Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Tiredness; headache; Shoulder tenderness/ shoulder pain upon movement; Injection site itching; hardness; non-productive cough; throat hoarseness; Injection site swelling; chills; redness at the ijection site; burning; hotness; tingling; Back pain; Leg pain; muscle aches/ all over muscle pain; joint pain/all over joint pain/joints in her fingers of her hands hurt; fever; pain in entire body/ body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019 10:50, the patient received the 1st dose of Shingrix. On 29th May 2019, several hours after receiving Shingrix, the patient experienced back pain, leg pain, generalized muscle aches, generalized joint pain, fever and generalized aching. On 29th May 2019 13:15, the patient experienced injection site erythema, injection site burning, injection site warmth and injection site tingling. On 30th May 2019, the patient experienced injection site swelling and chills. On 31st May 2019, the patient experienced headache, shoulder pain, injection site itching, injection site induration, cough nonproductive and hoarseness. On an unknown date, the patient experienced tiredness. The patient was treated with ibuprofen (Advil), hydrocortisone, paracetamol (Tylenol), non-drug therapy (Cold Compress) and benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tingling were not recovered/not resolved and the outcome of the injection site burning, back pain, leg pain, generalized muscle aches, generalized joint pain, fever, generalized aching, injection site swelling, chills, headache, shoulder pain, injection site itching, injection site induration, cough nonproductive, hoarseness and tiredness were unknown.   It was unknown if the reporter considered the injection site erythema, injection site burning, injection site warmth, injection site tingling, back pain, leg pain, generalized muscle aches, generalized joint pain, fever, generalized aching, injection site swelling, chills, headache, shoulder pain, injection site itching, injection site induration, cough nonproductive, hoarseness and tiredness to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in the left arm. In the afternoon of the vaccination day, the patient noted she was having redness, burning, tingling and hotness at the site. Later that evening her back and legs were hurting and had all over muscle and joint aches. The patient was also feverish and temperature was at 100.4 degree F. She had pain in her entire body that night.  The patient took advil and that did not really help so she also took tylenol and that allowed her to sleep.  The next morning of the vaccination day, the patient called her physician office to report fever, chills and injection site reaction symptoms of redness and swelling. She was told that, these were common symptoms and would resolve in about 2 to 3 days. On the second day of vaccination, the patient also noted tenderness in her left shoulder area, especially with movement along with headache and all over joint and muscle pain. She noted even the joints in her fingers of her hands hurt. On that day, the patient remained in bed the whole day, took alternating Advil and Tylenol for fever, pain and injection site reaction. On Friday 31st May 2019, her fever symptoms improved in the afternoon as well as the body aches were less. But the injection site was worse. The patient developed more redness and hardness, it was hot and itching. She also noted throat hoarseness and had a cough but it was non productive that began in the afternoon.  The patient tried cold compress, benadryl itch cream but not got much help from either.  The night before the reporting day, she tried hydrocortisone cream but that also did not help much. The patient was encouraged to notify her physician of these events as she had not done so already. The patient was not sure if she would receive the 2nd dose at this point. The patient consented to follow up and provided her physician's details.