Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
sepsis; it activated an autoimmune system issue; This serious case was reported by a consumer via interactive digital media and described the occurrence of sepsis in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sepsis (Verbatim: sepsis) (serious criteria GSK medically significant) and autoimmune disorder (Verbatim: it activated an autoimmune system issue) (serious criteria GSK medically significant). The outcome of the sepsis and autoimmune disorder were not reported. The reporter considered the sepsis and autoimmune disorder to be related to RSV vaccine. The company considered the sepsis and autoimmune disorder to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 12-OCT-2025 This case was reported by a patient via interactive digital media. Patient had a horrible reaction to RSV vaccine as it activated an autoimmune system issue that led to sepsis. The reporter mentioned that not for him/her but what did they consider helpful. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Sepsis and Autoimmune disorder, an unknown time 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.