Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Hallucination, visual, Joint swelling, Loss of personal independence in daily activities, Musculoskeletal pain, Myalgia
Clinical narrative: hallucinating/patient saw her mother, her brother her sister, and her dog sitting at the end of her bed; bright red lumpy rash; bright red lumpy rash; ankles became swollen; temperature of 100 degrees F; pain was from her waist; could not walk; could not remember anything; lost her memory; feel strange/began to feel strange; muscles in both legs; pain her thighs; pain to her knees; The pain was from her waist / buttocks; needed help getting undressed; her back were raging in pain; This serious case was reported by a consumer via call center representative and described the occurrence of visual hallucinations in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included partial lung resection (had partial removal of lung) and pneumonia. Concurrent medical conditions included chronic obstructive pulmonary disease and lung cancer (in 2007 was diagnosed with lung cancer). Concomitant products included INFLUENZA VACCINE and COVID-19 VACCINE.   On 07-DEC-2024, the patient received Arexvy (left arm). On 07-DEC-2024, less than a day after receiving Arexvy, the patient experienced fever (Verbatim: temperature of 100 degrees F), pain localized (Verbatim: pain was from her waist), unable to walk (Verbatim: could not walk), memory impairment (Verbatim: could not remember anything), memory loss (Verbatim: lost her memory), weird feeling (Verbatim: feel strange/began to feel strange), myalgia of lower extremities (Verbatim: muscles in both legs), pain in thigh (Verbatim: pain her thighs), knee pain (Verbatim: pain to her knees), buttock pain (Verbatim: The pain was from her waist / buttocks), activities of daily living impaired (Verbatim: needed help getting undressed) and back pain (Verbatim: her back were raging in pain). On 08-DEC-2024, the patient experienced red rash (Verbatim: bright red lumpy rash), papular rash (Verbatim: bright red lumpy rash) and ankle swelling (Verbatim: ankles became swollen). In DEC-2024, the patient experienced visual hallucinations (Verbatim: hallucinating/patient saw her mother, her brother her sister, and her dog sitting at the end of her bed) (serious criteria GSK medically significant). In DEC-2024, the outcome of the visual hallucinations was resolved. The outcome of the red rash, papular rash and ankle swelling were not resolved and the outcome of the fever, memory impairment, memory loss and weird feeling were resolved and the outcome of the pain localized, myalgia of lower extremities, pain in thigh, knee pain, buttock pain and back pain were resolving and the outcome of the unable to walk was unknown and the outcome of the activities of daily living impaired was not reported.   It was unknown if the reporter considered the visual hallucinations, red rash, papular rash, ankle swelling, fever, pain localized, unable to walk, memory impairment, memory loss, weird feeling, myalgia of lower extremities, pain in thigh, knee pain, buttock pain, activities of daily living impaired and back pain to be related to Arexvy.     The company considered the visual hallucinations to be unrelated to Arexvy. It was unknown if the company considered the red rash, papular rash, ankle swelling, fever, pain localized, unable to walk, memory impairment, memory loss, weird feeling, myalgia of lower extremities, pain in thigh, knee pain, buttock pain, activities of daily living impaired and back pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-DEC-2024 The patient self-reported this case for herself.  The reporter received the Arexvy vaccine in the left arm and believed she received Arexvy on Friday midafternoon.  The reporter reported around 4 to 5 pm that day, the reporter began to feel strange.  The reporter lost her memory, she could not remember anything.  The reporter kept asking her husband to take her home when she was already home.  The reporter could not remember where her bedroom was in her own house.  The reporter could not walk because the muscles in both legs, and her back were raging in pain.  The pain was from her waist/buttocks all the way down the reporter's thighs and to her knees.  The reporter needed help getting undressed.  The reporter stated she had a temperature of 100 degrees (Fahrenheit). The following day, the reporter's ankles became swollen and a bright red lumpy rash had developed around her ankles and feet.  The reporter was hallucinating.  The reporter saw her mother, her brother, her sister, and her dog sitting at the end of her bed.  The reporter reported that all were deceased except her sister.  The hallucinations continued all night and most of the next day.  The reporter was still experiencing pain, but the pain is not as bad as it was in the beginning.  The reporter still had swelling and rash around her ankles.  The reporter also had the Flu vaccine (manufacturer not specified) and Covid vaccine prior to the Arexvy vaccine.  The Flu vaccine, Covid vaccine, and Arexvy were not administered together.  The reporter reported that there was about 2 weeks in between each of the vaccines.; Sender's Comments: Hallucination, visual is an unlisted event which is considered unrelated to GSK vaccine Arexvy.