Age: 2.08
Sex: M
Vaccine: HEP
Symptoms: Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: This report describes the occurrence of autism in a 25 month old male who was vaccinated with Engerix B for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The subject was a term male born by spontaneous vaginal delivery to a gravida IV, para II, abortus I mother. The subject's mother experienced premature labor in the seventh month of pregnancy, which was treated with bed rest. She also reported that she experienced "marked water retention." The subject's birth weight was 7 pounds, 14 ounces. Apgar scores were at 9 at both one and five minutes. A "marking/bruise" was noted on his 'head/neck." The subject experienced jaundice (maximum total bilirubin concentration, 18.2 mg/dL) treated with phototherapy. The subject's medical history included conjunctivitis, viral illness, croup, eight episodes of upper respiratory infection, five episodes of otitis media (four involving the right ear), serious otitis media, gastroenteritis with "mild" dehydration, cellulitis of a finger around ant bites, yeast diaper rash, ingestion of a glass ornament, and chronic diarrhea with intermittent vomiting beginning at 15 months of age. Following receipt of Tripedia at 6 months of age, the subject cried inconsolably for one hour. A diagnosis of "reaction to pertussis" was made and the pertussis immunization series was discontinued. The subject presented to the vaccine provider 10 days following receipt of MMR II and varicella virus vaccine with rash, fever, decreased appetite, and irritability. The physician's assessment was "MMR reaction, Teething syndrome." There were no known drug allergies. Family history was significant for chronic allergies and otitis in the subject's brother. The subject's parents "suspect that the brother may have Asperger's because of his inability to reac sodial situations and what we feel is his high intectual (sic) ability." The subject's paternal grandmother was described as "extremely intelligent, no friends, no very social/like the subject's brother." Family history was also significant for eczema in the subject's father, "thyroid problems as child" in the subject's maternal grandfather. Crohn's disease in the subject's maternal great grandfather and hearing loss caused by "ossicular chain disintegration." Concurrent medications received at various times prior to the diagnosis of autism included erythromycin ophthalmic ointment, gentamicin ophthalmic solution, unspecified steroids, amoxicillin, Cefzil, Tylenol, Advil, Motrin, Triaminic, Dimetapp, Lotrimin, and unspecified vitamins. Developmental history revealed that the subject's "parents do not remember many of his early milestones, but they do state that he walked prior to one year of age." In addition, he "began to use a few words" at approximately one year of age. Review of medical records indicated that developmental assessment at 17 days, 2, 4, 6, 12 and 18 months all noted "well child ? (question) speech delay, refer to audiology." Specific findings at each assessment were as follows. At 17 days, he raised his head while in a prone position, followed objects, turned to a voice or rattle, vocalized, and smiled.  At 2 months, he followed past midline, cooed responsively, and smiled spontaneously. At 4 months, he rolled from stomach to back, lifted his chest with his arms, demonstrated no head lag, reached for dangling objects, regarded and followed objects 90 degrees, brought his hands together, laughed, vocalized responsively, and regarded his own hand. At 6 months, he demonstrated no head lag on pull to sitting position, sat alone, bore some weight on his legs, generally kept his hands open, passed a toy from hand to hand, initiated speech sounds, said "Dada," put objects into his mouth, and grasped objects and resisted pull. At 9 months, he stood while holding on, cruised, sat alone, crawled, finger fed himself, used a thumb/finger grasp ("inferior pincher"), banged two cubes together, initiated speech sounds, said "Dada," responded to his name, and played repetitive games like pat-a-cake. At 12 months, he walked with his hand held, cruised, stood alone briefly, used a neat pincer grasp, banged two cubes together, said "Dada," drank from a cup, indicated his wants, played pat-a-cake, and responded to his parents' presence and voices. At 15 months, he walked well, stooped and recovered, walked upstairs with help, said "Mama' and "Dada," drank from a cup, and attempted to use a spoon. At 18 months, he walked upstairs without help, walked backwards, kicked a ball forward/threw a ball overhand, said three words (his sister's name, "No No," and "go"), pointed to one named body part, assisted with removal of clothing, and fed himself with a cup or spoon. At 25 months, he walked up and down stairs, ran well, stacked six or more blocks, worked puzzles, bulit a tower of four cubes, put on clothing, tried to remove clothing, and used a spoon well. At that time, he did not form three-word sentences, did not say any words, and did not point to two pictures. The subject received an injection of Engerix B on 7/3/98 (2521A9). He also recieved Recombivax-HB 1/13/99; Tripedia 9/2/98, 11/9/98, 1/13/99; diphtheria and tetanus toxoids 10/4/99; ActHIB 9/2/98, 11/9/98, 1/13/99 and 10/4/99; IPOL 9/2/98, 11/9/98; Orimune 7/20/99; MMR II 7/20/99 and Varivax 7/20/98. The subject's attorney alleged that "As a result of the mercury in the thimerosal-containing vaccinations that the subject received as infants, he now suffer and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." The attorney also alleged that "Because of his heightened vulnerability to heavy metals poisoning and his compromised condition related to the mercury poisoning discussed above, he was and is unable to process heavy metals and suffer neurological compromise as a result of the heavy metals contributed by the fossil-fuel burning utilities. His impaired condition is compounded by these exposure and his injuries made worse by them." The following info was obtained from medical records. The subject was under the care of the vaccine provider from birth until at least 4/25/02. The subject underwent hearing screening on 7/4/98; the reason for the screening was not recorded. The audiologist wrote, "This child's hearing has been screened using transient evoked otoscoustic emissions and/or screening auditory brainstem responses. Screening to date indicates essentially normal peripheral auditory function in both ears." On 8/02/00, at the age of 25 months, the subject presented for his 24 months well child visit. The physician noted that the subject did not use three-word sentences, did not point to two pictures, and said no words. "Speech 1/2 understanding" was also marked "negative." The physician's diagnosis was "? speech delay." Th subject was referred to an audiologist. The pediatrician also referred the subject to an early childhood interventionist, a speech pathologist, and a neurologist. The subject was evaluated by an early childhood interventionist using the Batelle Developmental Inventory on 11/20/00. The results of the evaluation were as follows: "Adaptive: 14 months, Cognitive: 16-18 months, Fine Motor: 21 months, Gross Motor: 23 months, Language-Expressive: 9 months, Language-Receptive: 7 months, Personal/social: 2 months." The interventionist noted that "The subject worked well with the examiner while sitting in his high chair. It appears that Gross and Fine Motor scores were affected by limited language and imitation skills. His parents are concerned that he may have Autism. This diagnosis has not yet been made, but further testing is being sought." The interventionist also noted that the subject was receiving applied behavioral analysis therapy. Noting cognitive and language delay, the interventionist recommended developmental intervention, occupational therapy, psychological services, and speech therapy. The subject was evaluated by another audiologist on 12/19/00 to "rule out hearing loss as cause of speech and language concerns." The subject's father reported a family history of "ossicular chain disintegration." The father reported that "He was a lot worse a month ago and we changed his diet. He now has better receptive vocabulary." Testing revealed "mild" hearing loss for 4000 Hz and 8000 Hz. The audiologist wrote, "He have ruled out current hearing loss for this child today as a cause of speech concerns. A mild hearing loss at 8000 Hz is not significant for speech and language development, however a mild hearing loss at 4000 Hz may affect speech sounds including 'r,' 's,' and 'th.' These may sound a little muffled. Hearing is very normal for all other speech sounds. The subject should hear most speech sounds that are important for speech and language development." The subject was evaluated by a speech pathologist on 1/30/01 "to determine what language level he was functioning at compared with other children his ago." The pathologist noted that "Mom questioned the subject falling and hitting his head as the cause of his lack of speech she stated that he began losing language between 18 and 19 months. At this time he also became less social. The mother reported that he uses mainly gestures to communicate and he has just recently begun to imitate words. When asked about his ability to understand what is said to him, she reported that "his comprehension appears to be at a higher level than his expressive abilities." He reportedly will follow simple commands with prompts." He also "Appears to be sensory defensive to sounds." The pathologist observed that the subject used gestures as his primary means of communication. Speech observed during the session was very limited and consisted of only four or five words )mama, dada, bye, ju). When asked to communicate he would withdraw from task or continue with his toy not responding at all. The subject was assessed using the Rossetti Infant-Toddler Language Scale. Under "Interaction-Attachment," the subject "achieved 100% of the skills at 9-12 months and 30% of the skills at 15-18 months, which is the ceiling for this subtest." Under "Pragmatics," the subject "achieved 100% of the skills at 6-9 months, 30% of the skills 9-12 months, and 0% at the 12-15 month level." Under "Gesture," the subject "achieved 100% of the skills at 9-12 months, 60% of the skills at 12-15 months, 40% at 18-21 months. 50% at 21-24 months, and 0% of the skills at 24-27 months, which is the ceiling for this subtest." Under "Play," the subject "achieved 100% of the skills from 15-18 months, 33% from 18-21 months, 66% from 21-24 months, 66% from 24-27 months, and 0% from 27-30 months." Under "Language Comprehension: the subject demonstrated 100% of the skills at 3-5 months, 55% of the skills at 6-9 months, 16% of the skills at 9-12 months, 50% at 15-18 months, 20% at 18-21 months, and reached a ceiling at 21-24 months with 0%." Under "Language Expression," the subject "mastered 100% of the skills at 6-9 months, 50% of the skills at 9-12 months, 23% of the skills at 12-15 months, and reached a ceiling at 15-18 months with 0%." The evaluator's assessment was "The results of this assessment indicated the following: 1. A severe receptive language delay. 2. A severe expressive language delay." She added," Prognosis is good for stated goals with appropriate and timely intervention." Recommendation included speech therapy, neuropsychological testing, occupational therapy evaluation, and a "home program to assist family in carrying-over techniques into the home." On 3/7/01, the subject was evaluated by a pediatric neurologist because of speech delay. The physician noted that the subject "has been noted to have marked speech delay in that he is essentially using no words at this time and does not follow commands. He has no history of convulsions, meningitis, or encephalitis, although occasionally he will stare off into space and it is difficult to get his attention. He was dropped and bumped his head during infancy when an infant carrier in which he was riding was dropped. He had no real change in behavior after this head bump, nor was there any loss of consciousness. The parents do not remember many of his early milestones, but do state that he walked prior to one year of age. Around one year of age, he began to use a few words, although never really said mama or dada. He was initially able to say phone, which was the first word he used, and then was able to say all gone, hot, sissy, and bye-bye, although never used these words very consistently. He has been noted to somehow have lost these words and has very minimal speech now. Occasionally he will exhibit some echolalia and some babbling, jargon type speech, but very little communicative speech has been noted. His eye contact is poor. He exhibits a fair amount of flapping of his hands. He is resistant to changes in his routine. He seems to crave being in closed spaces such as under cabinets, etc." The neurologist noted that the subject's parents "have felt that he has autism and have involved him in an applied behavioral analysis program. The family has also been treating him with a special gluten free ad casein free diet, as well as some megavitamin therapies. They feel that since beginning the therapy program and the dietary changes, he has made some improvement, although continues to have a great deal of difficulty." On physical examination, there were "no dysmorphic facial features." The skin was "Clear, without stigmata of neurocutaneous disorders." During the neurological examination, "He was very active. He would not follow commands. Several times he tried to leave the exam room. When he was unable to do so, he would crawl under the cabinet under the sink and close the door, and seemed to be content in this type of setting. He does occasionally tend to have some toe walking." The neurologist's impression was that the subject "appears to have decreased social interaction, a limited range of interest, and markedly deficient speech. This most likely represents an autistic spectrum disorder." The neurologist recommended a full evaluation by a pediatric neuropsychologist, an electroencephalogram to exclude the possibility of absence seizures, continuation of the current "intensive therapy program," occupational therapy, and speech therapy. The pediatrician ordered speech therapy on 3/9/01. On 11/15/01, the subject was evaluated by an out-of-state physician that the parents referred to as an "autism specialist," the physician's letterhead indicated that he was a family practitioner. Two months prior to the evaluation, the parents completed a history form via the internet. On the form, they indicated that the subject had "very low frequency of ear infections. We usually withheld antibiotics because most ear infections subsided within 24 hrs." The form asked the question, "Did you associate a decline in your child's functions after a vaccine?" The parents responded, "He cried 24 hrs straight after the DPT vaccine. We didn't associate it at the time but after ready (sic) several different articles, etc. we think we can attribute it to that date." The physician's handwritten notes stated, "Was developing completely normal prior to six month vaccines. After the DPT number 3 1/13/99-child was ill but not febrile at time of event and pediatrician said 'allergic reaction' to pertussis. Then post 18 month vaccine series he lost language, social and affection. Symptoms developed within about one month of this series." According to the vaccine provider's records, the 18 month vaccines were administered on 10/4/99. In another section of the form, the parents indicted that they first began to notice delayed development in July 2000. The physician noted that "symptoms developed within about one month of this series." The parents reported that the subject had sustained no injuries, did not demonstrate pica, and did not mouth toys or objects. They also reported that an electroencephalogram had been performed, and the results interpreted as "normal." As the time the form was completed, the subject was being treated with Pro-biotic Gold, Super Nu Thera, and trimethylglycine. The parents reported that the subject "did well" three weeks after beginning therapy with trimethyglycine. While the subject was in the office on 11/15/01, the physician noted "rare" eye contact and "fair" social interest in parents and staff. Activity was rated "Hyperactive: +2, Self-Stimulating: +2, flapping rate: 2." The physician observed "rare" toe walking. Although the physician indicated that the subject was 'very quite here (no utterances)," he also noted that his phonation was dyspraxic. The physician also noted "Pica-rather marked. Passive when television is on-occasional stimulations, flaps, eats anything he finds on floor. No interaction with toys. Generally happy." On physical examination, the physician noted that the subject had dark circles under his eyes and eyelid edema. He noted, "very atopic," The physician also noted "very poor postural control, DTR's (deep tendon reflexes), etc." He made diagnosis of "1. Very allergic. 2. Encephalopathy with autistic features. 3. probable Hg (mercury/thimerosal issues. 4. ? MMR issues. 5. Sensory dysfunction." Lab analyses performed on 11/15/01 demonstrated abnormal results. The physician prescribed intravenous secretin,intravenous glutathione, and eicosapentanoic acid. The subject remained under the care of this "autism specialist" via telephone consultation with his parents until at least 7/16/02. On 12/6/01, the specialist noted "Hyperactive 10 to 12 days post Secretin and Glutathione adn then Big Boost in Language. Now six to seven words and using a sentence. 'What is that?' Increased echolalia-great. Increased eye contact. Increased receptive/language." On 4/25/02, the physician wrote, "Overall he is doing some very good things post Secretin/Glutathione. Also good response to Flagyl." Additional lab analyses demonstrated abnormal results. Although blood concentration of lead and mercury were below the reference ranges, the physician noted, "positive lead, positive mercury." He made additional diagnoses of "metabolic disorder (5/2/02," "immune disorder 5/2/02," and persistent dysbiosis 7/8/02. The specialist prescribed Probiotics, Culturalle, Diflucan, Flagyl, selenium, zinc, AKA, vitamin E6 and Super Nu Thera, TMG, "occasional" flax seed oil, activated charcoal, BayGam, vancomycin, and Pepcid. On 7/16/02, the specialist noted, "Doing really well overall." He planned to "start antibiotics." Following the reported onset of autism, the subject experienced streptococcal throat infection with urticaria, multiple food and dye allergies, other unspecified allergies, groin and buttocks rash, vomiting, otitis media, pharyngitis, upper respiratory infection, three episodes of viral illness/syndrome, "persistent dysbiosis," possible gastroesophageal reflux, sensory dysfunction, and a second degree burn due to an accident. These events were not reported as adverse events due to vaccine administration, but were found during the review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info, received on 10/29/02, indicated that the autism persisted as of 7/16/02, although the subject was "doing really well overall." The outcome of the alleged mercury poisoning was not reported. The autism and mercury poisoning in this report are considered medically serious (OMIC).