Received Feb 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 9429J | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
received a dose of Boostrix at 28 weeks; received a dose of Boostrix at 37 weeks; then mistakenly received another dose at 37 weeks; 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 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9429J, expiry date 19-MAR-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 27-JAN-2025, the patient received the 2nd dose of Boostrix. On an unknown date, the patient received the 1st dose of Boostrix. On 27-JAN-2025, an unknown time after receiving Boostrix and Boostrix, the patient experienced extra dose administered (Verbatim: then mistakenly received another dose at 37 weeks). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: received a dose of Boostrix at 28 weeks) and vaccine exposure during pregnancy (Verbatim: received a dose of Boostrix at 37 weeks). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 37 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing 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: 28-JAN-2025 The nurse reported that they had a pregnant who received a dose of Boostrix at 28 weeks and then mistakenly received another dose at 37 weeks, which led to extra dose administered and vaccine exposure during pregnancy. The Vaccine Administration Facility was the same as Primary Reporter