Age: 0.92
Sex: M
Vaccine: MMR, DTAP, HIBV, IPV, MMR
Symptoms: Psychomotor hyperactivity, Rhinitis allergic, Sinusitis, Speech disorder
Clinical narrative: Initial report received on 10/24/06 from another manufacturer, report number WAES0609USA03134. The initial reporter to this manufacturer was reported as confidential. A two year old male pt had received an injection of Tripedia, lot number 8J91156, on 9/28/88, and an injection of Prohibit, lot number 8L01022, on 6/30/1989. He had also received an injection of poliovirus vaccine inactivated, manufacturer unspecified, lot number 88178621, on 4/22/88 and an injection of MMR II, lot number unk, on 1/28/89. IN approx Oct 1989, the pt was noted to have a speech delay as he was no longer saying distinct words and could only be heard to utter jargon in a sing song manner. He was also noted to have stopped developing. in Approx April 1990, a diagnosis of autism was made. On 5/10/1992, the pt was hospitalized in a pediatric ward for reactive airway disease, developmental delays, and to rule out pervasive developmental delay. At that time, the pt was noted to have poor speech with a vocabulary of approx 15 words. He was evaluated by a developmental pediatrician who noted that the pt appeared to be showing very stereotypical behavior consistent PPD, in particular, autism. The physician noted that the pt had a severe verbal and non verbal communicative disorder with some deviant social interactions. In addition, the pt had chromosomes which were also sent for fragile X, which were neg. High resolution chromosomes that were done revealed that the pt was a 46XX normal male by chromosome appearance. The pt also had a normal EEG and Audiological evaluation. A speech evaluation concluded that the pt had a severe speech delay pattern. Discharge diagnoses included PPD, probably moderate to severe mental retardation, and reactive airway disease. On 7/1/92, the pt was seen by a developmental pediatrician who confirmed a diagnosis of PDD, but was unclear of the specific etiology of the pts developmental difficulties. On 9/15/92 a MRI of the brain was normal. On 3/19/01, a cranial CT scan was normal. The pt was also noted to have ADHD and neurobehavioral problems for which he was treated with multiple medications. As of 7/12/01, the pt was becoming more violent, screaming all the time and hitting family members especially his mother. AS of 7/25/01, the pt has very serious behavioral disturbances marked by violent behavior, hitting, destructiveness and unpredictability about his behaviors. In spite of those behaviors, he had learned some single word sight vocabulary and spelling and numbers, but continued to converse in single words at best and his verbal reasoning was rudimentary at best. The pt was currently taking Ativan, Depakote and Clonidine. Medical records were obtained that provided the following information. The pt was born by cesarean due to failure to progress. He had an unremarkable neonatal course. It was reported that the pts disability began on 10/29/1987 (which is also the pts date of birth). The pts family history included his father with a history of reactive airway disease, a brother with cerebral palsy, and a cousin with autism. At 15 years of age, the pt had a diagnosis of mild mental retardation, autism and epilepsy. The pt has seizures associated with his use of Zyprexa. He also has seasonal allergies and allergic rhinitis for which he was taking an unspecified antihistamine. It was reported that Ritalin caused hyperactivity and that Ativan caused seizures. From an evaluation of the pts level of educational performance from an unspecified date, it was reported that the pt was able to understand pictures and written words, also using both a communicate, that the pt verbalized his wants and needs when asked, through he seldom initiated that information. The pt exhibited most age appropriate gross and fine motor skills independently wand with ease. Additional information from an unspecified date indicated that the pts mother noted that the pts behavior had improved at home, he was able to set the table each night independently though his mother took care of many of his personal care needs. It was also noted that the pts behavior improved drastically in that year. A psychological evaluation date 9/10/01 noted that the pt was operating at the level of a three to four month old. Autism and moderate to severe mental retardation were determined to be an important medical event (OMIC). Medical records noted reactive airway disease (approx 10/1989 and 5/3/1992 requiring hospitalization, and ethmoideral and sphenoid sinus disease (9/20/01 revealed via cranial CT scan).