Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM |
Pain in knees; Swelling of knees; Muscle pain; swelling of the ankles; weakness in legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included diabetes. On 24-SEP-2024, the patient received Arexvy (intramuscular). On 24-SEP-2024, less than a day after receiving Arexvy, the patient experienced swelling of knees (Verbatim: Swelling of knees), muscle pain (Verbatim: Muscle pain), ankle swelling (Verbatim: swelling of the ankles) and lower extremities weakness of (Verbatim: weakness in legs). On an unknown date, the patient experienced knee pain (Verbatim: Pain in knees). The outcome of the swelling of knees, muscle pain, ankle swelling and lower extremities weakness of were not resolved and the outcome of the knee pain was unknown. It was unknown if the reporter considered the swelling of knees, muscle pain, ankle swelling, lower extremities weakness of and knee pain to be related to Arexvy. It was unknown if the company considered the swelling of knees, muscle pain, ankle swelling, lower extremities weakness of and knee pain to be related to Arexvy. Additional Information: GSK receipt date: 17-MAR-2025 Consumer stated he received an RSV shot in Sept 2024 from Pharmacy. Reporter was unable to verify if he received Arexvy, just stated it was an RSV vaccine. This vaccine was administered in left arm as he recalled. Consumer asked questions in regards to his symptoms for swelling of the knees and ankles, weakness in knees and muscle pain and how long will it last. Consumer stated that he saw in the advertisement on tv that muscle pain and pains all over are side effects of the vaccine. He stated that he had a lot of muscle pain after 6 months of receiving it. He has had a lot of pain in the knees, weakness in knees, and a lot of swelling in the legs. The pain started about 2 days after the injection. He had to use both hands to get up from the chair because of the weakness in his knees. He went to the emergency room about a week or so after receiving the shot and they could not tell him what the problem could be. The pain and swelling were not as bad as the first few days, he still had some swelling in his legs. His doctor prescribed water pills and they didn't helped him much, it helped a little with the swelling. This case is linked with US2023000765 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021090108:same reporter US-GSK-US2023000765:same reporter
Diabetes