Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; RSV infection/ RSV vaccine last fall and I have it now/cough; been very sick for about 10 days; 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: RSV infection/ RSV vaccine last fall and I have it now/cough) and sickness (Verbatim: been very sick for about 10 days). The patient was treated with antibiotics. The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the sickness was resolved (duration 10 days). It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness 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 and sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date:18-JUN-2025 and 19-JUN-2025 This case was reported by a patient via interactive digital media. The patient had been very sick for 10 days and now (during the reporting days) the urgent care had sent the patient home with an antibiotic and cough pills, but the patient continued to get worse. They did not even take an x-ray of the patient's chest and was going to the emergency room (ER) on the day of reporting and believed it was respiratory syncytial virus infection (RSV) even though the patient had the RSV shot last fall in 2024 and have it now and had been very sick for about 10 days. So, the patient hates to say it just like the covid vaccine not every vaccine was perfect to do have RSV vaccine. The hospital did an x-ray and test for RSV covid flu and he/she was positive for RSV and felt very bad. The cough was so bad, and his/her oxygen level stayed at about a 90 to 94. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Test Date: 2025; Test Name: Oxygen level; Result Unstructured Data: (Test Result:90 to 94,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: RSV test; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:)