Age: 0.18
Sex: M
Vaccine: HEP, DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Affect lability, Autism, Drug toxicity, Dyskinesia
Clinical narrative: From initial information received on 7/20/04 from another manufacturer regarding an adverse event occurring in the USA, it was reported: Information has been received regarding a case in litigation concerning a female patient and her son who received injectable globulin products containing the mercury based preservative thimerosal. The mother, while pregnant with her son, received injectable globulin products containing thimerosal. During the first two years of his life, the son was vaccinated with thimerosal containing vaccines. It was alleged that as a result of cumulative exposure to the injectable globulin products and thimerosal containing vaccines, the son suffered and will continue to suffer from the toxic neurological effects of mercury poisoning. Follow up information from medical records indicated the mother's first pregnancy ended in miscarriage at three months and her son was an only child. The pregnancy was uncomplicated. No alcohol, smoking nor drugs reported. Labor was spontaneous and without complications at term. On 8/9/97 at 36 years of age, the mother gave birth to her son. Delivery was normal vaginal. Birth weight was 6 pounds and 0 ounces. On 8/9/97, the son was vaccinated with a first dose of hepatitis B virus vaccine. Subsequent vaccinations included hepatitis B virus vaccine (10/14/97; 3/10/98), MMR (9/14/98), oral poliovirus vaccine (9/14/98), poliovirus vaccine inactivated (10/14/97), HIB conjugate vaccine (10/14/97; 1/15/98; 3/10/98; 9/14/98) and varicella virus vaccine live (12/8/98). The neonatal period was notable for a week long stay for the treatment of jaundice. From 12/19/97 to 12/24/97, the patient was hospitalized for a high fever. In the fall of 1999, the patient began receiving speech-language therapy. The Rosseti Infant-Toddler Language Scales had the following results: Interaction Attachment 15-18 months mastery level; Pragmatics 15-18 month mastery level; Language Comprehension 12-15 month mastery; Language Expression 3-6 month master level. On5/8/00, the patient was evaluated for suspected developmental delays, disruptive behavior disorder and pervasive developmental disorder. The patient had no known drug allergies and there were no current medications. Infant motor milestones were acquired at appropriate ages, but speech/language milestones were delayed. Eating problems included restricted food choices and difficulty with chewing. Sleep problems included difficulty getting to sleep and head-banging against the mattress. Tactile problems included head and neck defensiveness. Auditory problems included hypersensitivity and neglect. Oral problems included mouthing and hyperactive gag reflex. Pain responses were decreased. Atypical body movements included hand flapping and rocking. Self-injurious behaviors included teeth grinding and head banging. The patient had mood liability, excessive responses, poor consolability, lack of fear response and tantrums. The patient had a lack of show and tell behavior, poor eye contact, inconsistent response to non-verbals, excessive shyness, aloofness, preference for solitary play and limited social reciprocity. The patient had speech/language delays, limited non-verbal communication and used only a few single words inconsistently. The patient had a restricted range of interests in toys, perserveration with objects, lack of imaginative play, poor imitation skills and banged/threw objects. Behavioral problems included tantrums and hyperactivity. Physical examination showed no developmental level. He was not observed to track objects across midline. A complete audiological evaluation revealed hearing within normal limits in at least one ear. Type A (normal) tympanograms were obtained bilaterally, indicative of normal middle ear function. The Vineland Adaptive Behavior Scales had the following results (age equivalents): Communication 10 months; Daily Living Skills 1 year, 5 months; Socialization 7 months; Motor Skills 1 year, 8 months. The Rossetti Infant-Toddler Language Scales had the following results: Interaction Attachment 9-12 months mastery level; Pragmatics no mastery; Gesture no mastery; Play 3-6 month mastery level; Language Comprehension 6-9 month mastery level; Language Expression 3-6 month mastery level. The impression was the patient met DSM IV diagnostic criteria for Autistic Disorder, moderate. This was substantiated by developmental history, observed behaviors, number of identified symptoms, the presence of social and communicative impairment, atypical sensory responses, limited and unusual play skills/object use, motor stereopathies, difficulty modulating emotional responses and poor imitation skills. Upon internal review, autism and mercury poisoning were considered to be other important medical events (OMIC). From additional information receved from another manufacturer, on 10/5/04, it was reported that during a routine office visit on 6/8/99, he physician noted that the patient only said mama and go-go and hummed all the time. The physician felt the patient may have a possible developmental delay and ordered a referral to an early childhood intervention program. On 7/8/99 the patient had an initial intake screening for early childhood intervention. There was concern with the patient's language development, as he did not use voice to get what he wants or to communicate and he does get familiar objects kept in a regular place when asked. The mother was not concerned with the patient's hearing at the initial screening, therefore the patient was not referred for a hearing examination. The patient is affectionate with people. He functions well in his environment and does not use assistive technology. His needs were assessed as learing how to talk, not getting mad when someone tries to help him with a task, being able to better feed himself and becoming toilet trained. On 10/19/99, a developmental delay was noted. In the fall of 1999, he began receiving speech-language therapy. The services were eventually discontinued, but resumed again in May 2000. A parent questionnaire from a developmental center reported that the mother's concern about the patient were his speech and hearing because at two years of age, he would only say one single word and three words, and he had a lot of ear infections. A review of systems showed eating problems which included restricted food choices, avoidance of hard textures and difficulty chewing; and does not like vegetables. Physical examination showed no abnormalities. Formal vision screening could not be obtained due to the patient's developmental level. The Rossetti Infant-Toddler Language Scales, and Vineland Adaptive Behavior Scales scores indicated significant delay in language comprehension and language expression. He displayed sensory processing difficulties, tactile sensitivities, atypical visual responses, a hyper-responsive gag reflex, mouthing/chewing on objects, and mildly high pain threshold. The adaptive ability scales assessed in the low (mild to moderate deficit) range with adaptive equivalent of one year, two months, severe communication disorder with reliance on inappropriate behavioral communication, severely impaired verbal imitation skills, use of jargon-like speech and difficulty with pragmatics (mutual eye gaze, requesting, imitating, waiting, turn taking and using gestural communication) characteristics of autistic disorder. An occupation therapy evaluation on 8/28/00 showed the patient became agitated, but would quickly cam when held, used a lot of self-stimulating behaviors such as fidgeting with his fingers, and repeatedly made noises. He used a cylindrical grasp to place objects in a container and did not yet have a pincer grasp but used more of a whole hand and was not able to bring his hands together to string beads or stack objects. When observed on a playground he played by himself, was dependent or spoon feeding and was unable to drink from a cup or sip through a straw, but could feed himself crackers or cookies. He wore a pull up and was dependent for toileting. On 9/1/00 it was reported by the mother that he doesn't sleep well at night, hyperactivity at night and he constantly wakes from slumber, he had sleep problem. An occupational therapy evaluation noted him to have decreased attention span due to sensory processing deficit that effect his performance in the area of fine motor skills, play and self-help skills. He was recommended to receive direct occupational therapy two times a week for 30 minute sessions to address deficit in sensory integration and fine motor skills. On 5/3/01, at an annual review meeting of the individualized education plan, the patient was reported to feed self, toilet training was in progress, speaks approximately 20 words, matches letters, strings beads, puts puzzles together, beginning to take turns, learning to take his tray and open milk, can dress and undress, and can follow two-step commands in a routine. At a preventative health visit on 9/26/01 the patient was noted to be combative during the examination and in constant movement during the interview, he wants to climb on the examination table and jump. He taps tongue depressors on the window, toe walks, and occasionally walks heel to toe. It was noted that he still wears pull ups. On 4/25/03 at a school district review meeting it was determined based on the evaluation data reviewed that the patient has a disability which was reported as autism and speech/language impairment. It was suggested that the patient have direct speech sessions three time weekly for 20 minutes each. On 5/22/03, a comprehensive assessment from an occupational therapist reported that the patient's deficits in fine motor skills adversely affects his performance in the classroom and recommended the patient continue to receive occupational therapy once a week for 30 minutes to assist with gaining age appropriate fine motor skills. On 7/22/03 a preschool assessment, full individual evaluation for the determination of disability condition and educational need showed that the patient demonstrated significant educational and developmental disability in all developmental areas and is recommended for special education services. The evaluation was drawn from aptitude and achievement tests, parent input, teacher recommendations, physical condition, background and adaptive behavior. It was noted that the patient did not demonstrate significant emotional/behavioral disability, therefore, there were no recommendations at the time of the evaluation. The patient had been receiving speech therapy sessions as recommended at the evaluation and he had met some long-term objectives and progressed toward long term objectives, his verbal output increased as noticed by his mother and the clinician, he will occasionally repeat words and a few phrases, can demonstrate the understanding of 3/5 items when asked to showe a body part and will establish eye contact when he wants/needs something. On 3/25/04, the speech pathologist created a new speech language plan of care for the patient's diagnosis of autism, developmental articulation disorder and developmental language disorder. The patient has been receiving occupational therapy and continues to have delays in his fine motor skills but has shown progress in areas of sensory integration and self-care. In an evaluation and plan of new treatment goals initiated on 4/14/04 it was noted that during the time period from 12/21/03 to present, the patient had made excellent progress in being able to match 7-10 objects without assistance and being able to point to the correct body art with minimal facilitation. In sensory integration the patient demonstrated an increased attention span to perform a task with minimal verbal cues, he exhibited appropriate eye contact with the therapist and was able to cut on 3/3 lines with no assistance 2 of 3 times and was able to complete simple constructive craft play activities. On 4/19/04 an extended school year was recommended for the patient lasting two weeks after school it out and two weeks before school starts and the services scheduled included a self contained class (4 hour day - 3 times weekly); occupational therapy 30 minutes week and speech 30 minutes a week. Upon internal review, autism and speech/language impairment was considered to be disabling. No further information is available. All medical records will be provided upon request.