This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.1: STU 1 Update) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

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Resource Profile: ICSR Adverse Event ( Abstract )

The fields needed to submit an AdverseEvent for a ICSR Report.

Usage:

• Derived from this Resource Profile: Transfusion Adverse Event and Vaccination Adverse Event

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	This is an abstract profile. Child profiles: AdverseEvent, AdverseEvent Medical care, research study or other healthcare event causing physical injury
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ageAtTimeOfOnset		0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset
identifier	S	0..1	Identifier	Business identifier for the event
actuality	S	1..1	code	actual | potential Fixed Value: actual
category	S	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
event	S	1..1	CodeableConcept	Type of the event itself in relation to the subject
coding
system		0..1	uri	Identity of the terminology system Fixed Value: http://meddra.org
subject	S	1..1	Reference(ICSR Patient)	Subject impacted by event
encounter	S	0..1	Reference(US Core Encounter Profile)	Encounter created as part of
date	S	0..1	dateTime	When the event occurred
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
eventDuration	S	0..1	Duration	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
endDate	S	0..1	dateTime	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate
location	S	0..1	Reference(US Core Location Profile)	Location where adverse event occurred
seriousness	S	1..1	CodeableConcept	Seriousness of the event Binding: ICSR Top-Level Seriousness (required)
seriousness	S	0..1	CodeableConcept	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required)
outcome	S	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
recorder	S	0..1	Reference(Practitioner Author)	Who recorded the adverse event
suspectEntity	S	1..*	BackboneElement	The suspected agent causing the adverse event
instance	S	1..1	Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)	Refers to the specific entity that caused the adverse event
causality	S	1..1	BackboneElement	Information on the possible cause of the event
productRelatedness	S	1..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
AdverseEvent.seriousness	required	ICSRAESeriousness

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	This is an abstract profile. Child profiles: AdverseEvent, 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
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: SNOMEDCTClinicalFindings (example): Detailed type of event.
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
eventDuration	S	0..1	Duration	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
endDate	S	0..1	dateTime	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate
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)
seriousness	S	0..1	CodeableConcept	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required)
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
suspectEntity	SΣ	1..*	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(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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productRelatedness	SΣ	1..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
AdverseEvent.actuality	required	Fixed Value: actual
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.seriousness	required	ICSRAESeriousness
AdverseEvent.outcome	required	AdverseEventOutcome

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	This is an abstract profile. Child profiles: AdverseEvent, 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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
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: 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	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
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
eventDuration	S	0..1	Duration	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
endDate	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
seriousness	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
suspectEntity	SΣ	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 | 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.
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
AdverseEvent.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	Fixed Value: actual
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.seriousness	required	ICSRAESeriousness
AdverseEvent.severity	required	AdverseEventSeverity
AdverseEvent.outcome	required	AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod

This structure is derived from AdverseEvent

Summary

Mandatory: 5 elements
Must-Support: 18 elements
Fixed Value: 2 elements

Structures

This structure refers to these other structures:

• ICSR Patient (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient)
• US Core Encounter Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-encounter)
• US Core Location Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-location)
• Practitioner Author (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner)
• ICSR Immunization (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization)
• ICSR MedicationAdministration (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration)
• ICSR Transfusion (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-transfusion)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset
• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate
• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	This is an abstract profile. Child profiles: AdverseEvent, AdverseEvent Medical care, research study or other healthcare event causing physical injury
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ageAtTimeOfOnset		0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset
identifier	S	0..1	Identifier	Business identifier for the event
actuality	S	1..1	code	actual | potential Fixed Value: actual
category	S	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
event	S	1..1	CodeableConcept	Type of the event itself in relation to the subject
coding
system		0..1	uri	Identity of the terminology system Fixed Value: http://meddra.org
subject	S	1..1	Reference(ICSR Patient)	Subject impacted by event
encounter	S	0..1	Reference(US Core Encounter Profile)	Encounter created as part of
date	S	0..1	dateTime	When the event occurred
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
eventDuration	S	0..1	Duration	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
endDate	S	0..1	dateTime	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate
location	S	0..1	Reference(US Core Location Profile)	Location where adverse event occurred
seriousness	S	1..1	CodeableConcept	Seriousness of the event Binding: ICSR Top-Level Seriousness (required)
seriousness	S	0..1	CodeableConcept	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required)
outcome	S	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
recorder	S	0..1	Reference(Practitioner Author)	Who recorded the adverse event
suspectEntity	S	1..*	BackboneElement	The suspected agent causing the adverse event
instance	S	1..1	Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion)	Refers to the specific entity that caused the adverse event
causality	S	1..1	BackboneElement	Information on the possible cause of the event
productRelatedness	S	1..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
AdverseEvent.seriousness	required	ICSRAESeriousness

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	This is an abstract profile. Child profiles: AdverseEvent, 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
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: SNOMEDCTClinicalFindings (example): Detailed type of event.
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
eventDuration	S	0..1	Duration	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
endDate	S	0..1	dateTime	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate
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)
seriousness	S	0..1	CodeableConcept	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness Binding: ICSR Seriousness Codes (required)
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
suspectEntity	SΣ	1..*	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(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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productRelatedness	SΣ	1..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
AdverseEvent.actuality	required	Fixed Value: actual
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.seriousness	required	ICSRAESeriousness
AdverseEvent.outcome	required	AdverseEventOutcome

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	This is an abstract profile. Child profiles: AdverseEvent, 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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
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: 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	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
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
eventDuration	S	0..1	Duration	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
endDate	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
seriousness	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
suspectEntity	SΣ	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 | 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.
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
AdverseEvent.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	Fixed Value: actual
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.seriousness	required	ICSRAESeriousness
AdverseEvent.severity	required	AdverseEventSeverity
AdverseEvent.outcome	required	AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod

This structure is derived from AdverseEvent

Summary

Mandatory: 5 elements
Must-Support: 18 elements
Fixed Value: 2 elements

Structures

This structure refers to these other structures:

• ICSR Patient (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient)
• US Core Encounter Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-encounter)
• US Core Location Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-location)
• Practitioner Author (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner)
• ICSR Immunization (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization)
• ICSR MedicationAdministration (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration)
• ICSR Transfusion (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-transfusion)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset
• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration
• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate
• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness

Other representations of profile: CSV, Excel, Schematron