Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Injection site swelling, Myalgia, Pain
Clinical narrative: loss of hearing; shingles on the left leg above the knee / pain around the area of shingles; itching, redness, and pain around the area of shingles; redness / around the area of shingles; peeling skin around the area of shingles; dry skin; wrinkling skin; first dose of Shingrix vaccine on 12/10/19 and has not received the second dose yet; shingles on the left leg above the knee; ear infection; bronchitis; swelling around the injection site; soreness around the injection site; exhausted; headache; achy; muscle pain; chills / shivering; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 11th December 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced muscle pain, shivering, diarrhea, injection site swelling, injection site pain, exhaustion, headache and pain. In January 2020, the patient experienced ear infection and bronchitis. In July 2020, the patient experienced shingles. On an unknown date, the patient experienced hearing loss (serious criteria GSK medically significant), leg pain, pruritus, erythema, skin peeling, dry skin, skin wrinkling and incomplete course of vaccination. On an unknown date, the outcome of the hearing loss, leg pain, pruritus, erythema, skin peeling, shingles, ear infection, bronchitis, muscle pain, shivering, diarrhea, injection site swelling, injection site pain, exhaustion, headache, pain and dry skin were recovered/resolved and the outcome of the skin wrinkling and incomplete course of vaccination were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, leg pain, pruritus, erythema, skin peeling, shingles, ear infection, bronchitis, muscle pain, shivering, diarrhea, injection site swelling, injection site pain, exhaustion, headache, pain, dry skin and skin wrinkling to be related to Shingrix.  Additional details were received as follows: The patient received the first dose of Shingrix vaccine and has not received the second dose yet (Inappropriate schedule of vaccine). Patient reported the day after receiving the vaccine she was achy, had a headache, was exhausted, had soreness around the injection site, had chills, had swelling around the injection site, diarrhea, shivering, and muscle pain. Patient reported these events lasted 3 to 4 days and then resolved.  Patient reported she was diagnosed with shingles in July 2020. Patient reported shingles on the left leg above the knee, had itching, redness, and pain around the area of shingles. Patient reported dry skin, wrinkling skin, and peeling skin around the area of shingles. Patient reported these events lasted a couple of weeks with the exception of the wrinkling skin which is still ongoing at this time. Patient reported her doctor prescribed an antiviral medication for the shingles. The patient reported she had bronchitis and an ear infection in January 2020 and these have resolved. Patient reported she was prescribed steroids for the bronchitis. Patient reported she had a loss of hearing around January 2020 that lasted for 30 days and resolved. The reporter did not consent to follow-up. This case was linked with case US2020239776 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239776:same reporter