Age: 2.0
Sex: M
Vaccine: DTPHIB, HEP, OPV
Symptoms: Abnormal behaviour, Autism, Drug toxicity, Neurodevelopmental disorder, Sleep disorder
Clinical narrative: Report A0372390A describes autism in a 27 month old male who received hep b vaccine(Engerix-B). This report was received as part of litigation proceedings, with forwarding of medical records. The child was born at a gestational age of 38 weeks with vacuum extraction, to a 40 year old mother. Aminocentasis screening during pregnancy was reportedly "normal." The infant weighed 6 pounds 14 ounces. Apgar scores were 9 at one and five minutes. "Initial exam was unremarkable except for a right parietal cephalohematoma with some bruising. The pt initially had some mildly low oxygen saturations with room air blood gas of 7.36/30/165/24 and a normal CBC. He quickly stabilized with good O2 saturations on room air, but because of occasional desaturation episodes with mild color change he was observed in the Intensive Care Nursery. On 11/03/93 he was transferred to the Well Baby Nursery. The baby was noted to be mildly icteric on the fourth, which time a bilirubin was drawn as well as a Type and Coombs. The baby was found to be O positive, DAT (direct antiglobulin test) negative. Bilirubin was 14.7. The infant was placed under phototherapy. The following morning the bilirubin had reached 18.3, the bilirubin dropped to 16.3, the evening of November 5. It was 16.7 on November 6." The infant was discharged from the hospital at that time. The medical history included "slight" pectus excavatum, "occasional" ear infections, and conjunctivitis, upper respiratory infections, ear effusions and possible failure to thrive. Family history included an older brother with attention deficit hyperactivity disorder (ADHD) and "defiance problems," who was treated with Ritalin. The father may also have the ADHD. The child's mother had one miscarriage between the sibling and the vaccinee. Following the reported onset of autism,the child experienced upper respiratory infections, right otitis media, acute gastroenteriris with one episode of dehydration, acute purulent conjunctivitis, and possible allergic reaction manifested by a rash. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records Therefore, they are not listed as adverse events. Developmental history revealed that the child's "developmental milestones were within chronological age expectancies, except for language." Specifically, at 12 days of age, he rearded face and startled. At 2 months, he had a social smile, tracked past midline, cooed and could hear. At 4 months, he squealed, reached for objects, tracked 180 degrees, bore weight on legs, cooed and could hear. At 6 months, he rolled both ways, bore weight, sat with support, transferred objects, turned to sound and vocalized. At 9 months, he sat without support, crawled, said "mama-dada", had a pincer grasp, and pulled to stand. "Poor weight gain" was noted. At 10 months, he crawled, pulled to feet, walked holding on, sat, but did not sit up. At 12 months, he babbled, drank from a cup, stood, used a pincer grasp, and walked holding on. The physician suspected failure to thrive. At 15 months, he walked well, said "ma-ma", followed simple commands, and could hear. When the child was 21 months, he was shaken by the baby-sitter, but had no symptoms of increased cranial pressure. The child's weight and length were below the fifth percentile, while head circumference was at the 90th percentile. The child received Engerix-B vaccine on 12/30/93, 03/03/94, and 08/10/94. He also received "DPT/DT" (02/03/93, 03/03/94, 04/19 and 04/22/95); diphtheria and tetanus toxoids and accellular pertussis vaccine adsorbed              (Acel-Immune 05/29/98); diphtheria and tetanus toxoids and accellular pertussis vaccine adsorbed (06/28/99); Orimune (12/03/93, 03/03/94, 04/22/95, 05/29/98); inactivated poliomyelitis virus vaccine (06/28/99); haemophilus infuenzae type b conjugate vaccine (12/30/93, 03/03/94, 04/29/94, and 02/01/95); MMR II (02/01/95, 05/29/98 and 06/28/99); and varicella virus vaccine (09/25/95). In addition, the vaccinee participated in a clinical investigational study of intranasal influenza virus vaccine; he received study vaccine on 11/09/2000 and 12/07/2000. He also received inactivated influenza virus vaccine on 01/28/2000. On 01/06/96, the child presented to a new pediatrician with a chief complaint of discharge from the eyes. The pediatrician noted, "no words yet, only babbles." He suggested speech and developmental evaluations. The child was seen by the pediatrician on 02/12/96. The physician noted that he "Does not talk. First baby-now ae 5 years-ADHD-on Ritalin. Normal pregnancy, labor, delivery (38 weeks)." The child began saying "ma-ma-ma" at 18 months of age. He walked up steps, jumped and used a spoon without spilling. He did not form sentences. He was still in diapers, "He seems to understand parents. No history of trauma to the head. He likes to spin things (pots, pans, containers). He likes to listen to music from toys. Very remarkable in the office-he spins everything he sees and gets hold on. Plays with brother sometimes. No family history of hearing problems. Likes a baby-acts like a baby!" On a lead exposure questionnaire, the mother indicated that the child lived in or regularly visited a house "built before 1960 with recent or ongoing renovation or remodeling." On physical examination, the pediatrician noted "slight" pectus excavatum. He also noted that head circumference was in the 95th percentile. Weight and height were below the 5th percentile. The pediatrician's diagnosis was "Autism." The child was evaluated by an audiologist on 03/05/96. The audiologist noted, "Mother reports that he does not talk, only says 'ma ma ma.' Seems to ignore everybody. Reports pediatrician believes he may be autistic because he spins things. Reports that he responds 'slightly.' Does not follow directions. States he has 'spells where he just starts laughing for no reason. Mother repots that when he interacts with his five year old brother he doesn't vocalize at all. Was recently labelled autistic which mother thinks is premature." "Results," The audiologist recorded, "Pt cried or made noises throughout the testing. Results obtained at two frequencies. Could not obtain tymps (tympanograms) due to child's crying." On 06/18/96, the child underwent auditory brainstem response audiometry. The audiologist noted, "Attempts at behavioral testing were unsuccessful." The audiologist's impressions were, "The latency intensity function results were most consistent with normal hearing bilaterally at least in the frequencies above 1000HZ at the present time. The slightly prologned I-V and slightly delayed wave V bilaterally may represent brainstem pathlogy, however the rate series was within normal limits." On 07/16/96, the child returned to the pediatrician. The pediatrician noted  that the child's mother was "concerned about child's failure to talk. Mother not sure about socialization. He likes kids to chase him. Never formed a vocabulary. Couldn't say a single word except 'ma ma ma' repeatedly. Smiles at times. Usual sleep pattern-to bed at 12 midnight awake at 5 AM, naps for two hours in PM. Dumps books to floor. Takes clothes out of drawers. Tears paper and pages of books. Likes to be in the kitchen-opens and closes refrigerator; spins everything in he kitchen." The pediatrician indicated that during pregnancy, the mother's "aminocentesis is normal." The pediatrician's impression was 'Autism.' The child was referred to a psychiatrist. DNA analysis for fragile X syndrome was negative on 07/23/96. High-resolution chromosome analysis revealed 'Normal Male karyotype." On 08/14/96, the child underwent a psychological evaluation to "evaluate his intellectual and adaptivie functioning and to rule out autism." The clinical psychologist noted, "There is a family history of attention deficit hyperactivity disorder for brother and possibly father. The vaccinee was the second of two children born a then 40 year old mother. There is a history of one miscarriage between the two pregnancies." The psychologist also noted, "Developmental milestones were within chronological age expectancies, except for language. he is non-verbal. His health has been relatively good with occasional ear infections. A EA ER (brainstem audio evoked response) revealed normal hearing. Reportedly, he has been diagnosed by another physician with autism. He has not been involved in any school programs to date. His mother reported qualitative impairment in social interactions, qualitative impairment in communication and restricted repertoire of abilities for the child. Regarding qualitative impairment in social interactions, he experiences a lack of awareness of feelings of others, does not imitate others' actions, exhibits no social play, not an interest in making friends. He does not seek comfort from his mother when hurt. With respect to qualitative impairment in communication, he is non-verbal, does not engage in pretend play and may at times exhibit a high pitch tone in his voice, though as he does not speak words, this is difficult to assess fully. With regard to restricted repertoire of activities, there is no reported unusual body posture such as hand flicking. However, he does have a preoccupation with using toys in unusual ways, such as spinning objects repeatedly. He also licks "everything," including walls. In addition, the mother reported that he exhibits tantrums. He may cry uncontrollably with no known precipitator. He appears aloof as if he is in his own world. His body is stiff. At times, he will laugh for no reason." Under behavioral observations, the psychologist noted that "He wandered around the testing room, climbing on furniture and jumping off. This behavior did not appear to be reflective of attention deficit hyperactivity disorder symptoms; rather lack of awareness of interpersonal interactions and aloofness. He was observed to lick the walls. He repeatedly spinned (sic) test items, making completing test items impossible. He stated several sounds, such as "dada" or "baba" and appeared to be making high pitched noises. He briefly on two occasions only momentarily attempted eye contact with the examiner or his mother. There appeared to be no interest in the give and take and social interactions of the testing situation. Therefore, it was not possible to administer the intellectual assessment. The results of the assessment likely, reflect his functional level regarding autistic symptoms, though it was not possible to assess cognitive level. The psychologist attempted to administer the Stanford Binet Intelligence Scale. "Due to non-verbal ability, repeatedly spinning objects and lack of ability to interact in the interpersonal situation, the testing was discontinued." The Vineland adaptive Behavior Scales yielded the following standard scores: communication=daily living skills=60, socialization=51 motor skills=79, adaptive behavior composite=55. The interpretation of these scores was not specified. The psychologist noted, "He does not speak any words, though occasionally will smile in response to his mother and will lift up his arms up if he wants to be held. He at times does cry when his diapers are soiled. He feeds himself mainly with his fingers and sometimes attempts to use a spoon. He can feed himself with a glass and use a straw. He has shwon no interest in toilet training. He does not remove his clothing. He plays with toys, though in unusual ways such as spinning objects. He does demonstrate an interest in new people. He walks down stairs putting both feet on each step. He climbs on his play equipment. He opens the lid of jars. He can jump on two feet, though not one. He runs. He scribbles though has not made any identifiable shapes. On the Autism Behavior Checklist, he achieved a score of 76. Impressions: it is this examiner's opinion that he is exhibiting behavior consistent with the diagnosis of Autistic Disorder as evidenced by qualitative impairment and social interactions, qualitative impairment in social interactions, qualitative impairment in communication, and a restricted repertoire of activities. Due to those features, it is difficult to assess his true cognitive level." The psychologist recommended 'a special education program or some type of training particularly geared for children with autistic symptoms." Plasma amino acid analysis was performed on 09/09/96. The only abnormal amino acid concentration was a decreased concentration of hydroxyproline. The lab's interpretation was "Pattern is essentially within normal limits." On 12/10/96, the child underwent a developmental evaluation. The physician noted, "Although medical records were not available today, he has been seen by a number of professionals. The mother describes his current abilities as fairly limited. He makes a number of sounds and occasionally says a nonspecific 'daddy,' 'baby,' but does not use any true words to communicate his needs. Gestures are also rare. Usually he will just get up and get things that he wants by himself. His receptive language is slightly better and the mother describes him able to follow simple commands. However, this is also very limited. He also shows a very limited play repertoire. Most toys he simply picks up and licks or tosses. He does not show imitative or even simple creative play. He likes gross motor activities such as running and climbing, but he does not play any type of cooperative games with other children. The mother notes that he does like to watch children, but by description, he is simply watching the movement as they run about. He shows little interest in joining them. In addition to frequently licking objects, the mother also describes some unusual behaviors such as spinning movements. He does have some sleep difficulties, frequently waking for 2-3 hours in the middle of the night. He does seem to seek out tactile experiences in an excessive manner. Developmental evaluation: The mental scale from Bayley Scale of Infant Development was administered today. Chronological age at testing was 37 months, 9 days. During the evaluation, he did show a decreased interest in the testing items and a poor response to me. Therefore, his abilities may be underestimated by today's testing. He made a number of vowel/consonant sounds, but did not use true words. He showed poor responses to verbal directions and did not look up when I called his name. He would show brief attention to the testing items when I physically turned him toward me to get his attention. At these times, he would do a limited number of appropriate items. For instance, he placed a circle piece in the blue puzzle, put pegs in the peg board, and looked for the small beads when hidden in the box. However, his attention to these items was extremely limited and he spent most f his time during today's evaluation wandering the room and licking items. When given other testing items such as blocks, he easily picked them up, but frequently just tossed them over his shoulder. His eye contact today was extremely limited. He did not approach me or try to initiate social interactions. When I worked with him, he would attempt some items as noted above, but showed very little interaction with me. He did approach his mother a few times for hugs and tactile stimulation. However, he did not show social referencing or imitation. When his mother physically held his hand and showed him one of the items, he did then immediately perform it himself. His score today did not evidence of significant developmental delays. The mean score on this test is 100 with a deviation of 16. His Mental Developmental Index was less than 50. His performance on items today showed an age equivalency of 7 months. Impression: By history and observations today, he certainly fits the criteria for a diagnosis of autism. He currently has no true language and very little imitation. Intensive behavioral training would certainly be a first step in trying to achieve imitative skills and communication." On 03/28/97, the child's mother tok him to an otolaryngologist "to talk about auditory training for his autism ie listening to sounds to cure his autism. I've never heard of this but that doesn't mean it doesn't exist as a form of treatment. She showed me a book from library which discussed one cure with this therapy. She'll contact the national autism society regarding this form of therapy." The child returned to the pediatrician on 09/26/00. At that time, he was "on cod fish oil and gummy bears with antioxidants. Mother likes pt to be tried on topical secretin discussed in a local seminar on autism." The child was "hard to examine here-very hyper and uncooperative." His impression was "Autism" and he prescribed secretin 2.5 chemical units/patch, with one patch applied to the skin daily. On 11/09/00, the child returned to his pediatrician with a cough. The physician noted "secretin cream not working." An assay for blood mercury did not detect any mercury. On 02/26/01, the child's pediatrician wrote a letter stating that the child "has autism, a form of developmental disability which persists throughout the lifetime of the individual. He is not yet toilet trained. He needs help in all his personal needs on a day to day basis." On 1/3/02, the child returned to his pediatrician. The pediatrician noted that the child was non-verbal and wore diapers. The child still received thearpy every day at school and speech therapy every week. The pediatrician's physical examination revealed that the child was "small for age, difficult to examine, combative, non communicative." Hiss assessment was "Autistic - severe. Aggressive tendencies." In his plan, the pediatrician noted that the child's mother was not willing to actively treat the aggressive behavior.  On 07/01/02, the child's attorney alleged that "As a result of mercury in the thimerosal-containing vaccinations that he received as an infant, he now suffer, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." The most recent information received on 8/23/02, indicated that autism persisted as of 1/3/02 and did not provide the outcome of the alleged mercury poisoning.