US Core Implementation Guide
8.0.1 - STU 8

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 8.0.1 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: 8.0.1
Standards status: Trial-use | Maturity Level: 3 | Computable Name: USCoreImmunizationProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.31
Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

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.

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

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.
3. the encounter the immunization was part of
4. where the vaccine was administered
5. vaccine lot number*
6. a performer*

*see guidance below

Profile Specific Implementation Guidance:

- Use the status code: `not-done` to represent that an immunization was not given.
- Based upon the ASTP U.S. Core Data for Interoperability (USCDI) requirements, CVX vaccine codes1 are required, and the NDC vaccine codes SHOULD be supported as an additional code.
  - NDC codes are defined by manufacturer, and CVX codes, which are much less granular, are often limited to a single product made by a single manufacturer.
  - The preferred 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. The example Immunization-imm-1 illustrates using the CVX and 11-digit NDC codes based on this table.
- *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.

- *The 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.

Usages:

- Examples for this Profile: Immunization/imm-1
- CapabilityStatements using this Profile: US Core Client CapabilityStatement and US Core Server CapabilityStatement

You can also check for usages in the FHIR IG Statistics

Changes since version 7.0.0:

- The data elements list has changed
- One or more text definitions, invariants or bindings have changed

### Formal Views of Profile Content

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

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Immunization | C | 0..* | Immunization | Immunization event information Constraints: us-core-5
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S Σ | 1..1 | code | completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required)
statusReason | S | 0..1 | CodeableConcept | Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode | S Σ C | 1..1 | CodeableConcept | Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible)
patient | S Σ | 1..1 | Reference(US Core Patient Profile) | Who was immunized
encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter the immunization was part of
occurrence[x] | S Σ | 1..1 |  | Vaccine administration date
occurrenceDateTime |  |  | dateTime S |
occurrenceString |  |  | string |
primarySource | S Σ | 0..1 | boolean | Indicates context the data was recorded in
location | S | 0..1 | Reference(US Core Location Profile) | Where the vaccine was administered
lotNumber | S | 0..1 | string | Vaccine lot number
performer | S Σ | 0..* | BackboneElement | Who performed event
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
actor | S Σ | 1..1 | Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) | Individual or organization who was performing
isSubpotent | ?!Σ | 0..1 | boolean | Dose potency
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 | example | Immunization Status Reason Codes | 📦4.0.1 | FHIR Std.
Immunization.vaccineCode | Base | extensible | CVX Vaccines Administered Vaccine Set | 📦20250411 | VSAC v0.24

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Immunization | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Immunization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Immunization | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Immunization | C | 0..* | Immunization | Immunization event information Constraints: us-core-5
status | S | 1..1 | code | completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required)
statusReason | S | 0..1 | CodeableConcept | Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode | S C | 1..1 | CodeableConcept | Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible)
patient | S | 1..1 | Reference(US Core Patient Profile) | Who was immunized
encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter the immunization was part of
occurrence[x] | S | 1..1 |  | Vaccine administration date
occurrenceDateTime |  |  | dateTime S |
occurrenceString |  |  | string |
primarySource | S | 0..1 | boolean | Indicates context the data was recorded in
location | S | 0..1 | Reference(US Core Location Profile) | Where the vaccine was administered
lotNumber | S | 0..1 | string | Vaccine lot number
performer | S | 0..* | BackboneElement | Who performed event
actor | S | 1..1 | Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) | Individual or organization who was performing
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 | example | Immunization Status Reason Codes | 📦4.0.1 | FHIR Std.
Immunization.vaccineCode | Base | extensible | CVX Vaccines Administered Vaccine Set | 📦20250411 | VSAC v0.24

#### 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()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Immunization | C | 0..* | Immunization | Immunization event information Constraints: us-core-5
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | ?!S Σ | 1..1 | code | completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required)
statusReason | S | 0..1 | CodeableConcept | Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode | S Σ C | 1..1 | CodeableConcept | Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible)
patient | S Σ | 1..1 | Reference(US Core Patient Profile) | Who was immunized
encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter the immunization was part of
occurrence[x] | S Σ | 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 | S Σ | 0..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 the vaccine was administered
manufacturer |  | 0..1 | Reference(Organization) | Vaccine manufacturer
lotNumber | S | 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(4.0.1) | Amount of vaccine administered
performer | S 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 | S Σ | 1..1 | Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) | 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 Constraints: imm-1
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 | 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 | example | Immunization Status Reason Codes | 📦4.0.1 | FHIR Std.
Immunization.vaccineCode | Base | extensible | CVX Vaccines Administered Vaccine Set | 📦20250411 | VSAC v0.24
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
dom-2 | error | Immunization | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Immunization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Immunization | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
imm-1 | error | Immunization.education | One of documentType or reference SHALL be present | `documentType.exists() or reference.exists()`
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

Summary

Must-Support: 11 elements

Structures

This structure refers to these other structures:

- US Core Patient Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-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)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner)
- US Core PractitionerRole Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitionerrole)
- US Core Organization Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization)

Maturity: 3

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Immunization | C | 0..* | Immunization | Immunization event information Constraints: us-core-5
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S Σ | 1..1 | code | completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required)
statusReason | S | 0..1 | CodeableConcept | Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode | S Σ C | 1..1 | CodeableConcept | Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible)
patient | S Σ | 1..1 | Reference(US Core Patient Profile) | Who was immunized
encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter the immunization was part of
occurrence[x] | S Σ | 1..1 |  | Vaccine administration date
occurrenceDateTime |  |  | dateTime S |
occurrenceString |  |  | string |
primarySource | S Σ | 0..1 | boolean | Indicates context the data was recorded in
location | S | 0..1 | Reference(US Core Location Profile) | Where the vaccine was administered
lotNumber | S | 0..1 | string | Vaccine lot number
performer | S Σ | 0..* | BackboneElement | Who performed event
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
actor | S Σ | 1..1 | Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) | Individual or organization who was performing
isSubpotent | ?!Σ | 0..1 | boolean | Dose potency
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 | example | Immunization Status Reason Codes | 📦4.0.1 | FHIR Std.
Immunization.vaccineCode | Base | extensible | CVX Vaccines Administered Vaccine Set | 📦20250411 | VSAC v0.24

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Immunization | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Immunization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Immunization | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Immunization | C | 0..* | Immunization | Immunization event information Constraints: us-core-5
status | S | 1..1 | code | completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required)
statusReason | S | 0..1 | CodeableConcept | Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode | S C | 1..1 | CodeableConcept | Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible)
patient | S | 1..1 | Reference(US Core Patient Profile) | Who was immunized
encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter the immunization was part of
occurrence[x] | S | 1..1 |  | Vaccine administration date
occurrenceDateTime |  |  | dateTime S |
occurrenceString |  |  | string |
primarySource | S | 0..1 | boolean | Indicates context the data was recorded in
location | S | 0..1 | Reference(US Core Location Profile) | Where the vaccine was administered
lotNumber | S | 0..1 | string | Vaccine lot number
performer | S | 0..* | BackboneElement | Who performed event
actor | S | 1..1 | Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) | Individual or organization who was performing
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 | example | Immunization Status Reason Codes | 📦4.0.1 | FHIR Std.
Immunization.vaccineCode | Base | extensible | CVX Vaccines Administered Vaccine Set | 📦20250411 | VSAC v0.24

#### 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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Immunization | C | 0..* | Immunization | Immunization event information Constraints: us-core-5
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | ?!S Σ | 1..1 | code | completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required)
statusReason | S | 0..1 | CodeableConcept | Reason not done Binding: ImmunizationStatusReasonCodes (example)
vaccineCode | S Σ C | 1..1 | CodeableConcept | Vaccine Product Type (bind to CVX) Binding: CVX Vaccines Administered Vaccine Set (extensible)
patient | S Σ | 1..1 | Reference(US Core Patient Profile) | Who was immunized
encounter | S | 0..1 | Reference(US Core Encounter Profile) | Encounter the immunization was part of
occurrence[x] | S Σ | 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 | S Σ | 0..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 the vaccine was administered
manufacturer |  | 0..1 | Reference(Organization) | Vaccine manufacturer
lotNumber | S | 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(4.0.1) | Amount of vaccine administered
performer | S 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 | S Σ | 1..1 | Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) | 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 Constraints: imm-1
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 | 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 | example | Immunization Status Reason Codes | 📦4.0.1 | FHIR Std.
Immunization.vaccineCode | Base | extensible | CVX Vaccines Administered Vaccine Set | 📦20250411 | VSAC v0.24
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
dom-2 | error | Immunization | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Immunization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Immunization | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Immunization | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
imm-1 | error | Immunization.education | One of documentType or reference SHALL be present | `documentType.exists() or reference.exists()`
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

Summary

Must-Support: 11 elements

Structures

This structure refers to these other structures:

- US Core Patient Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-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)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner)
- US Core PractitionerRole Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitionerrole)
- US Core Organization Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization)

Maturity: 3

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:

- resource level scopes: `<patient|user|system>/Immunization.rs`

#### 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 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)

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)