Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | LMN4C | — |
Shortness of breath; Arm weakness/leg weakness; general weakness; This non-serious case was reported by a other health professional via sales rep and described the occurrence of shortness of breath in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number LMN4C, expiry date 29-FEB-2028) for prophylaxis. Concurrent medical conditions included peanut allergy. On 23-JUL-2025, the patient received Bexsero. In JUL-2025, 6 hrs after receiving Bexsero, the patient experienced shortness of breath (Verbatim: Shortness of breath), weakness in extremity (Verbatim: Arm weakness/leg weakness) and weakness generalized (Verbatim: general weakness). The outcome of the shortness of breath and weakness in extremity were unknown and the outcome of the weakness generalized was not reported. It was unknown if the reporter considered the shortness of breath, weakness in extremity and weakness generalized to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the shortness of breath, weakness in extremity and weakness generalized to be related 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: GSK Receipt Date: 25-JUL-2025 The reporter reported that so whiting approximately 6 hours of receiving the vaccine (Bexsero), the patient was at work, and he had sudden unset leg and arm weakness, and shortness of breath. Apparently, he was recently being diagnoses with a peanut allergy, but he never had an episode. The reporter was thought he was preparing something at work with peanuts, so in the intervention they received epi pen, that did not do anything. Then he was taken to the emergency room. It sound that they did a chest x-ray and EKG, they did not really have a diagnose, other than general weakness. The vaccine administration facility was the same as primary reporter.
Peanut allergy
Test Date: 202507; Test Name: EKG; Result Unstructured Data: (Test Result:Not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 202507; Test Name: X-ray; Result Unstructured Data: (Test Result:Not reported,Unit:unknown,Normal Low:,Normal High:)