Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | YA344 | — |
nodule at the injection site that is still present; patient has a swelling that it has not gone away since then; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site nodule in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number YA344, expiry date 31-JAN-2026) for prophylaxis. On 17-MAY-2024, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site nodule (Verbatim: nodule at the injection site that is still present) and swelling (Verbatim: patient has a swelling that it has not gone away since then). The outcome of the injection site nodule and swelling were not resolved. It was unknown if the reporter considered the injection site nodule and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site nodule and 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-FEB-2025 The medical assistant report that a patient received a dose of Bexsero and had a nodule at the injection site that was still present, patient had a swelling that it had not gone away since she received the dose. The health care professional wanted clinical advice, what they could did.