Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
one of the patients did not receive the full vaccination; one of the patients did not receive the full vaccination; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: one of the patients did not receive the full vaccination) and inappropriate dose of vaccine administered (Verbatim: one of the patients did not receive the full vaccination). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 05-JUN-2025 and 06-JUN-2025 The reporter had a customer one day before the reporting date who informed that their patient did not receive both components of the Shingrix vaccine. The back office coordinator called and they had identified 7 patients that were given the Shingrix vaccination, however they discovered that their component vials did not match, so then they determined that one of the 7 patients only received the adjuvant part of Shingrix, so they did not know which patient received just the adjuvant, it was misadministered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Honestly, he did not tell that which, he/she was assuming it was the adjuvant part, he did not tell which vial, let's just say one of the patients did not receive the full vaccination, they only received 1 vial. The reporter did not do any of the patient's information, did know that this was all of their first shots in the series. Field representative did not have lot number or expiration date of the vaccines, but she mentioned: the back office coordinator would know that. Caller did not know either date of administration for any of the 7 patients. Field representative gave vaccine service center phone number to the healthcare provider, but they do not know if the healthcare provider already called. Field representative mentioned that the healthcare provider requested for protocols for the 7 patients, but for that the representative did a medical query already, so they covered, and no medical information case was open during this call; the caller was only contacting us today to report the adverse event to Safety Team. Field representative gave consent from her side to follow up with Safety Team, but she also mentioned that she does not have further details.