Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, VARCEL, HEP, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Myringotomy, Sinusitis, Speech disorder, Stool analysis
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  This case was received from another manufacturer (reference number WAES0704USA00259) on 10 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received regarding a case in litigation from medical records concerning a 20 month old male who on 21-Jan-2000, was vaccinated with a third dose of Recombivax HB (634148/1736J). Concomitant therapy included MMR II (632344/10815J). Patient's vaccination history included: a first, second and third dose of ACEL-IMUNE) given on 25-JUN-1999, 13-AUG-1999, 29-OCT-1999, respectively, and a fourth dose of DAETACEL on 11-OCT-2000, a first, second, and third dose of IPOL, given on 25-JUN-1999, 13-AUG-1999, and 29-OCT-1999, respectively, first, second, third, and fourth dose of Hib conj vaccine on 25-JUN-1999, 13-AUG-1999, 29-OCT-1999, and 29-OCT-1999, respectively, a first dose of hepatitis B virus vaccine (manufacturer unknown) given while in the hospital at birth, April 1999, and a second dose of ENGERIX B on 25-JUL-1999. The patient was seen on 13-FEB-2001 at 22 months of age on 13-FEB-2001 for an evaluation. The patient was accompanied by his mother who reported that she "recognizes that he has autism". The patient's mother reported that the patient was previously seen by a neurologist who according to the patient's mother, said that the patient "appears to have PDD". The patient's mother reported that she noticed changes in the patient behavior when he was 15 months old. He was not answering and not following commands. He wanted to be alone. The mother reported that by 20 months, he "looked like he was on drugs". He did not vocalize for about a week. It was reported that the patient was evaluated by a physician who stated that he had autism. He performed a number of tests, including stool samples to evaluate for allergies and yeast infestation, and urine sample to evaluate for mercury. The Patient's mother put the patient on a gluten and casein-free diet and believed that he had become more responsive since eating it. She was planning to take him off soy. The evaluation stated that in review of the  patient's medical history, he was born at 41 weeks gestation to a Gravida VII mother with a history of two prior miscarriages after a pregnancy notable for what the patient's mother described as her being nervous and depressed. She disclaimed the use of alcohol, cigarettes, or drugs during the pregnancy. She stated that she did not take prenatal vitamins often. The patient's vaginal delivery required forceps assistance. His mother reported that his left arm did not move for the first five minutes of life, but seemed fine thereafter his birth weight was 8 pounds, 12 ounces and neonatal course was unremarkable. The patient was generally health with no significant major illnesses or hospitalizations. He had a history of gastroesoophageal reflux which appeared to have resolved. He had numerous ear infections early on and myringotomy tubes placed at 9 months. After they first fell out at 12 months, he again has an episode of otitis. He had tubes replaced at 19 months. The summary of the evaluation stated that the patient was a 22-month-old with language and behavioral features consistent with a diagnosis of pervasive developmental disorder/autism spectrum disorder. It was reported that the patient began chelarion on 19-MAY-2001. On 22-APR-2002, the patient underwent a placement of a left subclavian infusaport. On 10-APR-2003, the patient underwent a bilateral tube removal and bilateral gelfilrn myringoplasty. On 27-OCT-2003, the patient underwent an uneventful removal of his infusaport. Upon internal review, autism was determined to be an other important medical event. Information received on 28-MAR-2007 revealed the following adverse events: scratched cornea (2000) sinusitis (23-MAR-2000), viral infection (27-APR-2000), reflux issues (26-DEC-2000), and ear infection (02-JUL-2001), duodenitis (22-MAR-2001). No further information is available. All available medical record will be provided upon request."