Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles outbreaks that come back; not yet age 50 when she was administered the Shingrix shots; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 37-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 (had shingles in 6 and amp, 7 cranial nerves), vertigo and vestibular neuritis. Concurrent medical conditions included ramsay-hunt syndrome (had ramsay hunt syndrome (a complication of shingles)). Concomitant products included phentermine hydrochloride;topiramate (Qsymia).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles outbreaks that come back) and inappropriate age at vaccine administration (Verbatim: not yet age 50 when she was administered the Shingrix shots). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-OCT-2024 and 10-OCT-2024 The patient self-reported this case for herself. The patient had both shingles shots last year as a person who had lifelong complications from previously had shingles in her 6 and amp 7 cranial nerves and certainly never wanted to get it again.  The patient because of her age at the time (35), she asked for the vaccine and a year and a half later she received a bill that insurance was denying the coverage for the first dose and it was 907 dollars.  The patient asked was there anything she could do through GlaxoSmithKline's organization even though she had already gotten the vaccine. The patient was not yet age 50 when she was administered the Shingrix shots which led to inappropriate age at vaccine administration. The patient received the both shots and had shingles outbreaks that come back and used Valtrex to treat them. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).