This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.0: STU 1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
Defining URL: | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/vaers-adverseevent |
Version: | 1.0.0 |
Name: | VAERSAdverseEvent |
Title: | VAERS Adverse Event |
Status: | Active as of 1/19/22 1:49 PM |
Definition: | ICSR Adverse Event with a value set of vaccination-related events |
Publisher: | Biomedical Research & Regulation WG |
Source Resource: | XML / JSON / Turtle |
The official URL for this profile is:
http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/vaers-adverseevent
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ICSRAdverseEvent
Summary
Mandatory: 1 element
Must-Support: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
This structure is derived from ICSRAdverseEvent
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | 0..* | ICSRAdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
event | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Vaccination-related Adverse Events (extensible) | |
Slices for suspectEntity | 1..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by type:instance.resolve() | |
suspectEntity:Immunization | S | 1..1 | BackboneElement | The suspected agent causing the adverse event |
instance | 1..1 | Reference(ICSR Immunization) | Refers to the specific entity that caused the adverse event | |
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | 0..* | ICSRAdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
id | Σ | 0..1 | string | 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) Max Binding: AllLanguages: A human language. | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
icsr-ext-ageattimeofonset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 0..1 | Identifier | Business identifier for the event |
actuality | ?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Fixed Value: actual |
category | SΣ | 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: Vaccination-related Adverse Events (extensible) |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
coding | Σ | 0..* | Coding | Code defined by a terminology system |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
system | Σ | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org |
version | Σ | 0..1 | string | Version of the system - if relevant |
code | Σ | 0..1 | code | Symbol in syntax defined by the system |
display | Σ | 0..1 | string | Representation defined by the system |
userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
text | Σ | 0..1 | string | Plain text representation of the concept |
subject | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event |
encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of |
date | SΣ | 0..1 | dateTime | When the event occurred |
id | 0..1 | string | xml:id (or equivalent in JSON) | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
icsr-ext-eventduration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration |
icsr-ext-eventenddate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate |
value | 0..1 | dateTime | Primitive value for dateTime | |
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 | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred |
seriousness | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
icsr-ext-eventseriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) |
coding | Σ | 0..* | Coding | Code defined by a terminology system |
text | Σ | 0..1 | string | Plain text representation of the concept |
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): TODO (and should this be required?). |
recorder | SΣ | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event |
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
Slices for suspectEntity | SΣ | 1..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by type:instance.resolve() |
suspectEntity:All Slices | Content/Rules for all slices | |||
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(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event |
causality | SΣ | 1..1 | 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 | SΣ | 1..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. |
suspectEntity:Immunization | SΣ | 1..1 | 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(ICSR Immunization) | Refers to the specific entity that caused the adverse event |
causality | SΣ | 1..1 | 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 | SΣ | 1..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 |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | 0..* | ICSRAdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
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. Fixed Value: actual |
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: Vaccination-related Adverse Events (extensible) |
subject | Σ | 1..1 | Reference(ICSR Patient) | Subject impacted by event |
encounter | Σ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of |
date | Σ | 0..1 | dateTime | When the event occurred |
icsr-ext-eventduration | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration | |
icsr-ext-eventenddate | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate | |
location | Σ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred |
seriousness | Σ | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) |
icsr-ext-eventseriousness | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) | |
outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
recorder | Σ | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event |
Slices for suspectEntity | Σ | 1..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by type:instance.resolve() |
suspectEntity:All Slices | Content/Rules for all slices | |||
instance | Σ | 1..1 | Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event |
causality | Σ | 1..1 | BackboneElement | Information on the possible cause of the event |
productRelatedness | Σ | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
suspectEntity:Immunization | Σ | 1..1 | BackboneElement | The suspected agent causing the adverse event |
instance | Σ | 1..1 | Reference(ICSR Immunization) | Refers to the specific entity that caused the adverse event |
causality | Σ | 1..1 | BackboneElement | Information on the possible cause of the event |
productRelatedness | Σ | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
Documentation for this format |
This structure is derived from ICSRAdverseEvent
Summary
Mandatory: 1 element
Must-Support: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from ICSRAdverseEvent
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | 0..* | ICSRAdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
event | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Vaccination-related Adverse Events (extensible) | |
Slices for suspectEntity | 1..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by type:instance.resolve() | |
suspectEntity:Immunization | S | 1..1 | BackboneElement | The suspected agent causing the adverse event |
instance | 1..1 | Reference(ICSR Immunization) | Refers to the specific entity that caused the adverse event | |
Documentation for this format |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | 0..* | ICSRAdverseEvent | Medical care, research study or other healthcare event causing physical injury | |
id | Σ | 0..1 | string | 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) Max Binding: AllLanguages: A human language. | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
icsr-ext-ageattimeofonset | 0..1 | Age | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset | |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 0..1 | Identifier | Business identifier for the event |
actuality | ?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Fixed Value: actual |
category | SΣ | 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: Vaccination-related Adverse Events (extensible) |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
coding | Σ | 0..* | Coding | Code defined by a terminology system |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
system | Σ | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org |
version | Σ | 0..1 | string | Version of the system - if relevant |
code | Σ | 0..1 | code | Symbol in syntax defined by the system |
display | Σ | 0..1 | string | Representation defined by the system |
userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
text | Σ | 0..1 | string | Plain text representation of the concept |
subject | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event |
encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of |
date | SΣ | 0..1 | dateTime | When the event occurred |
id | 0..1 | string | xml:id (or equivalent in JSON) | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
icsr-ext-eventduration | S | 0..1 | Duration | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration |
icsr-ext-eventenddate | S | 0..1 | dateTime | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate |
value | 0..1 | dateTime | Primitive value for dateTime | |
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 | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred |
seriousness | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ICSR Top-Level Seriousness (required) |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
icsr-ext-eventseriousness | S | 0..1 | CodeableConcept | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required) |
coding | Σ | 0..* | Coding | Code defined by a terminology system |
text | Σ | 0..1 | string | Plain text representation of the concept |
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): TODO (and should this be required?). |
recorder | SΣ | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event |
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
Slices for suspectEntity | SΣ | 1..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by type:instance.resolve() |
suspectEntity:All Slices | Content/Rules for all slices | |||
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(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event |
causality | SΣ | 1..1 | 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 | SΣ | 1..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. |
suspectEntity:Immunization | SΣ | 1..1 | 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(ICSR Immunization) | Refers to the specific entity that caused the adverse event |
causality | SΣ | 1..1 | 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 | SΣ | 1..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 |
Other representations of profile: CSV, Excel, Schematron
Path | Conformance | ValueSet / Code |
AdverseEvent.language | preferred | CommonLanguages Max Binding: AllLanguages |
AdverseEvent.actuality | required | Fixed Value: actual |
AdverseEvent.category | extensible | AdverseEventCategory |
AdverseEvent.event | extensible | MedDRAVaccinationAdverseEventVS |
AdverseEvent.seriousness | required | ICSRAESeriousness |
AdverseEvent.severity | required | AdverseEventSeverity |
AdverseEvent.outcome | required | AdverseEventOutcome |
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment |
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
AdverseEvent.suspectEntity:Immunization.causality.assessment | example | AdverseEventCausalityAssessment |
AdverseEvent.suspectEntity:Immunization.causality.method | example | AdverseEventCausalityMethod |