Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Optic nerve operation, Papilloedema, Paraesthesia, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician and refers to a 15 year old male patient. The patient's concurrent conditions included  anaphylactic shock with tree nuts. The patient's medical history included herpes zoster. He did not have recent Varicella Zoster Virus exposure to chickenpox and shingles, and he never had chickenpox. Also, he had no history of herpes zoster ophthalmicus. His concomitant therapies included acetaminophen, acetazolamide, acyclovir, clindamycin, fluoxetine, gabapentin, ibuprofen, melatonin, methylprednisolone, nortriptyline, omeprazole, propranolol hydrochloride, BACTRIM and valacyclovir. On 27-MAR-2003, the patient was vaccinated with her second dose of VARIVAX 0.5 ml for (route, site of vaccination, lot# and expiration date were not provided), prophylaxis. On 17-JUL-2007, the patient was vaccinated with her first dose of VARIVAX 0.5 ml for (route, site of vaccination, lot# and expiration date were not provided), prophylaxis. The patient did not experienced rash at the site of injection following vaccination. On an unknown date in August 2015, the patient experienced herpes zoster dermatome in his left knee. On an unknown date, in September 2015, the patient experienced herpes zoster dermatome in the left part of his face (reported as "V1, V2, V3). Approximately in 2016, the patient experienced headache, diplopia, muscle pain, paresthesia, abnormal Magnetic Resonance Imaging (MRI) and abnormal Cerebrospinal Fluid (CSF) (herpes zoster meningitis), optic nerve swelling (papilloedema) resulting in visual loss (blindness) and requiring fenestration of the left and right optic nerve which were performed on 09-JUN-2016 and 01-JUL-2016 respectively. The reporting physician stated that since an unknown date, the patient was quite ill with central nervous system (CNS) involvement. It was reported that Varicella Zoster Virus (VZV) Identification - Polymerase Chain Reaction Test (PCR) was performed on an unknown date, and showed deoxyribonucleic acid (DNA) in saliva sample and Cerebrospinal fluid (CSF) sample, from the patient. The physician reported that it was unknown which strain of VZV was contained in the specimen: wild type VZV or Oka/Merck vaccine strain VZV. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Approximately in 2017, a CSF test was performed, which showed protein: 313, red blood cells (RBC): 517, glucose: <20, white blood cells (WBC): 59. Differential: 2 neutrophils, 22 lymphocytes, 74 monocytes, 2 vent lining cells (units not provided). At the time of reporting, the patient did not recover from herpes zoster meningitis, blindness and papilloedema. Nevertheless, the patient recovered from the first episode of herpes zoster and the outcome of herpes zoster and central nervous system (CNS) involvement was unknown. The reporter did not provide a causality assessment between VARIVAX and the events. Upon internal review, herpes zoster meningitis, blindness and papilloedema were considered as medically significant. Additional information has been requested.