Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
lost voice; coughing; exhausted; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of loss of voice in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2024, the patient received RSV vaccine. On an unknown date, 2 days after receiving RSV vaccine, the patient experienced loss of voice (Verbatim: lost voice), cough (Verbatim: coughing), exhaustion (Verbatim: exhausted) and sickness (Verbatim: sick). The outcome of the loss of voice was resolving and the outcome of the cough, exhaustion and sickness were not reported. It was unknown if the reporter considered the loss of voice, cough, exhaustion and sickness to be related to RSV vaccine. It was unknown if the company considered the loss of voice, cough, exhaustion and sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. Patient got the RSV shot in October and 2 days later he got very sick, he lost his voice and stated that it is just now coming Back. Patient was, coughing, sick and exhausted for more than 6 months. This case is linked with case US2025AMR048219, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR048219: