Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Gait disturbance, Immunoglobulins increased, Laboratory test abnormal, Neurodevelopmental disorder
Clinical narrative: Report A0379221A describes the occurrence of autism in 3 year old female who was vaccinated with hepatitis B recombinant (Engerix B). This case was received as a result of the litigation process with forwarding of medical records. The attorney alleged that "as a result of the thimerosal-containing vaccination that the subject received as an infant, the subject now suffers and in the future will continue to suffer the toxic neurological effects of mercury poisoning." The following was obtained from medical records. The subject had no known food or drug allergies. Medical history included recurrent otitis media and eczema. Her brother diagnosed with autism at the age of two years six months. She was taking no concurrent medications. The child's mother had a normal pregnancy and birth and delivery were normal. The mother breastfed. She had four amalgams. The subject received her first injection of Engerix B on 7/15/99 (lot 2932A2). She received her second and third injection of hepatitis B vaccine recombinant on 10/25/99 and 4/19/00. She had also received the following vaccinations: IPOL, DTaP/DTP/DT/Td, hib B, MMR II, Varivax and hep A and Prevnar. During office visits with pediatrician between 4/7/99 and 4/02, the following was observed: Normal growth and development at age two months, four months, five and a half months, nine months, and one year. At 15 months, an occupational therapist felt subject was behind by three months. At age 18 months, speech delay and concerns in some behavior in slapping her hands were noticed. The pediatrician made note of "questionable autism." At age 24 months, she was noted to have developmental delay as she "understands a lot but far below normal for age." At age three years subject "still doesn't socialize appropriately with other kids." Assessment were "autism syndrome." On 8/26/01, it was noted the child had "possible mercury poisoning due to immunization shot, allergies." The subject was started on chelation therapy. On 12/12/01, the subject was seen for evaluation for "possible mercury poisoning." On 2/18/02, history of the subject's problems were noted as "Milestones slowed and reversed following MMR vaccination, sleep problems, nightsweats, irritable, unhappy, unalbe to stay on task nor concentrate. Physical exam was normal. Impression was "1. Possible immune/metabolic dysfunction: and "2. Possible environmental toxicity." Urine screen detected elevated levels of indioylacrylglycine (IAG), dermorphin and meth enkephalem. On 15 and 30 May 2002, urine and fecal mercury levels were within reference range. Psychological evaluations were performed between 8/21/00 and 12/17/01. Source of assessment information included behavioral observations in structured and semi-structured environments, interviews with parents and lead behavior therapist and informal and developmental tasks. The following observations were noted: Her language development was inconsistent. She had her first words at age 12 months but seemed to stop talking at 15 months. She would play baby games but would not initiate. Eye contact was a problem. She had no interest in other children and would not initiate contact. She would laugh and cry for no reason and became upset with transitions. She reportedly had an unusual gait. At age 15 months, the subject's skills were at the following levels: cognitive 13 months; language 11 to 12 months; personal-social 12 months; fine motor 12.5 months and gross motor 14 months. She was diagnosed with "mild developmental delays." At age 18 months, her skills were rated to be at the following levels: communication one year old; daily living skills one year one month old; motor skills one year five months; interpersonal relationships were that of a 10 month old; her play and leisure time were that of a 6 month old. She was diagnosed with autism (provisional) in August 2000. She was enrolled in an intensive early intervention program, speech therapy, and occupational therapy. A second psychologist saw her in December 2000 (at age 22 months) who diagnosed her autistic disorder. By age 29 months, the subject showed improvement in her attention skills. At age two years, eight months, she utilized echolalia as one form of communication. She was observed to have behaviors such as flapping her hands. She was inconsistent in her ability to listen and use directions for up to five-minute periods of time. Her pronunciation of language was not clear. According to the results of the Bayley Scales of Infant Development, the subject's overall level of cognitive functioning was more than one and one-third standard deviations above the mean. In summary, her functioning varied from that of a child one year and nine months of age to that of a child four years and seven months of age. A third psychologist concurred with the diagnosis of autistic disorder. At age two years 11 months, the "area of concern" seemed to be in her limited interaction with peers. However, she had shown significantly improved attention and decreased distractibility that positively impacted her ability to follow through with given instructions. Her strength appeared to be in her imitation skills. Her ability to follow through with instructions also improved. She was showing "steady gains" in the area of expressive language. Her area of relative weakness appeared to be in her fine motor skills. Subsequently, she had some difficulty with self-help tasks. She had shown improvement in playing and interacting with other children in a structured setting. The subject began speech and language therapy in September 2000. Progress reports from the speech and language therapist written between 8/7/01 and 10/7/01 revealed the following: At age two years six months, subject had made excellent progress in the areas of expressive language and receptive language skills. Significant areas of concern at that age included expanding her play skills to support more varied language development and socializing with age matched peers in a variety of settings. At age two years 11 months, what she wants to do as well as directing others in play. However, she occasionally fell into a role pattern of questioning in an attempt to initiate communication or to carry out particular communication intent. At age 31 months, subject had made consistent progress in therapy in the areas of increased willingness to try new activities and more appropriate play skills. Areas of concern included delays in her fine motor skills, self-care abilities, and motor planning skills. As of 8/23/02, the outcome of the events were unknown.