Received Apr 25, 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 female 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 find out what to, what we should be doing moving forward with the vaccines. The name of the vaccine is Boostrix, was the only one, the highest temperature it reached was 11.2 degrees Celsius it was been out of temperature for 55 days. These have been administered to a patient which led to incorrect storage of drug. This case has been linked to the US2025048460 case reported by the same reporter.; Sender's Comments: US-GSK-US2025048460:same reporter