Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Enterovirus test negative, Herpes simplex test negative, Herpes zoster, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from the Centers for Disease Control (CDC) (VAERS # 187837) lab concerning a 44 month old male with no previous history of disease or immunosuppressive illness, who on 19-AUG-1999 was vaccinated with a dose of varicella virus vaccine live Oka/Merck. On 27-APR-2002 the patient developed pain in the right arm, the next day the patient developed a zoster-like rash. On 30-APR-2002 the patient was admitted to the hospital with aseptic meningitis. CSF PCR performed for herpes simplex and enterovirus were negative and VZV was positive. The VZV was confirmed to be vaccine strain by the CDC lab. The patient was treated with IV acyclovir and had rapid improvement. No further information was provided. Follow-up information has been received from the FDA (VAERS# 187837) through the CDC concerning the 4 year old male who was vaccinated with varicella virus vaccine live Oka/Merck. Three years following the vaccination the patient developed herpes zoster (HZ) on his right arm. Three days later, the patient developed meningitis. Lab data was performed which indicated a polymerase chain reaction (PCR) analysis was performed on a CSF specimen which revealed a positive PCR and vaccine strain (DNA from CSF sent from Viromed to CDC) and a skin lesion specimen was performed on the patient which revealed: PCR positive. Follow-up information was received on 24-AUG-2012 in published literature: The following neurological complications of varicella vaccine have been reported. Case 3: A healthy patient (gender unspecified) who was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose not reported) at 16 months of age. At 4 years, a zoster rash developed on the right arm, followed by meningitis (important medical event, upon internal review). The article does not state where the patient was vaccinated. Cerebrospinal Fluid (CSF) DNA was sent to the Centers for Disease Control (CDC), GA for strain typing, and the presence of Oka Varicella-zoster-virus (VZV) was confirmed. Polymerase Chain Reaction (PCR) of zoster lesions also identified VZV, but genotyping was not performed. Of note, in several cases, the zoster event occurred in the same extremity as had received the varicella vaccination or was the likely site of vaccination. Since 4 million children are immunized yearly in the country, the neurovirulence of the live attenuated vaccine is dramatically less than that of the wild-type infection. Only a few cases of zoster and meningitis secondary to vaccine virus have been reported since 1995. Nevertheless, these cases illustrate that vaccine virus can occasionally establish latency in the dorsal root ganglia, especially those providing sensory fibers to the arm. Of note, at least 4 children with wild-type Central Nervous System (CNS) disease had had one varicella vaccination. The authors now know that one dose is insufficient to assure immunity throughout childhood. Therefore, these children undoubtedly had breakthrough varicella. Two doses of varicella vaccine during early childhood are now recommended to avoid the problem of breakthrough infection with wild-type varicella. In summary, the aforementioned data from the most populous state in the country demonstrate a dramatic reduction in the CNS complications of wild-type varicella in children. Implementation of the 2-dose varicella vaccination policy should eliminate the few cases of breakthrough disease. The detection of only one case of vaccine virus-related zoster demonstrates a diminished neurovirulence of the live attenuated vaccine. This is one of several cases from the same source. All telephone attempts to obtain follow up information have been unsuccessful. A copy of the published article is attached as further documentation of the patient's experience. Upon internal review performed on 25-MAY-2018, it has been determined that case # 1209USA001014 is a duplicate of case # 0702USA01275 Therefore, case # 1209USA001014 is being deleted from our files and the cases are consolidated into case # 0702USA01275. Sender's Comments: MERCK 0702USA01275:Mfr number.