Purpose
Dose-Level Program Eligibility and Funding Status
Description: The eligibility criteria determining program coverage for a vaccine and specifies the funding source used for the vaccine administered.
Rationale for inclusion:
- Supports vaccine inventory management by tracking eligibility and funding sources for vaccines.
- Assists in managing vaccine programs by ensuring vaccines are provided to eligible individuals according to funding guidelines.
Functional Standard(s): 14.0, 15.0
Repeat: Yes
Data Source: Vaccination Event (for example, reported by an Electronic Health Records (EHR) of a hospital system)
Description: The program responsible for payment of a specific vaccine dose based on patient eligibility criteria and vaccine type at the time of administration (e.g., Vaccines for Children (VFC)-eligible, state vaccine program, private pay).
Rationale for inclusion: Ensures appropriate vaccine administration by validating eligibility at the dose level, supporting inventory management.
Functional Standard(s): 15.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | OBX-5 where OBX-3=’64994-7’ | R | PHVS_FundingEligibilityObsMethod_IIS |
| USCDI V5 |
Description: The funding source of the vaccine administered.
Rationale for inclusion:
- Tracks funding sources for vaccines administered, ensuring compliance with federal and jurisdictional guidelines.
- Supports inventory management, ensuring vaccines are allocated based on available funding.
Functional Standard(s): 14.0, 15.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | OBX-5 where OBX-3='30963-3' | R | PHVS_ImmunizationFundingSource_IIS |
| USCDI V5 |
Exemptions/Refusals
Description: Decisions made by patients to forgo receiving an immunization.
Rationale for inclusion:
- Ensures correct reporting of vaccine exemptions or refusals, linking reasons to individual patient records and supporting the transparency of the immunization process.
- Provides complete context about a patient's vaccination decisions, which can clarify whether an adverse event occurred after an actual vaccination versus a refused dose.
- Helps the IIS avoid sending inappropriate reminders to patients who have formally declined specific vaccines, reducing provider burden and patient frustration.
- Aids the IIS with generating accurate forecasts by excluding refused vaccines from recommendations while continuing to forecast for accepted vaccines.
Functional Standard(s): 6.0, 9.0, 11.0, 13.0
Repeat: Yes
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Description: The reason for an exemption/refusal.
Rationale for inclusion:
- Ensures correct reporting of vaccine exemptions or refusals, linking reasons to individual patient records and supporting the transparency of the immunization process.
- Enables investigators to distinguish between adverse events following actual immunizations versus events unrelated to refused vaccines.
- Prevents the system from generating reminders for vaccines that patients have officially declined, minimizing unnecessary outreach and improving both provider efficiency and patient satisfaction.
Functional Standard(s): 9.0, 11.0, 13.0
Repeat: Yes
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | RXA-18 where RXA-20=“RE” | C(R/X) | NIP002 |
| USCDI V5 |
Description: The date for an exemption/refusal.
Rationale for inclusion: Facilitates accurate immunization forecasting by using expiration date data to ensure that vaccination schedules for pediatric, adolescent, and adult populations align with the availability of effective vaccines as recommended by relevant guidelines.
Functional Standard(s): 6.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage |
| HL7 v2 | RXA-3 where RXA-18 is populated | R |
| USCDI V5 |
Lot Expiration Date
Description: The expiration date of the vaccine lot administered. Note: Based on local need, this may include immunoglobulin or other medical substances.
Rationale for inclusion: Enhances accurate immunization forecasting by leveraging expiration date data to verify that vaccination schedules for pediatric, adolescent, and adult populations align with the availability of effective vaccines as advised by relevant guidelines.
Functional Standard(s): 6.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage |
| HL7 v2 | RXA-16 | C(RE/O) |
| USCDI V5 |
Lot Number
Description: The lot number of the vaccine administered. Note: Based on local need, this may include immunoglobulin or other medical substances.
Rationale for inclusion:
- Enhances validation of vaccination data by incorporating lot number information, which ensures accurate tracking of specific vaccine doses administered to patients within the IIS.
- Aids in the investigation and reporting of vaccine adverse events by providing critical details about specific vaccine lots associated with reported adverse reactions, enabling public health officials to assess potential safety concerns related to particular vaccine lots.
- Strengthens management and quality assurance functions for federal and jurisdictional vaccine programs by ensuring comprehensive lot number information is available for monitoring product effectiveness, safety, and compliance with regulatory requirements.
- Ensures accurate documentation of vaccine administration, facilitating timely responses during vaccine-preventable disease outbreaks and public health emergencies.
- Enables tracking of specific vaccine lot numbers used at each administration, supporting accurate inventory reconciliation and accountability for federally-supplied vaccines as required by programs like VFC.
Functional Standard(s): 4.0, 11.0, 14.0, 15.0, 17.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage |
| HL7 v2 | RXA-15 | C(R/O) |
| USCDI V5 | Lot Number |
Manufacturer Name
Description: The manufacturer of the vaccine that was administered.
Rationale for inclusion:
- Facilitates efficient electronic data exchange and integration by managing interfaces that allow for the seamless transfer of vaccine manufacturer information between the IIS and other health information systems, in compliance with federal and jurisdictional standards.
- Enhances accurate immunization forecasting by using manufacturer name data to guide vaccination schedules for pediatric, adolescent, and adult populations in line with recommended guidelines.
- Aids in the investigation and reporting of vaccine adverse events by providing essential details about specific vaccines linked to their manufacturers, enabling public health officials to assess potential safety concerns associated with particular products.
- Strengthens management and quality assurance functions for federal and jurisdictional vaccine programs by ensuring comprehensive tracking of vaccine manufacturer information, which is critical for monitoring product effectiveness, safety, and regulatory compliance.
- Helps the IIS track specific vaccine products administered from inventory, enabling accurate reconciliation of doses used against doses received by lot number and manufacturer.
Functional Standard(s): 5.0, 6.0, 11.0, 14.0, 15.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | RXA-17 | C(R/O) | MVX |
| USCDI V5 |
Vaccination Event Record Type
Description: Indicates whether the vaccination event is based on a historical record or was given by the administered at location.
Rationale for inclusion: Ensures the proper validation of vaccination event data for appropriate record classification.
Functional Standard(s): 4.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | RXA-9 | C(R/O) | NIP001 |
| USCDI V5 |
Vaccine Information Statement Group
Description: Information about the document that provides information about a vaccine type. Vaccine information statement, or VIS, is expected to be captured if the IIS is used as the primary vaccination event record (e.g., a mass vaccination clinic).
Rationale for inclusion:
- Facilitates integration of vaccine information statement data to ensure accurate information is provided to patients.
- Assists in quality assurance functions and reporting for federal and jurisdictional vaccine programs.
Functional Standard(s): 5.0, 14.0
- Facilitates integration of vaccine information statement data to ensure accurate information is provided to patients.
- Assists in quality assurance functions and reporting for federal and jurisdictional vaccine programs.
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Note: IIS may store VIS information if they are not the primary vaccination event record. However, when an IIS serves as the primary vaccination event record, such as during mass vaccinations, they are required to store VIS information.
Description: Information about the vaccine information statement, or VIS.
Rationale for inclusion: Assists in quality assurance functions and reporting for federal and jurisdictional vaccine programs.
Functional Standard(s): 14.0
Repeat: Yes
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | OBX-5 where OBX-3=’69764-9’ (preferred)/ OBX-5 where OBX-3=’30956-7 |
R | PHVS_VISBarcodes_IIS |
| USCDI V5 |
Note: IIS may store VIS information if they are not the primary vaccination event record. However, when an IIS serves as the primary vaccination event record, such as during mass vaccinations, they are required to store VIS information.
Description: The date the VIS information was provided to the patient.
Rationale for inclusion:
- Supports the incorporation of vaccine information statement data to ensure patients receive correct and up-to-date information.
- Contributes to quality control processes and reporting for federal and jurisdictional immunization programs.
Functional Standard(s): 5.0, 14.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage |
| HL7 v2 | OBX-5 where OBX-3=29769-7’ | R |
| USCDI V5 |
Vaccine Product
Description: The vaccine type for the immunization event, identified by Vaccine Administered (CVX) or National Drug Code (NDC) codes. IIS should support both code sets, preferring CVX, and may also receive additional codes such as Current Procedural Terminology (CPT). Note: based on local need, this may include immunoglobulin or other medical substances.
Rationale for inclusion:
- Enhances validation of vaccination data by incorporating detailed vaccine product information, ensuring accurate tracking and matching of vaccination records within the IIS.
- Facilitates accurate immunization forecasting by using vaccine product data to create customized vaccination schedules for pediatric, adolescent, and adult populations in accordance with recommended guidelines.
- Aids in the investigation and reporting of vaccine adverse events by providing critical details about specific vaccine products administered, enabling public health officials to assess potential correlations between vaccines and reported adverse reactions.
- Strengthens management and quality assurance functions for federal and jurisdictional vaccine programs by ensuring that comprehensive vaccine product information is available for monitoring program effectiveness and compliance with regulatory requirements.
- Enhances vaccine inventory management by providing essential data on vaccine products used, facilitating accurate reconciliation according to federal and jurisdictional program requirements as well as local provider business needs for tracking their own vaccine inventory.
Functional Standard(s): 4.0, 6.0, 11.0, 14.0, 15.0
Repeat: Yes
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Description: The Vaccine Administered (CVX) code of the vaccine product.
Rationale for inclusion:
- Enhances validation of vaccination data by incorporating CVX codes, which provide standardized identifiers for vaccines administered, ensuring accurate tracking and matching of vaccination records within the IIS.
- Enhances accurate immunization forecasting by employing CVX codes to develop personalized vaccination schedules for pediatric, adolescent, and adult populations based on recommended guidelines.
- Aids in the investigation and reporting of vaccine adverse events by providing essential details linked to specific vaccines through their CVX codes, enabling public health officials to assess potential correlations between vaccines and reported adverse reactions.
- Strengthens management and quality assurance functions for federal and jurisdictional vaccine programs by ensuring comprehensive CVX code information is available for monitoring program effectiveness and compliance with regulatory requirements.
- Enhances vaccine inventory management by providing critical data associated with CVX codes, facilitating accurate reconciliation according to federal and jurisdictional program requirements.
Functional Standard(s): 4.0, 6.0, 11.0, 14.0, 15.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | RXA-5, OBX-5 where OBX-3=’30956-7’ | R | CVX |
| USCDI V5 | Immunizations |
Description: The National Drug Code (NDC) of the vaccine product.
Rationale for inclusion:
- Enhances validation of patient demographic and vaccination data by incorporating NDC information, which ensures accurate identification and tracking of specific vaccine products administered to patients within the IIS.
- Aids in the investigation and reporting of vaccine adverse events by providing essential details about specific vaccines associated with their NDCs, enabling public health officials to analyze potential correlations between vaccines and reported adverse reactions.
- Strengthens management and quality assurance functions for federal and jurisdictional vaccine programs by ensuring comprehensive NDC information is available for monitoring program effectiveness, compliance, and safety.
Functional Standard(s): 4.0, 6.0, 11.0, 14.0
Repeat: No
Data Source: Vaccination Event (for example, reported by an EHR of a hospital system)
Standards Mapping:
| Standard | Data Element | Usage | Value Set |
| HL7 v2 | RXA-5 | R | NDC Unit of Sale (UoS)/Unit of Use (UoU) |
| USCDI V5 | Immunizations |