Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
feeling unwell; chills; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included pulmonary embolism. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz). In JAN-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: feeling unwell) and chills (Verbatim: chills). The outcome of the feeling unwell and chills were resolved (duration 1 day). It was unknown if the reporter considered the feeling unwell and chills to be related to Shingles vaccine. It was unknown if the company considered the feeling unwell and chills to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAY-2025 The patient reported that the start of xeljanz 5 mg tablet by mouth twice daily, many years, at least 10 years, est 2015, for rheumatoid arthritis. The patient reported in 2015 was diagnosed with a pulmonary embolism, she was unable to recall if this was before or after start of xeljanz therapy, no further occurrences, md aware, first dose of shingles vaccine given in January 2025 (after start of therapy), exact date unknown, after vaccine one evening if chills, not feeling well, resolved by next day, patient reports taking her xeljanz during this time, unknown if md aware, advised to update.
Rheumatoid arthritis
Medical History/Concurrent Conditions: Pulmonary embolism
XELJANZ