Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Inappropriate schedule of product administration, Pain, Rash
Clinical narrative: Suspected vaccination failure; shingles on the top of the spine/shingles 3 times in the past year (2023)/shingles started down to her privates; Burning sensation; Rash; pain; First Shingrix dose was on March 2022 and the second Shingrix dose was on December 2022.; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis and osteitis. Concomitant products included methotrexate and hydroxychloroquine.   In DEC-2022, the patient received the 2nd dose of Shingrix. In MAR-2022, the patient received the 1st dose of Shingrix. In DEC-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: First Shingrix dose was on March 2022 and the second Shingrix dose was on December 2022.). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles on the top of the spine/shingles 3 times in the past year (2023)/shingles started down to her privates), burning sensation (Verbatim: Burning sensation), rash (Verbatim: Rash) and pain (Verbatim: pain). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles, rash and pain were resolved and the outcome of the burning sensation and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, rash and pain to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, burning sensation, rash and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 06-AUG-2024 The patient received 2 doses of Shingrix and suffered shingles 3 times a on the past last year (2023).  In the past year 2023, patient stated that shingles started down to her privates and then up at the top of the spine and each time, that was where started.  And then she have had a two more times since where could tell all sensations were the same. The patient took Methotrexate one a week for rheumatology arthritis and osteitis and one pill name Hydroxychloroquine 200 mgrs. Patient's Rheumatologist Doctor indicated a booster dose but patient's Pharmacist said no.  The patient was trying to get more information prior to visit her doctor again.  At the moment of the call no additional Shingrix dose has been administered. The vaccine administration facility was the same as primary reporter. The last case of shingles (2024) was treated with valacyclovir 1 gram daily for 7 days.  Her shingles (rash, pain) cleared by day two of valacyclovir treatment.  The patient clarified that her rheumatologist's nurse recommended a third Shingrix dose, not her rheumatologist. Nothing else was reported. 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. The patient received the 2nd dose late which led to lengthening of vaccination schedule. Consented to follow up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (2 doses).