Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENMENVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 5S723 | — |
Hypotension; Syncope; This serious case was reported by a nurse via sales rep and described the occurrence of syncope in a 16-year-old male patient who received Men ABCWY NVS (Penmenvy) suspension for injection in pre-filled syringe (batch number 5S723) for prophylaxis. On 15-MAY-2026, the patient received the 1st dose of Penmenvy. On 15-MAY-2026, less than a day after receiving Penmenvy, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant). On an unknown date, the patient experienced hypotension (Verbatim: Hypotension). On 15-MAY-2026, the outcome of the syncope was resolved. The outcome of the hypotension was not reported. The reporter considered the syncope to be related to Penmenvy. It was unknown if the reporter considered the hypotension to be related to Penmenvy and Penmenvy Pre-Filled Syringe Device. It was unknown if the reporter considered the syncope to be related to Penmenvy Pre-Filled Syringe Device. The company considered the syncope 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: 03-JUN-2026 The patient had been afraid to get vaccinated. The patient had experienced dizziness, hypotension, sweaty and never completely fainted. The batch number was not provided upon follow up with the reporter; Sender's Comments: A case of Syncope, less than a day after receiving 1st dose of Penmenvy and Men ABCWY Vaccine + OMV PRE-FILLED SYRINGE DEVICE in a 16-year-old female patient. Case lacks further information on medical history, concurrent conditions concomitant medications and laboratory data. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.