Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Polymyalgia Rheumatica; This serious case was reported by a consumer via interactive digital media and described the occurrence of polymyalgia rheumatica in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2024, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced polymyalgia rheumatica (Verbatim: Polymyalgia Rheumatica) (serious criteria GSK medically significant). The outcome of the polymyalgia rheumatica was not reported. It was unknown if the reporter considered the polymyalgia rheumatica to be related to RSV vaccine. The company considered the polymyalgia rheumatica to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 22-SEP-2025 This case was reported by a patient via interactive digital media. The patient got his/her RSV shot last October and the reaction was polymyalgia rheumatica. The patient would take chances this year; Sender's Comments: A case of Polymyalgia rheumatica, on an unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received