Sex: M
Vaccine: DTPHIB, HEP, OPV
Symptoms: Irritability, Nervous system disorder, Otitis media, Psychomotor hyperactivity, Speech disorder
Clinical narrative: This report describes the occurrence of autism in a male child of unspecified age who was vaccinated with hep B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings with forwarding of limited medical records. The subject's concurrent medications were not reported. On 8/16/95, the subject received a dose of diphtheria and tetanus toxoids and pertussis vaccine. He received Engerix B on 2/20/94, 4/8/94, and 8/22/94. He also received combination diphtheria and tetanus toxoids and pertussis vaccine absorbed, Haemophilus influenzae type B conjugate vaccine; oral poliomyelitis virus vaccine; MMR; and Haemophilus influenzae type B conjugate vaccine. On 3/14/03, the subject's attorney alleged that as a result of the mercury in the thimerosal-containing vaccinations received during these developmental years, the subject now suffers, and in the future will continue to suffer, from the toxic neurological effects of his mercury poisoning, including but not limited to autism. The autism and mercury poisoning in this report are considered to be medically serious (OMIC). The following information was obtained via additional medical records provided by the attorney. This report describes the occurrence of autism in an 18 month old male child who received diphtheria and tetanus toxoids and pertussis vaccine and hepatitis B vaccine recombinant for prophylaxis. The patient's mother gained 70 pounds during the pregnancy. During delivery, the patient's mother had a temperature of 100.8 degrees F and was subsequently placed on antibiotic therapy. Another complication of the delivery was that thick meconium was noted. The mother was negative for hepatitis B surface antigen. The patient was delivered via Cesarian section and weighed 10 pounds 12 ounces. Apgar scores at 1 and 5 minutes were 9/9. The patient's medical history was significant for frequent otitis media beginning at 10 months of age...Family history significant for cerebral palsy, mental retardation. The first year of the patient's life was uneventful. He slept well. He was irritable and crid a lot but his parents attributed those symptoms to gas. At 15-18 months of age, the patient began using simple words. When the patient was 18 months of age, his condition worsened. He quit saying words when his ear infection became frequent. Despite placement of pressure equalization tubes in December 1995, he would babble. When the patient was 25 months of age, his recepitive language skills were judged to be delayed nine months and his expressive language skills were judged as delayed 17 months. His hearing and vision were intact. He was evaluated for autism on 10/18/96 due to his speech problems, humming, short attention span, and problematic behavior including biting, kicking and unspecified injuries to adults. The consulting physician felt his symptoms were the clinical picture of autism but she stated that "...this is not a diagnosis per se..." On 4/25/97, when the patient was over three years of age he was placed on nortriptyline for sleep and behavior problems. The tantrums had worsened since he developed chicken pox. Progress notes from 10/1/98 revealed that the patient was on carbamazepine for sleep. The physician stated that the patient was not doing well at all. His behavior was completely out of control and he was hyperactive and awake all night. He screams and has multiple obsessive-compulsive behaviors, which also are very difficult for the family to manage. His language had improved somewhat. At the time of observation, he was agitated and crying. The physician was going to place him on a regimen of clonidine for sleep and fluoxetine for his obsessive-compulsive behavior. Follow up visit on 11/13/98 revealed that the patient had improved on therapy with fluoxetine. However, he remained hyperactive and without clonidine, he did not sleep well. He also had exhibited improvement with his obsessive-compulsive behaviors. He still had some major tantrums and rages. Risperdal was added to his regimen. On 6/22/00, the patient underwent a psychological evaluation for the purpose of special education placement. The Wechsler Preschool and Primary Scale of Intelligence Revised showed a full scale IQ of 44, Verbal IQ of 46, and Performance IQ of 51. On 2/5/03, when the patient was 9 years of age, he was prescribed twice weekly occupational therapy sessions to facilitate improved sensory integration and praxis, behavior, motor skills, self-care skills, and social skill development. By April 2003, he had made consistent progress with improvement in his overall behavior and communication at home. Following the reported onset of autism, the vaccinee experienced an unspecified event requiring a visit to the emergency room. While in the emergency room, he had an episode where he had a blank stare and was unresponsive for 15 seconds. He also experienced chronic adenotonsillitis pneumonitis requiring tonsillectomy with adenoidectomy. He also had suspected right lower lobe and right perihilar pnuemonitis and chicken pox. These events were not reported as adverse events due to vaccine administration but were found during the course of review of the vaccinee's medical records. Therefore, they were not listed as adverse events. The most recent information, received on 6/10/04, did not provide the outcome of the reported events.    Follow up on 07/16/04 states: "The most recent information received on 07/09/04 did not provide the outcome of the reported events. The most recent information stated that on 06/22/00, the pt underwent a psychological evaluation for the purpose of special education placement. The preschool and primary scale of intelligence revised showed a full scale IQ of 44, Verbal IQ of 46 and Performance IQ of 51."  Follow up on 11/02/04 states: "On 02/05/03, when the pt was 9 years of age, he was prescribed twice weekly occupational therapy sessions to facilitate improved sensory integration and praxis, behavior, motor skills, self-care skills and social skill development. By April 2003, he had made consistent progress with improvement in his overall behavior and communication at home. At a visit with a child neurologist on an unspecified date in June 2004, the pt was continuing to experience problems with tics, obsessive compulsive behaviors and aggression. The neurologist commented "we feel that his diagnosis is appropriately autism. Other diagnoses have been excluded form the neurological standpoint....It is our opinion, and by that I mean that of the child neurology community, that autism is a congenital malformation of the brain with a largely genetic predisposition, recognizing that all that is genetic is not necessarily inherited. We do not feel that there is any data at this time for the role of immunizations and/or mercury poisoning in the etiology of this problem.'  Following the reported onset of autism, the vaccinee experienced an unspecified event requiring a visit to the ER. While in the ER, he had an episode where had had a blank stare and was unresponsive for 15 seconds. He also experienced chronic adenotonsillitis requiring tonsillectomy with adenoidectomy, cough, swollen neck glands and swelling behind ears, diarrhea, vomiting, low grade fever, upper respiratory infection, sinusitis, elevated triglycerides, elevated alkaline phosphatase, exaggerated valgus alignment of heels with some collapse of his midfoot (due to hypotonia), and otitis media.  He also had suspected right lower lobe and right perihilar pneumonitis and chickenpox. These events were not reported as adverse events due to vaccine administration but were found during the course of review of the vaccinee's medical records. Therefore, they were not listed as adverse events. The most recent information received on 10/20/04, did not provide the outcome of the reported events. "