Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | IM / LA |
pain around the injection site; swelling around the injection site; Injection site warmth; redness around the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 21-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. On 12-AUG-2025 18:30, the patient received Bexsero (intramuscular, left deltoid). On 13-AUG-2025, 1 days after receiving Bexsero, the patient experienced injection site pain (Verbatim: pain around the injection site), injection site swelling (Verbatim: swelling around the injection site), injection site warmth (Verbatim: Injection site warmth) and injection site erythema (Verbatim: redness around the injection site). The outcome of the injection site pain, injection site swelling, injection site warmth and injection site erythema were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site swelling, injection site warmth and injection site erythema 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: 15-AUG-2025 The reporter reported that patient received Bexsero vaccination and from beginning the following morning experienced pain, swelling, redness and swelling at and around the injection site. It has not yet subsided. No further information was obtained in this call.