Sex: F
Vaccine: UNK, UNK
Symptoms: Computerised tomogram normal, Dizziness, Fall, Ligament sprain, Loss of consciousness
Clinical narrative: Fell when passed out; Passed out twice; left foot/ankle sprain; Urinary tract infection (UTI); Lower back had been bothering her; Pelvic area had been bothering her; Nausea; Dizziness; This case was reported by a other health professional via other manufacturer and described the occurrence of fall in a adult female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included eculizumab (Soliris) for neuromyelitis optica spectrum disorder.   Concurrent medical conditions included neuromyelitis optica spectrum disorder.   On 14th June 2022, the patient received Hz/su + AS01B. On an unknown date, the patient started Soliris 300 mg at an unknown frequency. On 14th June 2022, several hours after receiving Hz/su + AS01B, the patient experienced fall (serious criteria hospitalization), passed out (serious criteria hospitalization and GSK medically significant), sprained ankle (serious criteria hospitalization and clinically significant/intervention required), urinary tract infection (serious criteria hospitalization), musculoskeletal discomfort, pelvic discomfort, nausea and dizziness. The action taken with Soliris was unknown. In June 2022, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the fall, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness were unknown.   It was unknown if the reporter considered the fall, passed out, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 13-JUL-2022  Reporter's Comments: The patient received the varicella-zoster vaccine RGE (CHO) (Shingrix) (dose, route, and frequency were not reported). On an unspecified date, the patient initiated treatment with eculizumab (Soliris) (dose, route, and frequency were not reported) for the treatment of neuromyelitis optic (NMO). The most recent dose of Eculizumab administered prior to the onset of the events was not reported. The batch or lot number and expiration date were reported as unknown. The patient reported that she passed out twice following a varicella-zoster vaccine RGE (CHO) two weeks ago on 14th June 2022.  The patient passed out several hours after receiving that vaccine and then passed out later in the evening. The patient fell when she passed out resulting in a left foot or ankle sprain. The patient went to the emergency room for evaluation and they admitted her overnight.  The patient had an MRI (Magnetic resonance imaging) and CAT (computed tomography) scan with negative results.  The patient was diagnosed with a UTI (Urinary Tract Infection) while at the hospital. It was reported that her lower back and the pelvic area had been bothering her earlier that day. It was also reported that since the vaccine she had intermittent nausea and dizziness. The patient reported that it was her off week from Eculizumab the week she received the vaccine.  Action taken with eculizumab in response to the events was not reported.  The corrective treatment for the events was not reported.  The reporter requested additional information. It was unknown if the reporter considered the fall, passed out, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness to be related to Soliris.