Report A0372394A describes autism in a 3 year old male who received hep b vaccine recombinant (Engerix B). This report was received as part of litigation proceedings, with forwarding of medical records. The child's mother had an uncomplicated birth history. She had a spontaneous vaginal delivery. She was given unspecified narcotics during labor. "He was the product of a 36 week pregnancy to a mother who gained 30-35 pounds during her pregnancy. Fetal activity began at four months. The baby was born in the vertex position with a birth weight of 3465gm, a length of 53.5cm  and a head circumference of 35cm." Apgar's were 9&9 at one and five minutes respectively. Medical history included obstruction NOS, chronic constipation with obstruction, allergy to sulfa 9characterized by urticaria of his right cheek), blocked nasolacrimal duct since birth, mild neonatal jaundice, upper respiratory infections, four episodes of otitis media, right otitis media, left otitis media, two episodes of bilateral otitis media, otitis media, serious otitis, minimal clinical jaundice at four days old, and "ghibs" syndrome. Surgican history included left nasolacrimal duct probe 07/30/96. The family history is significant for one older sibling with autism and mother with ADHD (attention deficit hyperactivity disorder). Concomitant medications included Amoxil, Septra, Augmentin, PPD, vitamins NOS, herbal supplements NOS, mineral oil, lactulose, and Senokot, psyllium, Maalox, milk of magnesia, Biaxin, Genoptic and Septra. Following the reported onset of autism, the child was diagnosed with the following: left otitis media, sinusitis, atopic dermatitis, pityriasis rosea, papular eczema, viral upper respiratory infection, and chornic encepresis. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. Developmental history revealed the following: at four days of age, the baby had "latching problems." He would "nurse briefly and then fall asleep." At his six week wel visit, the baby could smile, coo, and "lift." At four months he did not roll but he grasped, laughed, followed, listened, and had increased head control. At six months, he could sit with support, roll over, and grab objects. At nine months of age, the history was noted as "D's, B's, no M's," wobbly sit, crawl, transfer, bang, and "stranger anxiety." At ten months, he could sit. At 11 months, he didn't want to drink juice or water--only breast milk. At twelve months, he crawled. At thirteen months, he crawled and "pulls to stand." At thirteen to fourteen months, he walked. At nineteen months, he had "no speech" and "no babbling." He seemed to progress but was always hopotonic. His first words were spoken at 2 years 4 months." Family history is significant for two siblings with delayed development. "Older sibling with autism and a still older one with attention deficit hyperactivity disorder" and learning problems. His mother, father, and brother occasionally have eczema. Family history also significant for "allergies/asthma" NOS and cancer. The child received Engerix B on 06/02/1995 (lot ENG1308A2), 07/10/95 (lot ENG1308A2) and 12/04/95 (lot ENG1906A2). He also received combination diphtheria and tetanus toxoids and petussis vaccine adsorbed and Haemophilus influenzae type b conjugate (07/10/95, 10/02/95, 12/04/95, and 06/27/96), oral poliomyelitis virus vaccine (07/10/95, 10/02/95, 12/04/95), MMR vaccine (06/27/96) and varicella vaccine 11/12/96. On 03/04/97, when he was twenty-two-months old, the child's pediatrician wrote a referral for OT (occupational therapy). He noted the child had a "developmental delay." On 03/31/97, the occupational therapist wrote her assessment," 22 month old toddler boy who demonstrates significant delays in Fine-Motor/Adoptive/Personal/Social language areas. He demonstrated minimal social interactions with no significant purposeful play. He will engage in repeative behaviors such as opening and closing doors. A standarized test was not applicable secondary to inability to follow commands." It was noted that he would benefit from an OT component. He was assessed against an eighteen month evaluation and he was unable to perform the following "fine-motor skills/percetual skills: imitates stroke, turns 2-3 pages at once, stacks 3-4 blocks, 10 blocks in cup, and formboard-inserts 3 blocks after demonstration. Language: follows 2 directional commands, points to major body parts, 20-29 word vocabulary, beginning 2-word phrase, nams a few pictures, hands empty dish-"all gone," understands simple commands, asks for food and drinks from a cup well (just recently began)." Compared to a fifteen month evaluation he was not able to perform the following" fine-motor skills/perceptual skills: scribbles with crayon, stacks 3 blocks, 6 cubes in a cup, pellet in bottle, book:helps turn page, uses spoon with some spillage, and drinks from a cup (just starting-mom still breast-feeding). Language: uses jargon, 10-19 words including names, book: pats pictures, points to 1 body part on request (non consistently), and pulls to show (does not indicate needs)." On 03/06/98, when the child was two-years, nine-months old, he presented to his pediatrician. he was diagnosed with otitis media and was given a prescription for amoxicillin 250mg three times daily. When the child was two-years, 10 months old, he returned to his pediatrician with complaints of a cold with rhinitis for three days. He was diagnosed with conjunctivitis and "ghibs" syndrome. He was prescribed Biaxin 100 mg two times daily and gentamicin sulfate eye drops. On 07/22/98, when the child was three-years, one month old, he returned to his pediatrician. The pediatrician noted that his general appearance was "autisic" and that he had a history of "autism." He diagnosed the child with left otitis media and sinusitis and prescribed Septra 7ml twice daily for ten to fourteen days. On 04/08/99, the child's physician wrote a referral to a dermatologist to "evaluate persistent rash." On 04/26/99, the dermatologist wrote in his consult report "patient clinically c/w consistent with persistent rash. Pt on approximately 25 pills different vitamins and supplements. Discontinue all." His progress note stated "most consistent with papular eczema. Stopped all supplements except vitamins which had ginkgo biloba and PABA. Please stop vitamins." On 10/01/99, when the child was four years old, he presented to a neurologist. The neurologist noted "because of an older sibling with autism and a still older one with attention deficit hyperactivity disorder, the parents were tuned into potential problems during the first year of life or so. Around a year of age the pt became concerned because he did not point to things or share things with his mother as would he expected for his age. He also had little language development making only simple sounds. However, the parents report that he as an infant and presently makes eye contact and seems to be affectionate with them enjoying being held and hugged. Over the years his language and communication skills have continued to remain severely impaired. At about two and one half years of age he started imitating sounds and around that time he started to recite nursery rhymes that he has memorized. Language content is very simple addressing his immediate needs. He has not developed any significant conversational language nor does he voluntarily speak unless he wants something. There is also little spontaneous speech. One of his more frequent phrases is "I want." Play skills most of his activity is self-stimulatory, for example, he will look at his hand or shake his hand or look at things out of the corner of his eye. About 25 percent of the time he engages in some simple repetitive play like pushing of buttons or playing with toys that have repetitive motion. Over the last year or so the mother feels that he is even less interactive and does more self-stimulatory play than before although there is no regression in language which is still fairly limited. Past medical history mild delay in motor skills. He walked but not hop or skip. He can peddle or tricycle but not steer. He still has an improper grasp of utensils of writing tools, but he can draw a circle. He dressed himself to a degree putting on a shirt and pants but for the most part still needs help. He is not toilet trained. He has a 6 year old brother who is autistic and the 9 year old suffering from ADHD and learning problems. Interestingly both brothers seem to have better motor coordination  than their older 9 year old brother. The examination reveals an alert, happy, white male. Weight was 16.5 kg or 25 percentile, with a head circumference 52cm or 75th percentile. During the evaluation he appeared active jumping around the room in a playful fashion, but without any clear-cut organized play. he clearly made limited eye contact at least with the examiner, and for the most part appeared to make fleeting eye contact with different things around the room. Language and communication skills were severely impaired in that most vocalizations were sounds with occasional isolated words. He did not follow any commands given to him verbally. Motor examination revealed to be normal bulk, tone and power in upper and lower extremities. There appeared to be no tremor or dysmetria when reaching for manipulating objects. Deep tendon reflexes were 1-2+ with flexor plantar responses. His gait appeared normal and balance appeared petty good watching him jump and hop around the room and into the hallway, his movements appeared appropriately quick. Sensation was grossly intact. Assessment: This is a four year old with suspected autism. The history suggests that this was the result of a genetic defect in that his older six year old brother has the same symptoms and his nine year old brother is described with attention deficit hyperactivity disorder and learning problems and also by history seems to be at least somewhat socially inept. Recommendations: Referral to dysmorphology. Prednisone starting at approximately 20mg (1mg/kg epr day) and increasing in two weeks to 30mg a day. If the medication appears successful we will continue it for a period of six months before weaning." On 02/16/00, the child had a dysmorphology consultation. The physician noted "he is here today to rule out the possibility of a syndrome associated with his autism. His weight is 17.7kg, which is the 25th to 50th percentile. His height is 103cm which is the 10th to the 25th percentile. His head circumference is 52.5cm, standpoint. I have brought up the possibility that his developemental abnormalities were behavioral abnormalities might represent an X-linked recessive disorder, in that both of his siblings are boys with similar types of problems." On 04/10/00, the child presented to the neurologist. The neurologist wrote "more tactile defensive and more hyper and steroids but increased language skills, reponds now in short sentences instead of one word. Better tongue movement and articulation on prednisone 40mg. How many bothers? (I have 2 brothers). Seems at least subjectively to have better language increased tactile defensiveness. Plan: Wean prednisone slowly decrease 5mg per week." On 01/11/01, the child saw a pediatric gastroenterologist. The gastroenterologist noted he had a history of encopresis and "three months ago, at which point he began to experience pain and discomfort associated with stooling and begun to withhold his stools. His parents states that he requires mineral oil two tablespoons three times daily, milk of magnesia tow tablespoons three times daily and lactulose one ounce twice daily in order to have a adequate bowel movement. He refuses to sit on the toilet and will only have a bowel movement in his diaper." On 04/17/01, when he was five years old, the child returned to the pediatric gastroenterologist for encopresis. His current medications included two tablespoons of mineral oil twice daily, one tablespoon of lactulose twice daily, Senokot at bedtime, and a "scoop" psyllium twice daily. On 10/01/01, the six year, four month old child returned to the pediatric gastroenterologist for autism. His current medications included a Maalox one capful everyday. In a Second Amended Complaint, the child's attorney alleged that "as a result of the mercury in the thimerosal-containing vaccinations that the child received as an infant, the child now suffers and in the future will continue to suffer from teh toxic neurological effects of mercury poisoning." The most recent info was received on 07/01/2002. As of 10/01/2001, the autism was ongoing. The outcome of the mercury poisoning was unknown.