Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Mobility decreased, Pain, Pain in extremity, Paraesthesia oral
Clinical narrative: hypersensitivity reaction; tingling in her lips; pain in her right jaw joint; hives/hives presented in various areas around her whole body/belly, lower back hands and feet and legs; joint pain/joint pain started in her shoulders/Pain in the joints of her hands and feet./elbow and wrist pain; could not lift her arms away from her body; deep itching accompanied the hives. Not the kind you can scratch.  The itching was painful; itching was painful; first dose in 11/2019 and her second dose on 7/14/2020; arm achiness; Tenderness; fatigue; This case was reported by a consumer via call center representative and described the occurrence of hypersensitivity reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019). Concurrent medical conditions included drug allergy (allergy to aspirin).   On 14th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th July 2020, several hours after receiving Shingrix, the patient experienced pain in arm, tenderness, fatigue and drug dose administration interval too long. On 14th September 2020, the patient experienced hives, joint pain, mobility decreased, pruritus and pain. On an unknown date, the patient experienced hypersensitivity reaction, tingling lips and temporomandibular joint arthralgia. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hypersensitivity reaction, mobility decreased, pain and drug dose administration interval too long were unknown and the outcome of the pain in arm, tenderness, fatigue, joint pain, tingling lips and temporomandibular joint arthralgia were recovered/resolved and the outcome of the hives and pruritus were recovering/resolving.   It was unknown if the reporter considered the hypersensitivity reaction, pain in arm, tenderness, fatigue, hives, joint pain, mobility decreased, pruritus, pain, tingling lips and temporomandibular joint arthralgia to be related to Shingrix.  Additional details were reported as follows: The patient experienced the following adverse reactions in the same time frame after both doses.  Arm achiness and tenderness and fatigue which presented a few hours after the injection.  It became worse the following day and the next day and then started to resolve after 3-4 days.  2 months to the day that the second dose was received, joint pain and hives presented.  The joint pain started in her shoulders. She could not lift her arms away from her body.  Pain in the joints of her hands and feet. The pain would present after basic activities such as carrying her groceries caused elbow and wrist pain. She had a dental appointment and felt pain in her right jaw joint following that appointment from having her mouth open. The hives presented in various areas around her whole body. She mentioned the areas of her belly, lower back hands and feet and legs. A deep itching accompanied the hives, not the kind you can scratch.  The itching was painful.  She felt tingling in her lips which wa resolved.  Her physician diagnosed it as a hypersensitivity reaction.  She started prednisone on 18th Sep 2020 and took it for 5 days.  Day before reporting was the first day she did not feel joint pain.  She had intermittent hives but they were much better than prior to the steroid treatment.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201518:Same reporter