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Life Threatening? No
Write-up: Information has been received regarding a case in litigation concerning a male child who on 10/13/94, at the age of 12 months was vaccinated with a dose of MMR II (lot 609861/1037W; batch 850672). It is alleged that following the vaccination the pt developed Asperger''s syndrome and bowel problems. Upon internal review the pt''s Asperger''s syndrome and bowel problems were considered to be other important medical events (OMIC). No further info is available. A 15-day follow up report received 3/10/2003 adds: Information has been received concerning a 13 month old male child with mild asthma, mild hydroureteronephrosis and a medical history of clicking hips, bilateral ureteric reflux, and meconium staining of the liquor during during, who on 10/13/1994 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (Lot #609861/1037W: Batch #950672 (diluent)). It is alleged that following the vaccination the pt developed Asperger''s syndrome, Attention Deficit Disorder with Hyperactivity, and Lymphoid Nodular Hyperplasia in the terminal ileum. Additional info was received and indicted that the pt was crying, screaming and writhing about on one afternoon during the week post vaccination. This was unusual, as the pt never behaved like this before. Within 6 weeks post vaccination, the pt began to pick up his toys one after the other, look at them and then throw them away. He was no longer playing appropriately with them. Also the pt was extremely restless. He was not seeking out the company of adults as he had done before. He started to throw heavy objects around the house. Also within 8 weeks, his speech patterns had changed and from conversational cadences to being less talkative and expressing himself in a kind of gibberish that did not sound like conversational attempts. Within 3 to 4 months, his sleep patterns completely changed. He now needed little sleep, during which he was restless and twitchy. Within approximately 6 months, the pt had developed an obsession with the same audio and videocassettes. He would play then 30 or 40 times over and over again. If they were turned off, he would scream for hours. Within 6 months, the pt was displaying many typical autistic traits. He had gradually begun hand wringing and having temper tantrums. He had also lost all of his eye contact gradually in the 6 months post vaccination. He did not want to be near familiar people and developed a severe dislike of strangers. He would arch his body and go completely rigid if he was somewhere that he was uncomfortable with. In February 1997, the pt was seen by a pediatrician and was diagnosed as having attention deficit disorder with hyperactivity. He was prescribed methylphenidate (RITALIN) which made his condition worse and so he was brought off it after 3 months. On 05/07/1998, the pt was diagnosed with Asperger''s syndrome. Following continuous bouts of constipation for a period of around 12 months, the pt was seen and referred by a general practitioner on 06/16/1999. The pt underwent a colonoscopy on 05/16/2000 and the specialist in pediatric gastroenterology made a diagnosis of Grade 2 lymphoid nodlar hyperplasia in his terminal ileum with loss of vascular pattern up to the transverse colon. During the same appointment, the pt underwent an OGD (oesophagogastroduodenoscopy) that showed normal oesophagus, minimal antral erythema and duodenal erythema in ''D1''. In an assessment performed on 05/01/1997, at the age of 3.5 years old, a physician indicated that the pt''s mother had non-insulin dependent diabetes and needed insulin during pregnancy. The pt was born vaginally at 40 weeks without problems after an induction. He was an easy baby, slept a lot and was breast-fed until 8 months. He began verbalizing at about a year old and had a few words by the age 0f 2. He was talking in sentences now. His parents could not remember when the pt began to sit, crawl, stand, or walk but felt that they were within normal limits. He was an affectionate child. The pt was currently on methylphenidate (RITALIN) 5mg ''mane''. None at weekends. His parents indicated that his behavior was very destructive and had general motor over-activity. He would go around touching everything. He would interrupt others constantly and found it difficult to listen. They reported that he was generally quite easily distractible but with certain tasks, such as sitting with a book, using the computer or watching videos, he was able to maintain concentration. Mealtimes were also difficult in getting him to sit down and eat. His mother felt that the pt was more amenable since starting methylphenidate (RITALIN) with less tantrums and was more settled. His father felt that it made little difference. The pt appeared to have quite a number of ritualistic, almost obsessional behaviors. For istance, the pt insisted that he must eat this breakfast while wearing his dressing gown. He insisted that many tasks are done in a specific order and also had his own ''special tasks'' such as putting lids on bottles or putting fruit into plastic bags in the supermarket. He also appeared to have a compulsive need to touch things. He had a particular interest in books of any kind and will sit and ''read'' a book from cover to cover. He would throw a tantrum, lasting for an hour or so, if he were not allowed to finish the task. Recently, the pt had been experiencing night terrors. Toileting is another main problem. Toilet training had begun last summer and he was dry during the day to the point where he was able to wear ordinary pants but was still soiling. He appeared to be retaining his feces but constipation was ruled out as a possible cause and laxatives were of little help as he was producing small amounts often. Currently, he refused to use a pot; he said, ''I can''t''. He was back to wearing nappies full time now. He played quietly and appropriately with toys on his own for most of the interview. He seemed placid and happy. Although the pt did seem to have some of the features of ADHD (attention-deficit hyperactivity disorder), in general his behavior did not seem to have the pervasiveness that one would expect with such a diagnosis. Medication appeared to have helped with some of his behavior, but then it can also bring about improvements in concentration and ability to settle to tasks in children without such a diagnosis. Regarding his problems of soiling, if constipation has been ruled out as a cause, then it might be a behavioral expression over issue of control. A behavioral approach was suggested for toileting problems. In an assessment performed on 08/13/1997, a physician indicated that the pt was born at 40 weeks following induction. There was meconium staining of the liquor. Chicking hips were diagnosed at birth that resolved spontaneously. Bilateral ureteric reflux was also diagnosed early. Motor milestones were achieved without difficulty and the pt was walking by his first birthday. Theh 18-month check highlighted concerns about the pt''s hearing because of his speech was not making expected progress. He was starting to talk at about 2 years old. His vocabulary grew satisfactorily and sentences developed at the expected time. It was the content of his speech that was of concern and has continued to do so. The pt has no history of ENT (ear, nose, throat) problems; he recently had undergone a full audiological assessment. His inappropriate use of language such as I hungry. I''d better go to bed has been of concern. His mother suspected that he learned and recited verbatim and everything he did was parrot-fashion. He tended to find inappropriate uses for whatever he was given to play with. Formal assessment was not completed. He sat for a short while and attempted a number of tasks successfully. He then decided to get down from the table and left the room. Based on observation, his gross locomotor skills were probably age appropriate. He was a physically active, strong and energetic boy. Cognitive development appeared to be age appropriate. His personal/sociall skills were an area of concern. He dressed himself independently. He had an aversion to using the toilet and would hide when he needed to go. He could relate to other children but did not see the need for them. He paid no attention to visiting children and was very good at amusing himself. He was a messy eater. He was constantly up and down from the table during a meal and always had to dissect his sandwiches. He could use a spoon and fork independently. Hearing was within normal limits. There had been some discussion of language development earlier and of the pt''s sometimes-inappropriate use of language. He actively avoided fine motor tasks. He disliked drawing and avoided using a pencil as much as possible. In an assessment performed on 07/08/1996, a pediatrician indicated that the pt was diagnosed as having mild hydroureteronephrosis which was currently just being monitored and had no overt clinical effects. He had very mild asthma, which was well controlled. He used budesonide (PULMICORT) two puffs at night through a spacer. This was increased to two puffs in the jmorning and at night if he became wheezy. He also required albuterol (VENTOLIN) two puffs through a spacer if he became wheezy. There were no concerns about his vision but he has not had formal testing to date. He seemed to pick up very tiny details of things both near and far. He always had a problem with stool retention but was improving with a behavioral program of going to the toilet every evening. He wore diapers at night and had an occasional accident but in general his toileting during the day was problem free. Due to his disinterest, he needed help with dressing and washing.The pt was receiving help with social communication and developing his imagination. He had an exceptional memory and tended to learn language often by rote. His ability with language made him sound very mature but if asked to give an account of an event, he might provide a disjointed account. He had difficulties with conversations as he made literal interpretations and found difficulty with turn taking. His abstract understanding was also likely to be impaired, although his understanding of physical concepts such as shape, size, and color might well be ahead of his peers. He had a little concept of fear or danger and needed to be supervised. He was recently started a trial of a gluten-free diet. An immunization history indicated that the pt was vaccinated with diphtheria, pertussis, tetanus toxoid, polio and haemophilus B conjugate on 11/11/1993, 12/07/1993 and 01/11/1994. Upon internal review the pt''s Asperger''s syndrome, Attention Deficit Disorder with Hyperactivity, and Lymphoid Modular Hyperplasia in the terminal ileum were considered to be other important medical events. No further information is available. A copy of the pt''s complete medical records is available upon request.
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