Received Feb 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
VZV meningoencephalitis; Meningoencephalitis Despite Vaccination; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 42-year-old female patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Literature Reference: Co-suspect products included Herpes zoster (Zoster vaccine) for prophylaxis. The patient's past medical history included chickenpox (seven months prior to presentation for chickenpox). Concurrent medical conditions included interstitial lung disease, myositis (associated with connective tissue disease), immunosuppression and lung transplant. Additional patient notes included the patient had no prior history of headaches or seizures.. Concomitant products included prednisone, sulfasalazine, hydroxychloroquine and mycophenolate mofetil. On an unknown date, the patient received the 2nd dose of Zoster vaccine and the 1st dose of Zoster vaccine. On an unknown date, 7 months after receiving Zoster vaccine and Zoster vaccine, the patient experienced vaccination failure (Verbatim: Meningoencephalitis Despite Vaccination) (serious criteria GSK medically significant) and herpes zoster meningoencephalitis (Verbatim: VZV meningoencephalitis) (serious criteria hospitalization and GSK medically significant). The patient was treated with nimodipine, aciclovir (Acyclovir), antibiotics and valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster meningoencephalitis was resolving. The reporter considered the vaccination failure and herpes zoster meningoencephalitis to be related to Zoster vaccine and Zoster vaccine. The company considered the vaccination failure and herpes zoster meningoencephalitis to be unrelated to Zoster vaccine and Zoster vaccine. Additional Information: GSK received date: 02-FEB-2026 A 42-year-old woman with a complex medical history, including interstitial lung disease and myositis associated with connective tissue disease, was undergoing evaluation for lung transplantation. Patient was chronically immunosuppressed, receiving a regimen that included prednisone, sulfasalazine, hydroxychloroquine, and mycophenolate mofetil. The patient presented to the emergency department with a thunderclap headache that fluctuated in intensity and was accompanied by worsening shortness of breath. During evaluation, patient experienced a new-onset tonic-clonic seizure lasting approximately 3-4 minutes, characterized by right hand and gaze deviation and urinary incontinence. Notably, the patient had no prior history of headaches or seizures. Immunosuppressive therapy: The patient was on prednisone, sulfasalazine, hydroxychloroquine, and mycophenolate mofetil. Vaccination history: patient was seronegative for varicella zoster IgG but reported a history of childhood chickenpox. Patient received second dose of the Recombinant zoster vaccine (RZV), rather than Varivax due to high level of immunosuppression and childhood history of chickenpox, seven months prior to presentation. Imaging studies: MRI of the brain: Initially showed no acute intracranial processes. Magnetic resonance angiography: Revealed beading in the distal left M1 and proximal right M2 segments but no significant luminal narrowing, raising concerns for reversible cerebral vasoconstriction syndrome, cerebral vasculitis, or fibromuscular dysplasia. Cerebral angiogram: No evidence of cerebral vasculitis, but a small right posterior communicating artery infundibulum was identified. Infectious disease consultation: Given immunocompromised state, viral meningoencephalitis, particularly due to Varicella-zoster virus (VZV), became a leading concern after initial considerations of reversible cerebral vasoconstriction syndrome were ruled out due to lack of response to nimodipine. Lumbar puncture: Cerebrospinal fluid (CSF) analysis showed an elevated protein level and an abnormal white blood cell count with lymphocytic pleocytosis, consistent with a viral etiology. PCR of the Cerebrospinal fluid (CSF) revealed the presence of VZV, indicating VZV meningoencephalitis. The patient was started on a course of intravenous acyclovir (14-day course in accordance with infectious disease consultation recommendations and Infectious Diseases Society (IDS) guidelines) alongside symptomatic management for headache. Due to viral infection, dose of mycophenolate mofetil was reduced, and hydroxychloroquine was temporarily halted. Empiric antibiotics were maintained until cultures were finalized. Upon completion of the intravenous antiviral treatment, the patient was discharged home but later returned to the emergency department with increasing bilateral lower extremity weakness, leading to an inability to ambulate. Follow-up lumbar spine MRI: Revealed multifocal nodular leptomeningeal enhancement involving the cauda equina nerve roots. Repeat lumbar puncture: showed persistently elevated protein, lymphocytic pleocytosis, oligoclonal bands, and increased immunoglobulin synthesis rate, suggesting ongoing viral infection or inflammatory process. After comprehensive evaluations and consultations with infectious disease and neuroimmunology specialists, the diagnosis of ongoing VZV meningoencephalitis was confirmed. The patient was started on valacyclovir, and after showing continued improvement, patient was discharged on valacyclovir 1 g every 8 hours for 14 days. About six months after VZV meningoencephalitis, patient successfully underwent a lung transplantation without any complications. This patient was unlikely to have received live varicella vaccination as a child due to age, with routine childhood varicella vaccination. This article is not available for regulatory reporting purpose due to copyright restriction.; Sender's Comments: A case of Vaccination failure and Herpes zoster meningoencephalitis, 7 months after receiving Zoster vaccine (Dose 1 and dose 2), in a 42-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility for Herpes zoster meningoencephalitis and alternative risk factors (concurrent interstitial lung disease, immunosuppression and lung transplant).
Immunosuppression; Interstitial lung disease; Lung transplant; Myositis (associated with connective tissue disease)
Medical History/Concurrent Conditions: Chickenpox (seven months prior to presentation for chickenpox); Comments: the patient had no prior history of headaches or seizures.
PREDNISONE; SULFASALAZINE; HYDROXYCHLOROQUINE; MYCOPHENOLATE MOFETIL
Test Name: MRI of the brain; Result Unstructured Data: (Test Result:no acute intracranial processes,Unit:unknown,Normal Low:,Normal High:); Test Name: PCR of the Cerebrospinal fluid (CSF); Result Unstructured Data: (Test Result:VZV meningoencephalitis,Unit:unknown,Normal Low:,Normal High:); Comments: patient was seronegative for varicella zoster IgG. Magnetic resonance angiography: Revealed beading in the distal left M1 and proximal right M2 segments but no significant luminal narrowing, raising concerns for reversible cerebral vasoconstriction syndrome, cerebral vasculitis, or fibromuscular dysplasia. Cerebral angiogram: No evidence of cerebral vasculitis, but a small right posterior communicating artery infundibulum was identified. Cerebrospinal fluid (CSF) analysis showed an elevated protein level and an abnormal white blood cell count with lymphocytic pleocytosis, consistent with a viral etiology. Follow-up lumbar spine MRI: Revealed multifocal nodular leptomeningeal enhancement involving the cauda equina nerve roots. Repeat lumbar puncture: showed persistently elevated protein, lymphocytic pleocytosis, oligoclonal bands, and increased immunoglobulin synthesis rate, suggesting ongoing viral infection or inflammatory process.