Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Paraesthesia, Restless legs syndrome, Swollen tongue, Walking aid user
Clinical narrative: hand numbness; hand tingling; Restless Leg Syndrome; walk with a walker; anxious; she can hardly write/out of work for 2 months; Spinal tap; bladder infection; hyperventilating; fallen 3 times in the middle of the night; Guillain-Barre after receiving Arexvy; abnormal Sodium levels; Peripheral Neuropathy; tongue swelling; flu-like symptoms; This serious case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9R25L, expiry date 21-MAR-2025) for prophylaxis.   The patient's past medical history included chronic obstructive pulmonary disease. Concurrent medical conditions included hypertension. Additional patient notes included the patient was heart patient (not specified). Concomitant products included isosorbide mononitrate.   On 29-OCT-2023, the patient received Arexvy (intramuscular, left deltoid) .5 ml. On 30-OCT-2023, 1 days after receiving Arexvy, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms) (serious criteria hospitalization). In NOV-2023, the patient experienced peripheral neuropathy (Verbatim: Peripheral Neuropathy) (serious criteria hospitalization and GSK medically significant) and swollen tongue (Verbatim: tongue swelling) (serious criteria hospitalization). On an unknown date, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre after receiving Arexvy) (serious criteria hospitalization and GSK medically significant), numbness in hand (Verbatim: hand numbness) (serious criteria hospitalization), tingling of extremity (Verbatim: hand tingling) (serious criteria hospitalization), restless legs syndrome (Verbatim: Restless Leg Syndrome) (serious criteria hospitalization), walker user (Verbatim: walk with a walker) (serious criteria hospitalization), anxiety (Verbatim: anxious) (serious criteria hospitalization), activities of daily living impaired (Verbatim: she can hardly write/out of work for 2 months) (serious criteria hospitalization), spinal tap (Verbatim: Spinal tap) (serious criteria hospitalization), bladder infection (Verbatim: bladder infection) (serious criteria hospitalization), hyperventilation (Verbatim: hyperventilating) (serious criteria hospitalization), fall (Verbatim: fallen 3 times in the middle of the night) (serious criteria hospitalization) and blood sodium abnormal (Verbatim: abnormal Sodium levels) (serious criteria hospitalization). The outcome of the guillain barre syndrome, peripheral neuropathy, restless legs syndrome, walker user, anxiety, activities of daily living impaired, bladder infection, hyperventilation, fall and blood sodium abnormal were not reported and the outcome of the numbness in hand, tingling of extremity, swollen tongue and influenza-like symptoms were not resolved and the outcome of the spinal tap was resolved.   It was unknown if the reporter considered the guillain barre syndrome, numbness in hand, tingling of extremity, restless legs syndrome, walker user, anxiety, activities of daily living impaired, spinal tap, bladder infection, hyperventilation, fall and blood sodium abnormal to be related to Arexvy. The reporter considered the peripheral neuropathy, swollen tongue and influenza-like symptoms to be possibly related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, numbness in hand, tingling of extremity, restless legs syndrome, walker user, anxiety, activities of daily living impaired, spinal tap, bladder infection, hyperventilation, fall and blood sodium abnormal to be related to Arexvy. The company considered the peripheral neuropathy, swollen tongue and influenza-like symptoms to be possibly related to Arexvy.   Additional Information: GSK Receipt date: 13-NOV-2023 The next day of vaccination, the patient stated she started flu-like symptoms, and then several days after that developed neuropathy in her feet as well as tongue swelling.  Pharmacist did not know exact start dates. The patient had been seen twice in the emergency room, and they believed this to be a reaction to the Arexvy vaccine.  At the time of reporting, the symptoms remain ongoing. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.   Follow up received on 14-DEC-2023 The patient reported that after Arexvy vaccine first 2 weeks symptoms started on her muscles, then started in her feet then rose up to the rest of her body. The patient had made 5 visits to the emergency room and during her first visit she was diagnosed with peripheral neuropathy and restless leg syndrome and was referred to a neurologist.  In another visit, she was told that she was hyperventilating and anxious and was referred to a psychiatrist. During this time, she had fallen 3 times in the middle of the night. The patient spent 10 days in the hospital, 7 days in the ICU and 11 days in a rehabilitation facility.  When the patient was in the intensive care unit, she had a spinal tap and was treated with an infusion for 5 days which helped her symptoms to get reverse. During her stay in the hospital the patient developed a bladder infection and had abnormal sodium levels. The patient stated that it was recorded in her records the final diagnosis of Guillain-Barre was due to the vaccine. The patient was using walker to walk. She could hardly write as her hands were still numb and were tingling. The patient had been out of work for 2 months. The patient was currently in the middle of reporting the adverse events to vaers. Summary of changes: Patient details, event details and narrative were updated.