Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | EB499 | — |
Arm swelling; This non-serious case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 45-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis. On 09-JUN-2025, the patient received Boostrix. In JUN-2025, less than 2 weeks after receiving Boostrix, the patient experienced swelling arm (Verbatim: Arm swelling). The outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the swelling arm to be related to Boostrix and Boostrix Pre-Filled Syringe Device. 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: 17-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter The GlaxoSmithKline Account Manager called to report a Practice Manager mentioning the administration of Boostrix to a patient last week. GlaxoSmithKline Account Manager did not provide any vaccination date and no patient demographics at all and only provided lot number (no other vaccine detail). Account Manager requested a call back to the Practice Manager. Once the call back was successful, the Practice Manager confirmed all the vaccination date, vaccine detail and patient demographics. No Medical Information question or concern arise in this call back.; Sender's Comments: US-GSK-US2025075892:same reporter /different patient US-GSK-US2025075892:same reporter /different patient