Age: 1.51
Sex: F
Vaccine: VARCEL
Symptoms: CSF test abnormal, Coordination abnormal, Dermatitis bullous, Difficulty in walking, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an 18 month old previously healthy Polynesian female with no known drug allergies and no birth defects or medical conditions who on 07/12/04 was vaccinated SC in the left arm with a 0.5mL dose of varicella virus vaccine live (Lot # 645290/0326N). There was no illness at the time of vaccination. There was no concomitant medication. On 07/23/04 the pt developed a rash, described as scattered over her trunk and legs, not clustered, some lesions vesicular, some scratched open.  The pt also developed ataxia at that time.  On 07/23/04 the pt visited the pediatrician and on the evening of 07/27/04, the pt was admitted to the hospital. A CT scan without contrast was done, and a spinal tap was done. Both were negative. Spinal fluid for VZV was pending. The physician indicated that the pt was alert and awake when admitted to the hospital. Interventions included acyclovir (Zovirax) and varicella zoster immune globulin. The outcome was reported as not recovered. There was no product quality complaint. Follow up information received from the medical record, the pt's family, and the physician indicated that on 07/23/04, the pt was noted to walk funny and it was noted to be getting worse. She also started to develop lesions on her skin.  The family indicated that the child had not had a fever. The pt was seen by the physician on 07/27/04, and he was concerned about vaccine reaction and sent the pt for further evaluation. The physical examination revealed an alert child who did not appear toxic at all. She had some scattered lesions on her trunk, legs, and arms. Some of them were excoriated from scratching, but some of them did look like vesicular lesions on an erythematous base.  Examination shows the CSF with 3+ red cells, 1+ white cells, and no organisms in the Gram's stain. The cell count is 2 white cells, 1 seg, 70 lymphs, 20 monocytes, glucose 51, and protein 15.  The CT scan done without contrast was unremarkable. The child was admitted to the hospital for acyclovir.  After presenting 8-week previously for acute ataxia after receiving a dose of varicella virus vaccine live, she has had an MRI of her complete neuraxis, which was normal, she has had a spinal tap, which was normal, and her ataxia had been relatively persistent, although there had been mild improvement. On 09/15/04, the pt presented with fever and left esotropia.  She was admitted to the hospital for further evaluation. On physical examination, the pt was resting comfortably. She had a temperature overnight of 38.2. She was noted to have a poor neurologic prognosis for a full recovery.  The plan was to treat with IV gamma-globulin, 2 grams per kilogram divided over 4 days over 6 hours, and EEG, an MRI of the brain as an outpatient in 6 months, or sooner if necessary, and consider pediatric opthalmology consultation. The physician felt that the pt had a "probable adverse reaction to the varicella vaccine".  The reporter indicated that the ataxia, fever, vesicular rash, and esotropia were considered to be disabling.  Additional information has been requested.  Medical records are attached. Follow up 03/03/05: Patient has not recovered from the adverse event(s).