Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
undergo open heart surgery; This serious case was reported by a consumer via interactive digital media and described the occurrence of open heart surgery in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced open heart surgery (Verbatim: undergo open heart surgery) (serious criteria clinically significant/intervention required). The outcome of the open heart surgery was not reported. It was unknown if the reporter considered the open heart surgery to be related to RSV vaccine. The company considered the open heart surgery to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 18-JUN-2025 The patient got vaccinated with Respiratory Syncytial Virus vaccine and had undergo open heart surgery last month of reporting.; Sender's Comments: Cardiac operation is an unlisted event which is considered unrelated to GSK RSV vaccine. US-GSK-US2025AMR077284:same reporter different patient