Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | IM |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
pregnant woman in her 36.1 week of pregnancy, receive the Boostrix; already had the Boostrix during this pregnancy; However, looking back the woman already had the Boostrix during this pregnancy,; 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 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 24-SEP-2024, the patient received the 2nd dose of Boostrix (intramuscular). On an unknown date, the patient received the 1st dose of Boostrix. On 24-SEP-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: However, looking back the woman already had the Boostrix during this pregnancy,). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant woman in her 36.1 week of pregnancy, receive the Boostrix) and vaccine exposure during pregnancy (Verbatim: already had the Boostrix during this pregnancy). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): Trimester unknown 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 health care professional reported that a pregnant patient in her 36.1 week of pregnancy, received the Boostrix on the day of reporting, which led to vaccine exposure during pregnancy. However, looking back the women already had Boostrix during this pregnancy, which led vaccine exposure during pregnancy and extra dose administered. The reporter was unsure of the date due to computer being down, no symptoms. Upon internal review the case was updated on 11-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated.