Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Boostrix vaccines after a temperature excursion./The medication fridge had an excursion (32 degrees Celsius) that was outside of allowable limits; This non-serious case was reported by a other health professional 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: Boostrix vaccines after a temperature excursion./The medication fridge had an excursion (32 degrees Celsius) that was outside of allowable limits). 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 Reporter called to report a temperature excursion involving Boostrix and Shingrix vaccines. The Reporter stated that the vaccines were exposed to a temperature of 32.8?°C for 93 hours, with no prior excursions reported. During the call, the HCP 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. Follow up information received on 22-SEP-2025 There were no adverse events noted. The medication fridge had an excursion (32 degrees Celsius) that was outside of allowable limits. No adverse events were noted by the patients. Summary of changes: The primary reporter details and narrative were updated.; Sender's Comments: GSK-US2025117354:same reporter US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117361:same reporter US-GSK-US2025117358:same reporter US-GSK-US2025117367:same reporter, different patient US-GSK-US2025117369:same reporter