Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Condition aggravated, Erythema, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 74-year-old patient who received SHINGRIX for prophylaxis. The patient's past medical history included genital herpes (outbreaks on labia and buttock). Previously administered products included shingles vaccine (She had the shingles vaccine 9 years before the reporting date), Valtrex and Hydrocortisone cream. Concurrent medical conditions included burn (put a hot pot too close to her stomach and got a burn 2 inches on her stomach), erythema, pruritus and topical adhesive allergy. Concomitant products included Herpes zoster SHINGRIX. On 6th July 2018, the patient received the 2nd dose of SHINGRIX. On 7th July 2018, 1 days after receiving SHINGRIX, the patient experienced vesicular rash, erythema, pruritus aggravated, blister and burn. The patient was treated with valaciclovir hydrochloride (Valtrex). On 8th July 2018, the outcome of the pruritus aggravated was recovered/resolved. On an unknown date, the outcome of the vesicular rash was unknown and the outcome of the erythema, blister and burn were not recovered/not resolved. It was unknown if the reporter considered the vesicular rash, erythema, pruritus aggravated, blister and burn to be related to SHINGRIX. Additional details were provided as follows: The patient reported that in her 30s she contracted herpes progenitalis from her husband and she would have outbreaks on her labia and buttock when she was under stress. The patient went to an gynecologist in her 40s where he prescribed Valtrex. The patient could take Valtrex when she got an outbreak and also prophylactically for years.  The patient could take Valtrex 1,000 mg for 5 days and she had been on Valtrex since her 40's.  The patient said that she was not continuously taking Valtrex. The patient was not taking Valtrex when she burned. This was not an event as the patient was not on any medication made by GlaxoSmithKline at that point. The patient used band aid on the burn and after she started having redness and itchiness around the band aid. The patient went to an urgent care and the physician thought that she was becoming allergic to the adhesive. The patient used hydrocortisone cream which did not help. In April 2018, the patient received 1st dose of SHINGRIX. On Friday, the patient received 2nd dose over two months after 1st dose. On Saturday, the day after the vaccination, the patient noticed that the area around the band aid was blistery, burning, the redness spread and grew in size, got more itchy and distinctly more red. On Sunday, at night, the patient took 1,000 mg of Valtrex at around 9:30 pm and then at 3:30 am the itching went away. The patient was concerned and did not know if this was herpes or shingles. The patient did not have herpes on the stomach before but it looked like herpes. The patient was concerned it could also be shingles. Since the patient got the vaccine for shingles recently and she was waiting to hear back from the dermatologist to get a diagnosis. The reporter provided conatct details of the physician.