Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Paraesthesia, Rash, Scab
Clinical narrative: the rash; experiencing a tingling painful sensation in her left leg; painful sensation in left leg; area is crusted over; Suspected vaccination failure; outbreak was the size of a dollar piece or coin; on the backside of her left hip; her lower left leg toward her ankle or shin; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (Patient received Zostavax on unknown date). Concurrent medical conditions included psoriatic arthritis and rheumatoid arthritis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 16-AUG-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced shingles (Verbatim: her lower left leg toward her ankle or shin). On 16-OCT-2024, the patient experienced shingles (Verbatim: on the backside of her left hip). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: outbreak was the size of a dollar piece or coin), rash (Verbatim: the rash), tingling sensation (Verbatim: experiencing a tingling painful sensation in her left leg), pain in extremity (Verbatim: painful sensation in left leg) and crust (Verbatim: area is crusted over). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure, shingles, shingles and crust were not reported and the outcome of the shingles was resolving and the outcome of the rash was resolved and the outcome of the tingling sensation and pain in extremity were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, shingles, shingles, rash, tingling sensation, pain in extremity and crust to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, shingles, shingles, rash, tingling sensation, pain in extremity and crust to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-OCT-2024 Reporter was patient reported that she had Zostavax administered when the medication was available.  Also states that she had the complete series of Shingrix administered.  She provided vaccination date for first dose as 18th May and second dose vaccination date as 12th September.  She was unsure if she was vaccinated in 2022 or 2023.  She had an outbreak of Shingles three different times since vaccination with Shingrix. She stated that the first outbreak was either in March, April or May of 2024 and the outbreak was the size of a dollar piece or coin, for which prescribed Valtrex of unknown strength/dosage and the rash resolved. The second outbreak was on 16th August 2024 on her lower left leg toward her ankle or shin and a spot on the backside of her left hip. She stated third outbreak of shingles was on 16th October 2024.  The outbreak was on the backside of her left hip.  She was prescribed Valtrex of unknown strength or dose for all three outbreaks.  She stated the current outbreak was resolving and the area was crusted over and the size of a quarter.  She was experiencing a tingling painful sensation in her left leg that was encompassing her entire inner thigh. This case was considered as suspected vaccination failure as details regarding completion of 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 (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.