Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3959S | IM / LA |
Pt came in to health department for second dose of Shingrix. Nurse on clinic has never given this particular vaccine before and was unaware that the dilutent was included in the box with single does vials. Nurse reconstituted dose with sterile water. Vaccine was administered. Approx 1.5 weeks later during inventory the dilutent was was discovered left in the fridge. It was then discovered vaccine was reconstituted incorrect agent. Nurse that administered vaccine was made aware at this time. CDC was contacted for further advice at this time. Administering nurse reviewed Education material sent by CDC. Below is the answer from the CDC: Question: A dose of Shingrix was given with the sterile MMR/varicella diluent instead of the diluent provided in the box, does this dose of vaccine count or does it need to be repeated? If it does need repeated does there need to be an interval between the doses? CDC Response: Yes, the dose needs to be repeated. Diluents are not interchangeable unless specified by the manufacturer, and vaccine doses prepared using the wrong diluent are invalid. The diluent required to reconstitute the lyophilized component of Shingrix contains an AS01B adjuvant, which helps create a stronger immune response in people receiving the vaccine. The MMR/varicella diluent is unadjuvanted sterile water. The two diluents are not interchangeable; therefore, this was a vaccination error. Because the vaccination was invalid, the dose must be repeated. Since the vaccine is non-live and administered without the approved diluent, the repeated dose can be administered at any interval after the invalid dose (no minimum interval recommended). For all vaccine administration error: Inform the recipient of the vaccine administration error. Consult with the state immunization program and / or immunization information system (IIS) to determine how the dose should be entered into the ISS. Determine how the error occurred and implement strategies to prevent it from happening again. A discussion on strategies to prevent errors can be found in the "Vaccine Administration" chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Additional resources can be found on the CDC's vaccine administration web page, including a job aid for preventing errors. In addition, if not already done, we encourage you to report this error to the Vaccine Adverse Event Reporting System (VAERS) event if the patient has not symptoms. Reports to VAERS are important because they can help CDC and Food and Drug Administration (FDA) detect new or unusual adverse events or patterns that could indicate a problems with vaccines. To file an electronic report, see the VAERS website.