Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
cognitive disfunction; difficult to focus/loss of focus; Memory loss; Dizziness; lack of impulsivity control; Pain in arm/sore arm; Fatigue; This non-serious case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included drug hypersensitivity. Additional patient notes included had no medical, no physical or mental issues and that was why it was upsetting. On 03-SEP-2025, the patient received Arexvy (intramuscular, left arm) .5 ml. On 03-SEP-2025, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: Pain in arm/sore arm) and fatigue (Verbatim: Fatigue). On 04-SEP-2025, the patient experienced cognitive disturbance (Verbatim: cognitive disfunction), mental concentration difficult (Verbatim: difficult to focus/loss of focus), memory loss (Verbatim: Memory loss), dizziness (Verbatim: Dizziness) and impulse-control disorder (Verbatim: lack of impulsivity control). The patient was treated with ibuprofen sodium (Ibuprofen) and caffeine citrate (Caffeine). The outcome of the pain in arm and fatigue were resolving and the outcome of the cognitive disturbance, mental concentration difficult, memory loss, dizziness and impulse-control disorder were not resolved. The reporter considered the pain in arm, fatigue, cognitive disturbance, mental concentration difficult, memory loss, dizziness and impulse-control disorder to be related to Arexvy. The company considered the pain in arm, fatigue, cognitive disturbance, mental concentration difficult, memory loss, dizziness and impulse-control disorder to be related to Arexvy. Additional Information: GSK Receipt Date: 28-OCT-2025 The reporter was a female customer. She reported that she received Arexvy vaccine at a local pharmacy. She reports that she received the vaccine around 5 pm that day in the left arm. The patient reported that she has never had a reaction to any vaccine other than the normal symptoms. She reported that on the first day she experienced symptoms of sore arm, arm pain and fatigue. The next day in the morning she reported that cognitive disfunction, difficult to focus, loss of focus, memory loss, dizziness. She reported that it had been monitoring her symptoms for the past 2 months and reported that she felt slightly better. The reporter had some goods days and some bad days. She reported that having lack of impulsivity control. She could not control it mentally. She reported that she was not able to control it and need to focus to control it. The reporter reported that it did vary from day to day, and she was still working in his/herprofession. She would have to quit her job. She reported that a little bit of caffeine seems to help, but the symptoms do not go away. The patient reported that she was extremely sensitive to medications and had to take the smallest amount possible of Ibuprofen for the pain in the arm. She reported that cutting the smallest tablet of Ibuprofen and taking it for arm pain (might be 40 to 50 mg). The patient reported that he/she was very concerned it had not gone away. It would be for 2 months on 3rd November 2025.
Drug hypersensitivity
Comments: had no medical, no physical or mental issues and that was why it was upsetting