Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Muscular weakness, Nausea, Pain
Clinical narrative: Pain on the injection site and shoulder; Pain on shoulder; Lost of vision; Dizziness; Headache; Nausea (but not vomiting); feeling weak on all of her muscles; Body soreness; This serious case was reported by a other health professional via call center representative and described the occurrence of loss of vision in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 1234M24Z, expiry date 31-JUL-2026) for prophylaxis.   On 22-MAY-2024, the patient received the 1st dose of Bexsero. In MAY-2024, an unknown time after receiving Bexsero, the patient experienced general body pain (Verbatim: Body soreness). On 22-MAY-2024, the patient experienced generalized muscle weakness (Verbatim: feeling weak on all of her muscles). On 23-MAY-2024, the patient experienced loss of vision (Verbatim: Lost of vision) (serious criteria GSK medically significant), dizziness (Verbatim: Dizziness), headache (Verbatim: Headache) and nausea (Verbatim: Nausea (but not vomiting)). On an unknown date, the patient experienced injection site pain (Verbatim: Pain on the injection site and shoulder) and shoulder pain (Verbatim: Pain on shoulder). The outcome of the loss of vision, generalized muscle weakness, dizziness, headache, nausea and general body pain were not resolved and the outcome of the injection site pain and shoulder pain were unknown.   It was unknown if the reporter considered the loss of vision, injection site pain, shoulder pain, generalized muscle weakness, dizziness, headache, nausea and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the loss of vision to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, shoulder pain, generalized muscle weakness, dizziness, headache, nausea and general body pain 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: 03-JUN-2024 The healthcare professional (HCP) reported the patient received Bexsero and on the same day after the vaccination had a short swim practice and later, she started feeling weak on all of her muscles.  On the next day of vaccine around midday the patient felt dizziness, headache, nausea (but not vomiting) and loss of vision. The patient also had pain on the injection site and shoulder. On this 2nd day, the mother of the patient took vital signs and the patient looked well but she continued to had body soreness, nausea and dizziness.  The HCP reported that after the 2nd day of the vaccine, all these symptoms keep going for the rest of the week.  The patient had lunch before all these symptoms. The reporter asked us if it would be okay to administrate the 2nd dose to this patient. The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up.; Sender's Comments: Blindness is an unlisted event which is considered unrelated to GSK vaccine  Bexsero and Bexsero Pre-Filled Syringe Device.