Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Normal pressure hydrocephalus, Pain, Pruritus, Rash vesicular
Clinical narrative: Herpes zoster; subsequent varicella encephalitis; burning pain and pruritus involving the left hip and calf 2 days after receiving the second dose of the RZV.; burning pain and pruritus involving the left hip and calf 2 days after receiving the second dose of the RZV.; Vaccination failure; This serious case was reported in a literature article and described the occurrence of herpes zoster in a 75-year-old male patient who received Herpes zoster (Zoster vaccine) for prophylaxis.    Co-suspect products included Herpes zoster (Zoster vaccine) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia, confusion, weakness, nerve pain, memory impairment, cognitive impairment and vesicular eruption. Concomitant products included paracetamol (Acetaminophen).   On an unknown date, the patient received Zoster vaccine 2 and Zoster vaccine 1. On an unknown date, an unknown time after receiving Zoster vaccine and Zoster vaccine, the patient experienced herpes zoster (Verbatim: Herpes zoster), varicella encephalitis (Verbatim: subsequent varicella encephalitis) (serious criteria GSK medically significant), pain burning (Verbatim: burning pain and pruritus involving the left hip and calf 2 days after receiving the second dose of the RZV.), pruritus (Verbatim: burning pain and pruritus involving the left hip and calf 2 days after receiving the second dose of the RZV.) and vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant). The patient was treated with valaciclovir (Valacyclovir) and aciclovir (Acyclovir). The outcome of the herpes zoster, varicella encephalitis, pain burning and pruritus were not reported and the outcome of the vaccination failure was unknown.   The reporter considered the herpes zoster, varicella encephalitis, pain burning, pruritus and vaccination failure to be related to Zoster vaccine and Zoster vaccine.     The company considered the herpes zoster, varicella encephalitis, pain burning, pruritus and vaccination failure to be related to Zoster vaccine and Zoster vaccine.   Additional Information: GSK Receipt Date: 15-Apr-2024 The author reported a 75-year-old man presented to the emergency department with burning pain and pruritus involving the left hip and calf 2 days after receiving the second dose of the Recombinant Zoster Vaccine (RZV). He had a history of chronic lymphocytic leukemia (CLL) and was being clinically monitored. He received the first dose of the RZV without complication 3 months prior. In the emergency department, he was diagnosed with nerve pain, given acetaminophen, and discharged home; how-ever, he continued to have worsening pain 8 days later followed by a vesicular eruption that wrapped around the left leg and was concentrated on the inner thigh/groin area in a dermatomal distribution. His primary care physician diagnosed him with herpes zoster and prescribed valacyclovir 1000 mg every 8 hours for 7 days. Two days later, the patient developed weakness and confusion and returned to the emergency department. Upon admission, computed tomography and magnetic resonance imaging/ magnetic resonance angiography of the brain was normal. A lumbar puncture confirmed varicella encephalitis via a polymerase chain reaction assay. He was treated with intravenous acyclovir and discharged to a rehabilitation facility. His course was further complicated by a subarachnoid hemorrhage and normal pressure hydrocephalus. He did not require a shunt but continues to have memory impairment, weakness, and cognitive impairment. He is steadily improving with rehabilitative services. The RZV is an inactivated vaccine composed of the varicella-zoster virus (VZV) glycoprotein E antigen and an adjuvant, AS01B, that boosts both innate and adaptive immunity. It was approved in 2017 for prevention of herpes zoster in adults aged 50 years or older. It requires 2 separate injections administered 2 to 6 months apart. Its efficacy for the prevention of cutaneous herpes zoster and postherpetic neuralgia is 97percent and 80percent to 91percent, respectively. It was developed to improve on the existing zoster vaccine live, which contains a live attenuated virus, with efficacy ranging from 38percent to 70percent. The patient's herpes zoster and varicella encephalitis occurred following administration of the second dose of the RZV. Herpes zoster occurs from declining VZV-specific cell-mediated immunity. Given that the vaccine contains inactive virus, it is unlikely that patient's infection was the direct result of dissemination of the virus contained within the vaccine. The RZV specifically generates T-cell responses to the glycoprotein E subunit of VZV, which is thought to be responsible for the high levels of VZV-specific memory T cells with the RZV compared to the zoster vaccine live. However, this response does not occur until after the second dose of RZV. Although patient already had 1 dose of RZV, it was unlikely that he had a substantial number of glycoprotein E and VZV-specific memory T cells to combat virus reactivation. Additionally, his CLL, though mild, may have resulted in an aberrant T-cell response in the presence of already low VZV-specific lymphocytes, allowing for reactivation and dissemination of the virus. This article is not available for regulatory reporting purpose due to copyright restriction.