Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Dd72h | LA |
site developed a knot; administered the vaccine with the air pocket in the prefilled syringe; Arm swelling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site nodule in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number Dd72h) for prophylaxis. On 13-MAR-2025, the patient received Bexsero (left arm). On 13-MAR-2025, less than a day after receiving Bexsero, the patient experienced swelling arm (Verbatim: Arm swelling). On an unknown date, the patient experienced injection site nodule (Verbatim: site developed a knot) and wrong technique in product usage process (Verbatim: administered the vaccine with the air pocket in the prefilled syringe). The outcome of the injection site nodule, swelling arm and wrong technique in product usage process were unknown. It was unknown if the reporter considered the injection site nodule and wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The reporter considered the swelling arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site nodule and wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the swelling arm 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: 07-APR-2025 Other HCP reported that they followed updated guidelines and administered the vaccine with the air pocket in the prefilled syringe, which led to wrong technique in product usage process. Reporter stated that right away the site developed a knot.