Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Oral herpes, Paraesthesia, Vaccination failure
Clinical narrative: 2 shot series in 2019, diagnosed with shingles; Shingles bumps on head heading to his eye.; tingle of a cold sore; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (20 years ago had a very mild case of shingles bumps on the side of his head) and laser therapy (had an elective surgery on his right eye called Selective Laser Treatment (SLT)).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles and cold sores were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and cold sores to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The patient reported case for himself. The age at vaccination was not reported. He received Shingrix 2 shot series in 2019. He did not know the exact dates or lot numbers of the Shingrix he received but he did provide his pharmacy's contact information where he received the shots. The pharmacy should have that information on file. He said he confirmed with the pharmacy that it was the 2 dose Shingrix series, not  the 1 dose Zostavax shot. He did not remember which arm the Shingrix shots were given in. He could not confirm if the shots were given intramuscularly or other.  He stated that a week ago he had an elective surgery on his right eye called Selective Laser Treatment (SLT). The next day he had the tingle of a cold sore and took some Valtrex (which he had). On Saturday night 21st August 2021 a line on the top of his head was noticed that was heading toward his eye. He thought it might be shingles and he was worried that it would spread into his eye so he went to urgent care. He was diagnosed with shingles bumps and the doctor prescribed Valtrex 1000 mg three times a day for 7 days (which is a higher dose than he was taking for cold sores).  The patient wanted GSK to know that he feels that the SLT triggered the shingles outbreak. He said he read online of 2 case reports of patients who developed shingles after SLT surgery.  He stated he would not going to get the left eye done. The reporter wanted GSK to know that he did not think he was under any stress as he had read that stress could bring about shingles outbreaks. The reporter feels that there was a relationship between herpes and shingles, that they were cousins. The physician did not probe more into his history of cold sores (herpes) but it seemed to be a pre-existing condition otherwise he would not have had the Valtrex on hand. The reporter did not consent to follow up.