Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | XN575 | — |
Drug Exposure During Pregnancy; Extra dose to pregnant patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis. Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX). On 28-JAN-2025, the patient received the 2nd dose of Boostrix. On 28-JAN-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose to pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the extra dose administered and vaccine exposure during pregnancy were unknown. Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Estimated Delivery/Due date: 10-MAR-2025 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 medical assistant explained that they accidentally administered a second dose of Boostrix to a pregnant patient on 28th January 2025 which led to extra dose administered and vaccine exposure during pregnancy. First dose of Boostrix vaccine was administered on 19th December 2024.
BOOSTRIX