Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | UNK | LA |
Pain in arm; she is unable to continue daily activities; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. In APR-2025, the patient received the 1st dose of Bexsero (left arm). In APR-2025, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: Pain in arm) and activities of daily living impaired (Verbatim: she is unable to continue daily activities). The outcome of the pain in arm and activities of daily living impaired were not reported. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero 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: 23-APR-2025 Physician called to report that she has a 17.5-year-old female patient who received her first dose of Bexsero last week. Since then, the patient has had severe arm pain to the point where she is unable to continue daily activities. Patient stated that she was aware this is a side effect listed in the package insert but it is more severe than she has heard of in any patient and requested that report the incident. She would like any follow up and guidance of how to assist the patient.