Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
ministroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of ministroke 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 ministroke (Verbatim: ministroke) (serious criteria GSK medically significant). The outcome of the ministroke was not reported. It was unknown if the reporter considered the ministroke to be related to RSV vaccine. It was unknown if the company considered the ministroke to be related to RSV vaccine. Additional Information: GSK receipt date: 01-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she also had a mini stroke after the vaccine and patient's daughter had a heart attack. Patient also indicated they won't get another one. This case is 1 of 2 cases reported by same reporter.; Sender's Comments: Transient ischaemic attack is an unlisted event which is considered unrelated to GSK RSV vaccine.