COVID-19 Vaccine Code Set Update Publication Date: November 28, 2022
The individual filenames included in this distribution contain the publication date (20221128)
Release Notes: This release includes updates for COVID-19 related Recipient/Caregiver Fact Sheet Vaccine Information Statement (VIS) codes and maps.
Release notes are designed as a guide to highlight changes that have been made to the vaccine codes since the last publication. They should not be used as the primary source of code information. The vaccine code files themselves should be utilized.
COVID-19 Related VIS Code Updates
- Pfizer: On 11/19/2022 the FDA amended the Emergency Use Authorization (EUA) for Pfizer to add dizziness to the list of side effects that have been reported with these vaccines. This is reflected in the updated EUA Healthcare Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets. In addition, the authorization added information to the Healthcare Provide Fact Sheet for the under 5 years regarding the effectiveness of a 3-dose primary series in participants 6 months through 4 years of age.
- All three Pfizer EUA Recipient/Caregiver Fact Sheets have been updated with a new edition date of 11/22/2022.
See the following link for the latest CDC COVID-19 vaccine clinical guidance: Clinical Guidance for COVID-19 Vaccination | CDC
CDC's VIS Code Set incorporates codes for COVID-19 vaccine Emergency Use Authorization (EUA) Recipient/Caregiver Fact Sheets.
CDC-authored VIS documents will not be available for COVID-19 vaccines while under EUA. Under EUA, the FDA requires a vaccine-specific Fact Sheet for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) be provided to vaccine recipients or their caregivers (similar to Vaccine Information Statements for licensed vaccines). Each EUA Recipient/Caregiver Fact Sheet is developed by the manufacturer and authorized by the FDA. The COVID-19 vaccine related codes in this code set release are provided in anticipation of potential vaccine availability under EUA. If the vaccines are not authorized, these codes will be retired.
In addition to the FDA's EUA Fact Sheets for Recipients/Caregivers, the CDC may provide additional or updated clinical guidance for products under EUA. See the following link for the latest CDC COVID-19 vaccine clinical guidance: Clinical Guidance for COVID-19 Vaccination | CDC
- Updated Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet-12 years and older"
- Existing Barcode String: 253088698300033211210501
- New Edition Date: 11/22/2022
- New Last Updated date: 11/22/2022
- All other information remains the same
- Updated Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric 5yrs to <12 yrs"
- Existing Barcode String: 253088698300042411211001
- New Edition Date: 11/22/2022
- New Last Updated date: 11/22/2022
- All other information remains the same
- Updated Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric <5 yrs"
- Existing Barcode String: 253088698300048611220101
- New Edition Date: 11/22/2022
- New Last Updated date: 11/22/2022
- All other information remains the same
The above updates impact the following two VIS code files:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
The table on CDC's COVID-19 Related Vaccine Codes website: "COVID-19 Emergency Use Authorization Recipient and Caregiver Fact Sheets," has also been updated to reflect these changes.
Important Considerations:
The CDC is working to facilitate documentation of having provided an EUA Fact Sheet for Recipients/Caregivers in electronic medical records/immunization information systems (EMRs/IISs). As such, the VIS code set is being used to provide the EUA Recipient/Caregiver Fact Sheet codes for EHRs/EMRs for use in a manner analogous to the electronic system and workflow documentation of VIS. As with VIS documents, the COVID-19 Vaccine Recipient/Caregiver Fact Sheets will incorporate the CDC's scannable 2D barcode in the Fact Sheet document. The numeric string for a CDC 2D barcode is included for each EUA Fact Sheet record in the data code set for this release.
