Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | CX4HL | — |
Drug Exposure During Pregnancy; Drug Exposure During Pregnancy; Extra dose; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis. On 20-SEP-2024, the patient received the 2nd dose of Boostrix. On 03-SEP-2024, the patient received the 1st dose of Boostrix. On 20-SEP-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy) and vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in second trimester Pregnancy Exposure (Boostrix): To mother in second trimester Estimated Delivery/Due date: 02-DEC-2024 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: 24-SEP-2024 The reporter had a patient, who was pregnant, and who received the Tdap on 03-SEP-2024, and then another one on 20-SEP-2024, and reporter need to know if GSK had any research or data that know like any effects or anything like that. The reporter mentioned that both vaccines where administer during the 2nd pregnancy trimester of the patient. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Boostrix during pregnancy, which led to extra dose administered. Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated.