Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | PK9C5 | — |
Arthralgia; 1ml RSV vaccine was given; This non-serious case was reported by a consumer and described the occurrence of arthralgia in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number PK9C5) for prophylaxis. Concurrent medical conditions included diabetes and colitis. Concomitant products included azathioprine (Imuran), metformin hydrochloride (Medformin), atorvastatin calcium (Lipitor), balsalazide, mirabegron and esomeprazole. On 16-NOV-2024, the patient received RSV vaccine 1 ml. On 16-NOV-2024, an unknown time after receiving RSV vaccine, the patient experienced overdose (Verbatim: 1ml RSV vaccine was given). On 20-NOV-2024, the patient experienced arthralgia (Verbatim: Arthralgia). The outcome of the arthralgia was not resolved and the outcome of the overdose was not applicable. It was unknown if the reporter considered the arthralgia to be related to RSV vaccine. It was unknown if the company considered the arthralgia to be related to RSV vaccine. Additional Information: GSK Receipt Date: 01-APR-2025 Consumer reported that he took the RSV vaccine and experienced arthralgia. Patient received 1ml of RSV vaccine which led to overdose.
Colitis; Diabetes
IMURAN; MEDFORMIN; LIPITOR; BALSALAZIDE; MIRABEGRON; ESOMEPRAZOLE