Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M77CC | — |
pregnant women recived Boostrix vaccine; mentioned that they began to present swelling that exceeded the 50 mm; mentioned that they began to present redness that exceeded the 50 mm; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis. On 11-FEB-2025, the patient received Boostrix. On 11-FEB-2025, less than a day after receiving Boostrix, the patient experienced erythema (Verbatim: mentioned that they began to present redness that exceeded the 50 mm). On 12-FEB-2025, the patient experienced swelling (Verbatim: mentioned that they began to present swelling that exceeded the 50 mm). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant women recived Boostrix vaccine). The outcome of the erythema, swelling and vaccine exposure during pregnancy were unknown. It was unknown if the reporter considered the erythema and swelling to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the erythema and swelling to be related to Boostrix and Boostrix Pre-Filled Syringe Device. Pregnancy exposure: Gestation time at first exposure (Boostrix): 36 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Estimated Delivery/Due date: 27-FEB-2025 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: 13-FEB-2025 The pharmacist contacted GlaxoSmithKline to request data on how long grade 3 swelling and redness lasted before they resolved, mentioning that a patient 36 weeks pregnant received a dose of Boostrix. However, they mentioned that they began to present swelling and redness that "exceeded the 50 mm" described in the prescribing information. They wished to know if they had data on how long it took for the symptoms to resolve. The Vaccine Administration Facility is the same as Primary Reporter.