Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | LN4P2 | IM / LA |
fever; joint pain in knees/knees started to ache in the joints; I could not move legs because joints hurt; kicked in; Sleep disturbance; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LN4P2, expiry date 01-NOV-2025) for prophylaxis. Concomitant products included naproxen sodium (Aleve). On 16-JAN-2025 08:30, the patient received Arexvy (intramuscular, left deltoid). In JAN-2025, less than a day after receiving Arexvy, the patient experienced sleep disturbance (Verbatim: Sleep disturbance). On 16-JAN-2025, the patient experienced knee pain (Verbatim: joint pain in knees/knees started to ache in the joints), mobility decreased (Verbatim: I could not move legs because joints hurt) and feeling unwell (Verbatim: kicked in). On 17-JAN-2025, the patient experienced fever (Verbatim: fever). The action taken with Arexvy was unknown. The outcome of the fever and knee pain were not resolved and the outcome of the mobility decreased was resolved and the outcome of the feeling unwell and sleep disturbance were not reported. It was unknown if the reporter considered the fever and feeling unwell to be related to Arexvy. The reporter considered the knee pain, mobility decreased and sleep disturbance to be related to Arexvy. It was unknown if the company considered the fever and feeling unwell to be related to Arexvy. The company considered the knee pain, mobility decreased and sleep disturbance to be related to Arexvy. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter was the patient. The patient received Arexvy vaccine on 16th January 2025, intramuscularly in the left arm. The reporter said, a day before day of reporting the patient took the RSV vaccine, and patient wanted to report some of the symptoms that patient had because patient thought they were kind of unusual. Throughout the day her knees started to ache in the joints and by 1 am she could not move her legs because her joints hurt so much. The patient had never had a reaction to a vaccine before ever. The patient managed to get some Aleve and just kind of sat for about 2 hours while it kicked in. The patient was able to go back to sleep but she still had the pain when she got up this morning at 6:00 she could move but her joints still hurt. The patient was mobile, she was moving. Her right leg was fine. Her left knee still had some aching, and she had also developed a fever this afternoon. The patient mentioned it was only her knees that were bothering her (no other part of her body, no other joints). The patient was not sure if the fever was due to Arexvy or not because she indicated that there were cold or flu bugs going around in her area.
ALEVE