Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | UNK | — |
Guillain Barre syndrome; Eyelid operation; Lumbar puncture abnormal; Malaise; This serious case was reported by a pharmacist via regulatory authority and described the occurrence of guillain barre syndrome in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. On 14-AUG-2016, the patient received the 1st dose of Bexsero. On an unknown date, several weeks after receiving Bexsero, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), eyelid operation (Verbatim: Eyelid operation) (serious criteria clinically significant/intervention required), lumbar puncture abnormal (Verbatim: Lumbar puncture abnormal) and malaise (Verbatim: Malaise). The outcome of the guillain barre syndrome, eyelid operation, lumbar puncture abnormal and malaise were unknown. The reporter considered the guillain barre syndrome to be probably related to Bexsero. It was unknown if the reporter considered the eyelid operation, lumbar puncture abnormal and malaise to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the guillain barre syndrome to be related to Bexsero Pre-Filled Syringe Device. The company considered the guillain barre syndrome, eyelid operation, lumbar puncture abnormal and malaise to be unrelated to Bexsero and Bexsero 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: Additional details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient was 18 years. The patient never received the second dose of Bexsero. The patient became sick within a few weeks after the first dose. The guillain barre syndrome was confirmed with a lumbar puncture and the patient required eyelid surgery. Follow up information received on 22-OCT-2025 Summary of changes: Reporter information and event tab updated.; Sender's Comments: A case of Guillain-Barre syndrome, Eyelid operation, Lumbar puncture abnormal and Malaise, Several weeks after receiving 1st dose of Bexsero and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE, in a 18-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Test Name: lumbar puncture; Result Unstructured Data: (Test Result:Guillain Barre syndrome,Unit:unknown,Normal Low:,Normal High:); Comments: on an unknown date, the lumbar puncture test was performed.