Health eData 1 Sandbox
0.1.0 - CI Build
Health eData 1 Sandbox
0.1.0 - CI Build
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
| 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:
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:
Each AdverseEvent Must Support:
This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.
{% include structure-table.md sd=sd source="differential" show_must_support=true show_uscdi=true %}
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.
http://hl7.org/fhir/us/core/StructureDefinition/us-core-adverseeventAdverseEventhttp://hl7.org/fhir/StructureDefinition/AdverseEvent| 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 | Referencetarget: 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 | Referencetarget: 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 | Referencetarget: 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
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  AdverseEvent |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality |
?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required) |
 event |
SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (extensible) |
 subject |
SΣ | 1..1 | Reference(US Core Patient Profile(9.0.0-ballot) S | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) | Subject impacted by event |
| date |
SΣ | 0..1 | dateTime | When the event occurred |
| recordedDate |
SΣ | 0..1 | dateTime | When the event was recorded |
| outcome |
SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) |
| recorder |
SΣ | 0..1 | Reference(US Core Patient Profile(9.0.0-ballot) | US Core Practitioner Profile S | PractitionerRole | US Core RelatedPerson Profile) | Who recorded the adverse event |
 suspectEntity |
SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
 instance |
SΣ | 1..1 | Reference(US Core Immunization Profile S | US Core Procedure Profile | Substance | US Core Medication Profile S | US Core MedicationAdministration Profile S | MedicationStatement | US Core Device Profile) | Refers to the specific entity that caused the adverse event |
| Documentation for this format | ||||
| 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. |
| 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
| 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. |
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| 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 | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality |
?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required) | ||||
| category |
Σ | 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. | ||||
| event |
SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (extensible) | ||||
| subject |
SΣ | 1..1 | Reference(US Core Patient Profile(9.0.0-ballot) S | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date |
SΣ | 0..1 | dateTime | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
SΣ | 0..1 | dateTime | When the event was recorded | ||||
| resultingCondition |
Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | ||||
| location |
Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness |
Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
| severity |
Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
| outcome |
SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) | ||||
| recorder |
SΣ | 0..1 | Reference(US Core Patient Profile(9.0.0-ballot) | US Core Practitioner Profile S | PractitionerRole | US Core RelatedPerson Profile) | Who recorded the adverse event | ||||
| contributor |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | ||||
 suspectEntity |
SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
 id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance |
SΣ | 1..1 | Reference(US Core Immunization Profile S | US Core Procedure Profile | Substance | US Core Medication Profile S | US Core MedicationAdministration Profile S | MedicationStatement | US Core Device Profile) | Refers to the specific entity that caused the adverse event | ||||
| causality |
Σ | 0..* | BackboneElement | Information on the possible cause of the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessment |
Σ | 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. | ||||
| productRelatedness |
Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
| author |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
| method |
Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| subjectMedicalHistory |
Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument |
Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study |
Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| 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. |
| 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
Summary
Mandatory: 1 element
Must-Support: 9 elements
Structures
This structure refers to these other structures:
Maturity: 2
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality |
?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required) |
| event |
SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (extensible) |
| subject |
SΣ | 1..1 | Reference(US Core Patient Profile(9.0.0-ballot) S | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) | Subject impacted by event |
| date |
SΣ | 0..1 | dateTime | When the event occurred |
| recordedDate |
SΣ | 0..1 | dateTime | When the event was recorded |
| outcome |
SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) |
| recorder |
SΣ | 0..1 | Reference(US Core Patient Profile(9.0.0-ballot) | US Core Practitioner Profile S | PractitionerRole | US Core RelatedPerson Profile) | Who recorded the adverse event |
| suspectEntity |
SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance |
SΣ | 1..1 | Reference(US Core Immunization Profile S | US Core Procedure Profile | Substance | US Core Medication Profile S | US Core MedicationAdministration Profile S | MedicationStatement | US Core Device Profile) | Refers to the specific entity that caused the adverse event |
| Documentation for this format | ||||
| 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. |
| 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
| 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
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| 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 | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality |
?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required) | ||||
| category |
Σ | 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. | ||||
| event |
SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (extensible) | ||||
| subject |
SΣ | 1..1 | Reference(US Core Patient Profile(9.0.0-ballot) S | Group | US Core Practitioner Profile | US Core RelatedPerson Profile) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date |
SΣ | 0..1 | dateTime | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
SΣ | 0..1 | dateTime | When the event was recorded | ||||
| resultingCondition |
Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | ||||
| location |
Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness |
Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. | ||||
| severity |
Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. | ||||
| outcome |
SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required) | ||||
| recorder |
SΣ | 0..1 | Reference(US Core Patient Profile(9.0.0-ballot) | US Core Practitioner Profile S | PractitionerRole | US Core RelatedPerson Profile) | Who recorded the adverse event | ||||
| contributor |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | ||||
| suspectEntity |
SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance |
SΣ | 1..1 | Reference(US Core Immunization Profile S | US Core Procedure Profile | Substance | US Core Medication Profile S | US Core MedicationAdministration Profile S | MedicationStatement | US Core Device Profile) | Refers to the specific entity that caused the adverse event | ||||
| causality |
Σ | 0..* | BackboneElement | Information on the possible cause of the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessment |
Σ | 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. | ||||
| productRelatedness |
Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
| author |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
| method |
Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| subjectMedicalHistory |
Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument |
Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study |
Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| 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. |
| 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
Summary
Mandatory: 1 element
Must-Support: 9 elements
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ HL7 International / Cross-Group Projects. Package hl7.fhir.us.healthedata1-sandbox#0.1.0 based on FHIR 4.0.1. Generated 2026-08-11
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