Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
fluid in the lungs a week after getting the shot; The vaccine made me very sick; upper respiratory Infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of pulmonary edema in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 1 week after receiving RSV vaccine, the patient experienced pulmonary edema (Verbatim: fluid in the lungs a week after getting the shot) (serious criteria GSK medically significant), sickness (Verbatim: The vaccine made me very sick) and upper respiratory tract infection (Verbatim: upper respiratory Infection). The outcome of the pulmonary edema, sickness and upper respiratory tract infection were not reported. It was unknown if the reporter considered the pulmonary edema and upper respiratory tract infection to be related to RSV vaccine. The reporter considered the sickness to be related to RSV vaccine. The company considered the pulmonary edema to be unrelated to RSV vaccine. The company considered the sickness to be related to RSV vaccine. It was unknown if the company considered the upper respiratory tract infection to be related to RSV vaccine. Additional Information: GSK receipt date: 04-SEP-2025 This case was reported by a patient via interactive digital media. The vaccine made the patient very sick. The patient got an upper respiratory Infection and fluid in the lungs a week after getting the shot.; Sender's Comments: A case of Pulmonary oedema, 1 week after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.