Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: This report describes the occurrence of autism in a 6 month old male who was vaccinated with recombinant hepatitis B for prophylaxis. This report was received as part of litigation proceedings with forwarding of medical records. The subject's past medical history included allergy to erythromycin and sulfa. Family history was negative for hearing impairment (however, other medical records reported that the subject's mother had bilateral high-frequency hearing loss, sister, maternal grandfather, great-grandfather and uncle all positive for hearing loss with some that utilized hearing aids), seizures (however, other medical records indicated that an uncle was positive for febrile seizures), autism and pervasive developmental disorder; positive for anemia, hypertension, cholesterol problems, arthritis, tuberculosis, diabetes, unspecified kidney and stomach problems, unspecified cancer, and unspecified psychiatric problems; mother positive for Hashimoto thyroiditis, irritable bowel syndrome and chromium and toxicity, sister positive for hip dysplasia (otherwise developmental normal), reactive airway disease, chronic otitis media resulting in hearing problems and speech delay, father possibly positive for rheumatoid arthritis, paternal grandmother deceased due to rheumatoid arthritis, maternal uncle positive for Hodgkin's disease, and paternal uncle positive for retinopathy of prematurity and blindness. Developmental history revealed that the subject was eight pounds, 20 inches long at birth (normal spontaneous vaginal delivery with artificial rupture of membranes on 11/18/97 at 00:30) with a fronto-occipital circumference of 14-1/4 inches. During her pregnancy, the mother was on levothyroxine, unspecified antibiotics for sinus infection, Prilosec and Tagamet (which were discontinued upon learning she was pregnant), and she experienced  palpitations reportedly due to stress of death of family member. During delivery, the mother received an epidural, Pitocin and had electronic fetal monitoring. At the time of this delivery, she was gravida 4, para 1, hepatitis B surface antigen negative and blood type O positive. The initial examination of the newborn was noted to be normal with one minute Apgar 8 and five minute at 9. Both subject and his mother were discharged from the hospital the next day. The next day 11/20/97 he was presented to his pediatrician with mild facial jaundice (negative for sclerae) (total bilirubin 10.9, direct bilirubin 0.1) and a erythema toxicum rash over his trunk, extremities and face. At one month of age 12/18/97, his pediatrician noted that he had normal growth and development. Neurologic examination was intact and nonfocal. He performed at the 0-1 month tasks by the DDST. The subject's mother reported that he had been become fussy (one week in duration) where he'd cry for a half hour period (8pm to 8:30pm). In addition, the mother reported that he had been given formula as she had bilateral mastitis and was unable to breastfeed. At two months of age 1/22/98, his pediatrician noted that he perform all the two month tasks and had normal growth and development. His mother reported that he was back on breast milk only and also had a five week history of congestion which reportedly only occurred between the hours of 4 and 6am. The pediatrician noted that the subject had possibly had an upper respiratory infection. He was vaccinated with hepatitis B, acellular DTP, inactivated polio and HIB. It was reported that following vaccination he developed a nystagmus (improved a lot with the addition of eye glasses) (however, other medical reports indicated nystagmus onset at one month of age which is prior to immunization) and motor delays (could not roll over or push off a table). At four months of age, 3/23/98, the pediatrician noted that he performed most of the four to six month task by DDST and was developmentally up-to-date. He was vaccinated with hep B, acellular DTP, inactivated polio and HIB. The mother reported three to four week history of intermittent cold-like symptoms with ocncurrent family illness. The pediatrician noted that he had back-to-back viral illness. Concurrent medications at time of this visit included Polytrim, ophtahlmic solution. An x-ray of his hips performed on 3/26/98 was normal. At six months of age a MRI was reportedly normal, but hypotonia was noted. Over the course of his first year of life, the subject experienced multiple ear infections. He rolled over between the ages of nine to ten months, sat at ten months, said three words (mama, hug an dog) at 11 months (but never had any significant speech), pulled to stand at 26 months, and walked at 33 months. At 13 moths of age he received MMR and varicella vaccinations while concurrently experiencing improvement in an ear infection. Two to three days later on 12/10/98 he developed a fever and had four generalized Grand Mal seizures. He was seen in the ER and subsequently admitted to the hospital and experienced at least five to ten additional seizures. A sedated EEG was normal and he was placed on phenobarbital; however, he continued to have seizures for several weeks. At 14 months of age he lost his speech and developed hand flapping, spinning and head banging. He was given speech therapy. After the seizures stopped, the phenobarbital was reportedly tapered over the course of one month and the seizures recurred. He was restarted on phenobarbital. Following these initial seizures he developed recurrent rashes of unknown etiology, food sensitivities, severe chronic diarrhea, and reactive airway disease. A metabolic work up, a sleep deprived EEG and hearing tests were all normal. He was subsequently diagnosed with autism and received a number of unspecified alternative therapies. The subject received hep B recombinant on 1/22/98 (lot 2424A2), 3/23/98 (lot 2427A2), and 8/21/98 (lot 2717A2). He also received inactivated polio (on 1/22/98, 3/23/98 and 3/25/99), DTaP (on 1/22/98, 3/23/98, 5/18/98 and 3/25/99), haemophilus influenza type B (on 1/22/98, 3/23/98, 5/18/98 and unspecified date), MMR (on 12/2/98), and varicella (on 12/2/98).  In a Second Amended Complaint, the subject's attorney alleged that the subject suffers from "the toxic neurological effects of mercury poisoning." The following information was obtained from medical records. The subject presented to the vaccine provider on 5/14/98 with congestion, crankiness and pulling at the ears. At this time, the subject was six months old and his mother expressed concern over what she perceived as a lack of development since his last visit at the age of four months. She stated that he had not really improved at all or learned any other tasks. He was able to roll over from back to front, pull into a sit, coos a lot, but did not grasp or reach for things and did not smile at a mirror. The pediatrician noted that she had not seen the nystagmus on her prior examinations of the subject at ages 2 months and again at 4 months, even though the mother reported it had started at around 2 months of age. However, on physical examination on 5/14/98, the pediatrician noted that the subject did have a slow nystagmus to the left. She also noted that the subject was happy, smiling, alert, interactive, sucked on both hands, pulled to a sit (but was unable to sit by himself), used extremities equally, had good tone and strength, no evidence of clonus, deep tendon reflexes were 1+ in all extremities and he had a small amount of crusting yellow nasal discharge. The pediatrician's impression was "1. A 6 month old with URI 2. Developmental delay in addition to nystagmus." The pediatrician referred the subject to a pediatric ophthalmologist. The subject remained under the care of this pediatrician until at least 9/1/00. During this time, the subject's parents reported that the subject experienced improvement since he began wearing eye glasses (grasped objects, reaches for things, smiled at mirror), chronic right eye drainage possibly due to a blocked tear duct (treated with Polytrim with no improvement), vomiting, diarrhea, rash over body, hoarse voice, wheezing, multiple insect bites treated with Neosporin topical ointment and Benadryl, lived in old house built in 1962 and concerned about lead exposure. The pediatrician noted that the neurologist felt that the nystagmus was due to a "brain problem" as  it was very intermittent. In addition, the pediatrician noted head circumference went from 80th percentile to 40th percentile, initial developmental improvement, but the subject went from a mild degree of developmental delay to gross motor delay, diarrhea with associated weight loss of several months duration, elevation of methyl glutaric acid and suberic acid possibly due to fatty acid disorder, placement of politzerization eustachian tubes October 1999. Additional diagnoses included seizure disorder, astigmatism with hyperopia, amblyopia, multiple ear infections, nystagmus was determined to be congenital, exanthem secondary to MMR vaccine, sinusitis with reactive airway disease, asthma, atypical cerebral palsy, autism. During this time period, the pediatrician prescribed Amoxil, Augmentin, Motrin, Rocephin IM, Zithromax, Tylenol, phenobarbital, albuterol, Intal, Sudafed, Ciloxan drops in ears, vitamin E6, Omnicef, Cefzil, carbamazekpine. The results of a MRI of the brain on 6/3/98, 2/16/00 were interpreted as normal. Lab analyses performed on 5/14/98, 9/16/98, 12/10/98, 6/8/99, 9/16/99 demonstrated abnormal results. The pediatrician referred the subject to a pediatric neurologist, audiologist, occupational and physical therapists. The subject was evaluated by a neurologist on 5/20/98 for developmental delay. At that time the subject's parents (both were optometrists) reported that he had nystagmus (onset at one month of age) which was sometimes a jerk-type and other times was pendular. The parents reported that they themselves determined (via cycloplegic refraction) that the subject was extremely farsighted and had just begun to wear eye glasses in the week prior to this visit. The parents reported that with the addition of the glasses, the subject seemed to be more in tune with his environment and clearly appeared to have better visual tracking. They also reported that the subject was able to roll from supine to prone, but not prone to supine, they'd observed that he'd startled to loud sounds, squeal and giggle when tickled, swallow cereals, hold on object in his hand, reach, grasp and began to transfer. The parents reported that the subject had failed a behavioral audiometic examination. In addition, the parents reported a history of conjunctivitis and nasal congestion and that the subject's immunizations were current (at time of this visit). Concurrent medications at time of this visit included unspecified topical ocular antibiotic. A review of systems was negative for seizures or convulsion. A general physical examination was relatively normal. On neurological examination, the neurologist noted that the subject tracked for 45 minutes 75% of the time with his glasses on, but had poor visual tracking of neurologist's face or an object without the glasses. He was absent accustic blink response, and had a slow, roving pendular nystagmus; however, the neurologist could not confirm jerk nystagmoid movements. Motor examination revealed that when prop sat with hand support, he was unsteady and would lean to one side or the other. When prone, he could not push his chest off well and when supine, he could not to neck-righting response. Deep tendon reflexes were 3/4 and symmetrical at the knees. The neurologist noted his impression as "It is my impression that subject has nystagmus and gross motor delay. The nystagmus may ultimately prove to be a purely sensory nystagmus due to a severe degree of farsightedness, but this clearly requires further evaluation which is planned with physician." The neurologist referred the subject to a state run center for the developmentally disabled. The subject remained under the care of this neurologist until at least 5/3/00. During this time, the subject's parents reported that a brain stem auditory evoked response showed a normal intensity series, but with some delays in conduction beyond wave 1. They reported that he had his first seizure shortly after a MMR immunization. In addition, they reported that the subject experienced multiple colds, multiple seizures, had been placed on vitamin therapy which included DMG and on a gluten and casein-free diet. Since the changes to dietary intake, the parents reported improved attention and eye contact, increased babbling and improved cooperation. The mother reported that she had lived in an area of a toxic chemical spill and that the Centers for Disease Control was investigating those exposed as well as their offspring. As a result, she informed the neurologist that she planned to have the subject evaluated. The neurologist noted that the subject had been seen by an opthalmologist who noted severre hyperopia. He had also been evaluated by a psychologist who judged him to have scores of mild to moderate autistic range on the Childhood Autism Rating Scale. The neurologist noted that seizures were possibly related to MMR vaccination. The neurologist indicated that four months after his initial evaluation, the subject had made substantial gains in his developmental skills. As of 5/3/00, the neurologist noted that the etiology of the subject's disorder was still unknown. The subject was evaluated by an audiologist on 6/9/98 for a brainstem evoked response audiometry test to rule out a hearing loss. The audiologist's impression was "Normal peripheral auditory sensitivity for frequency region 1500-4000Hz, with abnormal neural conduction within the auditory brainstem pathways." The subject remained under the care of this audiologist until at least 12/1/99. The subject's mother reported that the subject experienced middle ear fluid. It was noted by the audiologist that the subject was experiencing developmental delay, neurologic impairment and significant speech delay. The results of auditory tests were abnormal. The audiologist referred the subject to an ear, nose and throat specialist. The subject was evaluated at a state run center for the developmentally disabled on 9/14/98 for his motor delays. At that time the subject's parents reported he responded to his name, at six months had rolled over and was sitting and a brain stem auditory evoked response exam was normal. The evaluation was performed at the subject's home. The evaluator noted that the subject was receiving physical therapy and that he rolled over, crawled, sat without support, made eye contact with the evaluator, appeared to be very happy, friendly and cooperative, attentive to his surroundings, imitated speech sounds, formed single syllables (no combining of syllables). He also noted that immunizations were current at time of evaluation. The evaluator noted that the agency would gather the subject's medical records from his healthcare providers and then if appropriate, would refer the subject for either medical or physical therapy evaluation. The subject remained under the care of this agency until at least 2/21/02. During this time period, the subject's mother reported that she was pregnant with an estimated delivery date of July 2002. During this time period, the agency noted that the subject required supervision at all time as he was often resistive, hostile when frustrated, ran away, required restraint when throwing tantrums, attention span between one and five minutes, not toilet trained and utilized brace/splint/cast and orthopedic shoes with walking varying from unsteady to good. He received therapy utilizing the Picture Exchange Communication System. Additional diagnoses noted by the agency included moderate to severe mental retardation, moderate ataxic cerebral palsy, moderate autism, epilepsy (seven to eleven seizures per year) under control with only fever break through seizures. Overall progress was noted to be slow despite excellent programming. It was noted that he would lose skills after having a seizure. As of 2/21, the medication regimen included nystatin, carnitore and multiple supplements. The subject presented to the ER on 12/10/98 after onset of a fever followed by an episode of seizure-like activity of approximately 35 minutes or seconds (physician noted conflicting units of time) duration, vomiting, sore throat, vision problems and was cranky. The subject's parents reported that the subject had received unspecified immunizations in the prior week, had developmental delay, symptoms of an upper respiratory infection for the prior two days, diarrhea for one week, had been drinking fluids, Pedialyte and was taking acetaminophen for at least two to three weeks. In addition, the parents denied any prior history of seizures. Review of systems was noted to be normal, except for temperature of 38.9 degrees Celsius. A chest x-ray was normal. The physician's impression was noted as "1. Otitis media 2. Febrile seizure." Lab analyses demonstrated abnormal results. He was treated with Rocephine IM and acetaminophen. The physician prescribed amoxicillin. The subject presented to the ER on 12/11/98 for IV treatment following two seizures without fever.  At time of arrival to the ER, the subject was crying, but did not produce tears. Neurologic examination revealed deep tendon reflexes of 2+/4+ bilaterally, no focal motor deficits were present and the subject was noted to be active, moved all extremities well and behaved appropriately with the parent and the physician. He was treated with Rigner's lactate IV. A dextrostix was 68 and the physician noted that this did not appear to be the cause of the seizures. The subject was subsequently transported to another hospital for a complete work-up of his seizures disorder in a developmentally disabled child. The subject was admitted to the hospital on 12/11/98 at 13 months of age for evaluation of his seizure disorder. On admission it was noted that all immunizations were up to date an that the subject was overall two to five months delayed in all motor and language functions. Concurrent medications included amoxicillin and acetaminophen. Physical examination revealed left tyspanic membrane red and bulging, mild hypotonia, deep tendon reflexes were 1/4 in lower extremities and could not be elicited in the upper extremities. He was treated with phenobarbital and a neurology consultation was requested. The attending neurologist noted that his physical examination of the subject was unremarkable. His impression was "It is my impression that this youngster does have developmental delay, but he has made rather good progress over the past several months." The subject was discharged on 12/12/98 with diagnoses of new onset seizure disorder, developmental delay, diarrhea, acute otitis media and congenital nystagmus. The subject was evaluated by a pulmonologist on 4/26/99 for wheezing not associated with coughing. It was noted that the wheezing has nearly stopped by the time pulmonary consultation was achieved. The physician noted that the wheezing appear to be triggered by activity. The subject had associated eczema and urticaria and he did snore. The physician also noted that the subject off all asthma medications and was being tapered off phenobarbital. The physician's impression was "It was my impression that this wheezing has resolved. I am not clear of the exact etiology, but it was probably prolonged postinfectious wheezing." The subject presented to the ER on 6/8/99 after having a generalized seizure of approximately seven to ten minutes duration. The subject's father reported that a prior work-up for seizure disorder was normal (MRIs, CT scans, EEG's all negative). In addition, he reported that the subject had been on phenobarbital, which was then discontinued with recurrence of seizures, so phenobarbital was restarted. At the time of this visit, medications included a low level of phenobaribital. The physician's impression was "Seizure disorder with an acute seizure." In addition, the physician noted "I believe the pt had a seizure because of a subtherapeutic phenobarbital level." He was treated with oxygen mask, normal saline IV and phenobarbital. The subject presented to the ER on 7/7/99 after having four seizures and temperature of 101 degrees. At this time he was 19 months of age and concurrent medications included phenobarbital and Tylenol. A phenobarbital level was drawn and determined to be low. The subject was given fluids. The physician's impression was "1. Seizure disorder 2. Pharyngitis." The physician prescribed amoxicillin and adjusted the doses of phenobarbital. The subject was not admitted to the hospital. the subject presented to a new pediatric physician on 10/30/00 for continued care of autism. At that time the subject's mother reported that in March (year unspecified), the subject accidentally "got gluten" by licking a power bar wrapper and then had a seizure. Since then he had two additional seizures. In addition the mother reported that the subject had a very bad allergic reaction to spider bites (date unspecified). The physician noted that the subject received hep B vaccination at 1 day old (however, this was not confirmed by birth/newborn medical records), experienced onset of developmental delay at three months of age, hospitalized for seizure three days after vaccination with MMR at 13 months of age, and had tubes in his ears (at eight months of age). The subject remained under the care of this pediatric physician until at least 4/23/02. Additional signs/symptoms were reported during this time: biting the inside of the cheek, frequent ear infections (staphylococcus), nasal and chest congestion, runny nose, spiking fevers, tugging at ears, otorrhea, sinusitis, lack of effect of phenobarbital (multiple seizures), and erythematosis lesions over body consistent with insect bites. During this time period, the pediatrician noted that the subject's attention at school improved, appetite had improved. In addition, the pediatrician supplied copies of her medical records to VAERS as per their request (#178527). Multiple lab analyses demonstrated abnormal results. The pediatrician prescribed Augmentin, chelation therapy, Flonase, calamine lotion, Cipro, Depakote, Ciloxan drops to the ear, and Cortisporin (unspecified if ointment or suspension). She referred the subject to an immunologist and neurologist. A pediatric neurologist evaluated the subject on 2/13/01 for a second opinion on his seizure disorder. The subject's mother reported that the subject had not made any real progress between the ages of 14 months to 30 months. In fact, the subject reportedly regressed as he had began not to recognize his parents or sibling, became withdrawn and developed head banging. The subject's mother also reported that in February 2000 (approximately one year prior to this visit to the pediatric neurologist), the subject's diet was changed and they noted that he was paying more attention and had more eye contact. In October 2000, the subject began discrete trial training and he only seems to respond to verbal and nonverbal commands while in discrete trial training. The subject's mother also reported that the subject climbs into a highchair and screams when he's angry (still takes a bottle and sometimes used a fork), gets into his crib when tired, helped a little with undressing, liked music, had a lot of repetitive behaviors (spinning wheels), did not play with other children, and did not have pretend play. The pediatric neurologist's impression was "This child has a major generalized seizure disorder which is uncontrolled at the present time on phenobarbital. He has findings consistent with autism, but also has very severe motor delay and nystagmus which suggest the possibility of a metabolic disorder. Because of his seizures and the regression at the same time I am also concerned about the possibility of epileptic aphasia. Finally because of his family history of his family history there may also be thyroid dysfunction." The results of a video EEG were abnormal. The subject remained under the care of this pediatric neurologist until at least 3/8/02. The subject's parents reported that the subject was more aware of his surroundings and other people (showed interest in activities of other children), appeared happier, made more gains at school, knew his colors, and shapes, manipulate puzzles, communication via the PEXs system, attempted to speak (but no actual words), appeared to follow basic verbal commands, improved use of a fork, able to suck through a straw, working on potty training, did not run or jump, experienced seizures resulting in an increase in dosage of divalproex sodium and seizures when divalproex sodium was missed. The neurologist  noted that the subject was on chelation therapy for 'presumed mercury toxicity," Depakote, carnitine, phenobarbital, and multiple vitamin and mineral supplements. In addition, she noted that the subject was on a "special diet' that included calcium, zinc, DMG, cod liver oil and Super Nuthera. During this time period the neurologist noted the subject was nonverbal, did not respond to her verbal or nonverbal commands, at times lacked interest in toys, and was unable to copy a circle or parallel lines but did scribble circular movements. A general physical examination was negative. Neurological examination revealed a strabismus, 2+ deep tendon reflex bilaterally, mildly diminished muscle tone in all four extremities and poor hand coordination. The neurologist prescribed an increase in divalproex sodium and noted that phenobarbital was being tapered. The subject was evaluated by an otolaryngologist on 3/26/01 for recurrent drainage (including one episode of bloody otorrhea) from tympanostomy tubes. These tubes were placed in November 1999 for recurrent otitis. On physical examination, from physician noted that the left ear showed no indwelling tympanostomy tube with no granulation. However, above the tube in the right ear was granulation tissue. It was also noted that the subject's nose had a thick mucoid discharge bilaterally. The physician prescribed TobraDex topical drops. The subject remained under the care of this otolaryngologist until at least 6/6/01. During this time period, the physician noted that the right ear granulation tissue reposnded to dexamethasone+tobramycin. However, microscopic examination revealed some residual tissue in the superior aspect of the tube, which he treated with an unspecified topical antibiotic powder. Approximately six weeks after this treatment, the physician noted that the right ear granulation had almost fully resolved and that there was minimal crusting by the superior aspect of the tube. As of 6/6/01, the physician noted that both tubes were in place and functioning. From unspecified date to at least 4/8/02, the subject was under the care of a medical practice specializing in autism. During this time period, the subject received behavioral interventions, attended a preschool for developmentally delayed students (where he received ABA therapy, speech and language therapy as well as occupation therapy), he gained and subsequently lost several skills including the ability to match objects and pictures. A therapist noted that the following behavior and frequency rates (where opportunity is defined as not closely observed and/or redirected): non-response to parent directions (30 times per day or 25-80% or opportunity), safety issues/escaping and interest in dangerous objects (5-6 times per day or 100% of opportunity), delays in functional self-help skills (100% of opportunity), self stimulatory behaviors (15-20 times per day or 100% of opportunity and climbing on furniture (10 times per day or 100% of opportunity). Following the administration of Engerix B, the subject experienced unspecified viral illness, chronic otitis media, food sensitivities, recurrent rashes, chronic diarrhea, weight loss, asthma, wheezing, upper repsiratory infections, hearing loss, reaction to spider bites, ear tube placement, chronic right eye drainage, vomiting, hoarse voice, astigmatism with hyperopia, amblyopia, atypical cerebral palsy, conjunctivitis. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events.