Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | PG3RP | — |
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number PG3RP, expiry date 11-JUL-2027) 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: Vaccine stored outside recommended conditions and administered to patient). 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: 21-APR-2025 The nurse called to report a temperature excursion and to determine the next steps regarding the vaccines. The vaccine in question was Boostrix, the only one affected. The highest temperature it reached was 11.2 degrees Celsius, and it had been out of temperature range for 55 days. These dose had already been administered to patient. This case is linked with US2025048454, reported by same reporter.; Sender's Comments: US-GSK-US2025048454:same reporter