Report A0379892A describes the occurrence of autism in a 30 month old male who was vaccinated with hep B recombinant vaccine for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The attorney alleged that "as a result of the thimerosal-containing vaccinations that the subject received as an infant, the subject now suffers, and in the future will continue to suffer the toxic neurological effects of mercury poisoning." Medical history included severe chronic otitis media, hospitalized for acute gastroenteritis and RotaVirus in March1999 for five days (received IV fluids due to dehydration), sinusitis, and eczema. The subject's younger sister was diagnosed with autism. The mother had toxemia and gestational diabetes during the pregnancy. She has four amalgams. The child had no known drug allergies. Concurrent medications, if any were unspecified. Developmental history revealed that the subject sat unaided at six months of age, and at seven and a half months, he began crawling. He also began to cruise at seven and a half months but especially preferred his parents to hold his hands for him to stand to walk. He began walking at approximately eight and a half months of age. He had femoral anteversion (toes in as he walked). The parents reported that the subject was always vocal and began babbling between five and six months of age. He began to speak several single words at approximately one year old, but language did not progress. Attention to others was extremely variable and he frequently ignored others to the degree that he appeared unaware of separating from caregiveers. The subject communicated by taking caregiver's hand and leading them, but did not volunteer information unrelated to his needs. At approximately two years of age, the subject had approximately ten words and he began preschool at that time. The subject received Engerix B on 3/25/98 (lot 2587A2), 6/24/99 (lot 2547A2) and 10/6/98 (lot 2720A2). He also received the following vaccinations: inactivated poliomyelitis virus vaccine on 11/20/97; Hib vaccine on 11/2097, 1/26/98, 3/25/98 and 10/6/98; Tripedia on 11/20/97, 1/26/98, 3/25/98 and 4/7/99; oral poliomyelitis vaccine on 1/26/98 and 4/7/99; MMR II on 10/5/98 and varicella on 10/6/98. In December 1999, the subject had a developmental evaluation, at the age of two years two months. His cognitive development was estimated to be at 22 months. His language age was 14-16 months. His orientation/engagement, emotional regulation, and motor quality were reportedly in the "questionable range." A speech and language evaluation was completed in January 2000, when the subject was two years three months old. His receptive language skills were reported to be at 18 months. His expressive language was at 16 months. He had some pre-academic skills above his age level (counting, labeling colors, spelling single words aloud). Social play skills were reported to be immature. At preschool, he was not interested in the other children. It was suspected that the subject may have had autism spectrum disorder. In March 2000, the subject "who has difficulty communicating" had been "out of sorts." He had difficulty sleeping, he had what appeared to be night terrors even with napping, he pulled at his ears constantly and did not appear to feel well. A computed tomography scan was performed to rule out chronic sinusitis as the possible cause of his unusual behavior. The impression was normal although some of his sinuses were not yet fully developed. The subject was diagnosed with autism (mild, high functioning) on 3/31/00 at age two and a half years. In April 2000, he was seen by a second psychologist who stated, "Based on review of his cognitive abilities, adaptive functioning, developmental history, parent report, and behaviors observed on examination, he presents with the diagnosis of autistic disorder." On 8/26/01, it was noted the subject "may have mercury poisoning due to immunization shots." The subject was seen on 2/18/02 for evaluation of his autism. His development was reportedly okay until he reached 13 months of age as his speech stopped and he displayed "odd behaviors." He had been "fussy" after some immunizations. The impression was "1. Possible immune/metabolic dysfunction 2. Possible environmental toxicity 3. Allergic rhinitis 4. Allergic dermatitis 5. Allergic gastroenteritis." A test for urinary peptides on 2/27/02 revealed elevated levels of indioylacrylglycine, meth enkephalin, and leu enkaphalin. Test for fecal metals on 3/26/02 revealed elevated levels of nickel and tungsten. Mercury level was within reference range. Urine toxic metals were within reference range on 5/15/02. A second test for fecal metals on 5/30/02 revealed elevated levels of antimony, arsenic, bismuth, nickel, tungsten, and uranium. Mercury levels were within reference range. Urine toxic metals were all within reference range. The subject was prescribed disulfhydryl supplements. The subject received speech therapy from January 2000 until at least 2/26/01 (age at that time was three years, five months). In summary, his spontaneous, novel language (those that cannot be attributed to learned patterns) were more characteristic of a child of 24 to 30 months old. In addition, he continued to show deficits in his ability to comprehend questions and age appropriate concepts. The subject was also seen by an occupational therapist until at least September 2001 (age at that time was three years, 11 months). In summary, his difficulty with praxid skills (coming up with novel play ideas, motor planning, follow through) effected his daily functioning and play skills. As of 8/23/02, the outcome of the events was unknown. This case has been assessed as medically serious.