Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Typical pain; Redness; swelling at injection site expanded to bicep area; hot to the touch upper arm; prickly; Itchy; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for primary prevention. The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis, fibromyalgia and hypertension. Concomitant products included sarilumab (Kevzara), gabapentin, candesartan and leflunomide. On 15-JUL-2025, the patient received the 1st dose of Shingrix. On 15-JUL-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Typical pain), erythema of extremities (Verbatim: Redness), swelling arm (Verbatim: swelling at injection site expanded to bicep area), hot feeling in hand (Verbatim: hot to the touch upper arm), tingling (Verbatim: prickly) and pruritus (Verbatim: Itchy). The patient was treated with prednisone, fexofenadine hydrochloride (Allegra) and doxycycline. The outcome of the pain in arm, erythema of extremities, swelling arm, hot feeling in hand, tingling and pruritus were not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm, hot feeling in hand, tingling and pruritus to be related to Shingrix. It was unknown if the company considered the pain in arm, erythema of extremities, swelling arm, hot feeling in hand, tingling and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 20-JUN-2025 The reporter reported that the patient received Shingrix vaccine and had typical pain, redness and swelling at injection site expanded to bicep area. It has been 6 days and now have constant prickly/itchy/pain, and a very red, swollen and hot to the touch upper arm. The patient have rheumatoid arthritis and fibromyalgia, because had high risk and a previous mild case of shingles. The doctor recommended being vaccinated, none of us expected this reaction. The patient currently being treated with 3 medications to treat this reaction with Prednisone, Allegra, and Doxycycline, but nothing was working. The doctors are not able to diagnose the reaction, the patient fear and would have permanent damage to the arm. The nerves were activated 24/7 throughout the entire red, swollen site.
Fibromyalgia; Hypertension; Rheumatoid arthritis
Medical History/Concurrent Conditions: Shingles
KEVZARA; GABAPENTIN; CANDESARTAN; LEFLUNOMIDE