WHO Immunization Implementation Guide, published by WHO. This guide is not an authorized publication; it is the continuous build for version 0.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/WorldHealthOrganization/smart-immunizations/ and changes regularly. See the Directory of published versions
Resource Profile: SMART Guidelines Immunizations AdverseEvent
| Official URL: http://smart.who.int/immunizations/StructureDefinition/IMMZ.AdverseEvent | Version: 0.2.0 | |||
| Draft as of 2025-06-25 | Computable Name: IMMZAdverseEvent | |||
AdverseEvent Profile for the Immunizations SMART Guidelines. From IMMZ.D17 Report AEFI
Usages:
- This Profile is not used by any profiles in this Implementation Guide
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.
| 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 |
  Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
   extension:otherMedicalEvent |
0..1 | string | Immunization Other Important Medical Event URL: http://smart.who.int/immunizations/StructureDefinition/IMMZOtherMedicalEvent | |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
 event |
Σ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: IMMZ.D.DE95 ValueSet for Reaction manifestation (required) |
 subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
| date |
Σ | 1..1 | dateTime | When the event occurred |
| seriousness |
Σ | 1..1 | CodeableConcept | Seriousness of the event Binding: IMMZ.D.DE107 ValueSet for Type of reaction (required) |
 outcome |
Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1From the FHIR Standard | |
| AdverseEvent.event | required | IMMZ_D_DE95http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE95From this IG | |
| AdverseEvent.seriousness | required | IMMZ_D_DE107http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE107From this IG | |
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1From the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:otherMedicalEvent |
0..1 | string | Immunization Other Important Medical Event URL: http://smart.who.int/immunizations/StructureDefinition/IMMZOtherMedicalEvent | |
 event |
1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: IMMZ.D.DE95 ValueSet for Reaction manifestation (required) | |
| date |
1..1 | dateTime | When the event occurred | |
| seriousness |
1..1 | CodeableConcept | Seriousness of the event Binding: IMMZ.D.DE107 ValueSet for Type of reaction (required) | |
| outcome |
1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Conformance | ValueSet | URI |
| AdverseEvent.event | required | IMMZ_D_DE95http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE95From this IG | |
| AdverseEvent.seriousness | required | IMMZ_D_DE107http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE107From this IG |
| 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 | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:otherMedicalEvent |
0..1 | string | Immunization Other Important Medical Event URL: http://smart.who.int/immunizations/StructureDefinition/IMMZOtherMedicalEvent | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| 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 |
Σ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: IMMZ.D.DE95 ValueSet for Reaction manifestation (required) | ||||
| subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date |
Σ | 1..1 | dateTime | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
Σ | 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 | 1..1 | CodeableConcept | Seriousness of the event Binding: IMMZ.D.DE107 ValueSet for Type of reaction (required) | ||||
| 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 |
Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder |
Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | 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 |
Σ | 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 |
Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | 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 | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | URI | |||
| AdverseEvent.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages|4.0.1From the FHIR Standard
| ||||
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1From the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1From the FHIR Standard | ||||
| AdverseEvent.event | required | IMMZ_D_DE95http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE95From this IG | ||||
| AdverseEvent.seriousness | required | IMMZ_D_DE107http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE107From this IG | ||||
| AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1From the FHIR Standard | ||||
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1From the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assess|4.0.1From the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1From the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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
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 |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:otherMedicalEvent |
0..1 | string | Immunization Other Important Medical Event URL: http://smart.who.int/immunizations/StructureDefinition/IMMZOtherMedicalEvent | |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
| event |
Σ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: IMMZ.D.DE95 ValueSet for Reaction manifestation (required) |
| subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
| date |
Σ | 1..1 | dateTime | When the event occurred |
| seriousness |
Σ | 1..1 | CodeableConcept | Seriousness of the event Binding: IMMZ.D.DE107 ValueSet for Type of reaction (required) |
| outcome |
Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1From the FHIR Standard | |
| AdverseEvent.event | required | IMMZ_D_DE95http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE95From this IG | |
| AdverseEvent.seriousness | required | IMMZ_D_DE107http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE107From this IG | |
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1From the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:otherMedicalEvent |
0..1 | string | Immunization Other Important Medical Event URL: http://smart.who.int/immunizations/StructureDefinition/IMMZOtherMedicalEvent | |
| event |
1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: IMMZ.D.DE95 ValueSet for Reaction manifestation (required) | |
| date |
1..1 | dateTime | When the event occurred | |
| seriousness |
1..1 | CodeableConcept | Seriousness of the event Binding: IMMZ.D.DE107 ValueSet for Type of reaction (required) | |
| outcome |
1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Conformance | ValueSet | URI |
| AdverseEvent.event | required | IMMZ_D_DE95http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE95From this IG | |
| AdverseEvent.seriousness | required | IMMZ_D_DE107http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE107From this IG |
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 | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:otherMedicalEvent |
0..1 | string | Immunization Other Important Medical Event URL: http://smart.who.int/immunizations/StructureDefinition/IMMZOtherMedicalEvent | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| 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 |
Σ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: IMMZ.D.DE95 ValueSet for Reaction manifestation (required) | ||||
| subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date |
Σ | 1..1 | dateTime | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
Σ | 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 | 1..1 | CodeableConcept | Seriousness of the event Binding: IMMZ.D.DE107 ValueSet for Type of reaction (required) | ||||
| 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 |
Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder |
Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | 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 |
Σ | 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 |
Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | 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 | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | URI | |||
| AdverseEvent.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages|4.0.1From the FHIR Standard
| ||||
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1From the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1From the FHIR Standard | ||||
| AdverseEvent.event | required | IMMZ_D_DE95http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE95From this IG | ||||
| AdverseEvent.seriousness | required | IMMZ_D_DE107http://smart.who.int/immunizations/ValueSet/IMMZ.D.DE107From this IG | ||||
| AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1From the FHIR Standard | ||||
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1From the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assess|4.0.1From the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1From the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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
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