Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Diabetic complication, Diabetic neuropathy, Herpes zoster, Leg amputation
Clinical narrative: shingles lesion; shingles lesion/one softball-sized lesion on my lower right back; hospitalized with complications of diabetes, neuropathy; sepsis; intense pain from the lesion; taking the Shingrix vaccine and booster and I still got a tremendously large softball size wound; begun itching; Suspected vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pruritus. Concurrent medical conditions included diabetic neuropathy and diabetes.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In AUG-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced pruritus (Verbatim: begun itching) (serious criteria hospitalization). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles lesion) (serious criteria hospitalization), skin lesion (Verbatim: shingles lesion/one softball-sized lesion on my lower right back) (serious criteria hospitalization), diabetic neuropathy (Verbatim: hospitalized with complications of diabetes, neuropathy) (serious criteria hospitalization), sepsis (Verbatim: sepsis) (serious criteria hospitalization and GSK medically significant), pain (Verbatim: intense pain from the lesion) (serious criteria hospitalization) and wound (Verbatim: taking the Shingrix vaccine and booster and I still got a tremendously large softball size wound) (serious criteria hospitalization). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles, skin lesion, diabetic neuropathy, sepsis, pain and wound were resolved and the outcome of the pruritus was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, diabetic neuropathy, sepsis, pain, pruritus and wound to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, skin lesion, diabetic neuropathy, sepsis, pain, pruritus and wound to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 11-Aug-2023 and 14-Aug-2023 The patient reported that he received both doses of Shingirx vaccination in 2018 and in October 2022 he was hospitalized with complications of diabetes, neuropathy and sepsis.  They performed an above knee amputation.  The patient stated that he was in 3 hospitals and one rehab center for 5 months.   The shingles lesion came up about 3 or 4 weeks into the hospitalization and was initially misdiagnosed and mistreated.  The patient described the lesion as 'one softball-sized lesion on my lower right back' and reported that it never blistered up or oozed liquid.  After about 3 weeks of having the lesion and intense pain from the lesion, it was finally diagnosed as a shingles lesion and he was treated with acyclovir, which, he stated, was not much help.   After returning home, the patient saw his physician who again prescribed acyclovir 600 mg 5 times a day for 10 days.  The patient stated that oh the nurse was very in kind and informative which she could be his concern was he must be one of the three percent people by taking the Shingrix vaccine and booster and still got a tremendously large softball size wound and he want to know if taking another booster would be advisable. The patient said it did eventually clear up, but now had begun itching again, and he was worried it will crop up again.   The patient called to ask about treatments for this and asked if he should repeat the Shingrix vaccine.   Referred the patient to his health care professional and provided medical information telephone number. The reporter consented to follow-up. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.