Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | LA |
Rheumatoid arthritis; Osteoarthritis; This serious case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis flare up in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis, osteoarthritis, penicillin allergy, sulfonamide allergy, food allergy and drug allergy (Codeine allergy). Additional patient notes included No additional vaccines were administered on the same day or within four weeks The patient denied any recent lab work within two weeks of the event and reported no other medications.. Concomitant products included tofacitinib citrate (Xeljanz Xr) and methotrexate. In AUG-2025, the patient received Shingrix (left arm). On an unknown date, less than a week after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant) and osteoarthritis flare up (Verbatim: Osteoarthritis) (serious criteria GSK medically significant). The patient was treated with paracetamol (Tylenol Arthritis). The outcome of the rheumatoid arthritis flare up and osteoarthritis flare up were not resolved. The reporter considered the rheumatoid arthritis flare up and osteoarthritis flare up to be related to Shingrix. The company considered the rheumatoid arthritis flare up and osteoarthritis flare up to be unrelated to Shingrix. Additional Information: GSK receipt date 16 Oct 2025: The patient had a flare up since she was off the medication (Xeljanz XR) due to a Shingles shot (Shingrix) and she was still in a flare-up. The patient's rheumatologist told her to stop the medication for one week, because he said it wouldn't absorb okay and eventually it was taking a quite a while to get. The patient still waking up achy in the morning which she had not been for years because she was on Xeljanz for many years and not had any flare-up like this. would suspect It was reported that within 3 days after receiving shot, my medication for about three or four days and then started flare-up. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Rheumatoid arthritis flare up and Osteoarthritis flare up, less than a week after receiving a dose of Shingrix in a 76-year-old female subject. Report is inconsistent with causal relation to the vaccine product, absence of biological plausibility and alternative risk factors (underlying rheumatoid arthritis and osteoarthritis and patient stopped her medication for a week).
Drug allergy (Codeine allergy); Food allergy; Osteoarthritis; Penicillin allergy; Rheumatoid arthritis; Sulfonamide allergy
Comments: No additional vaccines were administered on the same day or within four weeks The patient denied any recent lab work within two weeks of the event and reported no other medications.
XELJANZ XR; METHOTREXATE