Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; I did get the shot before the second time; i was breaking all my ribs and truly wanted to die; I was very ill for a month both times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included respiratory syncytial virus infection and illness. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I did get the shot before the second time), illness (Verbatim: I was very ill for a month both times) and chest pressure sensation (Verbatim: i was breaking all my ribs and truly wanted to die). The outcome of the vaccination failure, respiratory syncytial virus infection and chest pressure sensation were not reported and the outcome of the illness was resolved (duration 1 month). It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, illness and chest pressure sensation to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, illness and chest pressure sensation to be related to RSV vaccine. Additional Information: GSK Receipt Date: 30-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that he /she had it (RSV infection) twice. The reporter stated that it was no fun, thought it was breaking all ribs and truly wanted to die. The reporter was very ill for a month both times and still had some issues after. He/she did get the shot before the second time, but not sure it was RSV the second time as he/she didn't do a test. The reporter mentioned get the shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 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.
Medical History/Concurrent Conditions: Illness; Respiratory syncytial virus infection