Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Sick; little coughing; chest congestion; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 78-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included bronchitis (had to be hospitalized twice). In SEP-2025, the patient received RSV vaccine. In SEP-2025, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick), cough (Verbatim: little coughing) and chest tightness (Verbatim: chest congestion). The outcome of the sickness, cough and chest tightness were not resolved. It was unknown if the reporter considered the sickness, cough and chest tightness to be related to RSV vaccine. It was unknown if the company considered the sickness, cough and chest tightness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 17-SEP-2025 The patient got the respiratory syncytial virus vaccine shot two weeks ago from reporting. The patient was sick, only had a little coughing and very little chest congestion. There was no sinus congestion or headaches. The reporter convinced respiratory syncytial virus shot prevented from getting sicker. This case was linked with case US2025AMR120795 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025AMR120795:Case for husband/same reporter
Medical History/Concurrent Conditions: Bronchitis (had to be hospitalized twice)