Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Swelling, Vaccination failure
Clinical narrative: extreme breakout around my nose and mouth/ suspected vaccination failure; extreme breakout around my nose and mouth after 2nd shot; breakout on my face after 1st shot; red pimple; burning; itching bumps; itching bumps; red pimple; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: extreme breakout around my nose and mouth/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: extreme breakout around my nose and mouth after 2nd shot), shingles (Verbatim: breakout on my face after 1st shot), pimples (Verbatim: red pimple), burning sensation (Verbatim: burning), itchy rash (Verbatim: itching bumps), swelling (Verbatim: itching bumps) and erythema (Verbatim: red pimple). The patient was treated with steroids and neomycin sulfate, polymyxin b sulfate (Antibiotic). Rechallenge with Shingrix was positive. The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving and the outcome of the shingles, pimples, burning sensation, itchy rash, swelling and erythema were resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, pimples, burning sensation, itchy rash, swelling and erythema to be related to Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, pimples, burning sensation, itchy rash, swelling and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-NOV-2023 The patient received Shingrix vaccine. Within a week of her first shot she developed a breakout on her face.  The reporter stated that a dozen or so extremely red pimple looking burning and itching bumps. The patient used over the counter steroid cream for several weeks and they eventually went away. After her second shot, she experienced an extreme breakout around her nose and mouth.  Since that time, she had used over the counter steroid and antibiotics creams.  The patient had taken prescribed oral steroids and antibiotics as well as oral fungal medication.  The patient was now using her second prescribed steroid cream which cleared up the breakout.  If she stopped using the cream within 3 days, the breakout returned. The reporter question was if this was related to Shingrix and if there was a way to completely cure it.  The patient asked that if she had to assume Shingrix was the cause since she had never had an issue before.  The reporter further stated that eleven months of this was enough. She had seen two doctors regarding this. The reporter did not want to share her MD contact information with GlaxoSmithKline. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.