Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
10 different patients received a dose of Boostrix after a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a specified number of patients 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: 10 different patients received a dose of Boostrix 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: 18-JUL-2025 Registered nurse called to ask about the stability of Boostrix, after a temperature excursion of 12-degree Fahrenheit for 5 minutes. After agent confirmed the vaccines were not stable anymore the Nurse mentioned that they administered 10 doses of Boostrix after this temperature excursion to 10 different patients, which led to incorrect storage of drug. The reporter wants to ask that they need to revaccinate them or not. Nurse did not provide more details about initials, age or gender for the patients and did not have the lot number and expiration dates of the doses of Boostrix that were administered.