Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | DH382 | — |
pregnant accidentally received 1st dose; pregnant accidentally received a second dose; Live birth; received a second dose of Boostrix; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of live birth in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number DH382) for prophylaxis. On 03-AUG-2023, the patient received the 2nd dose of Boostrix. In JUL-2023, the patient received the 1st dose of Boostrix. On 03-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: received a second dose of Boostrix). The patient experienced live birth (Verbatim: Live birth). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant accidentally received 1st dose) and vaccine exposure during pregnancy (Verbatim: pregnant accidentally received a second dose). The outcome of the live birth, vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 30 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Details (Neonate 1): Actual Delivery Date: Delivery Type: vaginal Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 3270 grams (7lbs 3oz) Delivery Notes: The healthy baby was born at 38 weeks, 6 days gestation, baby's length was 48.3 centimeter (19 inches) and head circumference was 31.5 centimeter 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: 03-AUG-2023 The pharmacist reported that patient was 30 weeks pregnant when she accidentally received the second dose of Boostrix. The patient administered first dose of Boostrix (batch numer DH382) two weeks prior of second dose (July2023). The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. Follow-up information received on 07-MAY-2024. A previous report was received because a pregnant women received a second Boostrix dose in error. The patient and her baby was discharged on postpartum day 1. Summary of changes: The patient's pregnancy details, event details and narrative were 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.