HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction United States of America flag

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.1: STU 1 Update) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: VaccinationAdverseEvent - Detailed Descriptions

Draft as of 2023-08-29

Definitions for the vaccination-adverseevent resource profile.

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

0. AdverseEvent
2. AdverseEvent.event
BindingUnless not suitable, these codes SHALL be taken from Vaccination-related Adverse Events
4. AdverseEvent.suspectEntity
SlicingThis element introduces a set of slices on AdverseEvent.suspectEntity. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • type @ instance.resolve()
6. AdverseEvent.suspectEntity:Immunization
Slice NameImmunization
Control1..1
Must Supporttrue
8. AdverseEvent.suspectEntity:Immunization.instance
TypeReference(ICSR Immunization)

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:ageAtTimeOfOnset
Slice NameageAtTimeOfOnset
Definition

The age of the patient when the event occurred.

ShortExtension
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(AgeAtTimeOfOnset) (Extension Type: Age)
Is Modifierfalse
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())
6. 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())
8. 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
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()))
10. 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

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
Fixed Valueactual
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. 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 AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-category

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

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. 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
Control10..1
BindingUnless not suitable, these codes SHALL be taken from For example codes, see Vaccination-related Adverse Eventshttp://hl7.org/fhir/ValueSet/adverse-event-type
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. 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(ICSR 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()))
18. 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(US Core Encounter Profile, Encounter)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. 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()))
22. AdverseEvent.date.extension:eventDuration
Slice NameeventDuration
Definition

The duration of the adverse event.

ShortExtension
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(EventDuration) (Extension Type: Duration)
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.date.extension:endDate
Slice NameendDate
Definition

When the event ended.

ShortExtension
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(EventEndDate) (Extension Type: dateTime)
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())
26. AdverseEvent.location
Definition

The information about where the adverse event occurred.

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

Assessment whether this event was of real importance.

ShortSeriousness of the event
Control10..1
BindingThe codes SHALL be taken from For example codes, see ICSR Top-Level Seriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousness
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. AdverseEvent.seriousness.extension:seriousness
Slice Nameseriousness
Definition

Additional codes that give more detail around the adverse event seriousness.

ShortExtension
Control0..1
TypeExtension(EventSeriousness) (Extension Type: CodeableConcept)
Is Modifierfalse
Must Supporttrue
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())
32. 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

TODO (and should this be required?).

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. 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(Practitioner Author, Patient, Practitioner, PractitionerRole, RelatedPerson)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. AdverseEvent.suspectEntity
Definition

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

ShortThe suspected agent causing the adverse event
Control10..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
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.suspectEntity. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • type @ instance.resolve()
38. 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())
40. 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(ICSR Immunization, ICSR MedicationAdministration, ICSR Transfusion, Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Alternate NamesSubstance or Medication or Device
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. AdverseEvent.suspectEntity.causality
Definition

Information on the possible cause of the event.

ShortInformation on the possible cause of the event
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. 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())
46. AdverseEvent.suspectEntity.causality.productRelatedness
Definition

AdverseEvent.suspectEntity.causalityProductRelatedness.

ShortAdverseEvent.suspectEntity.causalityProductRelatedness
Control10..1
Typestring
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.suspectEntity:Immunization
Slice NameImmunization
Definition

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

ShortThe suspected agent causing the adverse event
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. AdverseEvent.suspectEntity:Immunization.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())
52. AdverseEvent.suspectEntity:Immunization.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(ICSR Immunization, 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()))
54. AdverseEvent.suspectEntity:Immunization.causality
Definition

Information on the possible cause of the event.

ShortInformation on the possible cause of the event
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. AdverseEvent.suspectEntity:Immunization.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())
58. AdverseEvent.suspectEntity:Immunization.causality.productRelatedness
Definition

AdverseEvent.suspectEntity.causalityProductRelatedness.

ShortAdverseEvent.suspectEntity.causalityProductRelatedness
Control10..1
Typestring
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()))

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: 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
Control0..*
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 are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
16. AdverseEvent.extension:ageAtTimeOfOnset
Slice NameageAtTimeOfOnset
Definition

The age of the patient when the event occurred.

ShortExtension
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(AgeAtTimeOfOnset) (Extension Type: Age)
Is Modifierfalse
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.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.

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())
20. 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
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()))
22. 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: 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
Fixed Valueactual
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. 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: Overall categorization of the event, e.g. product-related or situational.
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. 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
Control1..1
BindingUnless not suitable, these codes SHALL be taken from Vaccination-related Adverse Events
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. 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
30. 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 are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
32. 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
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()))
34. AdverseEvent.event.coding.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.event.coding.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.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
38. AdverseEvent.event.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

ShortIdentity of the terminology system
Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

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

Need to be unambiguous about the source of the definition of the symbol.

Fixed Valuehttp://meddra.org
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. AdverseEvent.event.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

ShortVersion of the system - if relevant
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

NoteThis is a business versionId, not a resource version id (see discussion)
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()))
42. AdverseEvent.event.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

ShortSymbol in syntax defined by the system
Control0..1
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

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

A representation of the meaning of the code in the system, following the rules of the system.

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

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

ShortIf this coding was chosen directly by the user
Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. 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
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()))
50. 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(ICSR 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()))
52. 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(US Core Encounter Profile)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. 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()))
56. AdverseEvent.date.id
Definition

unique id for the element within a resource (for internal references)

Shortxml:id (or equivalent in JSON)
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
58. AdverseEvent.date.extension
Definition

An Extension

ShortExtension
Control0..*
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.date.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
60. AdverseEvent.date.extension:eventDuration
Slice NameeventDuration
Definition

The duration of the adverse event.

ShortExtension
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(EventDuration) (Extension Type: Duration)
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())
62. AdverseEvent.date.extension:endDate
Slice NameendDate
Definition

When the event ended.

ShortExtension
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(EventEndDate) (Extension Type: dateTime)
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())
64. AdverseEvent.date.value
Definition

The actual value

ShortPrimitive value for dateTime
Control0..1
TypedateTime
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
66. 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()))
68. 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()))
70. 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()))
72. AdverseEvent.location
Definition

The information about where the adverse event occurred.

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

Assessment whether this event was of real importance.

ShortSeriousness of the event
Control1..1
BindingThe codes SHALL be taken from ICSR Top-Level Seriousness
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. AdverseEvent.seriousness.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
78. AdverseEvent.seriousness.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.seriousness.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
80. AdverseEvent.seriousness.extension:seriousness
Slice Nameseriousness
Definition

Additional codes that give more detail around the adverse event seriousness.

ShortExtension
Control0..1
TypeExtension(EventSeriousness) (Extension Type: CodeableConcept)
Is Modifierfalse
Must Supporttrue
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())
82. AdverseEvent.seriousness.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()))
84. AdverseEvent.seriousness.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()))
86. 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: 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()))
88. 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: TODO (and should this be required?).
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. 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(Practitioner Author)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. 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()))
94. AdverseEvent.suspectEntity
Definition

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

ShortThe suspected agent causing the adverse event
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
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.suspectEntity. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • type @ instance.resolve()
96. 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
98. 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())
100. 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.

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.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(ICSR Immunization, ICSR MedicationAdministration, ICSR Transfusion)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Alternate NamesSubstance or Medication or Device
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. AdverseEvent.suspectEntity.causality
Definition

Information on the possible cause of the event.

ShortInformation on the possible cause of the event
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. 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
108. 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())
110. 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.

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())
112. 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: 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()))
114. AdverseEvent.suspectEntity.causality.productRelatedness
Definition

AdverseEvent.suspectEntity.causalityProductRelatedness.

ShortAdverseEvent.suspectEntity.causalityProductRelatedness
Control1..1
Typestring
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()))
116. 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()))
118. AdverseEvent.suspectEntity.causality.method
Definition

ProbabilityScale | Bayesian | Checklist.

ShortProbabilityScale | Bayesian | Checklist
Control0..1
BindingFor example codes, see AdverseEventCausalityMethod: TODO.
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. AdverseEvent.suspectEntity:Immunization
Slice NameImmunization
Definition

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

ShortThe suspected agent causing the adverse event
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. AdverseEvent.suspectEntity:Immunization.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
124. AdverseEvent.suspectEntity:Immunization.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())
126. AdverseEvent.suspectEntity:Immunization.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.

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())
128. AdverseEvent.suspectEntity:Immunization.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(ICSR Immunization)
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()))
130. AdverseEvent.suspectEntity:Immunization.causality
Definition

Information on the possible cause of the event.

ShortInformation on the possible cause of the event
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. AdverseEvent.suspectEntity:Immunization.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
134. AdverseEvent.suspectEntity:Immunization.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())
136. AdverseEvent.suspectEntity:Immunization.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.

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())
138. AdverseEvent.suspectEntity:Immunization.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: 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()))
140. AdverseEvent.suspectEntity:Immunization.causality.productRelatedness
Definition

AdverseEvent.suspectEntity.causalityProductRelatedness.

ShortAdverseEvent.suspectEntity.causalityProductRelatedness
Control1..1
Typestring
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()))
142. AdverseEvent.suspectEntity:Immunization.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()))
144. AdverseEvent.suspectEntity:Immunization.causality.method
Definition

ProbabilityScale | Bayesian | Checklist.

ShortProbabilityScale | Bayesian | Checklist
Control0..1
BindingFor example codes, see AdverseEventCausalityMethod: TODO.
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. 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()))
148. 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()))
150. 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()))