Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4YA34 | — |
Patients pregnant; 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 11-MAY-2027) for prophylaxis. On 01-OCT-2025, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Patients pregnant) 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 patient was given Boostrix that had a high temperature excursion. Their refrigerator was out of range we 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 Boostrix vaccine to our pregnant patient unknowingly. Problem started happening from September 30th and they had given to different patients. Nurse would call back with and provide this after seeking permission from patients due to all 11 patients involved were pregnant, also its not confirmed whether all patients was affected as the time for excursion was yet to be determined but they believe few were affected during this time frame. Same lot number and expiration for Boostrix and Flulaval respectively. This was 1 out of 11 linked cases, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025AMR148674: US-GSK-US2025AMR148675: US-GSK-US2025AMR148676: US-GSK-US2025AMR148677: US-GSK-US2025AMR148673: US-GSK-US2025AMR148672: US-GSK-US2025AMR148678: US-GSK-US2025AMR148670: US-GSK-US2025AMR148669: US-GSK-US2025AMR148671: