Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | A274J | RA |
develop a BB like bump on the injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number A274J) for prophylaxis. On 03-MAR-2025, the patient received the 1st dose of Bexsero (right arm). On 03-MAR-2025, less than a day after receiving Bexsero, the patient experienced injection site swelling (Verbatim: develop a BB like bump on the injection site). The outcome of the injection site swelling was resolving. The reporter considered the injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the injection site swelling 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: 27-MAR-2025 The mother of patient was a Medical Assistant. The patient had small BB like bump at the injection site and was reported as worsened. It had gone down a little but the bump still was there.