Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site scab, Mobility decreased, Neuralgia, Product administered at inappropriate site
Clinical narrative: scab from the Shingrix injection; nerve pain; can't lay down in bed; whole left arm from her elbow to her shoulder are in pain; whole left arm from her elbow to her shoulder are in pain; whole left arm from her elbow to her shoulder are in pain; she has been sleeping in a recliner chair; needle hit a nerve during the administration/inserted too high or too low or too deep; This case was reported by a consumer via call center representative and described the occurrence of injection site scab in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic kidney disease stage 3 and diabetes mellitus.   On 15th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th July 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site scab, nerve pain, mobility decreased, pain in arm, shoulder pain, pain in elbow and sleep disturbance. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site scab, nerve pain, mobility decreased, pain in arm, shoulder pain, pain in elbow and sleep disturbance were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   The reporter considered the injection site scab and nerve pain to be related to Shingrix. It was unknown if the reporter considered the mobility decreased, pain in arm, shoulder pain, pain in elbow and sleep disturbance to be related to Shingrix.  Additional details were reported as follows: On 15th July 2020, patient received 1st dose of Shingrix 0.5 ml (intramuscularly) in the left deltoid at her pharmacy. Patient stated that ever since then she could not lay down in bed because within 5 to 10 minutes her whole left arm from her elbow to her shoulder was in pain, the pain starts slowly and gradually increases and after an hour of laying down the pain was so intense and sharp that she had been sleeping in a recliner chair instead of a bed. Patient visited her primary care physician and well as an orthopedic doctor and she had X-rays done and an ultrasound done. Physician think that the needle hit a nerve during the administration of the Shingrix vaccine because it was inserted too high or too low or too deep and the patient thinks that it was an error on the part of her pharmacy, which led to vaccine administered at inappropriate site. patient states that they were going to send her for physical therapy because they say this nerve pain could go on for months or even years. Patient stated she had the scab from the Shingrix injection, and it was about 4 to 5 inches below the shoulder line. Patient had been taking therapy with Tylenol, but she says that the Tylenol did not touch the pain.  Patient said physician want to prescribe a different medication for pain, but she had pre-existing conditions (stage 3 kidney disease, diabetes) which prevent her from being able to take certain medications. Patient said that her local pharmacy had reported this adverse event to their corporate office, and it was the corporate office who asked her to contact GSK. On 17th September 2020, patient received flu shot in her right arm and had no problem. Patient said she was scared to get the 2nd Shingrix shot. Patient mentioned that she did not like wearing a mask because they cause her to get a panic attack. The reporter consented to follow-up.