Age: 74.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Diplopia, Dysstasia, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: GBS; A-fib; double vision; his ankles and his calves were tightening up and getting harder for him to stand or walk; his ankles and his calves were tightening up and getting harder for him to stand or walk; his ankles and his calves were tightening up and getting harder for him to stand or walk; he wasn't in state that day; blood sugar went up; weaker; He had no reflexes from the knee down.; He had no reflexes from the knee down.; The pain in his legs; fatigue; This is a spontaneous report and received from Consumer or other non HCPs from Regulatory Authority. Regulatory number: 2744229-1 (VAERS ID).  A 74-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Dec2023 at 10:45 as dose 1, single (Lot number: 6215364) at the age of 74 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "A-fib" (unspecified if ongoing). Concomitant medication(s) included: JANUVIA; JARDIANCE; LIPITOR; METFORMIN; TRULICITY. The following information was reported: ATRIAL FIBRILLATION (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "recovered", described as "A-fib"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "not recovered", described as "GBS"; MUSCULOSKELETAL STIFFNESS (hospitalization, disability, life threatening), AREFLEXIA (hospitalization, disability, life threatening) all with onset 07Dec2023 at 08:00, outcome "not recovered" and all described as "He had no reflexes from the knee down."; PAIN IN EXTREMITY (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "not recovered", described as "The pain in his legs"; BLOOD GLUCOSE INCREASED (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "recovered", described as "blood sugar went up"; DIPLOPIA (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "not recovered", described as "double vision"; FATIGUE (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "not recovered"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "not recovered", described as "he wasn't in state that day"; MUSCLE TIGHTNESS (hospitalization, disability, life threatening), DYSSTASIA (hospitalization, disability, life threatening), GAIT DISTURBANCE (hospitalization, disability, life threatening) all with onset 07Dec2023 at 08:00, outcome "recovered" and all described as "his ankles and his calves were tightening up and getting harder for him to stand or walk"; ASTHENIA (hospitalization, disability, life threatening) with onset 07Dec2023 at 08:00, outcome "not recovered", described as "weaker". The patient was hospitalized for guillain-barre syndrome, atrial fibrillation, diplopia, muscle tightness, dysstasia, gait disturbance, loss of personal independence in daily activities, blood glucose increased, asthenia, musculoskeletal stiffness, areflexia, pain in extremity, fatigue (hospitalization duration: 5 day(s)). The events "gbs", "a-fib", "double vision", "his ankles and his calves were tightening up and getting harder for him to stand or walk", "he wasn't in state that day", "blood sugar went up", "weaker", "he had no reflexes from the knee down.", "the pain in his legs" and "fatigue" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: went up; back under control; Computerised tomogram: Unknown results; lot of testing: diagnosed with GBS; Unknown results, notes: tons of labs; Lumbar puncture: Unknown results. Therapeutic measures were taken as a result of guillain-barre syndrome, atrial fibrillation, diplopia, muscle tightness, dysstasia, gait disturbance, loss of personal independence in daily activities, blood glucose increased, asthenia, musculoskeletal stiffness, areflexia, pain in extremity, fatigue. Clinical course was as follows: The patient was approximate 74-year-old (the age at vaccination was 74-year-old). He had no allergies to medications, food, or other products; no other illnesses at the time of vaccination and up to one month prior. The patient got his vaccine, he noticed in his ankles and his calves were tightening up and getting harder for him to stand or walk. It got to a point that he could not stand long enough to brush his teeth. The pain in his legs kept climbing up his body and fatigue. He started to get double vision, and his symptoms were all over the place. He was weaker and weaker each day, were out of town, and did a video visit appointment and could not do it as he wasn't in state that day. His wife packed them up and on 15Dec2023 drove back home and took him to the ER. He had a lot of testing and diagnosed with GBS. He had no reflexes from the knee down. Then he was admitted to the hospital and had a lumbar puncture, multiple labs, CT scan, and tons of labs. He was in the hospital for 5 days and was then sent home and started him on physical therapy, which he is having still. He did have IVIG while inpatient in the hospital. His symptoms are gradually improving day by day and feels that he is getting a little bit better. He is able to walk and stand now. He was informed that it was caught pretty early and if they had waited any longer that he would not be so lucky. His blood sugar went up, he fell into A-fib which he has a history of. His blood sugar is back under control. His A-fib has now gone back to sinus rhythm.   Follow-up (27Apr2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (01Oct2024): This is a spontaneous follow-up report received from the same Consumer via FDA (2744229-1).  Updated information: patient age, Lab data added; Vaccine administration time and lot number was added. Event onset time was captured, Emergency Room Visit and Physician Office Visit was checked for all the events.