Health eData 1 Sandbox
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Health eData 1 Sandbox, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/argonautproject/USCDIV7/ and changes regularly. See the Directory of published versions

Resource Profile: US Core AdverseEvent Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-adverseevent Version: 0.1.0
Active as of 2026-08-11 Maturity Level: 2 Computable Name: USCoreAdverseEventProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.77

The US Core AdverseEvent Profile inherits from the FHIR AdverseEvent resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) Adverse Events Data Class and its Adverse Event and Adverse Event Outcome Data Elements. It sets minimum expectations for the AdverseEvent resource to record, search, and fetch information about a change to patient condition that could be an unintended effect of clinical interventions. It specifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

Example Usage Scenarios:

The following are example usage scenarios for the US Core AdverseEvent profile:

  • Query for AdverseEvent resources belonging to a Patient
  • [Record or update] a Patient AdverseEvent

Mandatory and Must Support Data Elements

The following data elements must always be present ([Mandatory] definition) or must be supported if the data is present in the sending system ([Must Support] definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The [Formal Views] below provides the formal summary, definitions, and terminology requirements.

Each AdverseEvent Must Have:

  1. whether the event is an actual or potential adverse event (actuality)
  2. the type of adverse event
  3. the patient the event is about

Each AdverseEvent Must Support:

  1. when the event occurred
  2. when the event was recorded
  3. the outcome of the event
  4. who recorded the adverse event
  5. the suspected entity (immunization, medication administration, or medication) that caused the event

Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.

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Liquid Script to Generate StructureDefinition All Nice N Pretty Like

{% include structure-table.md sd=sd source="differential" show_must_support=true show_uscdi=true %}

USCoreAdverseEventProfile — US Core AdverseEvent Profile

The US Core AdverseEvent Profile inherits from the FHIR AdverseEvent resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) Adverse Events Data Class and its Adverse Event and Adverse Event Outcome Data Elements. It sets minimum expectations for the AdverseEvent resource to record, search, and fetch information about a change to patient condition that could be an unintended effect of clinical interventions. It specifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

  • URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-adverseevent
  • Version: 0.1.0
  • Status: active
  • Kind: resource
  • Type: AdverseEvent
  • Base Definition: http://hl7.org/fhir/StructureDefinition/AdverseEvent
  • Derivation: constraint

Elements (differential)

Element Must Support Add'l USCDI Cardinality Type Description
AdverseEvent     0..*   Medical care, research study or other healthcare event causing physical injury
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.
↳actuality ✅   1..1 code actual | potential
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.
Binding: http://hl7.org/fhir/ValueSet/adverse-event-actuality (required)
↳event ✅   1..1 CodeableConcept Type of the event itself in relation to the subject
This element defines the specific type of event that occurred or that was prevented from occurring.
Binding: http://hl7.org/fhir/ValueSet/adverse-event-type (extensible)
↳subject ✅   1..1 Reference
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient
target: http://hl7.org/fhir/StructureDefinition/Group
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson		 Subject impacted by event
This subject or group impacted by the event.
↳date ✅   0..1 dateTime When the event occurred
The date (and perhaps time) when the adverse event occurred.
↳recordedDate ✅   0..1 dateTime When the event was recorded
The date on which the existence of the AdverseEvent was first recorded.
↳outcome ✅   0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Describes the type of outcome from the adverse event.
Binding: http://hl7.org/fhir/ValueSet/adverse-event-outcome (required)
↳recorder ✅   0..1 Reference
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner
target: http://hl7.org/fhir/StructureDefinition/PractitionerRole
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson		 Who recorded the adverse event
Information on who recorded the adverse event. May be the patient or a practitioner.
↳suspectEntity ✅   0..* BackboneElement The suspected agent causing the adverse event
Describes the entity that is suspected to have caused the adverse event.
↳instance ✅   1..1 Reference
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-immunization
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-procedure
target: http://hl7.org/fhir/StructureDefinition/Substance
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-medication
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-medicationadministration
target: http://hl7.org/fhir/StructureDefinition/MedicationStatement
target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-device		 Refers to the specific entity that caused the adverse event
Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.		 


## USCoreAdverseEventProfile — US Core AdverseEvent Profile

The US Core AdverseEvent Profile inherits from the FHIR [AdverseEvent](https://hl7.org/fhir/R4/adverseevent.html) resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) *Adverse Events Data Class* and its *Adverse Event* and *Adverse Event Outcome* Data Elements. It sets minimum expectations for the AdverseEvent resource to record, search, and fetch information about a change to patient condition that could be an unintended effect of clinical interventions. It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

- **URL:** `http://hl7.org/fhir/us/core/StructureDefinition/us-core-adverseevent`
- **Version:** 0.1.0
- **Status:** active
- **Kind:** resource
- **Type:** `AdverseEvent`
- **Base Definition:** `http://hl7.org/fhir/StructureDefinition/AdverseEvent`
- **Derivation:** constraint


### Elements (differential)

| Element | Must Support | Add'l USCDI | Cardinality | Type | Description |
|---|:---:|:---:|---|---|---|
| `AdverseEvent` |  |  | 0..* |  | **Medical care, research study or other healthcare event causing physical injury**<br/>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. |
| <span style="padding-left: 1.5em;">↳</span>`actuality` | ✅ |  | 1..1 | `code` | **actual \| potential**<br/>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.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/adverse-event-actuality` (required)</span> |
| <span style="padding-left: 1.5em;">↳</span>`event` | ✅ |  | 1..1 | `CodeableConcept` | **Type of the event itself in relation to the subject**<br/>This element defines the specific type of event that occurred or that was prevented from occurring.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/adverse-event-type` (extensible)</span> |
| <span style="padding-left: 1.5em;">↳</span>`subject` | ✅ |  | 1..1 | `Reference`<br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/StructureDefinition/Group</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson</span> | **Subject impacted by event**<br/>This subject or group impacted by the event. |
| <span style="padding-left: 1.5em;">↳</span>`date` | ✅ |  | 0..1 | `dateTime` | **When the event occurred**<br/>The date (and perhaps time) when the adverse event occurred. |
| <span style="padding-left: 1.5em;">↳</span>`recordedDate` | ✅ |  | 0..1 | `dateTime` | **When the event was recorded**<br/>The date on which the existence of the AdverseEvent was first recorded. |
| <span style="padding-left: 1.5em;">↳</span>`outcome` | ✅ |  | 0..1 | `CodeableConcept` | **resolved \| recovering \| ongoing \| resolvedWithSequelae \| fatal \| unknown**<br/>Describes the type of outcome from the adverse event.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/adverse-event-outcome` (required)</span> |
| <span style="padding-left: 1.5em;">↳</span>`recorder` | ✅ |  | 0..1 | `Reference`<br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/StructureDefinition/PractitionerRole</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson</span> | **Who recorded the adverse event**<br/>Information on who recorded the adverse event.  May be the patient or a practitioner. |
| <span style="padding-left: 1.5em;">↳</span>`suspectEntity` | ✅ |  | 0..* | `BackboneElement` | **The suspected agent causing the adverse event**<br/>Describes the entity that is suspected to have caused the adverse event. |
| <span style="padding-left: 3.0em;">↳</span>`instance` | ✅ |  | 1..1 | `Reference`<br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-immunization</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-procedure</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/StructureDefinition/Substance</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-medication</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-medicationadministration</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/StructureDefinition/MedicationStatement</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-device</span> | **Refers to the specific entity that caused the adverse event**<br/>Identifies the actual instance of what caused the adverse event.  May be a substance, medication, medication administration, medication statement or a device. |

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: doco
AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
AdverseEvent.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
AdverseEvent.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
AdverseEvent.actuality This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code actual | potential
Binding: AdverseEventActuality (required)
AdverseEvent.event This element must be supported. This element is included in summaries. 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (extensible)
AdverseEvent.subject This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile(9.0.0) This type must be supported. | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) Subject impacted by event
AdverseEvent.date This element must be supported. This element is included in summaries. 0..1 dateTime When the event occurred
AdverseEvent.recordedDate This element must be supported. This element is included in summaries. 0..1 dateTime When the event was recorded
AdverseEvent.outcome This element must be supported. This element is included in summaries. 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
AdverseEvent.recorder This element must be supported. This element is included in summaries. 0..1 Reference(US Core Patient Profile(9.0.0) | US Core Practitioner Profile This type must be supported. | PractitionerRole | US Core RelatedPerson Profile) Who recorded the adverse event
AdverseEvent.suspectEntity This element must be supported. This element is included in summaries. 0..* BackboneElement The suspected agent causing the adverse event
AdverseEvent.suspectEntity.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.instance This element must be supported. This element is included in summaries. 1..1 Reference(US Core Immunization Profile This type must be supported. | US Core Procedure Profile | Substance | US Core Medication Profile This type must be supported. | US Core MedicationAdministration Profile This type must be supported. | MedicationStatement | US Core Device Profile) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.event Base extensible SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent 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 error AdverseEvent 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 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraints    Filter: doco
AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
AdverseEvent.actuality This element must be supported. 1..1 code actual | potential
Binding: AdverseEventActuality (required)
AdverseEvent.event This element must be supported. 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (extensible)
AdverseEvent.subject This element must be supported. 1..1 Reference(US Core Patient Profile(9.0.0) This type must be supported. | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) Subject impacted by event
AdverseEvent.recordedDate This element must be supported. 0..1 dateTime When the event was recorded
AdverseEvent.outcome This element must be supported. 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
AdverseEvent.recorder This element must be supported. 0..1 Reference(US Core Patient Profile(9.0.0) | US Core Practitioner Profile This type must be supported. | PractitionerRole | US Core RelatedPerson Profile) Who recorded the adverse event
AdverseEvent.suspectEntity This element must be supported. 0..* BackboneElement The suspected agent causing the adverse event
AdverseEvent.suspectEntity.instance This element must be supported. 1..1 Reference(US Core Immunization Profile This type must be supported. | US Core Procedure Profile | Substance | US Core Medication Profile This type must be supported. | US Core MedicationAdministration Profile This type must be supported. | MedicationStatement | US Core Device Profile) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.event Base extensible SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📦4.0.1 FHIR Std.
NameFlagsCard.TypeDescription & Constraints    Filter: doco
AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
AdverseEvent.id This element is included in summaries. 0..1 id Logical id of this artifact
AdverseEvent.meta This element is included in summaries. 0..1 Meta Metadata about the resource
AdverseEvent.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
AdverseEvent.language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
AdverseEvent.text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
AdverseEvent.contained 0..* Resource Contained, inline Resources
AdverseEvent.extension 0..* Extension Additional content defined by implementations
AdverseEvent.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
AdverseEvent.identifier This element is included in summaries. 0..1 Identifier Business identifier for the event
AdverseEvent.actuality This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code actual | potential
Binding: AdverseEventActuality (required)
AdverseEvent.category This element is included in summaries. 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
AdverseEvent.event This element must be supported. This element is included in summaries. 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (extensible)
AdverseEvent.subject This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile(9.0.0) This type must be supported. | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) Subject impacted by event
AdverseEvent.encounter This element is included in summaries. 0..1 Reference(Encounter) Encounter created as part of
AdverseEvent.date This element must be supported. This element is included in summaries. 0..1 dateTime When the event occurred
AdverseEvent.detected This element is included in summaries. 0..1 dateTime When the event was detected
AdverseEvent.recordedDate This element must be supported. This element is included in summaries. 0..1 dateTime When the event was recorded
AdverseEvent.resultingCondition This element is included in summaries. 0..* Reference(Condition) Effect on the subject due to this event
AdverseEvent.location This element is included in summaries. 0..1 Reference(Location) Location where adverse event occurred
AdverseEvent.seriousness This element is included in summaries. 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
AdverseEvent.severity This element is included in summaries. 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
AdverseEvent.outcome This element must be supported. This element is included in summaries. 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
AdverseEvent.recorder This element must be supported. This element is included in summaries. 0..1 Reference(US Core Patient Profile(9.0.0) | US Core Practitioner Profile This type must be supported. | PractitionerRole | US Core RelatedPerson Profile) Who recorded the adverse event
AdverseEvent.contributor This element is included in summaries. 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
AdverseEvent.suspectEntity This element must be supported. This element is included in summaries. 0..* BackboneElement The suspected agent causing the adverse event
AdverseEvent.suspectEntity.id 0..1 string Unique id for inter-element referencing
AdverseEvent.suspectEntity.extension 0..* Extension Additional content defined by implementations
AdverseEvent.suspectEntity.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.instance This element must be supported. This element is included in summaries. 1..1 Reference(US Core Immunization Profile This type must be supported. | US Core Procedure Profile | Substance | US Core Medication Profile This type must be supported. | US Core MedicationAdministration Profile This type must be supported. | MedicationStatement | US Core Device Profile) Refers to the specific entity that caused the adverse event
AdverseEvent.suspectEntity.causality This element is included in summaries. 0..* BackboneElement Information on the possible cause of the event
AdverseEvent.suspectEntity.causality.id 0..1 string Unique id for inter-element referencing
AdverseEvent.suspectEntity.causality.extension 0..* Extension Additional content defined by implementations
AdverseEvent.suspectEntity.causality.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.causality.assessment This element is included in summaries. 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
AdverseEvent.suspectEntity.causality.productRelatedness This element is included in summaries. 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
AdverseEvent.suspectEntity.causality.author This element is included in summaries. 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
AdverseEvent.suspectEntity.causality.method This element is included in summaries. 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
AdverseEvent.subjectMedicalHistory This element is included in summaries. 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
AdverseEvent.referenceDocument This element is included in summaries. 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
AdverseEvent.study This element is included in summaries. 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base extensible SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.seriousness Base example AdverseEventSeriousness 📍4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📦4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base example AdverseEventCausalityAssessment 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent 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 error AdverseEvent 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 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: doco
AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
AdverseEvent.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
AdverseEvent.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
AdverseEvent.actuality This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code actual | potential
Binding: AdverseEventActuality (required)
AdverseEvent.event This element must be supported. This element is included in summaries. 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (extensible)
AdverseEvent.subject This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile(9.0.0) This type must be supported. | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) Subject impacted by event
AdverseEvent.date This element must be supported. This element is included in summaries. 0..1 dateTime When the event occurred
AdverseEvent.recordedDate This element must be supported. This element is included in summaries. 0..1 dateTime When the event was recorded
AdverseEvent.outcome This element must be supported. This element is included in summaries. 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
AdverseEvent.recorder This element must be supported. This element is included in summaries. 0..1 Reference(US Core Patient Profile(9.0.0) | US Core Practitioner Profile This type must be supported. | PractitionerRole | US Core RelatedPerson Profile) Who recorded the adverse event
AdverseEvent.suspectEntity This element must be supported. This element is included in summaries. 0..* BackboneElement The suspected agent causing the adverse event
AdverseEvent.suspectEntity.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.instance This element must be supported. This element is included in summaries. 1..1 Reference(US Core Immunization Profile This type must be supported. | US Core Procedure Profile | Substance | US Core Medication Profile This type must be supported. | US Core MedicationAdministration Profile This type must be supported. | MedicationStatement | US Core Device Profile) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.event Base extensible SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent 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 error AdverseEvent 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 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraints    Filter: doco
AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
AdverseEvent.actuality This element must be supported. 1..1 code actual | potential
Binding: AdverseEventActuality (required)
AdverseEvent.event This element must be supported. 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (extensible)
AdverseEvent.subject This element must be supported. 1..1 Reference(US Core Patient Profile(9.0.0) This type must be supported. | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) Subject impacted by event
AdverseEvent.date This element must be supported. 0..1 dateTime When the event occurred
AdverseEvent.recordedDate This element must be supported. 0..1 dateTime When the event was recorded
AdverseEvent.outcome This element must be supported. 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
AdverseEvent.recorder This element must be supported. 0..1 Reference(US Core Patient Profile(9.0.0) | US Core Practitioner Profile This type must be supported. | PractitionerRole | US Core RelatedPerson Profile) Who recorded the adverse event
AdverseEvent.suspectEntity This element must be supported. 0..* BackboneElement The suspected agent causing the adverse event
AdverseEvent.suspectEntity.instance This element must be supported. 1..1 Reference(US Core Immunization Profile This type must be supported. | US Core Procedure Profile | Substance | US Core Medication Profile This type must be supported. | US Core MedicationAdministration Profile This type must be supported. | MedicationStatement | US Core Device Profile) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.event Base extensible SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📦4.0.1 FHIR Std.

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: doco
AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
AdverseEvent.id This element is included in summaries. 0..1 id Logical id of this artifact
AdverseEvent.meta This element is included in summaries. 0..1 Meta Metadata about the resource
AdverseEvent.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
AdverseEvent.language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
AdverseEvent.text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
AdverseEvent.contained 0..* Resource Contained, inline Resources
AdverseEvent.extension 0..* Extension Additional content defined by implementations
AdverseEvent.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
AdverseEvent.identifier This element is included in summaries. 0..1 Identifier Business identifier for the event
AdverseEvent.actuality This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code actual | potential
Binding: AdverseEventActuality (required)
AdverseEvent.category This element is included in summaries. 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
AdverseEvent.event This element must be supported. This element is included in summaries. 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (extensible)
AdverseEvent.subject This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile(9.0.0) This type must be supported. | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) Subject impacted by event
AdverseEvent.encounter This element is included in summaries. 0..1 Reference(Encounter) Encounter created as part of
AdverseEvent.date This element must be supported. This element is included in summaries. 0..1 dateTime When the event occurred
AdverseEvent.detected This element is included in summaries. 0..1 dateTime When the event was detected
AdverseEvent.recordedDate This element must be supported. This element is included in summaries. 0..1 dateTime When the event was recorded
AdverseEvent.resultingCondition This element is included in summaries. 0..* Reference(Condition) Effect on the subject due to this event
AdverseEvent.location This element is included in summaries. 0..1 Reference(Location) Location where adverse event occurred
AdverseEvent.seriousness This element is included in summaries. 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
AdverseEvent.severity This element is included in summaries. 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
AdverseEvent.outcome This element must be supported. This element is included in summaries. 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required)
AdverseEvent.recorder This element must be supported. This element is included in summaries. 0..1 Reference(US Core Patient Profile(9.0.0) | US Core Practitioner Profile This type must be supported. | PractitionerRole | US Core RelatedPerson Profile) Who recorded the adverse event
AdverseEvent.contributor This element is included in summaries. 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
AdverseEvent.suspectEntity This element must be supported. This element is included in summaries. 0..* BackboneElement The suspected agent causing the adverse event
AdverseEvent.suspectEntity.id 0..1 string Unique id for inter-element referencing
AdverseEvent.suspectEntity.extension 0..* Extension Additional content defined by implementations
AdverseEvent.suspectEntity.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.instance This element must be supported. This element is included in summaries. 1..1 Reference(US Core Immunization Profile This type must be supported. | US Core Procedure Profile | Substance | US Core Medication Profile This type must be supported. | US Core MedicationAdministration Profile This type must be supported. | MedicationStatement | US Core Device Profile) Refers to the specific entity that caused the adverse event
AdverseEvent.suspectEntity.causality This element is included in summaries. 0..* BackboneElement Information on the possible cause of the event
AdverseEvent.suspectEntity.causality.id 0..1 string Unique id for inter-element referencing
AdverseEvent.suspectEntity.causality.extension 0..* Extension Additional content defined by implementations
AdverseEvent.suspectEntity.causality.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.causality.assessment This element is included in summaries. 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
AdverseEvent.suspectEntity.causality.productRelatedness This element is included in summaries. 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
AdverseEvent.suspectEntity.causality.author This element is included in summaries. 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
AdverseEvent.suspectEntity.causality.method This element is included in summaries. 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
AdverseEvent.subjectMedicalHistory This element is included in summaries. 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
AdverseEvent.referenceDocument This element is included in summaries. 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
AdverseEvent.study This element is included in summaries. 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base extensible SNOMED CT Clinical Findings 📦4.0.1 FHIR Std.
AdverseEvent.seriousness Base example AdverseEventSeriousness 📍4.0.1 FHIR Std.
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📦4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base example AdverseEventCausalityAssessment 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent 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 error AdverseEvent 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 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

 

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