Received Jun 11, 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 | — |
suspected vaccination failure; Vaccine-strain reactivation varicella zoster virus meningitis; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 12-year-old male patient who received Herpes zoster (Zoster vaccine) solution for injection for prophylaxis. Literature Reference: 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 GSK medically significant). The patient was treated with aciclovir (Acyclovir) 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 healthy patient, twice-vaccinated with varicella vaccine (at ages 12 months and 4 years and 6 months) child presented for evaluation of left knee pain with accompanying rash and new-onset headache. The patient reported superolateral left knee pain with radiation along the lateral aspect of the left thigh. In addition, patient reported a 2-day history of a 9/10 frontal headache and subjective fever and chills. The patient arrived afebrile with normal vital signs. Physical exam demonstrated a painful papular rash on the superolateral aspect of the left knee. Stabbing pain was elicited upon palpation of the lateral aspect of the thigh. Patient had positive Kernig's and Brudzinski's signs. A full neurologic exam was otherwise without abnormalities. Basic serum studies were obtained and unremarkable, demonstrating normal leukocyte count (8.15 × 103/µL) and normal liver enzymes (aspartate aminotransferase of 16 U/L and alanine aminotransferase of 16 U/L). CRP (C-reactive protein) and procalcitonin were also normal at less than 0.30 mg/dL and 0.08 ng/mL, respectively. Head computed tomography was without acute intracranial findings. A lumbar puncture was performed with CSF (cerebral spinal fluid) showing a lymphocyte-predominant pleocytosis (total nucleated cells 377 cells/mm3 with 99% lymphocytes), presence of red blood cells (5 cells/mm3), and normal glucose (65 mg/dL) and protein (46 mg/dL). The meningo-encephalitis PCR (polymerase chain reaction) panel from the CSF was positive for VZV (varicella zoster virus). CSF culture remained negative. Additionally, the patient underwent magnetic resonance imaging of the brain with and without contrast, which did not reveal any leptomeningeal enhancement or findings suggestive of encephalitis. An immunodeficiency workup was completed, including measles, mumps, rubella and varicella titers, total immunoglobulin (Ig)A, IgG and IgM levels, all of which returned within normal limits. Flow cytometry revealed 270 NK cells/mcL, 1908 CD3+ cells/mcL, 915 CD8+ T cells/mcL, 882 CD4+ T cells/mcL, 816 CD19+ B cells/mcL and a CD4/CD8 ratio of 0.96. Human immunodeficiency 1/2 antibody tests were negative. Comprehensive immunodeficiency screening evaluating 592 genes via Fulgent Genetics (Fulgent Comprehensive Primary Immunodeficiency-592 genes) was collected for further evaluation and returned negative. Patient CSF was sent to labs and confirmed the Oka strain of VZV. The patient was started on intravenous (IV) acyclovir 30 mg/kg/d divided into 3 doses and displayed progressive improvement in his symptoms, including resolution of rash after 7 days of therapy. IV acyclovir was continued for 12 days until patient experienced complete resolution of headache and was transitioned to oral valacyclovir to complete a total 14-day course of antiviral treatment.; Sender's Comments: A case of Vaccination failure and Herpes zoster meningitis, unknown time after receiving 2nd dose of Zoster vaccine in a 12-year-old male patient. Case lacks further information on time to onset, medical history, concurrent conditions. 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-US2026GSK076134:Same article, different patient
Test Name: alanine aminotransferase; Result Unstructured Data: (Test Result:16,Unit:u/L,Normal Low:,Normal High:); Test Name: aspartate aminotransferase; Result Unstructured Data: (Test Result:16,Unit:u/L,Normal Low:,Normal High:); Test Name: glucose; Test Result: 65 mg/dl; Test Name: total immunoglobulin A; Result Unstructured Data: (Test Result:within normal limits,Unit:unknown,Normal Low:,Normal High:); Test Name: immunoglobulin G; Result Unstructured Data: (Test Result:within normal limits,Unit:unknown,Normal Low:,Normal High:); Test Name: immunoglobulin M; Result Unstructured Data: (Test Result:within normal limits,Unit:unknown,Normal Low:,Normal High:); Test Name: CD19+ B; Result Unstructured Data: (Test Result:816,Unit:cells per microlitre,Normal Low:,Normal High:); Test Name: CD3+; Result Unstructured Data: (Test Result:1908,Unit:cells per microlitre,Normal Low:,Normal High:); Test Name: CD4+ T; Result Unstructured Data: (Test Result:882,Unit:cells per microlitre,Normal Low:,Normal High:); Test Name: CD4/CD8 ratio; Result Unstructured Data: (Test Result:0.96,Unit:unknown,Normal Low:,Normal High:); Test Name: CD8+T; Result Unstructured Data: (Test Result:915,Unit:cells per microlitre,Normal Low:,Normal High:); Test Name: Head computed tomography; Result Unstructured Data: (Test Result:without acute intracranial findings,Unit:unknown,Normal Low:,Normal High:); Test Name: CRP; Result Unstructured Data: (Test Result:less than 0.30,Unit:mg/dL,Normal Low:,Normal High:); 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:5,Unit:cells/mm3,Normal Low:,Normal High:); Test Name: CSF evaluation; Result Unstructured Data: (Test Result:Oka strain of VZV,Unit:unknown,Normal Low:,Normal High:); Test Name: Human immunodeficiency 1/2 antibody tests; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: lymphocytes; Test Result: 99 %; Test Name: NK; Result Unstructured Data: (Test Result:270,Unit:cells per microlitre,Normal Low:,Normal High:); Test Name: neurologic exam; Result Unstructured Data: (Test Result:without abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: meningo-encephalitis PCR panel; Result Unstructured Data: (Test Result:positive for VZV,Unit:unknown,Normal Low:,Normal High:); Test Name: procalcitonin; Result Unstructured Data: (Test Result:0.08,Unit:ng/mL,Normal Low:,Normal High:); Test Name: protein; Test Result: 46 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:8.15,Unit:x10(3)/uL,Normal Low:,Normal High:); Comments: Patient's frontal headache was reported as 9/10. Physical exam demonstrated a painful papular rash on the superolateral aspect of the left knee. The patient underwent magnetic resonance imaging of the brain with and without contrast, which did not reveal any leptomeningeal enhancement or findings suggestive of encephalitis. An immunodeficiency workup was completed, including measles, mumps, rubella and varicella titers all of which returned within normal limits. Comprehensive immunodeficiency screening evaluating 592 genes via Fulgent Genetics (Fulgent Comprehensive Primary Immunodeficiency-592 genes) was collected for further evaluation and returned negative. Patients Brudzinski's sign and Kernig's sign was positive. Patient's Nucleated red cells was 377 cells/mm3.