Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: itching at injection site; rheumatoid arthritis; generalized weakness; nausea; headache; joint pain; Generalized muscle pain; fatigue; rapid breathing/fast breathing; pounding heart; Arm inflamed at injection site diameter of a grapefruit; injection site soreness; Injection site inflammation; shivering; dizziness; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rheumatoid arthritis (Verbatim: rheumatoid arthritis) (serious criteria GSK medically significant), extensive swelling of vaccinated limb (Verbatim: Arm inflamed at injection site diameter of a grapefruit), injection site pain (Verbatim: injection site soreness), injection site itching (Verbatim: itching at injection site), injection site inflammation (Verbatim: Injection site inflammation), shivering (Verbatim: shivering), dizziness (Verbatim: dizziness), weakness generalized (Verbatim: generalized weakness), heart pounding (Verbatim: pounding heart), nausea (Verbatim: nausea), headache (Verbatim: headache), joint pain (Verbatim: joint pain), generalized muscle aches (Verbatim: Generalized muscle pain), fatigue (Verbatim: fatigue) and breathing rate increased (Verbatim: rapid breathing/fast breathing). The patient was treated with methotrexate. The outcome of the rheumatoid arthritis was not reported and the outcome of the extensive swelling of vaccinated limb and injection site pain were resolved (duration 2 weeks) and the outcome of the injection site itching, injection site inflammation, weakness generalized, nausea and headache were resolved and the outcome of the shivering was resolved (duration 2 hrs) and the outcome of the dizziness, heart pounding and breathing rate increased were resolved (duration 20 min) and the outcome of the joint pain, generalized muscle aches and fatigue were resolved (duration 2 days).   It was unknown if the reporter considered the rheumatoid arthritis, extensive swelling of vaccinated limb, injection site pain, injection site itching, injection site inflammation, shivering, dizziness, weakness generalized, heart pounding, nausea, headache, joint pain, generalized muscle aches, fatigue and breathing rate increased to be related to Shingrix.     It was unknown if the company considered the rheumatoid arthritis, extensive swelling of vaccinated limb, injection site pain, injection site itching, injection site inflammation, shivering, dizziness, weakness generalized, heart pounding, nausea, headache, joint pain, generalized muscle aches, fatigue and breathing rate increased to be related to Shingrix.   Additional Information: GSK Receipt date: 27-JUL-2023 The patient self-reported this case. About 15 hours after the shot, while she was sleeping, she experienced a pounding heart, fast breathing, and dizziness which work her from a deep sleep and lasted about 15 to 20 minutes. Shivering, which started at the same time, lasted about 2 hours.  She also noted at that time that her arm had a raised, inflamed, sore area about the diameter of a grapefruit at the injection site which lasted about 2 weeks, subsiding slowly.  She experienced muscle and joint pain and fatigue for 2 days following the injection.  She did had rheumatoid arthritis and takes methotrexate. The reporter wanted to know if she would experience the same adverse events after her 2nd dose of Shingrix which was now due.