Received May 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | UNK | LA |
pain at injection site; Fatigue; Skin sensitivity/hyperesthesia; Alternating sweating and being really cold; Weird dreams; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. On 19-MAY-2025, the patient received the 1st dose of Bexsero (left arm) and COVID-19 vaccine. On 19-MAY-2025, less than a day after receiving Bexsero, the patient experienced abnormal dreams (Verbatim: Weird dreams). On 20-MAY-2025, the patient experienced injection site pain (Verbatim: pain at injection site), fatigue (Verbatim: Fatigue), hyperesthesia skin (Verbatim: Skin sensitivity/hyperesthesia) and cold sweat (Verbatim: Alternating sweating and being really cold). On 20-MAY-2025, the outcome of the abnormal dreams was resolved (duration 1 day). The outcome of the injection site pain, fatigue, hyperesthesia skin and cold sweat were not resolved. The reporter considered the injection site pain, fatigue, hyperesthesia skin, abnormal dreams and cold sweat to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the injection site pain, fatigue, hyperesthesia skin, abnormal dreams and cold sweat 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: 20-MAY-2025 The reporter reported that a male patient had received first dose of Bexsero vaccine at the same time as the Covid booster vaccine and experienced fatigue, pain at injection site, skin sensitivity or hyperesthesia, weird dreams and alternating sweating and being really cold (never in the middle). It was reported that fatigue, pain at injection site, skin sensitivity or hyperesthesia and alternating sweating and being cold had worsened. The weird dreams occurred the night that he received the vaccines.