Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | — | — |
tunnel vision; hearing loss; almost passing out/ she was almost passed out this morning; severe headache; muscle pain; lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days; can barely walk/ not being able to walk; Fatigue; This serious case was reported by a physician via call center representative and described the occurrence of tunnel vision in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received first dose on an unknown date, refer case US2025AMR109704). On 11-AUG-2025, the patient received the 2nd dose of Bexsero. In AUG-2025, 2 days after receiving Bexsero, the patient experienced tunnel vision (Verbatim: tunnel vision) (serious criteria GSK medically significant), hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), presyncope (Verbatim: almost passing out/ she was almost passed out this morning) (serious criteria GSK medically significant), headache (Verbatim: severe headache), muscle pain (Verbatim: muscle pain), supraclavicular lymph nodes enlarged (Verbatim: lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days), unable to walk (Verbatim: can barely walk/ not being able to walk) and fatigue (Verbatim: Fatigue). The outcome of the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue were not resolved. The reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. The company considered the tunnel vision, hearing loss and presyncope to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to 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. Linked case(s) involving the same patient: US2025AMR109704 Additional Information: GSK Receipt Date: 18-AUG-2025 On 18 August 2025, a physician called to inform her college-aged daughter just starting freshman year on last Monday took her for a Bexsero second vaccine, she got it at a pharmacy, and on Tuesday was brought to her to school. She did fine with the first dose, but the arm was very sore way back. However, within two days of receiving the second dose, she began experiencing severe systemic symptoms. She developed a severe headache, headache, fatigue, lymphadenopathy. The reporter stated as she walks feels like almost passing out, she started to get tunnel vision, muscle pain and her lymph nodes are all dilated and painful supraclavicular even, like out of the blue. The reporter enquired if patient was having cancer as the lymph were enlarged, she ended up going, her roommate took her to the hospital, yesterday emergency (not hospitalized) She had a CAT scan of the neck, head and chest because she got lymphadenopathy up the wazoo, huge, painful in the sentinel area/ supraclavicular. She was going to student services they may have to put her in the hospital as she had almost passed out this morning with tunnel vision and hearing loss. The reporter stated that her daughter (patient) was not immunocompromised and did not have any weight loss or fatigue. There were no signs of lymphoma (like she was getting some signs of issues before). Her daughter was a healthy and happy kid. The patient had sentinel area with huge lymph nodes and then another hard lymph node. The patient had severe headaches and, all of a sudden, upon getting up, was unable to walk, requiring her to lie back down. She experienced fatigue and muscle aches in her legs and the back of her shoulders. Today, this morning, a mono test that was run came back negative. The patient was going to try to get a TB test since she had been out of the country. She has no coughing or respiratory condition. The reporter stated it was all systemic and when she looked at GlaxoSmithKline list of things it included fatigue, severe headaches, muscle aches, and maybe even lymphadenopathy, she feels like it was all related. The reporter mentioned that now, a week later, the patient was still experiencing symptoms. They were continuing to evaluate what steps needed to be taken next. The patient was not immunocompromised.; Sender's Comments: A case of Tunnel vision, Deafness and Presyncope, 2 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device in a 18-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. US-GSK-US2025AMR109704:same reporter
Test Date: 20250818; Test Name: CAT scan; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250818; Test Name: mono test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)