This report was received from one manufacturer and reportedly listed on another manufacturer's product. The lot number provided for DTaP(092880) does not match and Aventis Pasteur product. The corresponding lot number could be 0925880. From initial information received on 12/26/03 regarding an adverse event, it was initially reported by a physician that a 23 month old male patient received a MMR vaccine, route and site of administration unknown on 8/24/98. Concomitant suspect therapy included varicella virus vaccine live, DTaP, lot number 092880 and HIB (reported lot number 05941L). In 2000 the patient was diagnosed with autism. The physician reported that the patient also has a sibling, who was not seen by this particular office, who has autism. The reporting physician felt that autism was related to therapy with MMR. Upon internal review autism was considered an other important medical event (OMIC). Additional information has been received from the physician. The child had been seeing another pediatrician. The child was first seen by the reporting physician at four months of age, at this visit the child was seen for wheezing. The child did not come to the practice on a regular basis for well visits and was mostly seen only when ill. The physician reported that this caused the child to get behind in his immunizations. The child did not have any significant past medical history for any allergies, but he did have a history of pneumonia, bronchitis, and a questionable RSV at four months of age. At nine months of age the mother expressed a concern that the child was not talking, and as a result was not behaving properly, she began to have problems with the child. At nine months of age the child was seen by another physician who is a child developmental specialist at another hospital. On 7/8/98 the child was seen by the reporting physician for a diaper dermatitis. The physician noted that the child was way behind on his immunizations and so she immunized the child with DTaP, and HIB. The doctor told the mother to follow up in two weeks, so on the follow up visit of 8/24/98 the child was well and was vaccinated with his first dose of MMR (lot number 0231H/626053), and his first varicella virus vaccine live from (lot number 0652H/626690). The mother reported that it was from these immunizations, and the mercury that caused her son to go into a shell and regress. The physician reported that at two years of age it is documented in the child chart that the child only spoke 15 single words, and that he was developmentally delayed. On 2/8/00 the child was seen by a neurologist who reported that the child should be evaluated further, but the mother has since left the practice and reported that for financial reasons and her health insurance not covering her bills that she could no longer take her son to see that physician. The reporting physician stated that the child was last seen in her practice on 11/11/99 for an ill visit of gastroenteritis on this visit it was documented in the child's chart that the child was now three years old, had poor social skills, was still wearing diapers and was not potty trained. The mother reported to the physician that the child is now being seen by her family doctor for alternative treatment and reports that the child had mercury levels done and they have resulted to be mercury toxic. The physician reported that the patient also has a sibling who has autism. The mother blames the mercury in the vaccines on this child's autism also. The reporting physician felt that autism was related to therapy with MMR. Additional medical records had been received from the physician and a neurologist in child clinical and neuropsychology. The child had speech delay at one year of age and continuing through three and a half years of age. He did not pass beyond 15-30 words at the age of three and a half years never putting two words together only using single words. The mother was to have the child evaluated developmentally with another physician, but she refused to go through with the exam. The child became combative when going to a physician's office. The patient's mother left the reporting physician's practice on 2/3/03 and now claims that he is autistic due to MMR as a result of mercury intoxication. The child's evaluation was not completed and is reported as follows: According to the Randi Hagerman fragile X syndrome scoring system the child's clinical features included: mental retardation, hyperactivity, short attention span, tactile defensiveness, hand flapping, hand biting, poor eye contact, hyperextensible finger joint and large or prominent ears. All of these clinical features were definitely present (represented score of (2) each). The child's total score was 18. The physician reported that she could not visualize a Silam crease of Sydney line, because the child was agitated. The history reported that the mother was a 28 year old G3 P3 with no complications except for anemia with Fe++, cigarettes, ETOH, SA, and spotting. She had a spontaneous onset of labor at 36.5 weeks. Spontaneous vaginal delivery with the need for external rotation 12 hours prior to labor and there was a knot in his umbilical cord. He was large for gestational age nine pounds and five ounces apgars were nine. Post delivery she was discharged from the hospital within 24 hours without problems. The child's milestones: sitting 4 months, walking 7 months, ran 8 months, single words 12 months, phrases (does not use phrases currently). Temperament: poor appetite, happy non-demanding, preschool: cared for by grandparents while parents work, limited interaction with other children. History of present illness: medications NKDA, major illnesses: pneumonia at four to five months of age. The chief complaint was that the child does not speak or interact with people, desalgia socialization and at times he lived in a shell. The concerns at 9 months of age was that he wasn't of talking. He used gestures, he would take his hands and take her down the hall. He did not respond to environmental areas or early language. He turned to voices. bobbling, gestures showed age appropriate or earlier. At nine to 12 months, mom and dad would leave or go bye bye and he did not carry on. The child was not talking. Hearing had never been tested. He was sent to speech therapy at two years of age. He went for a few months. No standardized testing or treatment. OT and PT was recommended, but mom refused. He was taught to sign and stopped speaking totally. No other regression. The diet consisted of apples, pancakes, dry cereal, top ramen only chicken, french fries, fruits and vegetables. He loves sweets and loves nuts. Diet consists of no meats and cheeses. PICA. His weight was 53 and his height was three feet. Appetite: the child is completely vegetarian. He stopped eating meat at two years of age. He used to eat everything, but will not eat food with meat mixed in. He only drinks milk from a bottle, prefers to eat with fingers, but he will use utensils; he drinks from a cup, will eat hard crunchy food. Sleeps: eight to ten hours easily, no paranoia. Somatic complaints: not demanding, plays with puzzles, US maps, wooden shapes and building blocks. He will share. Routines and ritual: needs both everyday or he gets angry. He gets upset if he doesn't get his vitamins at noon. He sorts his socks in the middle of the night and took them to bed with him. His shoelaces needed to be tied a certain way. He exhibits anxiety symptoms: when he sees the Popeye cartoons, hair dryer and when he wants to leave the bathroom. Elimination: toilet trained - urinates in the toilet. Tried to train at approximately 2 years of age and mother hasn't been real persistent afraid of traumatizing him. Now he is refusing to do at all. Activities of daily living: dresses and undresses self. He rides a tricycle and loves to paint, color, and likes to draw for long periods of time. Play: plays appropriately with care. Sorts laundry according to color and plays hide and seek. He likes to wrestle. Peer relationships: he can be jealous, mostly easy going gives up toys easily to other children. The child has two siblings nine and a half and six and a half. The six and a half year old boy didn't learn to talk. It was suggested by an MD that this child may be partially autistic. The physician's assessment of appearance and behavior: he is a very large child - was three and a half year old who is near the size of a five year old. Blonde soft hair shaking up his head, slightly flattened, occiput, large earlobes, fix and nasal bridge. Child hygiene good dressed in tye dyed tee shirt, jeans and sneakers. Carries two wooden pegs from the waiting room. His mom was reluctant to take them from him because it produces distress. Poorly related interpersonally and has a short attention span goes from object to object. Stands on the chair looks out the window. Rarely orients to his name. Some stereotypes: hand twiddles, sniffing, mouthing and toe walking. Hygiene: clean. Build: large. Unusual characteristics: large ears and flat nasal bridge. Speech characteristics and thought processes: emits sounds nothing was heard, no true bobbling very fretful, easily frustrated and agitated. Mood and affect: irritable and blunted. Gaint: unremarkable. Motor skills: perseveratively draws circles on paper, doll hose. Tics/mannerisms: some stereotypical. History of moving objects across visual field, hand twiddle sniffing, licking and toe walking. Eye contact: very brief. Attention: concentration was poor, impulse control was poor, distractibility: highly distractible. Cognition: miderate mentally retarded repetively draws circles, won't copy. Orientation: he has no orientation to person, place and time and no insight: impaired, judgement impaired, reasoning: impaired. He became distressed after asked to relinquish pen, no directed play - unable to engage. Blood not assessed. He was highly irritable agitated. Affective range remained. No smile, prn eye contact. No stereo/evaluative play observed. He carried the objects around. His attachments at home includes his book the Grinch that stole Christmas. He loves Flintstone tape. He said, Wilma, but stopped. He occasionally repeats Z and combos but inconsistent. The diagnosis: Axis: MR mod add-combined severe, r/o autism and r/o FRAX, Axis II: mental retardation mod. Axis IV: mother gets stressed by behavior and delayed dev. Axis V 35. The reporting physician considered autism to be disabling. Upon internal review autism was considered an other important medical event. The physician reported that the patient also has a sibling who is autistic. The mother blames the mercury on the child's autism also. Additional information is expected.