Received Jun 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | N4935 | — |
Unstable Boostrix after temperature excursion administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) suspension for injection in pre-filled syringe (batch number N4935 with expiry date 19-MAY-2028) for prophylaxis. Co-suspect products included HBV (Engerix B) solution for injection for prophylaxis. On 14-APR-2026, the patient received Boostrix. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Boostrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Unstable Boostrix after temperature excursion administration). 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: 03-JUN-2026 The pharmacist wanted to get information on the administration of 6 vaccines (5 Boostrix and 1 Engerix B) that went through a temperature excursion (15.3 degree Celcius as the maximum for 706 hours, no longer stable). The vaccine administration facility was the same as primary reporter. The batch number was not provided upon follow up with the reporter.