Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
I went septic; 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: I went septic) (serious criteria GSK medically significant). The outcome of the sepsis was not reported. The reporter considered the sepsis to be related to RSV vaccine. The company considered the sepsis to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 04-SEP-2025 This case was reported by a patient via interactive digital media. Patient's physician had told him/her into it and he/she had nearly died. Patient had gone septic.; Sender's Comments: A case of Sepsis, unknown time after receiving unknown dose of RSV vaccine in a subject. 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.