US Core Implementation Guide
10.0.0-ballot - STU 10 Ballot United States of America flag

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 10.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: US Core Immunization Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-immunization Version: 10.0.0-ballot
Standards status: Trial-use Maturity Level: 5 Computable Name: USCoreImmunizationProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.31

The US Core Immunization Profile inherits from the FHIR Immunization resource; refer to it for scope and usage definitions. This profile sets minimum expectations for the Immunization resource to record, search, and fetch immunization history associated with a patient. It specifies which core elements, extensions, vocabularies, and value sets SHALL be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

US Core Maturity: 5

Example Usage Scenarios:

The following are example usage scenarios for the US 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 must always be present (Mandatory definition) 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 Views below provides the formal summary, definitions, and terminology requirements.

Each Immunization Must Have:

  1. a status1
  2. a vaccine code that identifies the kind of vaccine administered2
  3. a patient
  4. a date the vaccine was administered

Each Immunization Must Support:

  1. a statusReason if the vaccine wasn't given1
  2. a flag to indicate whether the vaccine was reported by someone other than the person who administered the vaccine.
  3. the encounter the immunization was part of
  4. where the vaccine was administered
  5. vaccine lot number3
  6. a performer4

1,2,3,4 see guidance below

Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.

  • 1Servers SHALL use the status code: not-done to represent that an immunization was not given.§
    • Immunization.statusReason communicates the reason the vaccine was not administered at the point of care, such as patient refusal. Note that this binding is provisional, pending the review of the terminology aligned with the HL7 FHIR US Quality Core Implementation Guide.
  • 2Based upon the ONC U.S. Core Data for Interoperability (USCDI) requirements, CVX vaccine codes are required, and the NDC vaccine codes SHOULD be supported as an additional code.§
    • NDC codes are defined by the manufacturer, and CVX codes, which are much less granular, are often limited to a single product made by a single manufacturer.
    • In most cases, there are separate NDCs for the Unit of Use (primary) and Unit of Sale (secondary) packaging of a vaccine, but only the Unit of Use NDC codes should be used since they represent the product that is administered.
    • The code system identifiers are http://hl7.org/fhir/sid/cvx for CVX and http://hl7.org/fhir/sid/ndc for NDC vaccine codes. Note that the vaccineCode binding link in the formal definition and the CDC links below use the associated OID as the code system identifiers.
    • Be aware that there is a 10-digit (with dashes) NDC format displayed on drug packaging and an 11-digit (no dashes) NDC format for billing and prescribing (for example, "49281-121-65" and "49281012165"). Normalization may be required to avoid validation errors and warnings.
    • The CDC provides the CDC National Drug Code (NDC) Directory – Vaccine NDC Linker Table to assist implementers (note that both the Unit of Use and Unit of Sale NDC are mapped to CVX codes). The Immunization Example 1 uses both CVX and the 11-digit NDC Unit of Use code based on this table.
  • 3 There is no guarantee that vaccine lot numbers are globally unique, and they are not recommended for matching or de-duplication across systems unless used with other data elements such as a vaccine product code, manufacturer code, or date of administration. Implementers MAY communicate the Immunization.manufacturer to ensure global uniqueness to lot numbers.§
  • 4The profile element Immunization.performer.actor communicates the individual level provenance author data corresponding to the U.S. Core Data for Interoperability (USCDI) Provenance Author Data Elements.

  • For the USCDI Adverse Events Data Class, Immunization.reaction records a reaction following an immunization, which can be the change in condition that the USCDI Adverse Event Condition describes. Adverse events are recorded as ordinary clinical events and are not tagged as adverse events; see the Adverse Events: Clinical Records and Patient Safety Reporting page.

Usages:

You can also check for usages in the FHIR IG Statistics

Changes since version 9.0.0:

  • The data elements list has changed
  • Formal Views of Profile Content

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

    NameFlagsCard.TypeDescription & Constraints    Filter: doco
    Immunization C 0..* Immunization Immunization event information
    Constraints: us-core-5
    Immunization.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
    Immunization.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
    Immunization.status This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code completed | entered-in-error | not-done
    Binding: ImmunizationStatusCodes (required)
    Immunization.statusReason This element must be supported. 0..1 CodeableConcept Reason not done
    Binding: ImmunizationStatusReasonCodes (extensible)
    Immunization.vaccineCode This element must be supported. This element is included in summaries. C 1..1 CodeableConcept Vaccine Product Type (bind to CVX)
    Binding: CVX Vaccines Administered Vaccine Set (extensible)
    Immunization.patient This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile) Who was immunized
    Immunization.encounter This element must be supported. 0..1 Reference(US Core Encounter Profile) Encounter the immunization was part of
    Immunization.occurrence[x] This element must be supported. This element is included in summaries. 1..1 Vaccine administration date
    Immunization.occurrence[x].occurrenceDateTime dateTime This target must be supported.
    Immunization.occurrence[x].occurrenceString string
    Immunization.primarySource This element must be supported. This element is included in summaries. 0..1 boolean Indicates context the data was recorded in
    Immunization.location This element must be supported. 0..1 Reference(US Core Location Profile) Where the vaccine was administered
    Immunization.lotNumber This element must be supported. 0..1 string Vaccine lot number
    Immunization.performer This element must be supported. This element is included in summaries. 0..* BackboneElement Who performed event
    Immunization.performer.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.performer.actor This element must be supported. This element is included in summaries. 1..1 Reference(US Core Practitioner Profile This type must be supported. | US Core PractitionerRole Profile | US Core Organization Profile) Individual or organization who was performing
    Immunization.isSubpotent This element is a modifier element. This element is included in summaries. 0..1 boolean Dose potency

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
    Immunization.statusReason Base extensible Immunization Status Reason Codes 📦4.0.1 FHIR Std.
    Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set ⏿20260428 tx.fhir.org

    Constraints

    Id Grade Path(s) Description Expression
    us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

    This structure is derived from Immunization

    NameFlagsCard.TypeDescription & Constraints    Filter: doco
    Immunization C 0..* Immunization Immunization event information
    Constraints: us-core-5
    Immunization.status This element must be supported. 1..1 code completed | entered-in-error | not-done
    Binding: ImmunizationStatusCodes (required)
    Immunization.statusReason This element must be supported. 0..1 CodeableConcept Reason not done
    Binding: ImmunizationStatusReasonCodes (extensible)
    Immunization.vaccineCode This element must be supported. C 1..1 CodeableConcept Vaccine Product Type (bind to CVX)
    Binding: CVX Vaccines Administered Vaccine Set (extensible)
    Immunization.patient This element must be supported. 1..1 Reference(US Core Patient Profile) Who was immunized
    Immunization.encounter This element must be supported. 0..1 Reference(US Core Encounter Profile) Encounter the immunization was part of
    Immunization.occurrence[x] This element must be supported. 1..1 Vaccine administration date
    Immunization.occurrence[x].occurrenceDateTime dateTime This target must be supported.
    Immunization.occurrence[x].occurrenceString string
    Immunization.primarySource This element must be supported. 0..1 boolean Indicates context the data was recorded in
    Immunization.location This element must be supported. 0..1 Reference(US Core Location Profile) Where the vaccine was administered
    Immunization.lotNumber This element must be supported. 0..1 string Vaccine lot number
    Immunization.performer This element must be supported. 0..* BackboneElement Who performed event
    Immunization.performer.actor This element must be supported. 1..1 Reference(US Core Practitioner Profile This type must be supported. | US Core PractitionerRole Profile | US Core Organization Profile) Individual or organization who was performing

    doco Documentation for this format

    Terminology Bindings (Differential)

    Path Status Usage ValueSet Version Source
    Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
    Immunization.statusReason Base extensible Immunization Status Reason Codes 📦4.0.1 FHIR Std.
    Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set ⏿20260428 tx.fhir.org

    Constraints

    Id Grade Path(s) Description Expression
    us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()
    NameFlagsCard.TypeDescription & Constraints    Filter: doco
    Immunization C 0..* Immunization Immunization event information
    Constraints: us-core-5
    Immunization.id This element is included in summaries. 0..1 id Logical id of this artifact
    Immunization.meta This element is included in summaries. 0..1 Meta Metadata about the resource
    Immunization.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
    Immunization.language 0..1 code Language of the resource content
    Binding: CommonLanguages (preferred): A human language.
    Additional BindingsPurpose
    AllLanguages Max Binding
    Immunization.text 0..1 Narrative Text summary of the resource, for human interpretation
    This profile does not constrain the narrative in regard to content, language, or traceability to data elements
    Immunization.contained 0..* Resource Contained, inline Resources
    Immunization.extension 0..* Extension Additional content defined by implementations
    Immunization.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
    Immunization.identifier 0..* Identifier Business identifier
    Immunization.status This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code completed | entered-in-error | not-done
    Binding: ImmunizationStatusCodes (required)
    Immunization.statusReason This element must be supported. 0..1 CodeableConcept Reason not done
    Binding: ImmunizationStatusReasonCodes (extensible)
    Immunization.vaccineCode This element must be supported. This element is included in summaries. C 1..1 CodeableConcept Vaccine Product Type (bind to CVX)
    Binding: CVX Vaccines Administered Vaccine Set (extensible)
    Immunization.patient This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile) Who was immunized
    Immunization.encounter This element must be supported. 0..1 Reference(US Core Encounter Profile) Encounter the immunization was part of
    Immunization.occurrence[x] This element must be supported. This element is included in summaries. 1..1 Vaccine administration date
    Immunization.occurrence[x].occurrenceDateTime dateTime This target must be supported.
    Immunization.occurrence[x].occurrenceString string
    Immunization.recorded 0..1 dateTime When the immunization was first captured in the subject's record
    Immunization.primarySource This element must be supported. This element is included in summaries. 0..1 boolean Indicates context the data was recorded in
    Immunization.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.
    Immunization.location This element must be supported. 0..1 Reference(US Core Location Profile) Where the vaccine was administered
    Immunization.manufacturer 0..1 Reference(Organization) Vaccine manufacturer
    Immunization.lotNumber This element must be supported. 0..1 string Vaccine lot number
    Immunization.expirationDate 0..1 date Vaccine expiration date
    Immunization.site 0..1 CodeableConcept Body site vaccine was administered
    Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
    Immunization.route 0..1 CodeableConcept How vaccine entered body
    Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
    Immunization.doseQuantity C 0..1 SimpleQuantity(4.0.1) Amount of vaccine administered
    Constraints: sqty-1
    Immunization.performer This element must be supported. This element is included in summaries. 0..* BackboneElement Who performed event
    Immunization.performer.id 0..1 string Unique id for inter-element referencing
    Immunization.performer.extension 0..* Extension Additional content defined by implementations
    Immunization.performer.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.performer.function This element is included in summaries. 0..1 CodeableConcept What type of performance was done
    Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.
    Immunization.performer.actor This element must be supported. This element is included in summaries. 1..1 Reference(US Core Practitioner Profile This type must be supported. | US Core PractitionerRole Profile | US Core Organization Profile) Individual or organization who was performing
    Immunization.note This element is included in summaries. 0..* Annotation Additional immunization notes
    Immunization.reasonCode 0..* CodeableConcept Why immunization occurred
    Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.
    Immunization.reasonReference 0..* Reference(Condition | Observation | DiagnosticReport) Why immunization occurred
    Immunization.isSubpotent This element is a modifier element. This element is included in summaries. 0..1 boolean Dose potency
    Immunization.subpotentReason 0..* CodeableConcept Reason for being subpotent
    Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.
    Immunization.education C 0..* BackboneElement Educational material presented to patient
    Constraints: imm-1
    Immunization.education.id 0..1 string Unique id for inter-element referencing
    Immunization.education.extension 0..* Extension Additional content defined by implementations
    Immunization.education.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.education.documentType 0..1 string Educational material document identifier
    Immunization.education.reference 0..1 uri Educational material reference pointer
    Immunization.education.publicationDate 0..1 dateTime Educational material publication date
    Immunization.education.presentationDate 0..1 dateTime Educational material presentation date
    Immunization.programEligibility 0..* CodeableConcept Patient eligibility for a vaccination program
    Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.
    Immunization.fundingSource 0..1 CodeableConcept Funding source for the vaccine
    Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.
    Immunization.reaction 0..* BackboneElement Details of a reaction that follows immunization
    Immunization.reaction.id 0..1 string Unique id for inter-element referencing
    Immunization.reaction.extension 0..* Extension Additional content defined by implementations
    Immunization.reaction.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.reaction.date 0..1 dateTime When reaction started
    Immunization.reaction.detail 0..1 Reference(Observation) Additional information on reaction
    Immunization.reaction.reported 0..1 boolean Indicates self-reported reaction
    Immunization.protocolApplied 0..* BackboneElement Protocol followed by the provider
    Immunization.protocolApplied.id 0..1 string Unique id for inter-element referencing
    Immunization.protocolApplied.extension 0..* Extension Additional content defined by implementations
    Immunization.protocolApplied.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.protocolApplied.series 0..1 string Name of vaccine series
    Immunization.protocolApplied.authority 0..1 Reference(Organization) Who is responsible for publishing the recommendations
    Immunization.protocolApplied.targetDisease 0..* CodeableConcept Vaccine preventatable disease being targetted
    Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.
    Immunization.protocolApplied.doseNumber[x] 1..1 Dose number within series
    Immunization.protocolApplied.doseNumber[x].doseNumberPositiveInt positiveInt
    Immunization.protocolApplied.doseNumber[x].doseNumberString string
    Immunization.protocolApplied.seriesDoses[x] 0..1 Recommended number of doses for immunity
    Immunization.protocolApplied.seriesDoses[x].seriesDosesPositiveInt positiveInt
    Immunization.protocolApplied.seriesDoses[x].seriesDosesString string

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Immunization.language Base preferred Common Languages 📍4.0.1 FHIR Std.
    Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
    Immunization.statusReason Base extensible Immunization Status Reason Codes 📦4.0.1 FHIR Std.
    Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set ⏿20260428 tx.fhir.org
    Immunization.reportOrigin Base example Immunization Origin Codes 📍4.0.1 FHIR Std.
    Immunization.site Base example Codes for Immunization Site of Administration 📍4.0.1 FHIR Std.
    Immunization.route Base example Immunization Route Codes 📍4.0.1 FHIR Std.
    Immunization.performer.​function Base extensible Immunization Function Codes 📍4.0.1 FHIR Std.
    Immunization.reasonCode Base example Immunization Reason Codes 📍4.0.1 FHIR Std.
    Immunization.subpotentReason Base example Immunization Subpotent Reason 📍4.0.1 FHIR Std.
    Immunization.programEligibility Base example Immunization Program Eligibility 📍4.0.1 FHIR Std.
    Immunization.fundingSource Base example Immunization Funding Source 📍4.0.1 FHIR Std.
    Immunization.protocolApplied.​targetDisease Base example Immunization Target Disease Codes 📍4.0.1 FHIR Std.

    Constraints

    Id Grade Path(s) Description Expression
    us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

    Key Elements View

    NameFlagsCard.TypeDescription & Constraints    Filter: doco
    Immunization C 0..* Immunization Immunization event information
    Constraints: us-core-5
    Immunization.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
    Immunization.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
    Immunization.status This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code completed | entered-in-error | not-done
    Binding: ImmunizationStatusCodes (required)
    Immunization.statusReason This element must be supported. 0..1 CodeableConcept Reason not done
    Binding: ImmunizationStatusReasonCodes (extensible)
    Immunization.vaccineCode This element must be supported. This element is included in summaries. C 1..1 CodeableConcept Vaccine Product Type (bind to CVX)
    Binding: CVX Vaccines Administered Vaccine Set (extensible)
    Immunization.patient This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile) Who was immunized
    Immunization.encounter This element must be supported. 0..1 Reference(US Core Encounter Profile) Encounter the immunization was part of
    Immunization.occurrence[x] This element must be supported. This element is included in summaries. 1..1 Vaccine administration date
    Immunization.occurrence[x].occurrenceDateTime dateTime This target must be supported.
    Immunization.occurrence[x].occurrenceString string
    Immunization.primarySource This element must be supported. This element is included in summaries. 0..1 boolean Indicates context the data was recorded in
    Immunization.location This element must be supported. 0..1 Reference(US Core Location Profile) Where the vaccine was administered
    Immunization.lotNumber This element must be supported. 0..1 string Vaccine lot number
    Immunization.performer This element must be supported. This element is included in summaries. 0..* BackboneElement Who performed event
    Immunization.performer.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.performer.actor This element must be supported. This element is included in summaries. 1..1 Reference(US Core Practitioner Profile This type must be supported. | US Core PractitionerRole Profile | US Core Organization Profile) Individual or organization who was performing
    Immunization.isSubpotent This element is a modifier element. This element is included in summaries. 0..1 boolean Dose potency

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
    Immunization.statusReason Base extensible Immunization Status Reason Codes 📦4.0.1 FHIR Std.
    Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set ⏿20260428 tx.fhir.org

    Constraints

    Id Grade Path(s) Description Expression
    us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

    Differential View

    This structure is derived from Immunization

    NameFlagsCard.TypeDescription & Constraints    Filter: doco
    Immunization C 0..* Immunization Immunization event information
    Constraints: us-core-5
    Immunization.status This element must be supported. 1..1 code completed | entered-in-error | not-done
    Binding: ImmunizationStatusCodes (required)
    Immunization.statusReason This element must be supported. 0..1 CodeableConcept Reason not done
    Binding: ImmunizationStatusReasonCodes (extensible)
    Immunization.vaccineCode This element must be supported. C 1..1 CodeableConcept Vaccine Product Type (bind to CVX)
    Binding: CVX Vaccines Administered Vaccine Set (extensible)
    Immunization.patient This element must be supported. 1..1 Reference(US Core Patient Profile) Who was immunized
    Immunization.encounter This element must be supported. 0..1 Reference(US Core Encounter Profile) Encounter the immunization was part of
    Immunization.occurrence[x] This element must be supported. 1..1 Vaccine administration date
    Immunization.occurrence[x].occurrenceDateTime dateTime This target must be supported.
    Immunization.occurrence[x].occurrenceString string
    Immunization.primarySource This element must be supported. 0..1 boolean Indicates context the data was recorded in
    Immunization.location This element must be supported. 0..1 Reference(US Core Location Profile) Where the vaccine was administered
    Immunization.lotNumber This element must be supported. 0..1 string Vaccine lot number
    Immunization.performer This element must be supported. 0..* BackboneElement Who performed event
    Immunization.performer.actor This element must be supported. 1..1 Reference(US Core Practitioner Profile This type must be supported. | US Core PractitionerRole Profile | US Core Organization Profile) Individual or organization who was performing

    doco Documentation for this format

    Terminology Bindings (Differential)

    Path Status Usage ValueSet Version Source
    Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
    Immunization.statusReason Base extensible Immunization Status Reason Codes 📦4.0.1 FHIR Std.
    Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set ⏿20260428 tx.fhir.org

    Constraints

    Id Grade Path(s) Description Expression
    us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

    Snapshot View

    NameFlagsCard.TypeDescription & Constraints    Filter: doco
    Immunization C 0..* Immunization Immunization event information
    Constraints: us-core-5
    Immunization.id This element is included in summaries. 0..1 id Logical id of this artifact
    Immunization.meta This element is included in summaries. 0..1 Meta Metadata about the resource
    Immunization.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
    Immunization.language 0..1 code Language of the resource content
    Binding: CommonLanguages (preferred): A human language.
    Additional BindingsPurpose
    AllLanguages Max Binding
    Immunization.text 0..1 Narrative Text summary of the resource, for human interpretation
    This profile does not constrain the narrative in regard to content, language, or traceability to data elements
    Immunization.contained 0..* Resource Contained, inline Resources
    Immunization.extension 0..* Extension Additional content defined by implementations
    Immunization.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored
    Immunization.identifier 0..* Identifier Business identifier
    Immunization.status This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code completed | entered-in-error | not-done
    Binding: ImmunizationStatusCodes (required)
    Immunization.statusReason This element must be supported. 0..1 CodeableConcept Reason not done
    Binding: ImmunizationStatusReasonCodes (extensible)
    Immunization.vaccineCode This element must be supported. This element is included in summaries. C 1..1 CodeableConcept Vaccine Product Type (bind to CVX)
    Binding: CVX Vaccines Administered Vaccine Set (extensible)
    Immunization.patient This element must be supported. This element is included in summaries. 1..1 Reference(US Core Patient Profile) Who was immunized
    Immunization.encounter This element must be supported. 0..1 Reference(US Core Encounter Profile) Encounter the immunization was part of
    Immunization.occurrence[x] This element must be supported. This element is included in summaries. 1..1 Vaccine administration date
    Immunization.occurrence[x].occurrenceDateTime dateTime This target must be supported.
    Immunization.occurrence[x].occurrenceString string
    Immunization.recorded 0..1 dateTime When the immunization was first captured in the subject's record
    Immunization.primarySource This element must be supported. This element is included in summaries. 0..1 boolean Indicates context the data was recorded in
    Immunization.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.
    Immunization.location This element must be supported. 0..1 Reference(US Core Location Profile) Where the vaccine was administered
    Immunization.manufacturer 0..1 Reference(Organization) Vaccine manufacturer
    Immunization.lotNumber This element must be supported. 0..1 string Vaccine lot number
    Immunization.expirationDate 0..1 date Vaccine expiration date
    Immunization.site 0..1 CodeableConcept Body site vaccine was administered
    Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
    Immunization.route 0..1 CodeableConcept How vaccine entered body
    Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
    Immunization.doseQuantity C 0..1 SimpleQuantity(4.0.1) Amount of vaccine administered
    Constraints: sqty-1
    Immunization.performer This element must be supported. This element is included in summaries. 0..* BackboneElement Who performed event
    Immunization.performer.id 0..1 string Unique id for inter-element referencing
    Immunization.performer.extension 0..* Extension Additional content defined by implementations
    Immunization.performer.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.performer.function This element is included in summaries. 0..1 CodeableConcept What type of performance was done
    Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.
    Immunization.performer.actor This element must be supported. This element is included in summaries. 1..1 Reference(US Core Practitioner Profile This type must be supported. | US Core PractitionerRole Profile | US Core Organization Profile) Individual or organization who was performing
    Immunization.note This element is included in summaries. 0..* Annotation Additional immunization notes
    Immunization.reasonCode 0..* CodeableConcept Why immunization occurred
    Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.
    Immunization.reasonReference 0..* Reference(Condition | Observation | DiagnosticReport) Why immunization occurred
    Immunization.isSubpotent This element is a modifier element. This element is included in summaries. 0..1 boolean Dose potency
    Immunization.subpotentReason 0..* CodeableConcept Reason for being subpotent
    Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.
    Immunization.education C 0..* BackboneElement Educational material presented to patient
    Constraints: imm-1
    Immunization.education.id 0..1 string Unique id for inter-element referencing
    Immunization.education.extension 0..* Extension Additional content defined by implementations
    Immunization.education.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.education.documentType 0..1 string Educational material document identifier
    Immunization.education.reference 0..1 uri Educational material reference pointer
    Immunization.education.publicationDate 0..1 dateTime Educational material publication date
    Immunization.education.presentationDate 0..1 dateTime Educational material presentation date
    Immunization.programEligibility 0..* CodeableConcept Patient eligibility for a vaccination program
    Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.
    Immunization.fundingSource 0..1 CodeableConcept Funding source for the vaccine
    Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.
    Immunization.reaction 0..* BackboneElement Details of a reaction that follows immunization
    Immunization.reaction.id 0..1 string Unique id for inter-element referencing
    Immunization.reaction.extension 0..* Extension Additional content defined by implementations
    Immunization.reaction.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.reaction.date 0..1 dateTime When reaction started
    Immunization.reaction.detail 0..1 Reference(Observation) Additional information on reaction
    Immunization.reaction.reported 0..1 boolean Indicates self-reported reaction
    Immunization.protocolApplied 0..* BackboneElement Protocol followed by the provider
    Immunization.protocolApplied.id 0..1 string Unique id for inter-element referencing
    Immunization.protocolApplied.extension 0..* Extension Additional content defined by implementations
    Immunization.protocolApplied.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
    Immunization.protocolApplied.series 0..1 string Name of vaccine series
    Immunization.protocolApplied.authority 0..1 Reference(Organization) Who is responsible for publishing the recommendations
    Immunization.protocolApplied.targetDisease 0..* CodeableConcept Vaccine preventatable disease being targetted
    Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.
    Immunization.protocolApplied.doseNumber[x] 1..1 Dose number within series
    Immunization.protocolApplied.doseNumber[x].doseNumberPositiveInt positiveInt
    Immunization.protocolApplied.doseNumber[x].doseNumberString string
    Immunization.protocolApplied.seriesDoses[x] 0..1 Recommended number of doses for immunity
    Immunization.protocolApplied.seriesDoses[x].seriesDosesPositiveInt positiveInt
    Immunization.protocolApplied.seriesDoses[x].seriesDosesString string

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Immunization.language Base preferred Common Languages 📍4.0.1 FHIR Std.
    Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
    Immunization.statusReason Base extensible Immunization Status Reason Codes 📦4.0.1 FHIR Std.
    Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set ⏿20260428 tx.fhir.org
    Immunization.reportOrigin Base example Immunization Origin Codes 📍4.0.1 FHIR Std.
    Immunization.site Base example Codes for Immunization Site of Administration 📍4.0.1 FHIR Std.
    Immunization.route Base example Immunization Route Codes 📍4.0.1 FHIR Std.
    Immunization.performer.​function Base extensible Immunization Function Codes 📍4.0.1 FHIR Std.
    Immunization.reasonCode Base example Immunization Reason Codes 📍4.0.1 FHIR Std.
    Immunization.subpotentReason Base example Immunization Subpotent Reason 📍4.0.1 FHIR Std.
    Immunization.programEligibility Base example Immunization Program Eligibility 📍4.0.1 FHIR Std.
    Immunization.fundingSource Base example Immunization Funding Source 📍4.0.1 FHIR Std.
    Immunization.protocolApplied.​targetDisease Base example Immunization Target Disease Codes 📍4.0.1 FHIR Std.

    Constraints

    Id Grade Path(s) Description Expression
    us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

     

    Other representations of profile: CSV, Excel, Schematron

    Notes:


    Quick Start


    Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

    • See the Scopes Format section for a description of the SMART scopes syntax.
    • See the Search Syntax section for a description of the US Core search syntax.
    • See the General Requirements 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.

    US Core Scopes

    Servers providing access to immunization data SHALL support these US Core SMART Scopes:


    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={Patient/}[id]

      Example:

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

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

    2. SHALL support searching for all immunizations for a patient for a given status (for example all administered immunizations or all immunizations that were not given) using the combination of the patient and status search parameters

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

      Example:

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

      Implementation Notes: Fetches a bundle of all US Core Immunization Profile resources for the specified patient and status ( see how to search by reference and how to search by token).

    Optional Search Parameters:

    The following search parameters and search parameter combinations SHOULD be supported

    1. SHOULD support searching for all immunizations for a patient for a specified time period using the combination of the patient and date search parameters

      • Including optional support for AND search on date (e.g.date=[date]&date=[date]&...)

      • Including support for these date comparators: "gt", "lt", "ge", "le"

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

      Example:

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

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


    1 Although the CVX code system contains some concepts that are procedures, medications, or substances rather than immunizations, the value set defined in VSAC has removed those and retained only the vaccine codes (see the exclusion definition in VSAC for more detail)