Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Ageusia, Anosmia, Fatigue, Pain in extremity
Clinical narrative: Loss of taste; Loss of Smell; Memory Loss; difficulty with activities of daily living; Extreme Fatigue; difficulty walking; her voice became hoarse; she cannot stand; use a walker to walk; left arm had swelling; This serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included osteoarthritis.   On 17-SEP-2023, the patient received Arexvy (injection, left deltoid) .5 ml. In SEP-2023, 2 days after receiving Arexvy, the patient experienced taste loss (Verbatim: Loss of taste) (serious criteria hospitalization), loss of smell (Verbatim: Loss of Smell) (serious criteria hospitalization), hoarse voice (Verbatim: her voice became hoarse) (serious criteria hospitalization) and swelling arm (Verbatim: left arm had swelling). On 17-SEP-2023, the patient experienced fatigue (Verbatim: Extreme Fatigue) (serious criteria hospitalization), walking difficulty (Verbatim: difficulty walking) (serious criteria hospitalization) and activities of daily living impaired (Verbatim: difficulty with activities of daily living) (serious criteria hospitalization). In NOV-2023, the patient experienced memory loss (Verbatim: Memory Loss) (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (Verbatim: she cannot stand) and walker user (Verbatim: use a walker to walk). In SEP-2023, the outcome of the swelling arm was resolved (duration 1 day).  In MAR-2024, the outcome of the taste loss and loss of smell were resolved. The outcome of the fatigue, walking difficulty, hoarse voice, memory loss, activities of daily living impaired, difficulty in standing and walker user were not resolved.   It was unknown if the reporter considered the fatigue, walking difficulty, taste loss, loss of smell, hoarse voice, memory loss, activities of daily living impaired, swelling arm, difficulty in standing and walker user to be related to Arexvy.     It was unknown if the company considered the fatigue, walking difficulty, taste loss, loss of smell, hoarse voice, memory loss, activities of daily living impaired, swelling arm, difficulty in standing and walker user to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-MAY-2024 Reporter was the patient. The reporter stated that immediately after administration of vaccine she had extreme fatigue, difficulty walking, and difficulty with activities of daily living. These symptoms had not resolved. The reporter stated that 2 days after vaccination her left arm had swelling, she lost her sense of taste and smell, and her voice became hoarse. Reported that the left arm swelling did resolve in one day, but the loss of taste and smell did not resolve until March of 2024. Reporter hoarse voice had not resolved. Reporter stated symptoms caused her to go to the hospital via an ambulance on 9th November 2023. Reports when she went to the hospital, she began having memory loss that had not resolved. Stated she was in the hospital for a week then was transferred to a rehabilitation center. Reporter was not discharged from rehab until 30th December of 2023. Reporter stated currently she could not stand or use a walker to walk. She currently was being seen by occupational therapy and physical therapist.