 SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-type
(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()))
10. AdverseEvent.event.coding
Definition

A reference to a code defined by a terminology system.

ShortCode defined by a terminology system
Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control0..*
TypeCoding
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

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

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. 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(VAERS Patient, Patient, Group, Practitioner, RelatedPerson)
Is Modifierfalse
Must Supporttrue
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()))
16. AdverseEvent.date
Definition

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

ShortWhen the event occurred
Control0..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()))
18. 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 AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
(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()))
20. AdverseEvent.outcome.coding
Definition

A reference to a code defined by a terminology system.

ShortCode defined by a terminology system
Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control0..*
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on AdverseEvent.outcome.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ $this
  • 22. AdverseEvent.outcome.coding:va-outcome1
    Slice Nameva-outcome1
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1906: If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" (true)
    24. AdverseEvent.outcome.coding:va-outcome2
    Slice Nameva-outcome2
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1907: If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" (true)
    26. AdverseEvent.outcome.coding:va-outcome3
    Slice Nameva-outcome3
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1908: If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" (true)
    28. AdverseEvent.outcome.coding:va-outcome8
    Slice Nameva-outcome8
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1913: If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" (true)
    30. AdverseEvent.outcome.coding:va-outcome9
    Slice Nameva-outcome9
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1914: If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" (true)
    32. AdverseEvent.outcome.coding:va-outcome10
    Slice Nameva-outcome10
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1915: If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" (true)
    34. AdverseEvent.outcome.coding:va-outcome13
    Slice Nameva-outcome13
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1916: If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" (true)
    36. AdverseEvent.outcome.coding:va-outcome11
    Slice Nameva-outcome11
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1918: If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" (true)
    38. AdverseEvent.outcome.coding:va-outcome12
    Slice Nameva-outcome12
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control0..1*
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    vaersae-17-1919: If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" (true)
    40. AdverseEvent.suspectEntity
    Definition

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

    ShortThe suspected agent causing the adverse event
    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. 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())
    44. 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(VAERS Immunization[vac1], Immunization, Procedure, Substance, 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()))

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

    0. AdverseEvent
    2. AdverseEvent.actuality
    Must Supporttrue
    Pattern Valueactual
    4. AdverseEvent.event
    6. AdverseEvent.event.coding
    Must Supporttrue
    8. AdverseEvent.event.text
    Must Supporttrue
    10. AdverseEvent.subject
    TypeReference(VAERS Patient)
    Must Supporttrue
    12. AdverseEvent.date
    Must Supporttrue
    14. AdverseEvent.outcome
    16. AdverseEvent.outcome.coding
    SlicingThis element introduces a set of slices on AdverseEvent.outcome.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ $this
    • 18. AdverseEvent.outcome.coding:va-outcome1
      Slice Nameva-outcome1
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1906: If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" (true)
      20. AdverseEvent.outcome.coding:va-outcome2
      Slice Nameva-outcome2
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1907: If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" (true)
      22. AdverseEvent.outcome.coding:va-outcome3
      Slice Nameva-outcome3
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1908: If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" (true)
      24. AdverseEvent.outcome.coding:va-outcome8
      Slice Nameva-outcome8
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1913: If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" (true)
      26. AdverseEvent.outcome.coding:va-outcome9
      Slice Nameva-outcome9
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1914: If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" (true)
      28. AdverseEvent.outcome.coding:va-outcome10
      Slice Nameva-outcome10
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1915: If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" (true)
      30. AdverseEvent.outcome.coding:va-outcome13
      Slice Nameva-outcome13
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1916: If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" (true)
      32. AdverseEvent.outcome.coding:va-outcome11
      Slice Nameva-outcome11
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1918: If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" (true)
      34. AdverseEvent.outcome.coding:va-outcome12
      Slice Nameva-outcome12
      Control0..1
      Must Supporttrue
      Invariantsvaersae-17-1919: If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" (true)
      36. AdverseEvent.suspectEntity
      38. AdverseEvent.suspectEntity.instance
      TypeReference(VAERS Immunization[vac1])
      Must Supporttrue

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

      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

      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.

      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())
      16. 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())
      18. 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)
      Control0..1
      TypeIdentifier
      Is Modifierfalse
      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()))
      20. 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
      Pattern Valueactual
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. 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()))
      24. 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()))
      26. AdverseEvent.event.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
      28. AdverseEvent.event.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())
      SlicingThis element introduces a set of slices on AdverseEvent.event.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 30. AdverseEvent.event.coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCode defined by a terminology system
        Comments

        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control0..*
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

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

        A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

        ShortPlain text representation of the concept
        Comments

        Very often the text is the same as a displayName of one of the codings.

        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        34. 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(VAERS Patient)
        Is Modifierfalse
        Must Supporttrue
        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()))
        36. 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()))
        38. AdverseEvent.date
        Definition

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

        ShortWhen the event occurred
        Control0..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()))
        40. 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()))
        42. 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.

        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()))
        44. 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()))
        46. 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()))
        48. 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()))
        50. 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()))
        52. 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()))
        54. AdverseEvent.outcome.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
        56. AdverseEvent.outcome.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())
        SlicingThis element introduces a set of slices on AdverseEvent.outcome.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 58. AdverseEvent.outcome.coding
          Definition

          A reference to a code defined by a terminology system.

          ShortCode defined by a terminology system
          Comments

          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

          Control0..*
          TypeCoding
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows for alternative encodings within a code system, and translations to other code systems.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on AdverseEvent.outcome.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ $this
          • 60. AdverseEvent.outcome.coding:va-outcome1
            Slice Nameva-outcome1
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1906: If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" (true)
            62. AdverseEvent.outcome.coding:va-outcome2
            Slice Nameva-outcome2
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1907: If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" (true)
            64. AdverseEvent.outcome.coding:va-outcome3
            Slice Nameva-outcome3
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1908: If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" (true)
            66. AdverseEvent.outcome.coding:va-outcome8
            Slice Nameva-outcome8
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1913: If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" (true)
            68. AdverseEvent.outcome.coding:va-outcome9
            Slice Nameva-outcome9
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1914: If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" (true)
            70. AdverseEvent.outcome.coding:va-outcome10
            Slice Nameva-outcome10
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1915: If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" (true)
            72. AdverseEvent.outcome.coding:va-outcome13
            Slice Nameva-outcome13
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1916: If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" (true)
            74. AdverseEvent.outcome.coding:va-outcome11
            Slice Nameva-outcome11
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1918: If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" (true)
            76. AdverseEvent.outcome.coding:va-outcome12
            Slice Nameva-outcome12
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control0..1
            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            vaersae-17-1919: If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" (true)
            78. AdverseEvent.outcome.text
            Definition

            A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

            ShortPlain text representation of the concept
            Comments

            Very often the text is the same as a displayName of one of the codings.

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            80. 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()))
            82. 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()))
            84. AdverseEvent.suspectEntity
            Definition

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

            ShortThe suspected agent causing the adverse event
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            86. 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
            88. 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())
            90. 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())
            92. 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(VAERS Immunization[vac1])
            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()))
            94. 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()))
            96. 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
            98. 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())
            100. 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())
            102. 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()))
            104. 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()))
            106. 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()))
            108. 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()))
            110. AdverseEvent.subjectMedicalHistory
            Definition

            AdverseEvent.subjectMedicalHistory.

            ShortAdverseEvent.subjectMedicalHistory
            Control0..*
            TypeReference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            112. 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()))
            114. 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()))