Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Fibromyalgia, Laboratory test abnormal, Lethargy, Pain
Clinical narrative: Suspected vaccination failure; Shingles; worse blurred vision; Body-wide myalgia; Rashes on face; profuse sweating; Elevated liver enzymes; condition aggravated; Blurred vision; Body-wide myalgia; Rashes on face; Worsened urticaria; Fever; Sweating; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urticaria (had active urticaria on his face).   On 23rd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, sweating and urticaria aggravated. On 25th April 2019, the patient experienced blurred vision, myalgia and rash. On 30th June 2019, the patient experienced blurred vision, myalgia aggravated, rash, sweating, elevated liver enzymes and condition aggravated. On 13th October 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles, urticaria aggravated, blurred vision, myalgia aggravated, rash, sweating, elevated liver enzymes and condition aggravated were unknown and the outcome of the fever, sweating, blurred vision, myalgia and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fever, sweating, blurred vision, myalgia, rash and urticaria aggravated to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, blurred vision, myalgia aggravated, rash, sweating, elevated liver enzymes and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that he received both doses of Shingrix vaccine when he had active urticaria on his face. He reports that after he got the vaccines, it supercharged everything and made the urticaria worse. He said that he received the 1st dose of shingrix in April 2019 and had fever and sweating right away. He said two days later, he developed blurred vision, bodywide myalgia, slight breakout of rashes on his face. He received the 2nd dose of Shingrix in June 2019 and after two days he had even worse blurred vision, body-wide myalgia, profuse sweating and rashes on his face got worse and spread from his forehead to chin. He said symptoms after 2nd dose were worse and more severe than after the first dose. He also reports that his liver enzymes were elevated after the second dose. He reports going to the emergency room (ER) on October 13th and was officially diagnosed with Shingles.  The reporter did not consent to follow-up. This case was considered as suspected vaccination failure since the details regarding completion of laboratory confirmation of shingles for the event was unknown at the time of reporting.