Information has been received regarding a case in litigation concerning a 13 month old male child who on 11/8/94 was vaccinated with a dose of MMR II (lot 608111/0968W; batch 843960U). It is alleged that the pt developed autism immediately after receiving the vaccination. Additional info has been received regarding occurrences that followed vaccination. The child started to cry as soon as he was given the vaccination and continued for 48 hours without stopping. Within hours of vaccination, the child had a raised temperature and was given Calpol. The Calpol reduced his temperature slightly but it was necessary to bathe the child in tepid water. The child stopped screaming early on 11/10/94, and then did not utter another word. It was reported that the child had been very verbal prior to the vaccination. The child developed a rash on his chest on 11/9/94 that covered his whole body except his "caves," forearms, and face. He also developed flu like symptoms such as a runny nose and became lethargic. As soon as the rash appeared, the child developed diarrhea that lasted two to three days. The itchy rash persisted for ten to eleven days in total. The general practitioner confirmed that it was a mealses rash. The child's behavior changed as soon as the rash disappeared, within 2 weeks of the vaccination. The child became distant and rejected any close or physical contact. He stopped pointing to things that he wanted and would wait until offered something. The child's eye contact also changed immediately after the vaccination. The child only looked at his parents to get their attention or when he was about to do something. It was reported that  his eye contact was natural and spontaneous before vaccination. The child's playing skills was altered after vaccination. He started hand flapping and clapping  a lot. His pretend play and all other constructive play stopped. His spontaneous laughter stopped. The child's sleep pattern was disturbed from day 1 of the vaccination. The child lost his ability to feed himself immediately after vaccination. The child stopped responding to has name at around four weeks after vaccination or on approximately 12/8/94. The child's temperature control altered around four to eight weeks after vaccination. This was first noticed around Christmas 1994 when the child became very hot and flushed while only wearing a t-shirt. At approximately three moths post vaccination or approximately 2/95, the child stopped showing any awareness of danger. Prior to vaccination, the child was aware when something was hot and would not touch it. At approximately four months post vaccination or approximately 4/95, the child's appetite changed. His diet consisted of sandwiches, sausages, pasta and sauce. The child has contracted a chesty cough every winter since vaccination. In a report dated 7/30/96 by a physician at a health care facility, it was reported that the child may be autistic. This was confirmed at the end of 1996 after a number of assessments were performed at the facility. The child's changed appetite and chesty cough every winter were incidental findings. Upon internal review, the pt's autism was considered an important medical event. No further info is available. A 15-day follow-up report received 2/27/2003 adds: In an assessment performed on 07/30/1996, a physician indicated that an initial developmental assessment was done when the pt was 2 years and 10 months old. The pt's parents were concerned about his lack of speech. The pt said few words which were not clear and it would be only when he wanted to and to himself. As a baby, the pt did not babble much. He used to say "dada" arund the age of 9 to 10 months and it appeared that his speech had not progressed much since then. Occasionally, he used imitative sounds, although it cannot be sure that these were meaningful. He was able to get his shoes at request when his parents were getting ready to go out for a drive. His mother was quite sure that he could understand "no". He did not point to his needs, instead he would take things to his mother if he wanted it or he would lead his mother to what he wanted and used her hand to point to it. He would bang his head and scream in frustration if he was not able to make himself understood. He was happy in his own familiar environment, but in an unfamiliar setting, he showed anxiety and distress. He liked to be cuddled but he seldom kissed. He did take notice of people and he had a fascination for people's legs. He was happy to sit and watch his familiar children videos and listen to his mother read stories for up to 15 minutes. He liked to have a routine such as taking the same route with his mother to pick up his older brother from school. If his mother changed it, he was extremely upset. He enjoyed going out in the car but he liked occupying his own seat. He showed no awareness of danger and his behavior was unpredictable according to his different moods. He played with his cars lining them up and pushing them along making 'broom broom' sounds and if his cars needed winding, he brought it to his mother. He built towers with bricks, but he never attempted to make a train even though he had been shown how to do it on several occasions. He enjoyed playing on the swing and the slide. The pt liked anything that was circular in shape such as car wheels and a fascination for the washing machine. He tried to spoon feed, although in general he preferred to finger feed. He cried and moaned when he needed to go for a wee and was able to use a potty if placed on it, but not on his own. He did not indicate his bowel needs. The pt had difficulty settling in bed at night and his mother had to stay with him until he went to sleep. He woke up in the middle of the night around 11 PM and went looking for his parents either in their bedroom or downstairs. His mother's pregnancy was uneventful. He was delivered at 9 days post term and weighed 3.820kgs. The cord was around his neck and he was blue but was revived quickly with no further treatment. The pt was a happy and contented infant. He bottle-fed well and slept well. He smiled and cooed in the first month, but later he was noted to be a quiet baby and he did not babble much. He used few double syllable babbles around the age of 9 to 10 months, but it was limited and did not progress much. He sat at 5 months and walked at 9 months. There was no history of any hearing difficulties. His physical health was generally satisfactory apart from one episode of bronchopneumonia needing brief hospitalization in March 1996. His mother thought that he has also suffered from blocked sinuses. Family history included an older brother who was in good health and had satisfactory developmental progress. His mother did not talk until she was about 3 years old, but no problems since then. Theh pt's paternal grandmother had been diagnosed to have Schizophrenia. On examination, the pt was a well-built boy with good looks. He was unhappy and remained distressed for most of the session by screaming and crying, and throwing himself onto the floor. It was impossible to console him or get him distracted. He was not interested in any of the toys that were presented to him and although he was known to play with cars at home, he did not do so in the clinic. His activities were self directed and not organized in that he was physically restless moving around, pulling things, and climbing onto furniture in a reckless manner, showing no fear of danger. He hid himself under the table and behind a screen, which he brought down on to the floor on two occasions and showed no remorse for what he had done. He occasionally flapped his hands or flicked his fingers and he also covered his ears with his hands at times. The pt preferred to play with a circular bin lid rather than the selection of toys. He amused himself for several minutes with two strips of paper, which he waved around, holding one in each hand. He vocalized very little apart from his screaming and there was no meaningful imaginative play. He was not able to socially relate to the physician in any manner but he approached his mother for comfort when he was distressed or tired. In conclusion, the pt presented as a child with significant delay in speech and language development and impairment of social communication skills. The many features in the pattern of his development and social behavior would indicate Autistic Spectrum Disorder as a likely cause for his difficulties, however, it was felt that it was too early to arrive at the diagnosis at this stage. The pt was not ready for a formal Developmental Assessment at this time but better to perform this in six months time. In order to establish the diagnosis and to access appropriated programs of learning therapy, the pt would need a period of observation/assessment and monitoring by staff trained in dealing with children with speech and social communication difficulties. In an assessment performed on 10/31/1996, a physician indicated that the pt used body gesture when he wanted to go to the toilet. His mother noticed the pt had started to play imaginatively only now and this had all come on in the last 3 months. There was no history of pretend play. He managed to feed himself but preferred using his fingers rather than a fork. He ate well on the whole but he did not sleep well. He was almost dry during the daytime and was not clumsy. His mother and grandmother felft that his eye contact was much better than before. His mother felt that he suffered approximately one year of deafness between the age of one and two due to his sinuses, and that after receiving one month of antibiotics for treatment of his pneumonia at around the age of 2.5 years, everything was better. He could then be taken shopping tolerating new places and he was less sensitive to noises like aeroplanes. His hearing had been tested on 10/06/1996 using BSER (brain stem evoked responses) and was found to be normal after a hearing assessment was done on 07/31/1996 and the results were not very conclusive. The cord was around his neck twice during delivery. His development had been normal. He walked around the age of 9 months and his first clear word was around the age of one year. He could say a few words by then, but he lost them. He could not recognize his name before that age of 2.5 years and he did not respond to anything in the family. In addition to his mother not speaking until the age of 3, his father was also slow, not speaking until the age of 5 years. Regarding hte long-term prognosis, it was stated that his progress over the next two years would be important and that he was a boy who needed some degree of special educational needs when he starts school. It was felt that he could well fit into the autistic spectrum but not to label him yet until absolutely sure after observations. It was suggested that the pt's mother, who was 11 weeks pregnant at the visit, seek genetic counseling since she already has a child with developmental problems. In an assessment performed on 02/07/1997, a physician reported that the pt was observed in the nursery unit and it was confirmed that the pt had profound reciprocal social communication and interaction difficulties. His activities were self-absorbed and his play repetitive and lacked creativity. The pt could be engaged in some activities such as blowing bubbles or water play although he showed very little reciprocity. It was felt that the pt's developmental difficulties would fit into the Autistic Spectrum Disorder and therefore he would have special educational needs. Other immunizations indicated that the pt was vaccinated with a first, second and third dose of diptheria, pertussis, tetanus, polio, and haemophilus B conjugate (manufacturer Merieux) on 12/14/1993, 01/11/1994, and 02/08/1994, respectively. The child's changed appetite, chesty cough every winter, bronchopneumonia, altered temperature control, and blocked sinuses were incidental findings. Upon internal review, the pt's autism was considered an important medical event. No further information is available. A copy of the pt's complete medical records is available upon request.