Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
patient received doses of Boostrix vaccine 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 DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: patient received doses of Boostrix vaccine after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-SEP-2025 Chief of pharmacy called to report that they had a temperature excursion and asked about the stability of Boostrix and Shingrix after a temperature excursion of 32.8 degree C for 93 hours. No prior excursion. HCP (health care professional) mentioned they administered 6 doses of Boostrix and 4 doses of Shingrix after this temperature excursion to 10 different patients and wanted to know do they need to revaccinate them. HCP only mentioned the initials of the patients who received the doses but did not provide further information about gender, age, lot number or expiration date. The batch number was not provided upon follow- up with the reporter. This was 1 of 10 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025117354:same reporter US-GSK-US2025117367:same reporter, different patient US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117358:same reporter US-GSK-US2025117361:same reporter US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117369:same reporter