Report A0372386A describes autism in a 2 year old male who received deiphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). This report was received as part of litigation proceedings, with forwarding of medical records. The medical history included nucal umbilical cord, congenital malformation of the proximal left upper forearm secondary to amniotic band and requiring a prosthesis, mild jaundice, bronchiolitis, left otitis media, possible croup, and possible reactive airway disease, **and sulfa allergy manifested by rash and hives. Following the reported onset of autism, the vaccinee experienced irritable bowel syndrome, atopy, nutritional deficiency, mineral deficiency, and pneumonia. These events were not reported as adverse events due to vax admin. but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events.** The developmental history revealed the following: he sat at 5 months, although he produced some sounds at 5 months, he had still not developed language by 2 years; he stood at 6 months; at 9 months he rolled; he walked by 10 months. At 12 months he talked. At 15 months, he walked, used a pincer grasp, use a cup, indicated wants without crying, and had a satisfactory vision cover test. At 18 months he climbed into an adult chair, walked well, rarely fell, followed directions, pointed to body parts, used a spoon, and had a satisfactory cover test. At 19 months, the child's occupational therapist questioned the number of words the child used, and his hearing. The pediatrician noted that the child knows 15 words; follows commands. Responds to mom. Mom thinks he hears fine. The pediatrician's assessment was appropriate speech and boy/hearing for his age. The child received diphtheria and tetanus toxoids and acellular pertussis vaccines absorbed (Infanrix, lot # DTPA883A2) on 3/30/98. He also received hepatitis B vaccine on 9/16/96 (brand name unknown), 12/12/96 (Recombivax-HB), and 6/16/97 (Engerix-B; lot ENG2292A2). He also received DTP vaccine (11/15/96, 1/17/97, and 3/14/97), oral poliomyelitis virus vaccine (11/15/96, 1/17/97, and 3/20/98), Haemophilus influenzae type b conjugate vaccine (11/15/96, 1/17/97, and 3/14/97, and 12/12/97), and MMR vaccine (9/17/97). The vaccinee's attorney alleged that during the first years of his life, the vaccinee was injected with multiple childhood vaccinations containing the dangerous and highly toxic mercury based preservative thimerosal.....Through the thimerosal-containing vaccinations administered to him during the first two years of his life, the vaccine was poisoned by the cumulative dose of mercury in the thimerosal..... As a result of the mercury in the thimerosal-containing vaccinations that the vaccinee received as an infant, the vaccinee now suffers and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. On 12/15/99, the patient was evaluated by the psychoeducational therapist. The patient was referred to rule out possible autistic spectrum disorder by his parents, who were encouraged to seek the referral by a psychiatrist. The psychiatrist described in her 9/17/99 summary letter to the presence of purposeful toy play, social reciprocity which appeared to improve with the passage of time, and behavior which was not highlighted by stereotypy or restricted. The review of early history showed that the patient's mother described a normal pregnancy with some difficulty during labor and delivery. The patient was born with his umbilical cord around his neck and was jaundiced at birth. His birth weight was 7lbs, 12 oz and his Apgar scores were 7 and 9. Motor milestones were completed well within normal parameters. They included the following:  sitting at 5 months, standing at 7 months, and walking by 10 months. Although some sounds were produced at 5 months of age, he never developed word usage and his parents were concerned when he was 2 years old and still lacking language. The psychoeducational therapist made the following behavior observations:  Socially, the patient displayed inconsistent behaviors. At times he was engaged with others and enjoyed interactions such as tickling and sitting in the examiner's lap. Yet there were periods where he became unaware of other people in his surroundings. These inconsistencies were most notable during unstructured times outside of the testing room. During this time, the patient was very content to wander or lay around. He appeared to enjoy his solitude, but could be redirected to an activity quickly. The patient's use of language was significantly limited and only a few words were heard during this assessment. He clearly said "Hello" when picking up a phone and Mommy when he was ready to leave. Gestures were helpful in facilitating the patient's understanding of verbal requests and he also used gestures to indicate his needs. For example, he pulled the examiner to the door when he wanted to exit the room. Some unusual sensory responses were noted during the evaluation. THe patient seemed oblivious to many sounds within the testing environment, not responding to certain noisemakers. However, he did respond to his name. Some mouthing and rubbing of test materials was also exhibited. The patient was intrigued by his image in a mirror and grimaced when involved in activities that really excited him. At times, he also examined some materials out of the corners of his eyes. The patient's patter of behaviors and developmental history were indicative of a diagnosis of autism. Some of the behaviors noted on the day of testing included delayed language skills, inconsistent social relatedness, selected interest in materials and activities, and some unusual sensory skills, inconsistent social relatedness, selected interest in materials and activities, and some unusual sensory responses. Testing: Imitation: Verbal: the patient did not imitate any sounds or words from the test during the evaluation. However, he did seem to notice when his own sounds were imitated by his examiner. Motor: the patient's ability to imitate motor actions was better than his verbal imitation skills. He successfully imitated actions with noisemakers including ringing a bell, shaking a clapper, and banging a spoon on a table. He also initiated a game of tickle with the examiner. Overall imitation skills were estimated to be at the 14-15 months age level. Motor Development: Fine Motor: The patient demonstrated good fine motor skills. He had adapted well to his limb deficiency. He was able to grasp wooden dowels, drop blocks into a cup, remove beads from a pipe cleaner, and put beads on a string. He received an emerging score, partial credit for unscrewing a lid on a jar, and blowing bubbles. Other items not completed included poking and manipulating Pay-doh, touching his thumb to his fingers in sequence as demonstrated by the examiner, drawing a picture of a person, and cutting paper with scissors. Overall fine motor skills were estimated to be at the 24-26 months age level. Gross Motor: The patient also displayed good gross motor skills. He climbed into a chair independently, jumped up and down on both feet, caught and threw a ball, and drank water from a cup by himself. He did not respond to items such as standing on one foot, kicking a ball, or swinging beads on a string. Overall, gross motor skills were estimated approximately the 25-27 month age level. Visual-Motor integration: This was the patient's strongest area as reflected by this test. Successfully completed items including scribbling spontaneously with a crayon, placing geometric form board pieces into their correct slots, and putting blocks in a cup. He also stacked 8 one-inch square blocks into a tower formation and returned them to their container at the end of the activity. An emerging score was noted in his ability to match 9 alphabet letters to a lotto sheet (he matches all of them by E, Y, and V),. Overall visual-motor skills were estimated at the 26-29 months age level. Vision screening: The patient's visual acuity seemed adequate. Hearing Screening: although the patient's responses to sounds and speech were inconsistent and delayed at times, no difficulties with auditory acuity were suspected. His lack of response at times seemed more related to his language difficulties and his limited range of interests as opposed to his ability to hear. Cognitive performance/receptive language: The patient exhibited some difficulty understanding and processing language: therefore this was a weak area for him. He did sort 2 dissimilar objects into separate containers, match objects (shoe, cup, spoon, toothbrush, comb, etc) to identical pictures and responded to simple commands. Uncompleted items included pointing to body parts of himself and a hand puppet; receptively identifying shapes, colors, and sizes; giving objects to the examiner when requested, and demonstrating how each object was used. Gestures were most often needed to help the patient understand verbal requests. Overall cognitive performance/receptive language skills were estimated to be at the 13-14 month age level based on the results of direct testing. Cognitive verbal/expressive language: The patient was primarily non-verbal during the evaluation and passed only one item in this area. This item was indicating a need for help through the use of gestures. The patient pulled the examiner to the door when he was ready to leave. He was heard to say Hello and Mommy during the assessment. At the time of the evaluation he used gestures primarily to communicate his needs and wants. Vineland Adaptive Behavior Scales..... Communicative and socialization skills were in the mildly deficient range while daily living skills fell in the low range. These scales produced age equivalencies ranging from 12 to 22 months with the median being 14 months. His functioning in the motor skills produced an age equivalency of 29 months. Childhood Autism Rating Scale (CARS).....: The patient evidenced impaired interpersonal eye gaze and restricted ability to accept the presence of the examiner socially and emotionally. In addition, the patient accepted activities and materials that were introduced by the examiner in a limited manner and only on his own terms. Mild body awkwardness was observed in terms of lower limb coordination. Some difficulty was noted in his ability to shif or change activities. On one occasion, the patient was observed mouthing blocks, which had been placed before him. From both a statistical and clinical standpoint, the patient's observed and rated behavior was consistent with the presence of autism. Diagnosis: autistic disorder. General recommendations: (The patient's) developmental history, observed behavior, and test results were consistent with the presence of autistic disorder at this time. Inclusion in a structured school program designed to accommodate the needs of preschool aged children with atypical developmental patterns was suggested...." Autism is considered medically serious. **Follow-up report on 9/10/02: On 6/11/01, the vaccinee's parents sent for heavy metal analysis a hair sample that had been collected three days prior to the vaccinee's first b-day. This sample contained elevated concentrations of aluminum, antimony, cadmium, lead, mercury, nickel, tin, chromium, copper, iodine, sulfur, and zine. Please see Lab Data section. A now hair sample was collected on 9/15/01 and analyzed on 10/13/01. This analysis revealed elevated concentrations of aluminum, antimony, arsenic, bismuth, cadmium, lead, tin, copper, and selenium. Concentrations of calcium, magnesium, strontium, and sinc were below the reference ranges. Mercury concentration was w/in the reference range. The vaccinee was evaluated by another MD on 11/1/01. The MD noted under "History of Present Illness" that the child "Did not crawl classically - rolled to things. Babbling, 10 words at 12 mts. Got MMR vax at 12 mts - gradual regression in language. Down to Mama at 2 yrs old. Lost response to name. Appropriate toy play. Became very picky eater. Developmental evaluation of 2-5 - ASK [autism spectrum disorder], DMG [dimethylgycine] helped language, switched to TMG [trimathylglycine], GF [gluten free] since June 01. Peanut butter / peanuts - problem. Sweats at night - phenol prob. Stools - terrible smell, sometimes runny. Solid is rare, grey. Receptive language - OK. Expressive - impaired, some full sentences, dyspraxia. Texture sensitivity... Very social." The parents reported that the child was receiving a treatment regimen consisting of TMG, vitamin C, calcium, co-enzyme Q10, sicosapantaenoic acid (Omega/RPA), docosahexanoic acid (Omega/DHA), vitamins A & D, a multivitamin, papaya enzyme, "Probiotic", "Magne B-6", reduced L-glutathione, mino, "DANplex", flex seed meal, evening primrose, and aloe vera juice. On examination, the vaccinee "speaks in sentences. Very interactive." The MD's impressions were "1) Irritable bowel syndrome. 2) Atopic allergies. 3) Nutritional Deficiency. 4) Mineral Deficiency. 5) Developmental Delay." Urinalysis revealed elevated concentrations of hydroxymethylglutarate, phenylpropionate, tricarballylate, and citramalate. Concentrations of alpha-kotoglutarate and sulfate were below the reference ranges. "Erythrocyte" concentrations of selanium and zinc were below the reference ranges: mercury concentration was w/in the ref. range. Reduced glutathione concentration was below the ref range. Liver function testing revealed an increased serum concentration of aspartate transaminase. A stool sample collected on 11/14/01 contained increased amounts of Candida albicans. On 11/26/01, the MD wrote the following in the office records: "Problem areas: 1) Heavy metals. 2) Out Bugs. Good friendly bacteria. 4+ Candida albicans. 3+ Candida parapsilosis. DMPPA at upper limit of normal. 3) Minerals. Selenium slightly low. Zinc deficiency (even w/supplemental zinc). 5) Plasma sulfate OK, but urine sulfate low - wonder if he is starting to try to conserve sulfate (good)." The MD recommended a treatment regimen of "Pro Bio Gold", lactic-acid producing organisms (Culturello), metronidasole for 7 days followed by ketoconazole for 21 days. "Multiple Mineral Complex Pro Support", glutathione croam, milk thistle, zinc, and dimercaptocuccinic cold (DMEA). She recommended that "DANplex" be discontinued because of its copper content, but that the remainder of the pre-existing Tx regimen be continued. The child remained under the care of this MD until at least 5/20/02. On 3/16/02, the MD noted a reduced serum glucose concentration. She wrote, "This is commonly seen in our children and is secondary to increased adrenaline release." Total carbon dioxide concentration was also "abnormal" and was also noted to by "very commonly seen in our children." Urine mercury concentration was below the ref range on 3/22/02. On 5/20/02, the MD noted an elevated copper/zinc ratio and unbound copper concentration. During this time period the MD prescribed DMSA plus lipoic acid, intravenous secretin, and combination L-carnosine/zinc/vitamin E (CARN-AWARE). The most recent info, received 8/23/02, did not provide the outcomes of the reported events. Autism is considered GSK medically serious (OMIC).