Information has been received regarding a case in litigation concerning a 9-year-old male with no medical history or allergies who on 30-MAR-1998, 30-APR-1998 and 22-DEC-1998 was vaccinated with his first, second dose (Lot# 625397/1531E) in the left thigh and third 9628414/1478H) in the left arm doses of Recombivax HB. Additional vaccines received included: the first 0.5 ml intramuscular dose of Engerix B (Lot# ENG 2499A2) on 30-MAR-1998; the first (left arm), second (right arm), and third doses (left arm) of Purogenated; Lot # 451496, 4555838, 455838 on 03-JUN-1998, 06-AUG-1998, and 07-OCT-1998; the first dose of Hib conj vaccine (unspecified carrier) (lot # N0548AA) in the right arm; the first (right arm), second (left leg), and third doses (left arm) of poliovirus vaccine inactivated (IPOL) (Lot # N0291 and P0553) given on 03-JUN-1998, 06-AUG-1998, and 29-SEP-1999; the first dose of MMR II (Lot # 626985/1757H) on 15-JUL-1999 in the left arm; and the first dose of Varivax (Lot # 629261/1853H) on 15-APR-1999 in the left arm. Subsequently, the patient experienced an unspecified adverse event. Additional information, including medical records, has been received from a case in litigation. A medical observation from a speech pathologist on 16-AUG-2000 indicated that the patient had moderate disorder in receptive and expressive language development. It was also indicated that the patient's skill acquisition was following an atypical developmental pattern. A clinical history of patient at 30 months indicated autistic-type features, temper tantrums and episodes of inattentiveness. An EKG rhythm strip on 11-SEP-2000 demonstrated normal sinus rhythm throughout the recording. It was reported that the EKG was normal in wakefulness and sedated light sleep. It was also reported that the normal EKG does not preclude the diagnosis of epilepsy. A medical observation on 18-SEP-2000 stated that the pateint was not talking and did not interact with other children. The patient had no desire to look at books or toys and he did not make eye contact with other people. The patient's parents stated that the patient had lost skills, specifically regression of his speech. The patient could only identify his belly button from all the body parts. He communicated primarily by moving adult's hand or by negative behaviors (tantrums, pushing away, etc). He did not demonstrate any interest in books. The diagnostic impression was that he had a moderate delay in receptive and expressive language development and skill acquisition was following an atypical developmental pattern. The patient's past medical history stated that the mother had no history of medication use or maternal illness, no smoking, no use of illicit substances, or unusual stress during the pregnancy. The pateint had no history of serious illness, injuries, seizures, fainting or unconsciousness. The pateint was diagnosed with pervasive developmental disorder/autism. The patient demonstrated stereotypic repetitive interests and behaviors as well as preference for routine. He had preference for playing alone and had minimal verbal expression or gestures. A high resolution chromosome study on 12-SEP-2000 indicated that the patient was a normal male karyotype with high resolution Giemsa banded chromosome study. An occupational report on 04-JAN-2001 stated that the patient's attention to task had improved. The patient had demonstrated mild improvements  with vocalizations and some improvements with visual communication. A learning assessment report on 6-FEB-2001 stated that the patient demonstrated weakness in receptive and language development. The patient's skill acquisition was following an atypical developmental pattern. It was also noted that gross motor skills were developing with some skill scatter. A diagnostic urine toxic metals test on 8-JUL-2001 showed high levels of urinary mercury and bismuth. Urinary creatinine was 17 mg/dL. A selective and dietary choices evaluation on 15-AUG-2001 stated that the patient exhibited extreme food selectivity and refusal behaviors that places him at a risk for nutritional  deficiency. On 1-OCT-2001 the occupational therapy report stated that the patient resisted activities that required crayon and paper. The patient demonstrated decreased eye contact and poor attention to an activity. He had not independently been able to dress or undress himself. A diagnostic hair elements test on 11-MAR-2002 showed high aluminum, antimony, arsenic, bismuth, tin and titanium and low calcium, magnesium, manganese and vanadium. On 24-JUN-2002 the patient was admitted to the feeding program at a hospital due to his significant food selectivity. Upon discharge on 16-JUL-2002 the patient had increased acceptance and variety of foods, did self-feed from a prepped spoon and accepted a large variety of textures of food during meal. A diagnostic urine toxic metals on 3-AUG-2002 showed high levels of lead. Learning evaluation on 21-JUL-2004 at the age of 6 years and 4 months stated that the patient demonstrated some behaviors typically associated with autism such as lack of eye contact, some hand flapping and related self-stimulation behaviors, self biting when upset, visual learning style, and short attention span. The patient was very much aware of people and affectionate when he was comfortable with them. He responded to single verbal commands. He communicated via verbalizing vowel sounds and using signs. He was functional at a 2 year old level in visual reception and fine motor skills. Gross motor skills were delayed but were developing steadily and some were age appropriate. Expressive language and sign language was at a 1 year old level. Psychological evaluation on same day reported that cognitive measures placed the patient within the moderate to severe range of cognitive impairment, according to traditional classification systems. The severity of patient's autistic behavioral pattern was assessed through a checklist measure that was administered to the parents with the results indicating that number of traits were associated with the diagnosis and were indicative of a severe degree of autism. A second measure completed by the examiner based on observations also provided evidence of the presence of many of the behavioral criteria indicative of Autism as present to a severe degree. A speech evaluation on 9-JUN-2005 stated that the patient was utilizing sign language paired with vocalizations. The results revealed severe receptive and expressive language disorder, partially compromised by an apraxic component combined with attention and concentration difficulties. Compliance also played a role in otimal performance and slightly skewed results. An educational evaluation on 17-JUL-2006 stated that the patient was inconsistent in receptive identification of colors, shapes, and letters (by name). The patient also had difficulty with complex play interactions and following complex two-step directions. He had difficulty sustaining eye contact, showing a wide range of affect and seeking help from the examiner. The patient demonstrated an inconsistent ability to organize his behavior. The patient was observed to tap his desk and was reported to have difficulties with environments with loud noises. A psychological evaluation on 17-AUG-2006 stated that the patient continued to display a qualitative impairment in his social interaction which was evidenced by impairment in his eye contact and gestures to regulate social interaction; failure to develop peer relationships, delays in his social/emotional reciprocity. The patient also demonstrated qualitative impairments in communication, demonstrated by delays in his spontaneous make-believe play or social imitative play appropriate to his developmental lead. The patient also displayed restricted repetitive and sterotyped patterns of behavior, interests and activities that was evidenced by delays in his repertoire of play skills, some difficulty handling changes in his routine and some sterotyped and some self-injurious behavior. Upon internal review pervasive developmental disorder/autism was considered to be an other important medical events (OME). Follow-up information received on 22-AUG-2007 included the following adverse experiences: bronchitis (07-Oct-1998), viral symptoms (22-Dec-1998), conjunctivitis (11-Jan-1999) and asthma exacerbation (13-Jun-2000). No further details provided. Additional information is not expected. All medical records available upon request.