Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injury, Laboratory test abnormal, Mental retardation severity unspecified, Muscle spasms, Muscle twitching
Clinical narrative: This case was reported by a lawyer and described the occurrence of nerve damage in a female subject of unspecified age who was vaccinated with Dtap manufacturer unspecified, OPV, Hib for prophylaxis. On 11/5/1991 the subject received 3rd dose dose of Dtap, Hib and OPV, the subject experience nerve damage, toxic effect of mercury and its compounds, communication disorder, pervasive developmental disorder, autism, delays in development, encephalopathy, tic, episode of violence, agitation, obsessive compulsive disorder, social problems, spasm, twitch, disorder behavior, fluttering eyes and eye rolling. According to the legal complaint, at an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced neurological damage, which was attributed to cumulative mercury toxicity. The following information was received via medical records. Neurological evaluation on 11/26/1993 by a physician. At the time of the visit, the subject was 2 years and 7 months old. She presented with concerns regarding development, noted since she was approx 12 months of age. Mother had concerns about the subjects functioning, communication, social interactions, play skills, attention, speech and understanding. Mother was a 32 year old Gravida IV, para IV mother with no complications during mid to late pregnancy. She did have severe hyper emesis and viral infection in the first trimester. Subject was a full term neonate that weighed 8lbs 7oz with no perinatal complications. Earl milestones were appropriate, with tuning over by 5 months, crawling at nine months, walking at 13 months, and single words at one year. At 12-15 months ahs had 5-6 words ant then lost them. Gross motor balance are excellent. No significant head injuries or seizures. No family history of neurodevelopmental syndromes. The impression of the physician were severe communication disorder. He felt that she fell within the context of an autistic spectrum disorder, based on her problems with decreased eye contact and social relatedness. He also felt that she had pervasive developmental disorder. On 3/22/1994 a chromosome analysis was a normal female karotype. Direct DNA analysis for fragile X syndrome was negative for DNA changes associated with fragile X syndrome. On 10/17/97 the subject was 6 years and 6 months old and was seen by a developmental neurologist. It was reported at this visit that the subject had two brothers with ADHD and a maternal cousin with high functioning autism. The impression of this physician was one of encephalopathy characterized by disorder of language, social interactive and symbolic play impairments and autism. On 11/9/97, MRI of the brain was normal. On 12/11/00, and EEG was abnormal doe to the presence of lack of sleep, but transient during sleep. This most likely is attributable to the anesthetic agents. In addition there is abundant beta throughout, again most likely attributable to the drugs provided. A pre existing encephalopathy cannot be excluded. There are no definite epileptiform potentials. A note from the physician stated that there are no seizure indications and that the only abnormal were due to lack of sleep and sedation. An MRI of the brain on 12/11/00 appeared within normal limits. On 1/3/01 she was evaluated for spasms and twitching movements of the right side. It was determined to be a tic. On 8/29/01 she was evaluated for violent episodes to the point of hurting herself. The subject was treated with Concerta, Dexedrine, and Adderall. Physical exam noted agitation and obsessive compulsive tendencies. The physician concluded that the subject had autism with significant behavioral difficulties. She was started on Geodon. On 4/19/02, and EEG revealed normal awake and Drowsy EEG. On 8/13/02 she was evaluated for her spells subject was 11 years old at the time of the visit. Menarche in July 2002. It was reported that she was more agitated, more restless, difficulty with impulse control and frustration. She speaks only sporadically and has had self injurious behaviors and aggression. It was also reported that she had spells manifested by fluttering of eyelids, eyes rolling up, pause and resume of activities. These occur many times per day. It was noted that in the past she was treated with Risperidol, Prozac, Concerta, Dexedrine and Adderall. the physician considered that the spells could be consistent with seizures. 1/29/03 evaluation by a physician indicated that a video EEG was normal and concluded that her spells do not appear to be seizures. At the time of reporting the outcome of the events were was unspecified. This case was assessed as medically serious by manufacturer (OMIC).