Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Condition aggravated, Coordination abnormal, Encephalopathy, Hyperammonaemia
Clinical narrative: Information has been received from a consumer concerning his 3 year old granddaughter who about 6 years ago, in approx. 1995, was vaccinated with 1 dose of varicella virus vaccine live. Ten days to 2 weeks, post vax, the child manifested symptoms of encephalopathy, resulting in incoordination. She was taken to her pediatrician and was referred to a specialized hospital. She was found to have hyperammonemia and was dx'd with ornithine transcarbamoylase deficiency (OTC). The condition resulted in hospitalization. It was reported that the pt was treated for this condition for 6 years, but died in 2/01. The reporter stated that he did not "suspect cause and effect", but felt that varicella virus vaccine live triggered events and exposed the OTC. Additional information has been requested. Per F/U; information has been received from a health care professional concerning his 3 year old granddaughter who on 9/8/95 was vaccinated with 1 dose of varicella virus vaccine live (lot 608582/0410B). Ten days to 2 weeks, post vax, the child developed ataxis and was thought to have encephalopathy. She was taken to her pediatrician and was referred to a specialized hospital. She was found to have hyperammonemia and was dx'd with "de nova or a primary mutation of" ornithine transcarbamoylase deficiency (OTC), a urea cycle disorder, which the reporter felt was the "most likely cause of the elevated plasma ammonia and the encephalopathy. The condition resulted in hospitalization, on an unspecified date. The reporter stated he did not "suspect cause and effect" but felt that varicella virus vaccine live triggered events and exposed the OTC. F/U info was received on 10/11/01 from the initial reporter and he stated his granddaughter was a normal, healthy child, including no known history of immunosuppression prior to the events reported. She had no signs or symptoms of OTC prior to vaccination. He stated that his granddaughter died of "gross medical mismanagement", by some of the treating physicians, as well as, the managed care healthcare system. He reaffirmed that he did not necessarily believe there was a direct cause and effect relationship between vaccination with varicella virus vaccine live and the development of OTC deficiency; however, since the vaccine is a live virus, he wondered about the possibility of the vaccine "triggering" some type of response which lead to the manifestation of the OTC deficiency order. On 10/19/01, a retired office nurse, from the vaccinating physician's office, indicated that the child was only seen in their office for a short time and then transferred to another physician. Additional information has been requested. The adverse experience of blood urea decreased has been removed as an adverse experience. Follow-up medical records received from a physician on 11/20/2001 indicated that the pt had been seen in his office on 09/19/1995. The physician noted that the pt was not administered the vaccination at his office, but that she received the vaccination 10 days prior to her presentation at another clinic. It was reported that on Sunday, the pt was fussy and acted as if dizzy or off blalance. She was eating well. The pt was seen int eh ER the night before her presentation to the physician and "woke up" with a temp of 96.8 F. It was ntoed that the pt was "off balance" the morning of her exam. The pt was irritable, whiny and couldn't be pleased. She acted "drunk" and "staggered some." No fever or vomiting were present. It was reported that at am pre-school on Monday the pt seemed normal. A call was placed from a physician in the afternoon were it was noted that the pt was irritable, whiny and crying. At 5pm the pt staggered and ran into a car. That evening the pt was seen again in the ER. It was reported that the pt needed catheterization for a urinalysis and had a drug screen, an electrolyte screen and a CBC. An abdominal x-ray was "OK." On Thursday am the pt bumped into a wall and had an "unstable balance." It was noted that she was extra whiny and fussy. Her appetite and drinking were "OK." Her speech had changed and she was "harder to understand." A physician exam revealed the pt to have had a mild truncal ataxia. The pt was referred to the hospital for diagnostic work-up and treatment. No further info is available.