Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX. The patient's past medical history included knee arthroplasty (experienced a torn tendon afterwards), tendon rupture (surgically infected, then developed a MRSA infection) and methicillin-resistant staphylococcus aureus infection (had to have her artificial knee joint removed. Had no knee joint for 9 weeks). Previously experienced adverse reactions included spinal operation (7 to 8 weeks before the date of reporting). Previously administered products included rifampin with an associated reaction of pruritus (caused intense itching on palms and soles. No urticaria), Influenza shot (high dose flu shot), ZOSTAVAX (2009), pneumonia vaccine (high dose pneumonia) and Vancomycin. Concurrent medical conditions included restless legs syndrome, fibromyalgia, hypothyroidism, osteopenia and ophthalmic migraine. Concomitant products included Vitamin C, hydrochlorothiazide, triamterene, Vitamin D3, ZETIA, Aspirin, atenolol, doxycycline, Metformin ER, pantoprazole, potassium chloride, Venlafaxine, estradiol, SYNTHROID and pramipexole, In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 8th May 2018, 3 days after receiving SHINGRIX, the patient experienced generalized urticaria. In May 2018, the patient experienced injection site pain and pruritus. The patient was treated with ATARAX, prednisone, SOLU-MEDROL injection and PEPCID. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pruritus and generalized urticaria were not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the pruritus and generalized urticaria to be possibly related to SHINGRIX. Additional information was received as follows: (Missed to capture anatomical location in narrative). In May 2018, the patient was previously administered with BENADRYL. The patient experienced slight soreness at the injection site. On 8th May 2018, in the evening at 20:00, the patient developed intense itching on the plantar surface of her palms. The itching then progressed to urticaria on the lower side of both arms. The itching was so intense that the patient went to the emergency room (ER) and she was given several medications. The pruritus and urticaria persisted through the next day. The patient took maximum doses of BENADRYL as well as 40 mg of prednisone which were prescribed in the ER. In May 2018, the outcome of the injection site pain was resolved. On 9th May 2018, in the evening, the patient went to the ER again because the urticaria had spread to her face and ears and the pruritus was so intense. The patient was given with the injection of SOLU-MEDROL, PEPCID and ATARAX before going home around 2 AM on 10th May 2018. In the morning of the day of reporting, the patient woke up with urticaria on her legs. It was everywhere but her trunk. The patient still had intense pruritus. The patient stated, itching started on the palms of her hands and then spreads to the areas of urticaria. The patient would finish her course of prednisone the day after reporting.