Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENMENVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 5S723 | — |
Syncope; This serious case was reported by a nurse via sales rep and described the occurrence of syncope in a 16-year-old female patient who received Men ABCWY NVS (Penmenvy) suspension for injection in pre-filled syringe (batch number 5S723) for prophylaxis. Concurrent medical conditions included fear of injection (already afraid of getting vaccination). On 02-JUN-2026, the patient received the 1st dose of Penmenvy. On 02-JUN-2026, less than a day after receiving Penmenvy, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant). On 02-JUN-2026, the outcome of the syncope was resolved. The reporter considered the syncope to be related to Penmenvy. 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 received the first dose. The event was categorized as syncope. There was additional information indicating that the patient had fear of receiving the vaccine prior to administration. The patient was within an unspecified age category. Additional report information indicated that the patient had already been afraid of getting the vaccine. The patient experienced dizziness, hypotension, and sweating. The patient's blood sugar level was noted to be normal. The patient had never completely lost consciousness; 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.
Fear of injection (already afraid of getting vaccination)
Test Date: 20260602; Test Name: blood sugar; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:)