Received May 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENMENVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
redness at injection site; swelling at injection site; welt 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 adult patient who received Men ABCWY NVS (Penmenvy) for prophylaxis. In MAY-2026, the patient received the 1st dose of Penmenvy (unknown arm). In MAY-2026, less than a week after receiving Penmenvy, the patient experienced injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling at injection site) and injection site wheal (Verbatim: welt at injection site). In MAY-2026, the outcome of the injection site erythema, injection site swelling and injection site wheal were resolved. The reporter considered the injection site erythema, injection site swelling and injection site wheal to be related to Penmenvy. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site wheal to be related to Penmenvy Pre-Filled Syringe Device. The company considered the injection site erythema, injection site swelling and injection site wheal to be related to Penmenvy. It was unknown if the company considered the injection site erythema, injection site swelling and injection site wheal to be related to Penmenvy 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-MAY-2026 Patient had redness, swelling, and welt at injection site after first dose of Penmenvy that resolved with ice. The batch number was not provided upon follow- up with the reporter.