Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M4E4A | — |
third trimester of pregnancy (28 weeks gestation), received Boostrix; 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 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis. On 11-DEC-2023, the patient received Boostrix. On 11-DEC-2023, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: third trimester of pregnancy (28 weeks gestation), received Boostrix). The outcome of the vaccine exposure during pregnancy was unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Lost to follow up 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: 13-DEC-2023 A nurse reported that, the patient in her third trimester of pregnancy (28 weeks gestation), received Boostrix, which led to vaccine exposure during pregnancy. The date of last menstrual period and estimated delivery date were unknown. Nothing else was reported. The reporter consented to follow up. Follow-up information received on 20-SEP-2024 and 17-OCT-2024 VAERS details were updated. This pregnancy case was now considered lost to follow-up. Summary of Changes: FU Tracking memo in general tab updated, pregnancy outcome updated as lost to follow-up and narrative updated. 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.