Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Giant hives; Mastosyposis; This serious case was reported by a consumer and described the occurrence of giant hives in a 78-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 14-JUL-2025, the patient received RSV vaccine. On 14-JUL-2025, less than a day after receiving RSV vaccine, the patient experienced giant hives (Verbatim: Giant hives) (serious criteria GSK medically significant). In JUL-2025, the patient experienced mastocytosis (Verbatim: Mastosyposis). The outcome of the giant hives was not resolved and the outcome of the mastocytosis was not reported. It was unknown if the reporter considered the giant hives and mastocytosis to be related to RSV vaccine. The company considered the giant hives to be unrelated to RSV vaccine. It was unknown if the company considered the mastocytosis to be related to RSV vaccine. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter reported that the patient had mastosyposis and giant hives.; Sender's Comments: A case of Angioedema, less than a day after receiving RSV vaccine, in a 78-year-old female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.