Information has been received from a physician and a consumer concerning an approximately 18 months old female pt, the reporting consumer's daughter, with no past allergic reactions and no past medical history who on 1/16/02 at her 15 month old visit, was vaccinated with a first dose of MMR II (639918/0743L). Concomitant vaccination included a dose of Haemophilus B conjugate vaccine. There was no other concomitant medication. Previous vaccination on 10/17/01 included a dose of varicella virus vaccine (638906/0784L). According to the mother, in April 2002, the pt began having problems with her speech and in October 2002 the pt was diagnosed with autism. The physician reviewed the pt's chart and reported that she was born via a normal vaginal delivery without any complications. The pt's Apgar scores were 8 and 9. The pt has an older sibling that is fine and there are no genetic problems in the family with other children. The pt was developing normally. At the pt's 18 month old visit, the parents reported that she was speaking more than 3 to 7 words. At the pt's 2 year old visit, the parents expressed a concern and reported that the pt had stopped talking. The pt was referred to a developmental assessment program. In October 2002 at the age of 2 years old, the pt was therapy. At the time of the report, there was no change in the pt's condition. The physician noted that the parents are blaming the MMR II. It was noted that a product quality complaint was not involved. Upon internal review, pervasive developmental delay was considered to be an other important medical event (OMIC). Additional info has been requested.  A 15-day follow up report received 7/3/2003 adds: On 12/6/2002 the pt was evaluated by an early intervention program due to delays with receptive and expressive speech and language skills. At that time, the pt was 2 years and 2 months of age. It was reported that the pt had no significant history of ear infections (one ear infection) and her hearing was tested on 11/28/2002 (also reported as Oct 2002) and the results indicated normal hearing. There was no significant family history of speech/language difficulties. Developmental milestones for motor skills were normal. Her language skill development was fragmented. She babbled at 7-8 months, spoke her first words at 12 months; however, she not currently imitating new words and not putting 2-3 words together. The pt currently had 3-4 words and did not use them often. Her cognitivie and motor development appeared to be age appropriate. She presented with moderate to severe receptive and expressive language and speech delays. She communicated primarily through crying, yelling and hand leading. She had difficulty following simple directions consistently. She also demonstrated social play and self-help skill delays. She did not respond to simple one step directions, and it was not clear if she didi not have a strong understanding of these directions or was just not attending. She could often be non-responsive to those around her and inconsistently responded to her own name. She was unable to identify body parts, clothing items, and pictures in books. She was unable to give the therapist objects that the therapist asked for. It was reported that she generally played quietly and may not have said one word throughout an entire day. It was reported that the pt had just started to babble and mouth play again recently. It was reported that about 9 months to a year ago, the pt was consistently using 4-5 words but no longer uses them. The few words that she currently used were not consistent. She inconsistently attempted to copy some sounds made by her parents. Her cognitive skills appeared to be near or at age level. Her social skills appeared to be delayed. When the therapist attempted to initiate eye contact, the pt rarely responded, demonstrating letting eye contact from time to time. She had a difficult time allowing the therapist to interact with her, often ignoring the therapist altogether. She also had difficulty with transitions or changes in routine. It was noted that she did play with her older brother and was not adverse to being around other children and would play alongside of them, but rarely engaged or initiated interaction with them. Her gross and fine motor skills appeared to be age appropriate. Her play skills appeared to be delayed. She did not appear to gravitate towards the toys. After introducing the toys and demonstrating how to play with them, she appeared to engage in play. It was noted that she would engage in play by bringing items to her parents for play. She was beginning to demonstrate pretend play. Her self-help skills appear to be near age level. The therapist recommended that the pt could benefit from a group speech/language program to increase her receptive/expressive language skills and interactive social/play skills towards peers and adults. On 04/04/2003, at 2 years and 6 months of age, the pt had a a speech and language evaluation. It was noted that her vocabulary had not expanded, and she had not begun to combine two words together. Reportedly, she vocalized when playing with toys at home and has /b,n,m/ in her sound repertoire. She communicated with gesturing, reaching and leading. She is exposed to two languages at home and reportedly comprehends equally in both languages. It was reported that she understands the word "no" but does not follow directions. Since Dec 2002, she has been receiving speech services once a week and treatment has targeted teaching sign language to bridge her communication gap. She "often ignores other kids unless coaxed to participate". She is currently attending a social skills class twice a week. Her eye contact was determined to be minimal. During this evaluation, standardized testing to evaluate her receptive and expressive language skills was discontinued secondary to reduced attention and focus. Therefore, a play-based assessment was utilized to assess her communicative functioning level. In summary, it was noted that she exhibited a severe language disorder secondary to Prevasive Developmental Delay. It was recommended that she receive individual speech and language therapy once a week for 30 minute sessions for 6-8 months to improve communication. On 04/11/2003 the pt had an occupational therapy evaluationn due to sensory issues. The evaluation identified the problem areas as delays in sensory motor functioning, delays in self-help skills, delays in socialization skills, and delays in verbal skills. The therapist recommended that the pt receive weekly occupational therapy to augment and facilitate her development and growth. Since then, the pt had been sent to speech therapy. At the time of the report, 05/12/2003, there was no change in the pt's condition. The physician noted that the parents are blaming the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) for the pt's diagnosis of pervasive developmental delay, however the physician felt that these types of conditions have nothing to do with the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was noted that a product quality complaint was not involved. Pervasive developmental delay was considered to be disabling. Upon internal review, autism was determined to be an other important medical event. Additional info is not expected.