Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENMENVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | LA |
Rash; Inappropriate age at vaccine administration; This serious case was reported by a physician via sales rep and described the occurrence of rash in a 8-day-old female patient who received Men ABCWY NVS (Penmenvy) for prophylaxis. On 21-JAN-2026, the patient received the 1st dose of Penmenvy (left deltoid). On 21-JAN-2026, an unknown time after receiving Penmenvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 22-JAN-2026, the patient experienced rash (Verbatim: Rash) (serious criteria other: Serious as per reporter). The outcome of the rash was resolving and the outcome of the inappropriate age at vaccine administration was not applicable. The reporter considered the rash to be related to Penmenvy. It was unknown if the reporter considered the rash to be related to Penmenvy Pre-Filled Syringe Device. The company considered the rash to be unrelated to Penmenvy and 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 16-FEB-2026 The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Rash (BCWG Level 3), unknown time after receiving Penmenvy and Penmenvy PRE-FILLED SYRINGE DEVICE, in a 8-day-old female patient. Case lacks further information on medical history, concurrent conditions and relevant laboratory results. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.