Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3T74X | — |
Rash; burning sensation all throughout her arm; Pain in arm; really painful to lift her arm and move it; Blister; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in a 42-year-old female patient who received Herpes zoster (Shingrix) (batch number 3T74X, expiry date 28-APR-2027) for prophylaxis. Concurrent medical conditions included immunocompromised. Concomitant products included tofacitinib citrate (Xeljanz). On 24-OCT-2025, the patient received the 1st dose of Shingrix. On 25-OCT-2025, 1 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation all throughout her arm), pain in arm (Verbatim: Pain in arm) and mobility decreased (Verbatim: really painful to lift her arm and move it). On 26-OCT-2025, the patient experienced blister (Verbatim: Blister). On 27-OCT-2025, the patient experienced rash (Verbatim: Rash). The outcome of the burning sensation, pain in arm and rash were unknown and the outcome of the blister was resolved (duration 1 week) and the outcome of the mobility decreased was not reported. It was unknown if the reporter considered the burning sensation, pain in arm, rash, blister and mobility decreased to be related to Shingrix. It was unknown if the company considered the burning sensation, pain in arm, rash, blister and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 29-DEC-2025 The pharmacist called on 29-DEC-2025 to report an adverse reaction after the first dose of Shingrix had been administered to an immunocompromised patient. The healthcare professional stated, on day 1 after getting the shot, she had a burning sensation all throughout her arm. The pharmacist mentioned that the patient had reported it was really painful to lift her arm and move it, and that on day 2 she had developed a blister that lasted about a week, and on day 3 she had a chest rash as well. No further details were provided.
Immunocompromised
XELJANZ