Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: 2 days after the second dose, the patient broke out with Shingles; 2 days after the first dose, the patient broke out with Shingles; I have break out on my face and back on my right side; the patient broke out in a Shingles rash on her face and above right eye; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 55-year-old female 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, burn and pain.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 24-JUL-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: I have break out on my face and back on my right side) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: the patient broke out in a Shingles rash on her face and above right eye). On an unknown date, the patient experienced shingles (Verbatim: 2 days after the second dose, the patient broke out with Shingles) and shingles (Verbatim: 2 days after the first dose, the patient broke out with Shingles). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure and facial herpes zoster were not resolved and the outcome of the shingles and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, facial herpes zoster and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, facial herpes zoster and shingles to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster and shingles to be related to Shingrix. It was unknown if the company considered the facial herpes zoster and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUL-2024 and 26-JUL-2024 The patient stated that she had the vaccine and also take Acyclovir 400 mg twice a day, every day. The patient was trying to get into an Infectious Disease doctor. The patient had a break out on my face and back on my right side. The patient has a history of Shingles (disease), in which she breaks out every so often. The patient first came down with Shingles when she was in her 30's. Most times, the Shingles was on her back, and the patient did not have a break out / rash, it was pain and irritation. The patient can feel the burn and pain when clothes rub up against the affected area. About 2 years ago, the patient received the Shingrix Vaccine. 2 days after the first dose, the patient broke out with Shingles and was treated with Acyclovir. 2 days after the second dose, the patient broke out with Shingles and again treated with Acyclovir. The patient continued to break out with Shingles every so often The patient never received the Zostavax Vaccine. About two months ago, the patient was started on Acyclovir 400mg twice daily which she continued to take. Yesterday (July 24, 2024), the patient broke out in a Shingles rash on her face, above the right eye. The patient saw an eye Doctor today to evaluate the shingles around her eye. The eye was not infected. She was given some Refresh eye drops to use in the eye. The patient has an appointment with an Infectious Disease Doctor on July 26, 2024. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed events which is considered related to GSK vaccine Shingrix (Dose 1) and Shingrix (Dose 2).