Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M4E4A | — |
pregnant patient received 2 doses of Boostrix approximately 14 days apart; pregnant patient received 2 doses of Boostrix approximately 14 days apart; pregnant patient received 2 doses of Boostrix approximately 14 days apart; 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 27-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 23-AUG-2023, the patient received Boostrix. On 09-AUG-2023, the patient received Boostrix. On 23-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart) and vaccine exposure during pregnancy (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 29 Weeks Pregnancy Exposure (Boostrix): Trimester unknown Gestation time at first exposure (Boostrix): 27 Weeks Pregnancy Exposure (Boostrix): Trimester unknown Last Menstrual Period Date: 01-FEB-2023 Estimated Delivery/Due date: 08-NOV-2023 Pregnancy Details (Neonate 1): Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date 25 August 2023: A registered nurse called in to report that a pregnant patient received 2 doses of Boostrix approximately 14 days apart and wished to know how to proceed. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. The patient received 2 doses of Boostrix approximately 14 days apart which led to extra dose administered and vaccine exposure during pregnancy. Follow up information received on 22-Sep-2023. Summary of changes: The patient tab 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 and narrative were updated.