Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; was exposed to it multiple times; 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 chronic obstructive pulmonary disease. 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) and respiratory syncytial virus infection (Verbatim: was exposed to it multiple times). The patient was treated with paracetamol (Acetaminophen). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection 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 to be related to RSV vaccine. Additional Information: GSK Receipt Date: 24-JUL-2025 This case was reported by a patient via interactive digital media. The reporter stated that the RSV drug does not guarantee that one would not contract the virus and asked others to read more about the vaccine before getting injected. The reporter mentioned that RSV vaccine was used to boost the immune system so that RSV infection would not put people in the hospital or the morgue. The reporter stated he/she got the RSV injection and was exposed to it (Respiratory syncytial virus infection) multiple times due to events and was fortunate enough to have only mild symptoms, nothing an Acetometaphine could not handle. Further, reporter stated that if someone was not deceased or in the hospital, then vaccine worked. The reporter advised others to seek medical advice and questioned about how they know the symptoms are RSV related and asked to have a professional check them out. The reported stated that he/she was having Chronic obstructive pulmonary disease (COPD) which has the same symptoms as pneumonia and would rather take a twice-a-day antibiotic pill for a week than have another CT scan and a stronger inhaler for the rest of whatever. The reporter stated he/she was glad that other were intelligent enough and societally conscientious enough to get the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Chronic obstructive pulmonary disease