Age: 0.83
Sex: U
Vaccine: HEP, IPV, PNC
Symptoms: Alanine aminotransferase increased, Aphasia, Aspartate aminotransferase normal, Autism, Autism spectrum disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a patient who was vaccinated, as an infant, with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). As a result of the mercury contained in the thimerosal containing vaccination, the child suffers, and will continue to suffer from neurological and immunological damage with symptoms including, but not limited to developmental delay, loss of language and failure to meet certain social and motor milestones. Upon internal review, neurological and immunological damage, development delay and loss of language were considered to be other important medical events (OMIC). Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/20/2006: Information has been received regarding a case in litigation on concerning a patient who was vaccinated, as an infant, with a dose of hepatitis B virus vaccine rHBsAG (yeast) on 28-JAN-1999 (lot #628746/1667H), 06-MAR-1999 (lot#623354/1739H) and 29-OCT-1999 (lot #629872/1094J) respectively. As a result of the mercury contained in the thimerosal containing vaccinations, the child suffers, and will continue to suffer from neurological and immunological damage with symptoms including, but not limited to developmental delay, loss of language and failure to meet certain social and motor milestones. Other vaccination history included a first (lot 1001460), second (lot 7383AA), third (1387AA) and fourth (lot U004009) dose of diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) tetanus toxoid on 06-MAR-1999, 05-MAY-1999, 16-JUL-1999, and 01-MAY-2000 respectively, a first (lotN0788AA), second (lot N0877AA), third (lot N180AA), and fourth (lot N1166AB) dose of Hib conj vaccine (tet toxoid) (ACTHIB) given on 06-MAR-1999, 05-MAY-1999, 16-JUL-1999 and 01-MAY-2000 respectively, a first (lot P03001), second (lot P0358), and third (E1294) dose respectively of inactivated poliovirus vaccine on 06-MAR-1999, 05-MAY-1999 and 06-JUL-2000 respectively; a first dose of measles virus vaccine lives (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot 631474/1350J) on 13-JAN-2000 and first (lot 471207) and second (lot 471214) dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) on 01-MAY-2000 and 06-JUL-2000 respectively. Follow-up information was received from medical records which indicated that the 10-week-old male has an allergy to peanuts and nuts, amoxicillin (+) clavulanate potassium (AUGMENTIN) (resulting in hives), over-the-counter cold medication, and promethazine, dysmorphic facial features, hirsutism, a high arched palate, low axial tone, a history being born 18 day premature with an Apgar score of 6 and 9 and jaundice after birth. It was also noted that the maternal pregnancy was complicated by maternal exacerbation of asthma for which she was on inhaler medication (PROVENTIL). On 11-MAR-2000, the patient ws seen in the emergency room for a febrile seizure that lasted approximately two minutes. On 02-FEB-2001, he was seen by a physician where it was reported that he had a febrile seizure at 10:30 p.m. (on approximately 01-FEB-2001) while sleeping. The seizure lasted for four minutes. It was also noted that the patient had poor speech and autism was questioned. On 15-FEB-2001, the patient had an audiology consult due to delayed speech and development. The mother reported that her son was the product of a normal pregnancy, labor, and delivery, healthy at birth, with no significant history of ear disease or any other health problems. The audiology test results indicated that there were no consistent and reliable responses below 30 dBHL, however the possibility of a mild hearing loss could not be ruled out. On 28-FEB-2001, he was seen by a physician and noted to have poor eye contact and appeared to fixate on objects like a pen. He was referred to a neurologist to rule out autism versus neurological impairment. At the neurology consult on 05-MAR-2001, the physician noted that his hearing was felt to be normal. The assessment was childhood autism. He also appeared to be mentally retarded. It was suggested that he be enrolled in an early intervention program and be seen as a comprehensive autism program. He was seen again by an audiologist on 13-MAR-2001 nd found to have reliable and consistent responses to speech at 25 dBHL. On 14-JUN-2001, he was seen for a speech-language medical diagnosis of autism. On 08-AUG-2001, he was seen for a pediatric developmental evaluation and the impression was developmental delay, unspecified. On 15-AUG-2001, he was seen again for part two of the pediatric developmental evaluation. The diagnosis was autistic spectrum disorder/autism. On 17-SEP-2001, he was seen by a neurologist to review his Neuro developmental status within the context of childhood autism. The assessment was childhood autism, moderate to severe in degree. There were no neurologic issues that would prompt any further diagnostic studies. He was seen again by the neurologist on 26-APR-2002 and there were no new symptoms or concerns. Follow-up information was received from medical records which indicated that on 14-MAR-1999, the child was fine after immunizations. On 19-OCT-2002, he was seen at a physician's office, went home, took medications, and then had a febrile seizure. His lips were  blue and he was not breathing for a minute per the father. The child had received initial doses of azithromycin (Z-PAK) and promethazine hydrochloride (PHENERGAN) and it was unclear if he was sitting or lying down. His eyes were closed and were not fluttering. He had periorbital cyanosis times approximately four minutes. His body went limp. He was taken to the physician's office and was alert and sitting on a table with no distress. On 18-APR-2005, it was noted that he had a diagnosis of a seizure disorder. He was reported to have had five seizures in the past, in which his body shake, eyes roll, tongue clicks, and one time his breathing stopped. He had been seizure free since 2003. On 15-NOV-2005, he was seen by an endocrinologist for evaluation of his growth and vanillylmandelic acid (VMA) assay, which ws elevated. The impression revealed normal tests except for a minimal elevation of the erythrocyte sedimentation rate which was not suggestive of chronic illness. Follow-up information was received from medical records which indicated that as of 12-Jul-2006 the patient was undergoing chelation therapy for his autism and that they had found him to be more focused and aware of his surroundings. His verbal skills were improving. He had been off a gluten free, wheat free diet for approximately 3 weeks and was eating extremely well. Follow-up information was received from medical records which indicated on 04-MAR-2003 the patient underwent a cable-video EEG telemetry. This was reported as definitely abnormal four hour video EEG due to diffuse background slowing for age as well as one to two second bursts of 2.5 Hz generalized epileptiform discharges. These discharges were not associated with clinical signs. The EEG suggested diffuse cerebral dysfunction, but was not specific as to etiology. The epileptiform abnormalities seen suggested a predisposition to seizures, with a generalized mechanism of onset. However there were no correlation between these discharges and the patient's behaviors, nor were there any other epileptiform changes associated with the clinical events. Further information has been received in the form of medical records. The patient had a functional emotional assessment on 16-JAN-2005. The clinical impression was that the patient was a kindergartener who was in a self-contained classroom with opportunities for inclusion in specials. He demonstrated difficulty regulating his attention in all classroom tasks requiring prompting from his assistant. Internal self-regulatory strategies had been observed, although they were discouraged by the adults in his environment. A daily floortime session had been initiated by his teacher and was leading to some improvement in engagement, increased comfort with her interactions, and some expansion of simple sensory play beyond his stereotypic actions. It was his difficulty with maintaining self-regulation, engagement, and shared attention that impeded upon his abilities to communicate and interact with the people and objects in his environment. The patient had a functional behavior assessment on 20-MAY-2005, 23-MAY-2005, and 24-MAY-2005. The summary indicated that throughout the observation no reinforcement system, other than verbal praise was identified. Interpretation of the data and the observations suggested that the patient's problem behavior was communicative and had been reinforced over time. The patient's rare exhibition of aggression, dropping, darting, and disruption while with the instructor was evident of a lack of reinforcement for those behaviors. Due to lack of consistency, the patient had learned to escape demands and gain access to preferred items by engaging in problem behaviors. The patient had a consultation with a physician in a division of endocrinology on 17-MAY-2006 which indicated that the patient had grown 5.5 cm and gained a kilo in the last six months, which he noted meant that the patient's growth had normalized. Follow-up information received on 15-AUG-2007 contained the following adverse experiences: some decalcification (19-AUG-2002), upper respiratory tract infection (13-MAR-1999), diarrhea (31-MAR-1999), vomiting (31-MAR-1999), strep throat (31-MAR-2000), leg strain (26-MAY-2000), viral illness (02-OCT-2000), runny nose and cough (03-NOV-2000), lump on left side of neck (28-FEB-2001), eczema (02-MAR-2001), verrucous papule (26-JUL-2001), snores (onset unknown), bronchitis (onset unknown), encopresis (onset unknown), and constipation (onset unknown). Follow up information received on 22-Aug-2007 from medical records of a clinical genetics summary from 28-Nov-2001, indicated a high resolution karytype, that ws 46, XY normal, a normal fragile X studies and a normal FISH for 15q11-13 with methylation studies for Angelman syndrome also normal. There was recommendation of telomeric analysis to be completed, however no other further testing was recommended. Further information received indicates that changes after chelation therapy include: more aware of surroundings, follows directions better, willing to try diffferent foods, more acceptable with change, improved communication, and will stay with babysitters. Toxic metals were tested, all were within reference range (except nickel which was 18mg/g - range = <15). Further information received indicates that on 08-Apr-2006, there were orders for titers to be drawn for MMR, Hep B, HHV 1,2,6, ASO, CMV, KBV, herpes simplex panel 1 and 2, HHV6 antibody panel a CBC and "CMP". Results not provided. Upon internal review, childhood autism, mental retardation, and seizure disorder and febrile seizures were considered to be other important medical events.