Record of vaccine administration.

Data Element

Immunizations

Applicable Vocabulary Standard(s)

Applicable Standards (*Please confirm or update this field for the new USCDI version*)
  • CDC IIS: Current HL7 Standard Code Set, CVX -- Vaccines Administered, updates through January 31, 2020
  • CDC National Drug Code (NDC) Directory – Vaccine NDC Linker Table, updates through January 31, 2020

View guidance on Applicable Vocabulary Standards and versioning.

Comment

CDC comments for draft USCDI v8

Renaming "Immunizations" to "Vaccine Administered Code"

CDC recognizes that a similar comment was previously submitted for USCDI v7, and that other USCDI data elements carry required terminology codes without "Code" appended to their name. We appreciate this point and want to clarify where the confusion occurs and revise our recommendation accordingly.

The issue is not that the element lacks a code — it already requires one (CVX or NDC) — but that "Immunizations" is the name of both the USCDI data class and this specific data element within it. This creates ambiguity for implementers and public health partners reading USCDI documentation: a reference to "the immunizations data element" can be misread as the class, an immunization event, or the coded attribute itself. This is a naming collision specific to this element, not a general naming pattern issue, and does not apply to elements like Problems or Medications.

Given this, we withdraw the proposed name "Vaccine Administered Code" and instead recommend ONC resolve the class/element naming collision directly — for example, by renaming the data element (not the data class) to something that avoids duplicating the class name, using a naming convention consistent with other USCDI elements (e.g., "Vaccine Type" or "Vaccine Administered"), while leaving the data class named "Immunizations" unchanged. No change to the element's definition, datatype, or value set is proposed.

Supporting links:

- US Core Immunization Profile (US Core IG v9.0.0): https://build.fhir.org/ig/HL7/US-Core/StructureDefinition-us-core-immunization.html

- HL7 v2.5.1 Implementation Guide for Immunization Messaging (RXA-5 field): https://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdf

- HL7 FHIR Immunization resource — vaccineCode element: https://hl7.org/fhir/immunization.html

Level 2: Captured/stored/accessed in multiple production EHRs or other HIT modules from more than one developer.

Use Case: The coded vaccine identity element (currently named "Immunizations" in USCDI, using CVX or NDC codes) is essential for accurate, interoperable public health data exchange — supporting immunization reporting, vaccine inventory management, coverage assessment, and outbreak/exposure investigation across IIS, EHRs, and public health agencies. However, the current element name is ambiguous: "Immunizations" is easily misread as referring to an immunization event rather than a coded attribute, and it duplicates the name of the "Immunizations" data class itself, creating confusion for implementers and reviewers working across USCDI documentation.
Renaming this element to "Vaccine Administered Code" — with no change to its definition, datatype, or value set — resolves this ambiguity and aligns USCDI terminology with the existing FHIR Immunization resource's vaccineCode element. This improves clarity for implementers building to both USCDI and FHIR/US Core simultaneously, reducing the risk of misinterpretation in public health data exchange, without introducing any new technical or implementation burden.

US Core Immunization Profile (US Core Implementation Guide v9.0.0): https://build.fhir.org/ig/HL7/US-Core/StructureDefinition-us-core-immunization.html 

HL7 Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5) — RXA-5 field: https://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdfHL7  

FHIR Immunization resource — vaccineCode element definition: https://hl7.org/fhir/immunization.html  

Additional information-Supporting links:
- US Core Immunization Profile (US Core IG v9.0.0): https://build.fhir.org/ig/HL7/US-Core/StructureDefinition-us-core-immunization.html 
- HL7 v2.5.1 Implementation Guide for Immunization Messaging (RXA-5 field): https://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdf 
- HL7 FHIR Immunization resource — vaccineCode element: https://hl7.org/fhir/immunization.html 

U.S. Core inclusion- Yes.

U.S.Core details- The U.S. Core Implementation Guide v9.0.0 Immunization Profile lists "a vaccine code that identifies the kind of vaccine administered" as one of four elements every Immunization instance must have (Mandatory), corresponding to Immunization.vaccineCode. This is the same underlying FHIR element currently captured by the USCDI "Immunizations" data element, using CVX or NDC codes. The proposed change renames this data element to "Vaccine Administered Code" to align USCDI terminology with the existing FHIR element name (vaccineCode) and to eliminate confusion between the "Immunizations" data class and the "Immunizations" data element name. This is a terminology-only change; the definition, datatype, and value set remain unchanged, and no new Mandatory or Must Support designation is being introduced — the element is already Mandatory in US Core today.

CDC's comment for inclusion in USCDI v7

CDC recommends renaming “Immunizations” to “Vaccine Administered Code.” The inclusion of a coded data element representing the administered vaccine is essential for accurate and interoperable exchange within USCDI v7. The current “Immunizations” data element captures this information using CVX or NDC as part of the HL7 v2.7 RXA-5; however, the label is ambiguous and may be misinterpreted as referring to an immunization event rather than a coded attribute.

To improve clarity, CDC proposes renaming this data element to “Vaccine Administered Code.” This change does not modify the definition, datatype, or value set—it remains a coded representation of the administered vaccine—but instead clarifies the element’s purpose.

This revision also resolves confusion within USCDI, where “Immunizations” refers to both a data class and a data element. In addition, this terminology aligns with the FHIR Immunization resource, which defines a vaccineCode element to represent the coded identity of the administered vaccine, supporting standardized and unambiguous data exchange.

In summary, this terminology update improves clarity and alignment without altering the underlying data structure, supporting more accurate data exchange and public health outcomes.
 

CDC's comment for proposed inclusion in USCDI v7

Consider renaming "Immunization" to "Vaccine Code"

The inclusion of a "vaccine code" data element in USCDI v7 is crucial for enhancing the clarity and effectiveness of immunization data management across healthcare systems. Currently, there is a data element within the Immunizations data class that captures the type of vaccine administered, typically utilizing CVX or NDC codes. However, the term “Immunizations” has led to confusion, as it does not explicitly indicate that it refers to a specific vaccine code, especially for those working with vaccination data.

To resolve this issue, the CDC proposes renaming the existing "Immunizations" data element to "Vaccine Code." This change would eliminate ambiguity and ensure that references to immunization data within the USCDI are both accurate and intuitive.

The term "Vaccine Code" offers a more precise and descriptive representation of the administered vaccine, aligning with terminology commonly used in clinical and public health contexts. This revision would also address the duplication of the term "Immunizations," which currently refers to both a data class and a data element, potentially leading to misinterpretations.

Furthermore, adopting the term "Vaccine Code" promotes alignment with the US Core Implementation Guide, which advances interoperability and standardization across electronic health record systems.

In summary, renaming the data element to "Vaccine Code" will enhance the accuracy, usability, and consistency of immunization data in the USCDI, ultimately supporting improved data exchange and better public health outcomes. 

CDC's Comment for draft USCDI v6

The inclusion of a “vaccine code” data element in USCDI v6 is essential to improving the clarity and effectiveness of immunization data management across healthcare systems. Currently, within the Immunizations data class, a data element exists to capture the type of vaccine administered, typically using CVX or NDC codes. However, the term “Immunizations” has caused confusion, as it does not clearly convey that it refers to a specific vaccine code—especially for those working with vaccination data.

To address this, CDC proposes renaming the current “Immunizations” data element to “Vaccine Code.” This revision would eliminate ambiguity, ensuring that references to immunization data within USCDI are both accurate and intuitive.

The term “Vaccine Code” provides a more precise and descriptive representation of the administered vaccine, aligning with the terminology commonly used in clinical and public health contexts. This change would also resolve the duplication of the term “Immunizations,” which currently refers to both a data class and a data element, potentially leading to misinterpretation.

Additionally, adopting “Vaccine Code” promotes alignment with the US Core Implementation Guide, further advancing interoperability and standardization across electronic health record systems.

In summary, renaming the data element to “Vaccine Code” will improve the accuracy, usability, and consistency of immunization data in USCDI—ultimately supporting better data exchange and public health outcomes.

Rename the data element Immunizations to Vaccine Code

The inclusion of the vaccine code in USCDI v6 is essential for enhancing the clarity and effectiveness of immunization data management across healthcare platforms. Currently, within the immunizations data class, there exists an immunizations data element that captures information about the type of vaccine administered, using CVX or NDC codes. However, the term immunizations has often led to confusion, as it does not intuitively refer to vaccine code for those working with vaccination data. 

To address this issue, CDC proposes renaming the immunizations data element to vaccine code. This change will resolve the ambiguity associated with the term “Immunizations” and ensure that discussions about immunization data within USCDI are clear and precise.                                                                                                                                        

The vaccine code data element will provide a more descriptive and accurate representation of the type of vaccine administered, aligning with common terminology used in public health and healthcare settings. This adjustment will also eliminate the confusion caused by the duplicate use of the term immunizations, which currently refers both to a data class and a data element. 

By adopting vaccine code as the standardized term, we also ensure consistency with US Core, further promoting interoperability and clarity across different health information systems. 

In summary, renaming the data element immunizations to vaccine code will enhance the precision, understanding, and consistency of immunization data within USCDI, ultimately supporting better public health outcomes. 

CDC's Comment for draft USCDI v5

Since USCDI Version 1 to current draft v5, the "Immunizations" data class has included an "Immunizations" data element, capturing vaccine type information using CVX or NDC codes. However, confusion often arises regarding this element's meaning and its distinction from the data class. To address this, it's proposed to rename the data element to "Vaccine Code" for clarity, aligning with US Core terminology and resolving naming duplications, thus improving understanding and discussion surrounding immunization data within USCDI.

NCPDP Comments on USCDI draft V3

NCPDP applauds ONC for adding NDC and recommends ONC also add the Lot Number. Lot Number is critical for the reporting of immunizations and is included on the IIS form.

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