Received Nov 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
had Congestive heart failure/heart was working at 33 percent; got sick a week later; This serious case was reported by a consumer via interactive digital media and described the occurrence of congestive heart failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 31-OCT-2024, the patient received RSV vaccine. In NOV-2024, 1 week after receiving RSV vaccine, the patient experienced sickness (Verbatim: got sick a week later). In FEB-2025, the patient experienced congestive heart failure (Verbatim: had Congestive heart failure/heart was working at 33 percent) (serious criteria GSK medically significant). The outcome of the congestive heart failure and sickness were not reported. It was unknown if the reporter considered the congestive heart failure and sickness to be related to RSV vaccine. The company considered the congestive heart failure to be unrelated to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 25-OCT-2025 This case was reported by a patient via interactive digital media. Patient received the Respiratory syncytial virus vaccine last day in October last year on 31 Oct 2024, got sick a week later. In Feb 2025 of this year patient was told had Congestive Heart Failure. Patient experienced shortness of breath, tiredness, heart was working at 33 percent. If patient would have known, would have not taken the Respiratory syncytial virus vaccine. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Cardiac failure congestive, Less than 6 months after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received