This profile sets minimum expectations for the Immunization resource to record, fetch and search immunization history associated with a patient. It identifies which core elements, extensions, vocabularies and value sets SHALL be present in the resource when using this profile.

Example Usage Scenarios:

The following are example usage scenarios for the US Core-Core Immunization profile:

• Query for immunizations belonging to a Patient
• Record or update immunizations belonging to a Patient

Mandatory and Must Support Data Elements

The following data-elements are mandatory (i.e data MUST be present) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Profile Definition below provides the formal summary, definitions, and terminology requirements.

Each Immunization must have:

1. a status*
2. a vaccine code that identifies the kind of vaccine administered
3. a date the vaccine was administered
4. a patient

Each Immunization must support:

1. a statusReason if the vaccine wasn’t given
2. a flag to indicate whether the vaccine was reported by someone other than the person who administered the vaccine.

Profile specific implementation guidance:

• Use the status code: not-done to represent that an immunization was not given.
• Based upon the ONC U.S. Core Data for Interoperability (USCDI) v1 requirements, CVX vaccine codes are required and the NDC vaccine codes SHOULD be supported as a translation. CDC provides the CDC National Drug Code (NDC) Directory – Vaccine NDC Linker Table to assist implementers. The example Immunization-imm-1 illustrates using both the CVX and NDC codes based upon this table.

Examples

• Immunization-imm-1

• Text Summary
• Differential Table
• Snapshot Table
• Snapshot Table (Must Support)
• All

This structure is derived from Immunization

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	Immunization event information
status	S	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): Constrained list of immunizaiotn status
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SI	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible) us-core-1: SHOULD have a translation to the NDC value set
patient	S	1..1	Reference(US Core Patient Profile)	Who was immunized
occurrence[x]	S	1..1		Vaccine administration date
occurrenceDateTime			dateTime S
occurrenceString			string
primarySource	S	1..1	boolean	Indicates context the data was recorded in
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	Immunization event information
id	Σ	0..1	string	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
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): Constrained list of immunizaiotn status
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SΣI	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible) us-core-1: SHOULD have a translation to the NDC value set
patient	SΣ	1..1	Reference(US Core Patient Profile)	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		0..1	Reference(Location)	Where immunization occurred
manufacturer		0..1	Reference(Organization)	Vaccine manufacturer
lotNumber		0..1	string	Vaccine lot number
expirationDate		0..1	date	Vaccine expiration date
site		0..1	CodeableConcept	Body site vaccine was administered Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
route		0..1	CodeableConcept	How vaccine entered body Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
doseQuantity		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	I	0..*	BackboneElement	Educational material presented to patient imm-1: One of documentType or reference SHALL be present
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

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	Immunization event information
status	?!Σ	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): Constrained list of immunizaiotn status
statusReason		0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	ΣI	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible) us-core-1: SHOULD have a translation to the NDC value set
patient	Σ	1..1	Reference(US Core Patient Profile)	Who was immunized
occurrence[x]	Σ	1..1		Vaccine administration date
occurrenceDateTime			dateTime
primarySource	Σ	1..1	boolean	Indicates context the data was recorded in
Documentation for this format

This structure is derived from Immunization

Summary

Mandatory: 5 elements
Must-Support: 6 elements

Structures

This structure refers to these other structures:

• http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient

Differential View

This structure is derived from Immunization

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	Immunization event information
status	S	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): Constrained list of immunizaiotn status
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SI	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible) us-core-1: SHOULD have a translation to the NDC value set
patient	S	1..1	Reference(US Core Patient Profile)	Who was immunized
occurrence[x]	S	1..1		Vaccine administration date
occurrenceDateTime			dateTime S
occurrenceString			string
primarySource	S	1..1	boolean	Indicates context the data was recorded in
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	Immunization event information
id	Σ	0..1	string	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
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): Constrained list of immunizaiotn status
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode	SΣI	1..1	CodeableConcept	Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible) us-core-1: SHOULD have a translation to the NDC value set
patient	SΣ	1..1	Reference(US Core Patient Profile)	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		0..1	Reference(Location)	Where immunization occurred
manufacturer		0..1	Reference(Organization)	Vaccine manufacturer
lotNumber		0..1	string	Vaccine lot number
expirationDate		0..1	date	Vaccine expiration date
site		0..1	CodeableConcept	Body site vaccine was administered Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
route		0..1	CodeableConcept	How vaccine entered body Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
doseQuantity		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	I	0..*	BackboneElement	Educational material presented to patient imm-1: One of documentType or reference SHALL be present
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

Quick Start

Below is an overview of the required set of Server RESTful FHIR interactions - for example, search and read operations - for this profile. See the Capability Statements for a complete list of supported RESTful interactions for this IG.

• The syntax used to describe the interactions is described here.
• See the General Guidance section for additional rules and expectations when a server requires status parameters.
• See the General Guidance section for additional guidance on searching for multiple patients.

Mandatory Search Parameters:

The following search parameters and search parameter combinations SHALL be supported.:

1. SHALL support searching for all immunizations for a patient using the patient search parameter:

   GET [base]/Immunization?patient={Type/}[id]

   Example:

   1. GET [base]/Immunization?patient=1137192

   Implementation Notes: Fetches a bundle of all Immunization resources for the specified patient (how to search by reference)

Optional Search Parameters:

The following search parameter combinations SHOULD be supported.:

1. SHOULD support searching using the combination of the patient and date search parameters:
   • including support for these date comparators: gt,lt,ge,le
   • including optional support for composite AND search on date (e.g.date=[date]&date=[date]]&...)

   GET [base]/Immunization?patient={Type/}[id]&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

   Example:

   1. GET [base]/Immunization?patient=1137192&date=ge2019-01-14T00:00:00Z

   Implementation Notes: Fetches a bundle of all Immunization resources for the specified patient and date (how to search by date and how to search by reference)

2. SHOULD support searching using the combination of the patient and status search parameters:

   GET [base]/Immunization?patient={Type/}[id]&status={system|}[code]

   Example:

   1. GET [base]/Immunization?patient=1137192&status=completed

   Implementation Notes: Fetches a bundle of all Immunization resources for the specified patient and status (how to search by reference and how to search by date)