Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
very little chest congestion; little coughing; This serious case was reported by a consumer via interactive digital media and described the occurrence of lung congestion in a 87-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included pneumonia (had to be hospitalized twice). In SEP-2025, the patient received RSV vaccine. In SEP-2025, less than 2 weeks after receiving RSV vaccine, the patient experienced lung congestion (Verbatim: very little chest congestion) (serious criteria GSK medically significant) and cough (Verbatim: little coughing). The outcome of the lung congestion and cough were not resolved. It was unknown if the reporter considered the lung congestion and cough to be related to RSV vaccine. The company considered the lung congestion and cough to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 17-SEP-2025 This case was reported by a patient via interactive digital media. Patient received the RSV shot two weeks prior. The patient had numerous health issues, but when he became ill he only had little coughing and very little chest congestion. Patient had no sinus congestion or headaches. In previous years, the patient had suffered from pneumonia on multiple occasions, requiring hospitalization twice. Reporter believed that the RSV shot had prevented them from becoming more severely ill. This case is linked with case US2025AMR120788, reported by the same reporter.; Sender's Comments: A case of Pulmonary congestion and Cough, Less than 2 weeks after receiving RSV vaccine, in a 87-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received US-GSK-US2025AMR120788:Case for wife/same reporter
Medical History/Concurrent Conditions: Pneumonia (had to be hospitalized twice)