Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient received Shingrix. After receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 11-SEP-2025 Reporter called to report a temperature excursion involving Shingrix vaccines. The reporter stated that the vaccines were exposed to a temperature of 32.8?degree C for 93 hours, with no prior excursions reported. During the call, the healthcare professional inquired about the stability of Boostrix and Shingrix following the excursion. They also mentioned that 6 doses of Boostrix and 4 doses of Shingrix had already been administered to 10 different patients after the temperature deviation. They asked whether revaccination would be necessary for the affected individuals. This case is 1 of 6 cases reported by same reporter.; Sender's Comments: US-GSK-US2025117354:same reporter US-GSK-US2025117369:same reporter, Different patient US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117367:same reporter, different patient US-GSK-US2025117361:same reporter, different patient US-GSK-US2025117369:same reporter, different patient US-GSK-US2025117358:same reporter