Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 2YY25 | — |
large local reaction/took about a month for her arm to go back to normal; This non-serious case was reported by a nurse via call center representative and described the occurrence of arm discomfort in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2YY25) for prophylaxis. Previously administered products included Prevenar (received Prevenar 20 on an unknown date and had large local reaction). On 02-JUL-2018, the patient received the 1st dose of Boostrix. In JUL-2025, several hours after receiving Boostrix and several hours after starting Boostrix, the patient experienced arm discomfort (Verbatim: large local reaction/took about a month for her arm to go back to normal). The outcome of the arm discomfort was resolved (duration 1 month). It was unknown if the reporter considered the arm discomfort to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the arm discomfort 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: 16-SEP-2025 Nurse reported that a patient had some reactions to couple of vaccines and they wanted to see is that if there is a common ingredient between the 2 vaccines, one of them was Tdap the Boostrix. Patient had a large local reaction with Prevenar 20 and then in 2018 she received what they believe to be Tdap and got a very large reaction to that and it seemed that both of those they started within hours, over subsequent days and it took about a month for her arm to go back to normal. The Prevenar 20 was administered in JUN-2025 and second dose of Tdap was received by the patient on 01-NOV-2018, however for the 2nd dose, they are not sure if this was a Boostrix vaccine.