Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | UNK | — |
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | — |
Injection site redness/local reaction of redness at injection site; local reaction of swelling at injection site; local reaction of heat at injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero (unknown arm) and Menveo (unknown arm). On an unknown date, an unknown time after receiving Bexsero and Menveo, the patient experienced injection site erythema (Verbatim: Injection site redness/local reaction of redness at injection site), injection site swelling (Verbatim: local reaction of swelling at injection site) and injection site warmth (Verbatim: local reaction of heat at injection site). The outcome of the injection site erythema was resolved and the outcome of the injection site swelling and injection site warmth were not reported. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. It was unknown if the company considered the injection site erythema, injection site swelling and injection site warmth to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. 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: 24-JAN-2025 The reporter reported that a patient received Bexsero and Menveo in same arm at different sites during same visit and experienced local reaction of redness, swelling, heat at injection site and returned to clinic to be evaluated by physician. Physician did not think site was infected. Physician advised patient to treat with cold compress. Patient did not return for repeat evaluation.