HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions

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Resource Profile: ICSR Immunization

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

Usage:

• Refer to this Resource Profile: ICSR Adverse Event, ICSR Composition and Vaccination Adverse Event
• Examples for this Resource Profile: Immunization/VaccinationExampleImmunization

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 USCoreImmunizationProfile

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	USCoreImmunizationProfile	Immunization event information
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ageAtVaccination	S	0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination
status		1..1	code	completed | entered-in-error | not-done Fixed Value: completed
vaccineCode		1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: Vaccine Codes (extensible)
patient		1..1	Reference(ICSR Patient)	Who was immunized
location	S	0..1	Reference(US Core Location Profile)	Where immunization occurred
manufacturer	S	0..1	Reference(Organization)	Vaccine manufacturer
lotNumber	S	0..1	string	Vaccine lot number
expirationDate	S	0..1	date	Vaccine expiration date
site	S	0..1	CodeableConcept	Body site vaccine was administered
route	S	0..1	CodeableConcept	How vaccine entered body
doseQuantity	S	0..1	SimpleQuantity	Amount of vaccine administered
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Immunization.vaccineCode	extensible	VaccineCodeVS

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	USCoreImmunizationProfile	Immunization event information
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
ageAtVaccination	S	0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required) Fixed Value: completed
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SΣC	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: Vaccine Codes (extensible)
patient	SΣ	1..1	Reference(ICSR Patient)	Who was immunized
occurrence[x]	SΣ	1..1		Vaccine administration date
occurrenceDateTime			dateTime
primarySource	SΣ	1..1	boolean	Indicates context the data was recorded in
location	S	0..1	Reference(US Core Location Profile)	Where immunization occurred
manufacturer	S	0..1	Reference(Organization)	Vaccine manufacturer
lotNumber	S	0..1	string	Vaccine lot number
expirationDate	S	0..1	date	Vaccine expiration date
site	S	0..1	CodeableConcept	Body site vaccine was administered Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
route	S	0..1	CodeableConcept	How vaccine entered body Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
doseQuantity	S	0..1	SimpleQuantity	Amount of vaccine administered
isSubpotent	?!Σ	0..1	boolean	Dose potency
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Immunization.status	required	Fixed Value: completed
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	extensible	VaccineCodeVS
Immunization.site	example	CodesForImmunizationSiteOfAdministration
Immunization.route	example	ImmunizationRouteCodes

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	USCoreImmunizationProfile	Immunization event information
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
ageAtVaccination	S	0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier		0..*	Identifier	Business identifier
status	?!SΣ	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required) Fixed Value: completed
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SΣC	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: Vaccine Codes (extensible)
patient	SΣ	1..1	Reference(ICSR Patient)	Who was immunized
encounter		0..1	Reference(Encounter)	Encounter immunization was part of
occurrence[x]	SΣ	1..1		Vaccine administration date
occurrenceDateTime			dateTime S
occurrenceString			string
recorded		0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	SΣ	1..1	boolean	Indicates context the data was recorded in
reportOrigin		0..1	CodeableConcept	Indicates the source of a secondarily reported record Binding: ImmunizationOriginCodes (example): The source of the data for a record which is not from a primary source.
location	S	0..1	Reference(US Core Location Profile)	Where immunization occurred
manufacturer	S	0..1	Reference(Organization)	Vaccine manufacturer
lotNumber	S	0..1	string	Vaccine lot number
expirationDate	S	0..1	date	Vaccine expiration date
site	S	0..1	CodeableConcept	Body site vaccine was administered Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
route	S	0..1	CodeableConcept	How vaccine entered body Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
doseQuantity	S	0..1	SimpleQuantity	Amount of vaccine administered
performer	Σ	0..*	BackboneElement	Who performed 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
function	Σ	0..1	CodeableConcept	What type of performance was done Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization who was performing
note	Σ	0..*	Annotation	Additional immunization notes
reasonCode		0..*	CodeableConcept	Why immunization occurred Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.
reasonReference		0..*	Reference(Condition | Observation | DiagnosticReport)	Why immunization occurred
isSubpotent	?!Σ	0..1	boolean	Dose potency
subpotentReason		0..*	CodeableConcept	Reason for being subpotent Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.
education	C	0..*	BackboneElement	Educational material presented to patient
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
documentType		0..1	string	Educational material document identifier
reference		0..1	uri	Educational material reference pointer
publicationDate		0..1	dateTime	Educational material publication date
presentationDate		0..1	dateTime	Educational material presentation date
programEligibility		0..*	CodeableConcept	Patient eligibility for a vaccination program Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.
fundingSource		0..1	CodeableConcept	Funding source for the vaccine Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.
reaction		0..*	BackboneElement	Details of a reaction that follows immunization
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
date		0..1	dateTime	When reaction started
detail		0..1	Reference(Observation)	Additional information on reaction
reported		0..1	boolean	Indicates self-reported reaction
protocolApplied		0..*	BackboneElement	Protocol followed by the provider
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
series		0..1	string	Name of vaccine series
authority		0..1	Reference(Organization)	Who is responsible for publishing the recommendations
targetDisease		0..*	CodeableConcept	Vaccine preventatable disease being targetted Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.
doseNumber[x]		1..1		Dose number within series
doseNumberPositiveInt			positiveInt
doseNumberString			string
seriesDoses[x]		0..1		Recommended number of doses for immunity
seriesDosesPositiveInt			positiveInt
seriesDosesString			string
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Immunization.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Immunization.status	required	Fixed Value: completed
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	extensible	VaccineCodeVS
Immunization.reportOrigin	example	ImmunizationOriginCodes
Immunization.site	example	CodesForImmunizationSiteOfAdministration
Immunization.route	example	ImmunizationRouteCodes
Immunization.performer.function	extensible	ImmunizationFunctionCodes
Immunization.reasonCode	example	ImmunizationReasonCodes
Immunization.subpotentReason	example	ImmunizationSubpotentReason
Immunization.programEligibility	example	ImmunizationProgramEligibility
Immunization.fundingSource	example	ImmunizationFundingSource
Immunization.protocolApplied.targetDisease	example	ImmunizationTargetDiseaseCodes

This structure is derived from USCoreImmunizationProfile

Summary

Must-Support: 8 elements
Fixed Value: 1 element

Structures

This structure refers to these other structures:

• ICSR Patient (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient)
• US Core Location Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-location)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination

Differential View

This structure is derived from USCoreImmunizationProfile

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	USCoreImmunizationProfile	Immunization event information
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
ageAtVaccination	S	0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination
status		1..1	code	completed | entered-in-error | not-done Fixed Value: completed
vaccineCode		1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: Vaccine Codes (extensible)
patient		1..1	Reference(ICSR Patient)	Who was immunized
location	S	0..1	Reference(US Core Location Profile)	Where immunization occurred
manufacturer	S	0..1	Reference(Organization)	Vaccine manufacturer
lotNumber	S	0..1	string	Vaccine lot number
expirationDate	S	0..1	date	Vaccine expiration date
site	S	0..1	CodeableConcept	Body site vaccine was administered
route	S	0..1	CodeableConcept	How vaccine entered body
doseQuantity	S	0..1	SimpleQuantity	Amount of vaccine administered
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Immunization.vaccineCode	extensible	VaccineCodeVS

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	USCoreImmunizationProfile	Immunization event information
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
ageAtVaccination	S	0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required) Fixed Value: completed
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SΣC	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: Vaccine Codes (extensible)
patient	SΣ	1..1	Reference(ICSR Patient)	Who was immunized
occurrence[x]	SΣ	1..1		Vaccine administration date
occurrenceDateTime			dateTime
primarySource	SΣ	1..1	boolean	Indicates context the data was recorded in
location	S	0..1	Reference(US Core Location Profile)	Where immunization occurred
manufacturer	S	0..1	Reference(Organization)	Vaccine manufacturer
lotNumber	S	0..1	string	Vaccine lot number
expirationDate	S	0..1	date	Vaccine expiration date
site	S	0..1	CodeableConcept	Body site vaccine was administered Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
route	S	0..1	CodeableConcept	How vaccine entered body Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
doseQuantity	S	0..1	SimpleQuantity	Amount of vaccine administered
isSubpotent	?!Σ	0..1	boolean	Dose potency
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Immunization.status	required	Fixed Value: completed
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	extensible	VaccineCodeVS
Immunization.site	example	CodesForImmunizationSiteOfAdministration
Immunization.route	example	ImmunizationRouteCodes

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	USCoreImmunizationProfile	Immunization event information
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
ageAtVaccination	S	0..1	Age	Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier		0..*	Identifier	Business identifier
status	?!SΣ	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required) Fixed Value: completed
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SΣC	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: Vaccine Codes (extensible)
patient	SΣ	1..1	Reference(ICSR Patient)	Who was immunized
encounter		0..1	Reference(Encounter)	Encounter immunization was part of
occurrence[x]	SΣ	1..1		Vaccine administration date
occurrenceDateTime			dateTime S
occurrenceString			string
recorded		0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	SΣ	1..1	boolean	Indicates context the data was recorded in
reportOrigin		0..1	CodeableConcept	Indicates the source of a secondarily reported record Binding: ImmunizationOriginCodes (example): The source of the data for a record which is not from a primary source.
location	S	0..1	Reference(US Core Location Profile)	Where immunization occurred
manufacturer	S	0..1	Reference(Organization)	Vaccine manufacturer
lotNumber	S	0..1	string	Vaccine lot number
expirationDate	S	0..1	date	Vaccine expiration date
site	S	0..1	CodeableConcept	Body site vaccine was administered Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
route	S	0..1	CodeableConcept	How vaccine entered body Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
doseQuantity	S	0..1	SimpleQuantity	Amount of vaccine administered
performer	Σ	0..*	BackboneElement	Who performed 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
function	Σ	0..1	CodeableConcept	What type of performance was done Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization who was performing
note	Σ	0..*	Annotation	Additional immunization notes
reasonCode		0..*	CodeableConcept	Why immunization occurred Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.
reasonReference		0..*	Reference(Condition | Observation | DiagnosticReport)	Why immunization occurred
isSubpotent	?!Σ	0..1	boolean	Dose potency
subpotentReason		0..*	CodeableConcept	Reason for being subpotent Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.
education	C	0..*	BackboneElement	Educational material presented to patient
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
documentType		0..1	string	Educational material document identifier
reference		0..1	uri	Educational material reference pointer
publicationDate		0..1	dateTime	Educational material publication date
presentationDate		0..1	dateTime	Educational material presentation date
programEligibility		0..*	CodeableConcept	Patient eligibility for a vaccination program Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.
fundingSource		0..1	CodeableConcept	Funding source for the vaccine Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.
reaction		0..*	BackboneElement	Details of a reaction that follows immunization
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
date		0..1	dateTime	When reaction started
detail		0..1	Reference(Observation)	Additional information on reaction
reported		0..1	boolean	Indicates self-reported reaction
protocolApplied		0..*	BackboneElement	Protocol followed by the provider
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
series		0..1	string	Name of vaccine series
authority		0..1	Reference(Organization)	Who is responsible for publishing the recommendations
targetDisease		0..*	CodeableConcept	Vaccine preventatable disease being targetted Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.
doseNumber[x]		1..1		Dose number within series
doseNumberPositiveInt			positiveInt
doseNumberString			string
seriesDoses[x]		0..1		Recommended number of doses for immunity
seriesDosesPositiveInt			positiveInt
seriesDosesString			string
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Immunization.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Immunization.status	required	Fixed Value: completed
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	extensible	VaccineCodeVS
Immunization.reportOrigin	example	ImmunizationOriginCodes
Immunization.site	example	CodesForImmunizationSiteOfAdministration
Immunization.route	example	ImmunizationRouteCodes
Immunization.performer.function	extensible	ImmunizationFunctionCodes
Immunization.reasonCode	example	ImmunizationReasonCodes
Immunization.subpotentReason	example	ImmunizationSubpotentReason
Immunization.programEligibility	example	ImmunizationProgramEligibility
Immunization.fundingSource	example	ImmunizationFundingSource
Immunization.protocolApplied.targetDisease	example	ImmunizationTargetDiseaseCodes

This structure is derived from USCoreImmunizationProfile

Summary

Must-Support: 8 elements
Fixed Value: 1 element

Structures

This structure refers to these other structures:

• ICSR Patient (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient)
• US Core Location Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-location)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageatvaccination

Other representations of profile: CSV, Excel, Schematron