From initial information received on 8/18/04 regarding an adverse event occurring in the USA, it was reported: Information has been received regarding a case in litigation concerning an approximately 12 month old white male with eczema and a history of meconium aspiration in utero, delivered by Cesarean section, trouble breathing after delivery and received IV therapy for four days, Candidiasis (thrush), severe colic, gastroesophageal reflux disease and bowel problems who on 7/9/98 the patient was vaccinated on the right (site not specified) with a dose of MMR (lot # 625834/1611E). It was reported that before the patient was a month old, he was given his first vaccination (therapy unspecified). Concomitant suspect therapy included globulin, immune (RHOGAM) and Rho (D) immune globulin (BAYRHO-D). By 13 months old, the patient was given sixteen vaccinations, sometimes four at a time. Additionally, while she was pregnant with the patient, his mother received three injectable globulin products (RHOGAM) and (BAYRHO-D) containing thimerosal. It has been alleged that as a result of the mercury in the thimerosal-containing vaccinations and the MMR vaccine that the patient received as an infant, he how suffers, and in the future will continue to suffer neurological damage, including but not limited to developmental and speech delays. Further information has been received from medical records. The patient's vaccination record was reported as follows: 7/31/97 - hepatitis B virus vaccine (lot # 619345/1073D); 9/11/97 - diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot # 7G81514); 9/11/97 poliovirus vaccine inactivated (lot # M1069); 9/11/97 - HIB conjugate vaccine (ACTHIB) (lot # 7H91568); 11/7/97 - diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid (ACEL-IMUNE) (lot # 444255); 11/7/97 - poliovirus vaccine inactivated (IPOL) (lot # M1294); 11/7/97 - hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 622456/0662E); 2/9/98 - diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # 447833); 2/9/98 - poliovirus vaccine oral (lot # 771F3); 2/9/98 - hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 624774/0007H); 7/9/98 - MMR (lot # 625834/1611E); 7/9/98 - varicella virus vaccine live; 10/27/98 - diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (lot # 0934590); 10/27/98 - HIB conjugate vaccine (lot # 0975750) Note: lot number 0975750 not a valid lot number. On 7/9/98, the patient visited his pediatrician for a one year check up. It was reported that the patient was healthy and his exam was normal. It was also reported that shortly after the patient's first birthday all learning stopped. The patient's mother began to notice changes in his behavior. The patient began throwing temper tantrums, arching his back when being held, hitting and head banging. The patient progressed from banging his head on glass doors to concrete, and body slamming walls and doors. The patient's eye contact was non-existent, his expressive language consisted of approximately ten words that were unable to be understood, and his receptive language was minimal. In August of 1999, the mother had placed the patient in a day care program. It was reported that the day care personnel were unable to get the patient to participate in any of the activities, play with any of the other children, or sit down to eat lunch or a snack. On 11/30/99, the patient was seen by his pediatrician. The pediatrician's notes were as follows: Behavior problems - concentration for couple minutes only. Bumps on skin, diarrhea QOD...Teacher states that he's uncontrollable. Mother describes severe tantrums, uncontrollable behavior. Speech only a few two word sentences - still gestures primarily...Assessment: Speech delay. Behavioral problems. The patient was referred to a behavioral specialist and for a speech evaluation. On 1/18/00 the patient was evaluated by a neurodevelopmental pediatrician. According to the neurodevelopmental pediatrician: Behavior history indicated head banging frequently, overactivity. His parents stated there is destruction of other people's property. When they say no, he throws temper tantrums which are rather severe, as indicated in the initial chief complaint. He makes odd sounds and grunts. However, it is noted he is not talking. He is fearless, rebellious and oppositional. There is some tactile defensiveness. However, there is no auditory defensiveness. Eye contact is poor and there is some flapping and stemming, questionably when stimulated or under an adverse circumstance. It was reported that the patient had developed frequent ear infections between the ages of one to two, and that the father had a history of behavioral problems when he was younger. The neurodevelopmental pediatrician had diagnosed the patient with probable static encephalopathy, language delay, and developmental delay; rule out oppositional defiant problem versus normal variant in a language delayed child. Psychological, language and hearing tests were planned. On 2/16/00, the patient underwent an audiology evaluation. It was reported that the patient's hearing was normal. Further information received by the neurodevelopmental pediatrician reported that the patient was tested for hearing in February 2000, and supposedly had conductive loss between 500-2000 MHz in one ear. Speech therapy was being given to the patient at home, and the parents were counseled as far as behaviors toward the patient. The patient was placed on therapy with diphenhydramine, 25mg, four times a day, for the treatment of his oppositional defiant problem. On 2/24/00, the patient was seen for a follow up psychological evaluation. The patient underwent psychological testing, which revealed the following: Baylor Mental Scale: mental development index >50; mental developmental age - 17 months. The Developmental Profile II (which relies on parent report and observation) revealed the following: the patient is from 11 to 15 months delayed in the development of his social, cognitive, and communication skills. His physical and self-help skills are appropriate for his age... The patient's IQ equivalent was noted to be 55. The evaluation summary was as follows: ...a 2.5 year old boy whose development in social cognitive and communication skills are significantly delayed. He does not engage in reciprocal social interactions and verbal communications with others...(patient) does not maintain eye contact; he does not recognize danger and stop a potentially harmful behavior and he will initiate physical contact but may refuse contact if it is initiated by another. The patient was diagnosed with autism. In March 2000, the patient underwent speech and language evaluation. The conclusion was as follows: ...Overall communication skills were approximately at the 12 to 15 month old age range...Continued speech/language and occupation therapy...is endorsed. On 4/6/00, the mother spoke to the patient's pediatrician regarding the recent diagnosis of autism. The pediatrician's records stated: ...Mom reading a lot about autism. Very frustrated and confused about articles citing gluten allergy, other dietary (changes), immunizations (especially MMR) as possible causes of autism...Assessment: PPD (Pervasive Developmental Disorder). On 5/2/00, the patient was examined by a pediatric gastroenterologist. The patient's mother reported to the pediatric gastroenterologist that the patient was a good eater and that she had never seen blood in his stools. According to the gastroenterologist: This is a young man with pervasive developmental disorder, or autism, who has had problems with chronic diarrhea for most of his life. Mom says he rarely has a formed bowel movement and she has put him on a gluten free/milk free diet which is popular among parents of autistic children at this time...This is a child who clearly has some chronic diarrhea...I think he warrants evaluation as to any known or treatable cause of diarrhea such as celiac disease or colitis. We are going to schedule him for an appropriate clean out. On 5/23/00, the patient underwent an upper GI endoscopy with small bowel biopsies and colonoscopy due to complaints of persistent epigastric pain, bloating, gaseousness, and diarrhea, with the impression of a grossly normal-appearing esophagus, stomach and duodenum. A sample from the biopsy was sent for reverse transcriptive quantitative PCR procedure. The results of the upper endoscopy revealed lymphocytic infiltrate within the stomach. The small bowel biopsy was unremarkable without evidence of villous atrophy. The colonoscopy revealed lymphoid hyperplasia throughout the entire colon. On an unspecified date, the patient's stool was sent for Giardia and fat, both which were noted to be negative. From approximately June 2000 to January 2003, the patient was treated with Super-Nu-Thera, and calcium supplements. It was also reported that the patient was maintained on the gluten free/casein free diet, grapefruit extract and multivitamins. On 6/21/00, the results of the reverse transcriptive quantitative PCD procedure (TaqMan RT-PCR) revealed that measles virus was detected. On 6/27/00, the patient was seen by a pediatric gastroenterologist. The impression was as follows: ...(patient) most likely is having some component of eosinophilic gastroenteritis. This certainly could be residual casein or soy protein intolerance. It may be the result of a variety of different environmental exposures as well. Because of his small bowel biopsy, I think that it is very likely that he has true celiac disease. In addition, nonspecific irritable bowel syndrome related to his central nervous system disease is also a possibility. In August 2000, the patient was enrolled in preschool for children with disabilities. On 8/16/00, the patient underwent an occupational therapy evaluation. It was reported that the patient was overly sensitive to loud noises. Concerns included: decreased fine motor skills. A sensory based plan was recommended for the patient. On 2/13/01, the patient visited a second pediatric gastroenterologist regarding his loose stools. According to the pediatric gastroenterologist: He has had bowel problems all of his life. Initially he had some difficulty with constipation and stool withholding, but over the last year he has had 1 to 5 loose, foul smelling stools per day...His stool consistency has not improved on a gluten and casein free diet, or off fructose... It was reported that therapy with cyproheptadine hydrochloride, twice a day for the last year, not obviously helping. Impression: Chronic loose stools. Colonic lymphonodular hyperplasia documented at colonoscopy in 5/00...I would consider a carbohydrate malabsorption, bile acid malabsorption, toddler's diarrhea or colonic dysmotility. Giardiasis, or bacterial overgrowth. The physician also commented: Recent literature connecting bowel syndrome with autism remains highly speculative. At present, it has been reported that the patient has made great progress. The patient had participated in early childhood intervention until the age of three years, and has been started in speech and occupational therapy. The patient has gone from a vocabulary of approximately ten words, to speaking some full sentences. The patient's family history was remarkable for gallstones (maternal grandmother) and nonspecific gastritis (mother). It was also reported that on 7/31/97, chromosomal analysis was performed on the mother's amniotic fluid, which was noted to be normal. Upon internal review, mercury poisoning, conductive deafness, autism and pervasive developmental disorder were considered other important medical events (OMIC). Follow up information received on 2/10/04 contained the following adverse experiences: conductive deafness (onset 2000), cardiac murmur (onset unknown), frequent ear infections and food sensitivities treated with gluten free/casein free diet. No further information is available. All available medical records will be provided upon request. Additional information received on 31Aug04 from manufacturer. During internal review of this case the following information should be added: In March 2000, the pt was started on a gluten and case in free diet. It was reported that the change in diet made a remarkable difference in the pt within two weeks. On 31Mar00, the pt underwent speech and language evaluations. The conclusion was as follows: overall communication skills were approximately at the 12 to 15 month old age range...continued speech/language and occupation therapy...is endorsed. The adverse event coding was also updated to included frequent ear infections and food sensitivities treated with gluten-free/casein free diet. Follow up 12/06/04: From information received form the manufacturer on 11/09/04, there was no update for the patient's recovery outcome.