Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia, Skin warm, Swelling, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included psoriatic arthritis. Concomitant products included CONCERTA, famotidine, gabapentin, ibuprofen, methotrexate, Propranolol, VALIUM, ZYRTEC, baclofen, CELEBREX, CIMZIA, FIORICET, prazosin and prednisone. On 30th May 2018, the patient received the 1st dose of SHINGRIX. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, pain in arm, wrong injection technique and vaccine administered at inappropriate site. On 31st May 2018, the patient experienced fever, lethargy, erythema of extremities, local swelling and joint pain. On 1st June 2018, the patient experienced headache and nausea. On an unknown date, the patient experienced localized itching, appetite lost, general body pain and skin warm. On an unknown date, the outcome of the fatigue, erythema of extremities, local swelling, headache and pain in arm were recovering/resolving and the outcome of the fever, lethargy, localized itching, appetite lost, joint pain, general body pain and nausea were recovered/resolved and the outcome of the skin warm, wrong injection technique and vaccine administered at inappropriate site were unknown. The reporter considered the fatigue, fever, lethargy, erythema of extremities, local swelling, headache, localized itching, appetite lost, joint pain, general body pain, pain in arm, nausea and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. On the day of vaccination in the night she felt tenderness at the injection site and she was also very tired. The next evening (Thursday), the patient was very lethargic and had a fever with body temperature as 100 degree F, her arm was turning red and the redness was spreading and increasing in size. The patient stated that she also experienced swelling in her right arm on next day of vaccination. On 1st June 2018, 2 days after vaccination, the patient was in bed all day and was very fatigued, was nauseous and had a headache. In 2018, less than a week after vaccination, the patient's arm was hot to the touch and also itched. The patient was stated that, the swelling, pain, heat and itching was quite a ways away from the injection site. The patient stated that she also experienced a loss in appetite (latency was less than a week). On 3rd June 2018 (Sunday), the patient started feeling better and on the reporting date she went to visit her healthcare provider (HCP). The patient stated that she was feeling better on the day of reporting, however, she was still quite fatigued, had some redness on her arm. The patient stated that part of the redness on her arm had resolved and part of it had moved to a new spot. The patient also experienced joint pain on Thursday, Friday and part of Saturday. However, the joint pain was pretty much gone now. The patient stated that, she has psoriatic arthritis; however, this joint pain was not a flare up of her arthritis. In 2018, less than a week after vaccination, the patient had soreness all over (generalized body pain). The patient also stated that she and her HCP are not sure that the pharmacist injected the vaccine in the muscle or if it was injected into the tissue in her arm. The patient stated that her HCP looked at the injection site and it was a little lower than the deltoid and a little posterior to the deltoid, which led to possible wrong injection technique and vaccine administered at inappropriate site. The contact details of the physician were provided. This was a medication error with ADR.