Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
had it; Permanent lung damage; supraventricular tachycardia needing an ablation; Suspected vaccination failure; 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. 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: had it) (serious criteria hospitalization), lung injury (Verbatim: Permanent lung damage) (serious criteria hospitalization) and supraventricular tachycardia (Verbatim: supraventricular tachycardia needing an ablation) (serious criteria hospitalization). The outcome of the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia were not reported. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia to be related to RSV vaccine. The company considered the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 27-JUL-2025 This case was reported by a patient via interactive digital media. The patient had it and after that hospitalized for10 days. The patient had permanent lung damage and supraventricular tachycardia needing an ablation and now on permanent nocturnal oxygen. The patient had the vaccine too late. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. A case of Respiratory syncytial virus infection, Traumatic lung injury and Supraventricular tachycardia, unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.