Received Apr 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
Swelling; Redness; Pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 63-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 12-APR-2026, the patient received RSV vaccine (left arm). In APR-2026, less than a month after receiving RSV vaccine, the patient experienced swelling arm (Verbatim: Swelling), erythema of extremities (Verbatim: Redness) and pain in arm (Verbatim: Pain). The outcome of the swelling arm, erythema of extremities and pain in arm were not resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to RSV vaccine. It was unknown if the company considered the swelling arm, erythema of extremities and pain in arm to be related to RSV vaccine. Additional Information: GSK receipt date: 15-APR-2025 The reporter was the patient who received a dose of an RSV from her pharmacy on Saturday. She did not know the name of the manufacturer. She received the dose in her left arm and now her left forearm was swollen, red, and in pain. The batch number was not provided upon follow- up with the reporter.