Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Condition aggravated, Erythema, Glaucoma, Intraocular pressure increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin cancer in a 86-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 28th February 2021) for prophylaxis. Co-suspect products included valsartan for an unknown indication. The patient's past medical history included cataract extraction and skin cancer (years ago the patient had cancer removed from the same spot on the right collar bone area). Previously administered products included ZOSTAVAX. Concurrent medical conditions included glaucoma. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient started valsartan 320 mg once daily (320 mg daily). On 13th September 2018, 1 days after receiving SHINGRIX and an unknown time after starting valsartan, the patient experienced skin cancer (serious criteria GSK medically significant), localized erythema and pruritus. In November 2018, the patient experienced blurred vision. On 6th December 2018, the patient experienced glaucoma aggravated (serious criteria GSK medically significant). The action taken with valsartan was unknown. On an unknown date, the outcome of the skin cancer, blurred vision and glaucoma aggravated were unknown and the outcome of the localized erythema and pruritus were recovered/resolved. It was unknown if the reporter considered the skin cancer, blurred vision, glaucoma aggravated, localized erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient had glaucoma and cataract surgery in the past before she received SHINGRIX vaccine. The patient received SHINGRIX in the right arm. About a month ago she noticed that she was not seeing as clearly from one eye. The patient went to her ophthalmologist and 85 days after receiving vaccination, it was noticed that the pressure in one of her eyes was going up. The patient does not remember what eye. The day after getting the vaccine she had red spot on her right collar bone area which was flared up and itching. Years ago she had cancer removed from the same spot on the right collar bone area. Within few days after the patient visited her skin physician, he did a biopsy of the skin and it was diagnosed as skin cancer. A surgery was done and 2 by 2 inch of area was removed. During the time of surgery another biopsy was done for the area on the skin right below the elbow, about half way up the forearm area. This was diagnosed as skin cancer as well and it was removed. The patient also stated that she was on Valsartan 320mg one tablet every day manufactured by other manufacturer. The pharmacy had told her that they cannot refill the Valsartan for her since they were going to stop selling it due to concerns of it causing cancer. Therefore patient thought it could also be the Valsartan that could be causing the skin cancer. The reporter did not consent to follow-up. The Emergency visit was required. The patient had a follow up appointment with her skin doctor on 28th December 2018.