Received Jun 15, 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 | — |
Vaccine-strain reactivation varicella zoster virus meningitis; suspected vaccination failure; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 9-year-old male patient who received Herpes zoster (Zoster vaccine) solution for injection for prophylaxis. Concurrent medical conditions included phonophobia and photophobia. Additional patient notes included Patients family denied any altered mental status or concerning exposures." At arrival patient was nontoxic and in no apparent distress without meningeal signs.. On an unknown date, the patient received the 2nd dose of Zoster vaccine. On an unknown date, an unknown time after receiving Zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster meningitis (Verbatim: Vaccine-strain reactivation varicella zoster virus meningitis) (serious criteria hospitalization and GSK medically significant). The patient was treated with ceftriaxone, vancomycin, aciclovir (Acyclovir), doxycycline and valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster meningitis was resolved. The reporter considered the vaccination failure and herpes zoster meningitis to be related to Zoster vaccine. The company considered the vaccination failure and herpes zoster meningitis to be unrelated to Zoster vaccine. Additional Information: GSK receipt date: 05-JUN-2026 This case was considered as suspected vaccination failure since the details regarding TTO was unknown. This healthy patient, twice-vaccinated with varicella vaccine (at ages 1 year and 1 month and 4 years and 4 months) child presented with 3 days of worsening generalized headache, 2 days of fever and new emesis. The headache was described as 8/10 and was associated with phonophobia and photophobia. Five days prior, the patient developed a pruritic rash on the left lower back and inner left thigh. Patient's family denied any altered mental status or concerning exposures. The child arrived alert, nontoxic and in no apparent distress without meningeal signs. Patient was afebrile with normal vital signs. A full neurologic exam revealed no focal findings or altered mental status. Skin exam was significant for grouped, raised vesicles on an erythematous base over the left lower lumbar spine and left anterior thigh, in a dermatomal pattern. Initial evaluation consisted of basic serum studies, which revealed no abnormalities, including a normal leukocyte count (5.9 × 103/µL) and normal transaminases (aspartate aminotransferase of 31 U/L and alanine aminotransferase of 17 U/L). C-reactive protein (CRP) was normal at 0.15 mg/dL. Computed tomography of the head was normal. A lumbar puncture revealed cerebral spinal fluid (CSF) with a lymphocyte-predominant pleocytosis (total nucleated cells 169 cells/mm3 with 95% lymphocytes), presence of red blood cells (14 cells/mm3) and slightly elevated protein (52.1 mg/dL) with normal glucose (54 mg/dL). The meningo-encephalitis polymerase chain reaction (PCR) panel was positive for varicella zoster vaccine (VZV). Serum herpes simplex virus and VZV PCR studies, as well as CSF cultures, were negative. The patient was admitted and started on empiric ceftriaxone, vancomycin, acyclovir and doxycycline. The CSF sample was sent for molecular genotyping to Health labs. The patient had a rapid resolution of symptoms with antiviral therapy. Patient was treated with high-dose intravenous (IV) acyclovir at 1500 mg/m2 per day divided into 3 doses for 7 days and transitioned to oral valacyclovir at discharge to complete a total 14-day course of antiviral therapy.; Sender's Comments: A case of Vaccination failure and Herpes zoster meningitis, unknown time after receiving 2nd dose of Zoster vaccine in a 9-year-old female patient. Case lacks further information on time to onset, medical history. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2026GSK076928:Same article, different patient
Phonophobia; Photophobia
Comments: Patients family denied any altered mental status or concerning exposures." At arrival patient was nontoxic and in no apparent distress without meningeal signs.
Test Name: alanine aminotransferase; Result Unstructured Data: (Test Result:17,Unit:u/L,Normal Low:,Normal High:); Test Name: aspartate aminotransferase; Result Unstructured Data: (Test Result:31,Unit:u/L,Normal Low:,Normal High:); Test Name: glucose; Test Result: 54 mg/dl; Test Name: Computed tomography of the head; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: C-reactive protein; Test Result: 0.15 mg/dl; Test Name: CSF culture; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: red blood cells; Result Unstructured Data: (Test Result:14,Unit:cells/mm3,Normal Low:,Normal High:); Test Name: lymphocytes; Test Result: 95 %; Test Name: neurologic exam; Result Unstructured Data: (Test Result:no focal findings or altered mental status,Unit:unknown,Normal Low:,Normal High:); Test Name: meningo-encephalitis polymerase chain reaction; Result Unstructured Data: (Test Result:positive for VZV,Unit:unknown,Normal Low:,Normal High:); Test Name: VZV PCR; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: protein; Test Result: 52.1 mg/dl; Test Name: vital signs; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: leukocyte count; Result Unstructured Data: (Test Result:5.9,Unit:x10(3)/uL,Normal Low:,Normal High:); Comments: Skin exam was significant for grouped, raised vesicles on an erythematous base over the left lower lumbar spine and left anterior thigh, in a dermatomal pattern. A lumbar puncture revealed cerebral spinal fluid (CSF) with a lymphocyte-predominant pleocytosis (total nucleated cells 169 cells/mm3). Headache was described as 8/10.