Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Central nervous system vasculitis, Cerebral artery stenosis, Cerebrovascular accident, Colectomy total, Colitis
Clinical narrative: Vaccination Failure; cerebral VZV vasculopathy; cerebral VZV vasculopathy; left eye pain; herpes zoster ophthalmicus; possible episode of speech arrest; multiple seizures; This serious case was reported in a literature article and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference:  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, prednisone for immunosuppressant drug therapy, infliximab for immunosuppressant drug therapy and tofacitinib for ulcerative colitis.   Concurrent medical conditions included ulcerative colitis.   In 2018, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In AUG-2021, the patient received the 3rd dose of Shingrix. On an unknown date, the patient started prednisone and infliximab. In FEB-2022, the patient started tofacitinib. In 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: herpes zoster ophthalmicus) (serious criteria GSK medically significant). In JUL-2021, the patient experienced eye pain (Verbatim: left eye pain). In OCT-2021, the patient experienced speech disorder (Verbatim: possible episode of speech arrest). In 2022, the patient experienced varicella zoster virus infection (Verbatim: cerebral VZV vasculopathy), vasculitis cerebral (Verbatim: cerebral VZV vasculopathy) (serious criteria GSK medically significant) and seizure cerebral (Verbatim: multiple seizures) (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccination failure (Verbatim: Vaccination Failure) (serious criteria GSK medically significant and other: as reported). The patient was treated with acyclovir, valaciclovir (Valacyclovir) and levetiracetam. The action taken with prednisone was unknown. Infliximab was discontinued. Tofacitinib was discontinued. The outcome of the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral were unknown.   The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix.     The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix.   Additional Information  GSK receipt date: 14 Apr 2023 A 72-year-old woman with a history of ulcerative colitis who had received 2 doses of the Shingrix vaccine in 2018 developed left eye pain in July 2021, while on high-dose prednisone and during infliximab induction. She was diagnosed with herpes zoster ophthalmicus (HZO). Infliximab was discontinued, and she received a brief course of intravenous acyclovir followed by indefinite suppressive oral valacyclovir. In August 2021, she received a third dose of the Shingrix vaccine. In September 2021, magnetic resonance imaging of the brain was obtained for persistent eye pain, which revealed enhancement of the left cranial nerve 3 and V1 (not shown). In October 2021, she had a possible episode of speech arrest. In February 2022, she was started on tofacitinib for persistently active ulcerative colitis. The following month, she was admitted after multiple seizures. Tofacitinib was discontinued, and she was started on levetiracetam. A computerized tomography angiogram showed severe, multifocal left middle cerebral artery and left posterior cerebral artery narrowing. Magnetic resonance imaging was significant for multiple chronic-appearing infarcts in the left parietal lobe, new from September 2021, and vessel wall imaging (VWI) demonstrated enhancement of the distal left internal carotid artery, left middle cerebral artery, and left anterior cerebral artery segments consistent with varicella zoster (VZV) vasculopathy. A lumbar puncture showed normal protein and glucose without leukocytosis. VZV polymerase chain reaction was negative, but cerebrospinal fluid (CSF) testing for VZV antibodies was positive (IgG anti-VZV 1:2; IgM anti-VZV negative). Based on these results, she was diagnosed with cerebral VZV vasculopathy and treated with an oral prednisone taper and a 2-week course of intravenous acyclovir.2 In May 2022, she developed worsening colitis symptoms and was offered tofacitinib again to avoid a colectomy. Ten days after restarting tofacitinib, she presented to another hospital after 2 seizures at home. Her admission levetiracetam level was therapeutic and above the serum level obtained when she was previously checked and had excellent seizure control. Repeat magnetic resonance imaging brain revealed no new infarctions but persistent multifocal stenoses and vessel wall enhancement. Despite an additional levetiracetam load, EEG monitoring revealed 5 left hemispheric seizures. Tofacitinib was permanently discontinued, and 4 weeks later, she underwent total colectomy.