This report describes the occurrence of mercury poisoning in a one year old male who was vaccinated with hep B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The subject's past medical history included mild newborn jaundice, asthma, acute pharyngitis, leukocytosis, otitis media, septicemia and lactose intolerance. prenatal care included an aminocentesis due to a high level of alpha-fetoproteins. Delivery was complicated by a large amount of amiotic fluid, which made labor difficult. After delivery, the subject's mother experienced hemorrhaging. Family history included mother with a positive rheumatoid factor and mother born with a ureter closed. The subject's older brother stuttered and his sister did not walk until 18 months. Developmental history revealed that the subject smiled at two months, his first word was at five months, he crawled at six months, rolled over at seven months, sat unaided at about 7 1/2 months, he stood alone at 10-11 help with dressing at two years old. After the subject was one year old, he "lost his words." When the subject was approximately one and a half years old, he regressed developmentally. The subject received Engerix B on 12/19/97 (ENG2357A2), 2/13/98 (ENG2420A2) and 7/2/98 (ENG2429A2). He also received Tripedia on  2/13/98, 4/20/98, 7/2/98 and 12/21/98; Hib vaccine 2/13/98, 4/20/98 and 12/21/98; IPOL on 2/13/98 and 4/20/98; oral-poliomyelitus vaccine on 12/21/98; MMR II on 12/21/98 and varicella vaccine on 12/21/98. His attorney alleged, "As a result of the mercury in the thimerosol-containing vaccinaiton that the subject received as infant, the subject now suffers and in the future will continue to suffer from the toxic neurological effects of mercury poisoning." The following information was received from medical records. The subject presented to his primary care physician on 12/19/97. On physical assessment the PCP physician noted, "6 months no problems." At twelve months, developmental items of "babbles, jabbers; mama and dada specified; neat pincer grasp; bye-bye; pat a cake, peek-a-boo; sits alone; crawls on hands and knees and pulls to a stand" were all checked off. The subject remained under the care of his primary care physician to at least 7/2/02. At that time, his mother noted he had a decreased appetite, chills and decreased urine output. The physician then noted the subject's skin felt cold and he was not eating. On 3/14/01, the subject presented to the ER after a TV fell on him. Erythema and a contusion were noted on the back of the subject's neck. The subject was discharged to home with his parents. On 5/14/01, the subject presented to the ER with a staggering gait and falls. A lumbar puncture was subsequently performed. The following day, 5/15/01, the subject presented to the ER with complaints of not being able to walk post-procedure (lumbar puncture). The ER physician's note stated "Unfortunately the care of child was not handled by a central coordinating individual, but parents sought care from a variety of sources. Parents apparently consulted, on their own, a toxicology lab that was located out of state, and obtained some statement from this lab to the effect that the child was suffering from multiple heavy metal poisoning and that the child should undergo chelation therapy. This diagnosis has not been confirmed by a local pediatrician or toxicologist. Apparently the child has been evaluated by a neurologist." The subject was treated in the ER on 6/21/01 for a possible seizure. His parents reported that he had an episode of shaking all over while conscious. Facial twitching and shaking often was noted. On 7/8/01, the subject presented to the ER after he woke from a nap screaming and holding his penis. His parents indicated that he was pale during the episode. The subject was discharged to home with his parents later that night. An MRI was performed that night. The subject presented to the ER on 10/5/01 with a fever and vomiting. The subject was admitted to the hospital. The admission note indicated. "The child had immunizations of polio, DPT, hepatitis baby and MMR vaccine. Mother thinks that the cause of the autism is following the injection of the MMR." The subject was evaluated by a neurologist on 6/22/00 after a possible seizure episode. At that time, the subject's mother reported that she had elevated alpha-fetoprotein levels during her pregnancy with the subject and she had an aminocentesis performed. The subject was born by vaginal delivery which was complicated by bleeding secondary to a possible vaginal tear. His APGAR were 8.5 and 9. The subject sat at age 7 months and ambulation occurred at 14 months. His speech was limited to "mama" and "dada" which he started to say at age one year. He had not acquired any more words since then. He also could say "bye-bye" and wave, but had stopped doing that at 15 months. It was reported that he did not play with other children although he would make eye contact. The subject's mother further reported that the subject's hearing was checked and it was normal. The day previous to the initial evaluation, the subject's father found the subject "shaking all over but was conscious." This episode lasted 40 seconds and he was taken to the ER. An MRI of the brain was ordered. It was also noted that the subject is the youngest of three children whom have no neurological problems other than not ambulating before 18 months. On physical examination, the neurologist noted inarticulate mumbling, no formed words, the subject did not follow commands, pupils 3mm, reacted well to light, extrocular movements were normal, his face appeared symmetric, muscle strength and tone, gait and balance all appeared to be normal and the subject's deep tendon reflexes were +1. The physician's impression was: "Impression? 2 1/2 year old male with developmental delay, especially in language development and possible seizure episode yesterday." An EEG performed on 7/27/00 was normal. A second neurologist evaluated the subject on 10/10/00 for developmental delay. Medical history included mild neonatal jaundice and lactose intolerance. It was noted that since receiving interventiional services since July 2000, the subject had marked improvement. On physical examination, the physician noted, good eye contact with the examiner, he would scribble but did not copy vertical or horizontal lines on the Gesell figure test. The subject did not speak during the examination. The neurologist's impression was "A 2 year, 9 month old boy with a history of developmental delay with regards to language, poor eye contact, and abnormal social interactions. I think that the subject has autism, fortunately not towards the severe and of the spectrum. He has a normal neurological examination. The likelihood of finding an underlying condition responsible for the autism is low." A third neurologist evaluated the subject on 3/23/01. The neurologist's impression was "Impression 1. Question of autism 2. Rule out metabolic encephalopathy or vaccine induced encephalopathy." A letter written by the same physician on 4/6/01 stated, "I saw your patient in the clinic today. This time the mother brought the lab reports for heavy metal screening. The test shows albumin, arsonic, and also a very high in content. At this time the question is whether there are any neurological problems due to heavy metal poisoning." The subject was evaluated by a speech pathologist on 6/5/00. The pathologist's impression was," The subject is a sweet 29 month old boy who has been given the diagnosis of autism spectrum disorder by his pediatrician. The subject is not using any meaningful speech at this time." It was noted that the subject's receptive language skills were at the 8 month level, which is 21 months below his chronological expectancies. His expressive language was at the 9 month level, which is 20 months below his chronological expectancies. Recommendation included speech and language therapy, a comunication class, an audiological examination, education and other testing for further psychological, neurological and developmental testing. The subject received both occupational and speech therapy. Audiological examination performed on 6/19/00 was normal. The subject was evaluated by a psychologist on 7/25/00 and 8/1/00 for developmental delay and diagnosis clarification. The subject's mother reported that during the subject's delivery there was a great deal of aminiotic fluid impending delivery and she experienced hemorrhaging after delivery. The psychologist noted that although the subject's hearing evaluation were normal, the subject does not appear to respond to high tones. His impressions included: " The subject presented as an alert boy who appeared his stated age. He was observed to open and close doors repeatedly and pace back and forth. He did not evidence any interest in developmentally appropriate toys or items, but approached adults for tickles. He presented as active and happy. Measure of his cognituve abilities clearly underestimate his skills, as he would not attend to tasks and evidenced limited attention and interest." The Mullen Scale of Early Learning, Vineland Adaptive Behavior Scales were administered and results were abnormal. The psychologist's summary was, "The subject, a 2 year 7 month old Caucasian male was brought by his biological parents for diagnostic clarification. In January 2000 a physician indicated a diagnosis of possible pervasive developmental disorder or autism. The subject has evidenced halted language and social communication development. Although he incorporated syllables and babbling at an early age, these skills and have not progressed. Further, the subject engages in nonfunctional repetitive behaviors and often appears unaware of others. He has not evidenced a developmentally-appropriate interest in peers or siblings. Measures of cognitive abilities are a significant underestimate of the subject's skills, as he remains self-directed in preferred tasks. In addition, his adaptive level of functioning is significantly below age expectations. Specifically, progression of these skills is also noted to evidence impediments due to the subject's decreased motivation and initiation across a variety of developmentally appropriate tasks. Therefore, based on a review of the subject's cognitive abilities, level of adaptive functioning, parent report, behavior observed on examination, and developmental history, the subject presents with a diagnosis of Autistic Disorder. It was well-established that early intervention is critical to facilitate development for children with this diagnosis. At this juncture, the subject requires expectations across environments to facilitate the subject's development." Recommendations included, autism service including language proceeding and social skills in classrooms with a small student to teacher ratio, an in-home program, social skills goals and speech services. The subject was evaluated by a medical toxicologist on 4/17/01 for "not learning anything new." At that time, his mother reported the subject was not chewing his food, he choked on the food that he did eat "soft diet", unilateral weakness of the right side, bruising easily, crying, screaming and his tongue rolled back. She indicated that she first noticed his problems when he was one year old. On physical examination, the physician noted the subject used a bottle and had contortions. His impression was "Impression: Neurological injury, toxic leukoencephalopathy and lead, mercury and metal toxicity." Lab evaluation was performed on 4/26/01. The physician prescribed Chemet and DMSA. The subject remained under the care of the medical toxicologist until at least 9/13/01. During this time, the physician noted clenching fists, decreased screaming, no headaches, good eye contact, playful with kids, babbling with some improvement. The physician's impression on 9/13/01 also included,"Metals poisoning and aluminum toxicity." The subject was evaluated by a physician on 6/21/01 who indicated the following. "He needs one on one therapy. He needs behavioral analysis for educational behavioral therapy if available at school; if not, he needs to be placed at the nearest available facility. He needs to be in school on a full time basis." The subject was treated by a physician specializing in nutrition from at least 7/16/01 to at least 4/19/02. During this time, the subject's mother reported several loose or watery stools a day and he refused to chew. Lab evaluation was performed on 7/17/01. The physician's diagnosis included," metal toxicity, pervasive developmental disorder, metabolid disorder, intestinal dyabiosis and malabsorption." Comprehensive Digestive Stool Analysis was performed on 11/5/01. It was noted that when the subject was on a strict gluten and casein-free diet, he did "perceptively better" and he seemed "most normal when on DMSA." The physician recommended a casein-free diet and agreed with another physician who indicated DMSA. He also prescribed SuperNuther, Seren-Aid, magnesium, SymBiotics, essential fatty acids mix and vitamins. On 4/19/02, the physician noted, "Doing pretty good off DMSA about 2 months-regressed some. Autistic features return when his enzymes run out now back on product similar to Ultrase-12, plus another dissimilar to Seren-Aid. Hold off DMSA since done with course, but re-do challenge test in 4-6 months." The subject was evaluated by an allergist/immunologist on 8/2/01 **for "an immune evaluation". The MD wrote: "According to his mother, he was Dx'd w/autism. His mother is not convinced of this diagnosis and would like to pursue other possible etiologies for his condition." The MD wrote, "His previous medical records were reviewed extensively. Informed that mother that I believe that the child's immune system is normal and extensive evaluation is not needed. Despite that, the mother insisted on having him tested. The PT will have immunoglobulin levels performed. I do not believe any other immune evaluation is needed at this point." Please see Lab Data section for the results of immunoglobulin analysis. The parents took the subject to the ER on 10/5/01 w/chief c/o fever, vomiting, restlessness, and crying (non-events). The mother told the ER MD that the neurologist had recommended that the subject be evaluated for autism by a neurologist at a tertiary care center, but that the evaluation had not taken place. The MD wrote, "When I explained the importance of taking the child to Autism clinic because it is not a very clearly defined disease and treatments are also not clearly defined, so more knowledgeable people are at [a tertiary care center] and [another tertiary care center]. Mother thinks that she knows what the root cause of the autism is being the mercury in the MMR and she is getting treatments by a toxicologist and by alternative medicine MDs. She did not show interest at all to go to Autism clinic or neurologist at [the tertiary care centers]." On 12/10/01, the subject came under the care of a new primary MD. On 1/12/02, he underwent a physical exam. His mother reported that "he has heavy metal poisoning w/mercury and arsenic." Treatment at the time of the physical included Ultrase-12. The MD noted that the subject was energetic and excitable. His impression was "Autism". Lab analyses revealed some abnormal results. Please see Lab data section. The MD referred the subject to a tertiary care center. The subject remained under the care of this MD until at least 7/2/02. During this time, the subject experienced decreased appetite, decreased urine output, and his skin felt cold. As of 7/2/02, the autism persisted. Auditory brainstem response testing was performed on 2/25/02. At that time, the subject was "not speaking at all". Medications included "medication for pancreatio enzyme prob's, and chemation [sic] (DMSA) for mercury and arsenic poisoning of unknown cause." On a questionnaire, the parents reported that the subject had a tremor and had sustained a head injury. The subject was sedated and "slept throughout the testing, although was snoring loudly at times." The results of the test were interpreted as normal. Following the reported onset of developmental regression, the subject experienced upper respiratory infections, viral syndrome, viral rash, conjunctivitis, acute pharyngitis, gastritis, otitis media, septicemia, tinea corporis, allergic rhinitis, contact dermatitis, probable syncopal spell following lumbar puncture, and "pancreatic enzyme prob's". These events were not reported as adverse events due to vax admin, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events.** The MD noted, "This child has been significantly developmentally delayed. He was seen by various neurologist specialists and imaging of the brain was essentially unremarkable. His pediatrician has also pursued his case aggressively without finding any organic etiology for his condition. Because of that, the mother has sought toxicology evaluation, which revealed that the pt may have had a high mercury level in his body. As a result, he was started on chelation therapy. Plan 1. His previous medical records were reviewed extensively. Informed the mother that I believe that the child's immune system is normal and extensive evaluation is not needed. Despite that, the mother insisted on having him tested. The pt will have immunoglobulin levels performed. I do not believe any other immune evaluation is needed at this point." On 2/2/02 the subject was sent to the ER by his primary care physician for increased lactic acid. It was noted that the subject was crying, fighting and annoyed. On the progress notes it was stated, "Possible mercury poisoning from DPT w/ secondary autism treated w/ chelationtherapy, last mercury NL." An electrophysiology evluation performed on 2/23/02 was assessed as normal. *The most recent info, received on 9/4/02,did not provide the outcomes of the reported events. Info. received on 8/23/02 indicated that possible mercury poisoning, autism and developmental delays were ongoing as of 7/2/02.* **The most recent info, received on 11/26/02, did not provide the outcomes of the reported events. Info received on 8/23/02 indicated that possible mercury poisoning, autism, and developmental delays persisted as of 7/2/02. The follow up received on 10/3/02 states the subject was evaluated by another physician on 1/15/02 for diarrhea and a rahs on his buttocks. At that t ime, his mother reported the subject had a history of "heavy metal poisoning. Treated for mercury toxicity and arsenic. Hospitalized on 10/2001 for unkonwn cause of high whtie blood cell count. Currneltly on ultrase, probiotics and enzymes to aid with digestion and intestinal flora. Unable to talk. Measles titer 4 times the maximum. Mercury 4.7. Diagnosed with toxic encephalopathy." The physician made diagnoses of "Mucotaneous candidasis. Post antibiotic diarrhea. Toxic encephalopathy." The physician prescribed nystatin and referred the subject to a pediatric psychiatrist. Stool analyses for ova and parasites, culture and sensitivity and a Clostridium difficile toxin were negative. The pt also experienced "high" white blood cell count, post-antibiotic diarrhea, mucocutaneous candidiasis, and left foot toe laceration. The most recent info received on 10/3/02, did not provide the outcomes of the reported events.