Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Gait disturbance, Herpes zoster, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: body weakness; trouble walking; tingling in both hands; body weakness; trouble walking; tingling in both hands; suspected vaccination failure; diagnosed with shingles; drug dose administration interval too short; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19-JUN-2021, the patient received the 2nd dose of Shingrix. On 19-MAY-2021, the patient received the 1st dose of Shingrix. On 19-JUN-2021, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: drug dose administration interval too short). On 02-OCT-2024, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles). On an unknown date, the patient experienced weakness generalized (Verbatim: body weakness), walking difficulty (Verbatim: trouble walking), tingling of extremity (Verbatim: tingling in both hands), weakness generalized (Verbatim: body weakness), walking difficulty (Verbatim: trouble walking) and tingling of extremity (Verbatim: tingling in both hands). Rechallenge with Shingrix was positive. The outcome of the vaccination failure, shingles, weakness generalized, walking difficulty, tingling of extremity, weakness generalized, walking difficulty and tingling of extremity were not reported and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the vaccination failure, shingles, weakness generalized, walking difficulty, tingling of extremity, weakness generalized, walking difficulty and tingling of extremity 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, weakness generalized, walking difficulty, tingling of extremity, weakness generalized, walking difficulty and tingling of extremity to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 07-OCT-2024 This case was self-reported by patient. The patient had received 2 doses of Shingrix vaccine and after each vaccination patient had  body weakness, trouble walking, tingling in both hands.  The Patient was diagnosed with shingles. The patient received 2nd dose of Shingrix vaccine, earlier than the recommended interval, which led to shortening of vaccination schedule. This case was considered as suspected vaccination failure as details regarding, laboratory details and shingles were known at a time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). US-GSK-US2024AMR123515:same patient