Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
Headache; Temperature elevation; Myalgia; Fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of myalgia in a 70-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 05-AUG-2025, the patient received RSV vaccine (left arm). On 05-AUG-2025, less than a day after receiving RSV vaccine, the patient experienced myalgia (Verbatim: Myalgia) and fatigue (Verbatim: Fatigue). On 06-AUG-2025, the patient experienced headache (Verbatim: Headache) and body temperature increased (Verbatim: Temperature elevation). The outcome of the myalgia, fatigue and headache were not resolved and the outcome of the body temperature increased was resolving. It was unknown if the reporter considered the myalgia, fatigue, headache and body temperature increased to be related to RSV vaccine. It was unknown if the company considered the myalgia, fatigue, headache and body temperature increased to be related to RSV vaccine. Additional Information: GSK Receipt Date: 07-AUG-2025 The patient who received a Respiratory Syncytial Virus vaccine at local pharmacy. The patient did not get any paperwork from the pharmacy, and the name and manufacturer of the vaccine could not be verified. After receiving the Respiratory Syncytial Virus vaccine, she experienced myalgia, fatigue, headache, and a temperature elevation of 101.9 degrees Fahrenheit. All symptoms were ongoing, and her temperature has decreased to 99.0 degrees Fahrenheit as of reporting date.
Test Date: 20250806; Test Name: Body temperature increased; Result Unstructured Data: (Test Result:101.1,Unit:degree F,Normal Low:,Normal High:); Test Date: 20250807; Test Name: Body temperature increased; Result Unstructured Data: (Test Result:99,Unit:degree F,Normal Low:,Normal High:)