Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Cough; Sinus drainage; Hard time getting my breath; fatigued; Suspected vaccination failure; RSV; 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. Concurrent medical conditions included asthma. On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). On an unknown date, the patient experienced cough (Verbatim: Cough), postnasal drip (Verbatim: Sinus drainage), difficulty breathing (Verbatim: Hard time getting my breath) and fatigue (Verbatim: fatigued). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue were not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue 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, cough, postnasal drip, difficulty breathing and fatigue to be related to RSV vaccine. Additional Information: GSK Receipt Date: 24-JUN-2025 The patient had the RSV vaccine after the first of the year and about one month ago the patient was pretty sure about got respiratory syncytial virus infection because everyone around seemed to have it. The patient have asthma and still coughing and lots of sinus drainage. Hard time getting breath and so fatigued. At first thought it was really bad allergies but got worse. Still hoping anyway now would be back to normal. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection 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 details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection) is considered unrelated to GSK's RSV vaccine.
Asthma