Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
coding	SΣ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(VAERS Patient)	Subject impacted by event
date	SΣ	0..1	dateTime	When the event occurred
outcome	Σ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
Slices for coding	Σ	0..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:$this
coding:va-outcome1	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1906
coding:va-outcome2	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1907
coding:va-outcome3	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1908
coding:va-outcome8	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1913
coding:va-outcome9	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1914
coding:va-outcome10	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1915
coding:va-outcome13	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1916
coding:va-outcome11	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1918
coding:va-outcome12	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1919
suspectEntity	Σ	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(VAERS Immunization[vac1])	Refers to the specific entity that caused the adverse event
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
AdverseEvent.actuality	required	Pattern Value: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard
AdverseEvent.event	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/adverse-event-type From the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 From 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()
vaersae-17-1906	best practice	AdverseEvent.outcome.coding:va-outcome1	If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" : true
vaersae-17-1907	best practice	AdverseEvent.outcome.coding:va-outcome2	If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" : true
vaersae-17-1908	best practice	AdverseEvent.outcome.coding:va-outcome3	If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1913	best practice	AdverseEvent.outcome.coding:va-outcome8	If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1914	best practice	AdverseEvent.outcome.coding:va-outcome9	If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" : true
vaersae-17-1915	best practice	AdverseEvent.outcome.coding:va-outcome10	If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" : true
vaersae-17-1916	best practice	AdverseEvent.outcome.coding:va-outcome13	If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" : true
vaersae-17-1918	best practice	AdverseEvent.outcome.coding:va-outcome11	If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" : true
vaersae-17-1919	best practice	AdverseEvent.outcome.coding:va-outcome12	If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" : true

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
actuality	S	1..1	code	actual | potential Required Pattern: actual
event
coding	S	0..*	Coding	Code defined by a terminology system
text	S	0..1	string	Plain text representation of the concept
subject	S	1..1	Reference(VAERS Patient)	Subject impacted by event
date	S	0..1	dateTime	When the event occurred
outcome
Slices for coding		0..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:$this
coding:va-outcome1	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1906
coding:va-outcome2	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1907
coding:va-outcome3	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1908
coding:va-outcome8	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1913
coding:va-outcome9	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1914
coding:va-outcome10	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1915
coding:va-outcome13	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1916
coding:va-outcome11	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1918
coding:va-outcome12	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1919
suspectEntity
instance	S	1..1	Reference(VAERS Immunization[vac1])	Refers to the specific entity that caused the adverse event
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
vaersae-17-1906	best practice	AdverseEvent.outcome.coding:va-outcome1	If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" : true
vaersae-17-1907	best practice	AdverseEvent.outcome.coding:va-outcome2	If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" : true
vaersae-17-1908	best practice	AdverseEvent.outcome.coding:va-outcome3	If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1913	best practice	AdverseEvent.outcome.coding:va-outcome8	If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1914	best practice	AdverseEvent.outcome.coding:va-outcome9	If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" : true
vaersae-17-1915	best practice	AdverseEvent.outcome.coding:va-outcome10	If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" : true
vaersae-17-1916	best practice	AdverseEvent.outcome.coding:va-outcome13	If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" : true
vaersae-17-1918	best practice	AdverseEvent.outcome.coding:va-outcome11	If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" : true
vaersae-17-1919	best practice	AdverseEvent.outcome.coding:va-outcome12	If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" : true

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
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): Overall nature of the adverse event, e.g. real or potential. Required Pattern: 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	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(VAERS Patient)	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	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	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	Σ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:$this
coding:va-outcome1	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1906
coding:va-outcome2	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1907
coding:va-outcome3	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1908
coding:va-outcome8	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1913
coding:va-outcome9	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1914
coding:va-outcome10	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1915
coding:va-outcome13	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1916
coding:va-outcome11	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1918
coding:va-outcome12	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1919
text	Σ	0..1	string	Plain text representation of the concept
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	SΣ	1..1	Reference(VAERS Immunization[vac1])	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 / Code	URI
AdverseEvent.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages From the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	Pattern Value: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard
AdverseEvent.category	extensible	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category From the FHIR Standard
AdverseEvent.event	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/adverse-event-type From the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness From the FHIR Standard
AdverseEvent.severity	required	AdverseEventSeverity http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 From the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 From the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess From the FHIR Standard
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method From 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()
vaersae-17-1906	best practice	AdverseEvent.outcome.coding:va-outcome1	If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" : true
vaersae-17-1907	best practice	AdverseEvent.outcome.coding:va-outcome2	If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" : true
vaersae-17-1908	best practice	AdverseEvent.outcome.coding:va-outcome3	If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1913	best practice	AdverseEvent.outcome.coding:va-outcome8	If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1914	best practice	AdverseEvent.outcome.coding:va-outcome9	If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" : true
vaersae-17-1915	best practice	AdverseEvent.outcome.coding:va-outcome10	If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" : true
vaersae-17-1916	best practice	AdverseEvent.outcome.coding:va-outcome13	If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" : true
vaersae-17-1918	best practice	AdverseEvent.outcome.coding:va-outcome11	If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" : true
vaersae-17-1919	best practice	AdverseEvent.outcome.coding:va-outcome12	If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" : true

Summary

Must-Support: 15 elements

Structures

This structure refers to these other structures:

• VAERS Patient (http://va.gov/fhir/StructureDefinition/VAERSPatient)
• VAERS Immunization[vac1] (http://va.gov/fhir/StructureDefinition/VAERSImmunizationvac1)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of AdverseEvent.outcome.coding

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
coding	SΣ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(VAERS Patient)	Subject impacted by event
date	SΣ	0..1	dateTime	When the event occurred
outcome	Σ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
Slices for coding	Σ	0..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:$this
coding:va-outcome1	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1906
coding:va-outcome2	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1907
coding:va-outcome3	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1908
coding:va-outcome8	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1913
coding:va-outcome9	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1914
coding:va-outcome10	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1915
coding:va-outcome13	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1916
coding:va-outcome11	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1918
coding:va-outcome12	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1919
suspectEntity	Σ	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(VAERS Immunization[vac1])	Refers to the specific entity that caused the adverse event
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
AdverseEvent.actuality	required	Pattern Value: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard
AdverseEvent.event	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/adverse-event-type From the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 From 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()
vaersae-17-1906	best practice	AdverseEvent.outcome.coding:va-outcome1	If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" : true
vaersae-17-1907	best practice	AdverseEvent.outcome.coding:va-outcome2	If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" : true
vaersae-17-1908	best practice	AdverseEvent.outcome.coding:va-outcome3	If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1913	best practice	AdverseEvent.outcome.coding:va-outcome8	If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1914	best practice	AdverseEvent.outcome.coding:va-outcome9	If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" : true
vaersae-17-1915	best practice	AdverseEvent.outcome.coding:va-outcome10	If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" : true
vaersae-17-1916	best practice	AdverseEvent.outcome.coding:va-outcome13	If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" : true
vaersae-17-1918	best practice	AdverseEvent.outcome.coding:va-outcome11	If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" : true
vaersae-17-1919	best practice	AdverseEvent.outcome.coding:va-outcome12	If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" : true

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	Medical care, research study or other healthcare event causing physical injury
actuality	S	1..1	code	actual | potential Required Pattern: actual
event
coding	S	0..*	Coding	Code defined by a terminology system
text	S	0..1	string	Plain text representation of the concept
subject	S	1..1	Reference(VAERS Patient)	Subject impacted by event
date	S	0..1	dateTime	When the event occurred
outcome
Slices for coding		0..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:$this
coding:va-outcome1	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1906
coding:va-outcome2	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1907
coding:va-outcome3	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1908
coding:va-outcome8	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1913
coding:va-outcome9	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1914
coding:va-outcome10	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1915
coding:va-outcome13	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1916
coding:va-outcome11	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1918
coding:va-outcome12	SC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1919
suspectEntity
instance	S	1..1	Reference(VAERS Immunization[vac1])	Refers to the specific entity that caused the adverse event
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
vaersae-17-1906	best practice	AdverseEvent.outcome.coding:va-outcome1	If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" : true
vaersae-17-1907	best practice	AdverseEvent.outcome.coding:va-outcome2	If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" : true
vaersae-17-1908	best practice	AdverseEvent.outcome.coding:va-outcome3	If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1913	best practice	AdverseEvent.outcome.coding:va-outcome8	If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1914	best practice	AdverseEvent.outcome.coding:va-outcome9	If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" : true
vaersae-17-1915	best practice	AdverseEvent.outcome.coding:va-outcome10	If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" : true
vaersae-17-1916	best practice	AdverseEvent.outcome.coding:va-outcome13	If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" : true
vaersae-17-1918	best practice	AdverseEvent.outcome.coding:va-outcome11	If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" : true
vaersae-17-1919	best practice	AdverseEvent.outcome.coding:va-outcome12	If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" : true

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
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): Overall nature of the adverse event, e.g. real or potential. Required Pattern: 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	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(VAERS Patient)	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	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	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	Σ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:$this
coding:va-outcome1	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1906
coding:va-outcome2	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1907
coding:va-outcome3	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1908
coding:va-outcome8	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1913
coding:va-outcome9	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1914
coding:va-outcome10	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1915
coding:va-outcome13	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1916
coding:va-outcome11	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1918
coding:va-outcome12	SΣC	0..1	Coding	Code defined by a terminology system Constraints: vaersae-17-1919
text	Σ	0..1	string	Plain text representation of the concept
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	SΣ	1..1	Reference(VAERS Immunization[vac1])	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 / Code	URI
AdverseEvent.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages From the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	Pattern Value: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 From the FHIR Standard
AdverseEvent.category	extensible	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category From the FHIR Standard
AdverseEvent.event	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/adverse-event-type From the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness From the FHIR Standard
AdverseEvent.severity	required	AdverseEventSeverity http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 From the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 From the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess From the FHIR Standard
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method From 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()
vaersae-17-1906	best practice	AdverseEvent.outcome.coding:va-outcome1	If (21-1) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#drvisit "Doctor" : true
vaersae-17-1907	best practice	AdverseEvent.outcome.coding:va-outcome2	If (21-2) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ered "Emergency Room" : true
vaersae-17-1908	best practice	AdverseEvent.outcome.coding:va-outcome3	If (21-3) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1913	best practice	AdverseEvent.outcome.coding:va-outcome8	If (21-4) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#hospitalization "Hospitalization" : true
vaersae-17-1914	best practice	AdverseEvent.outcome.coding:va-outcome9	If (21-5) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#lti "Life threatening illness" : true
vaersae-17-1915	best practice	AdverseEvent.outcome.coding:va-outcome10	If (21-6) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#dis "Disability or permanent damage" : true
vaersae-17-1916	best practice	AdverseEvent.outcome.coding:va-outcome13	If (21-7) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#death "Death" : true
vaersae-17-1918	best practice	AdverseEvent.outcome.coding:va-outcome11	If (21-8) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#ca_db "Congenital anomaly or birth defect" : true
vaersae-17-1919	best practice	AdverseEvent.outcome.coding:va-outcome12	If (21-9) is =1 then fixed value https://www.vaers.hhs.gov/data/datasets.html/Patientoutcomes#noa "None of the above" : true

Summary

Must-Support: 15 elements

Structures

This structure refers to these other structures:

• VAERS Patient (http://va.gov/fhir/StructureDefinition/VAERSPatient)
• VAERS Immunization[vac1] (http://va.gov/fhir/StructureDefinition/VAERSImmunizationvac1)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of AdverseEvent.outcome.coding