Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4YA34 | — |
Patient pregnant/ had given the Boostrix vaccine to pregnant patient unknowingly; Vaccines administered after temp excursion; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4YA34, expiry date 05-NOV-2027) for prophylaxis. On 02-OCT-2025, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient pregnant/ had given the Boostrix vaccine to pregnant patient unknowingly) and incorrect storage of drug (Verbatim: Vaccines administered after temp excursion). The outcome of the vaccine exposure during pregnancy and incorrect storage of drug were not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 14-NOV-2025 Nurse reported that several patients were given Flulaval and Boostrix that had a high temperature excursion. Their refrigerator was out of range they found out it was broken and they were not receiving alerts that the temperatures were too high. So, while this was happening, they had given the Flulaval and Boostrix vaccine to their pregnant patients unknowingly. Problem started happening from 30-SEP-2025. Also, it was not confirmed whether all patients were affected as the time for excursion was yet to be determined but they believed few were affected during this time frame. This was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments: US-GSK-US2025AMR148674:Same reporter, different patient US-GSK-US2025AMR148675:Same reporter, different patient US-GSK-US2025AMR148676:Same reporter, different patient US-GSK-US2025AMR148677:Same reporter, different patient US-GSK-US2025AMR148673:Same reporter, different patient US-GSK-US2025AMR148672:Same reporter, different patient US-GSK-US2025AMR148678:Same reporter, different patient US-GSK-US2025AMR148670:Same reporter, different patient US-GSK-US2025148281:Same reporter, different patient US-GSK-US2025AMR148671:Same reporter, different patient