Report A0380290A describes the occurrence of autism in a male child of unspecified age who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. Medical history, concurrent conditions, and concurrent medications were not provided. *Concurrent medications included multiple vitamins w/iron and caffeine.* The child is one of four quadruplets *delivered by cesarean section at 31.5 wks gestation to a 33 y.o., gravide III, pare I, obertus I, mother following a pregnancy complicated by multiple gestation, preterm labor, preeclampsia, and urinary tract infection. The subject's mother was on bed rest for 4 mts and was hospitalized for 6 wks prior to delivery. She was treated w/terbutaline, magnesium, betamathasone to help induce fetal lung maturity, and "other medications". Complications of labor and delivery included toxemia, pulmonary edema, and HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Birth weight was 1348g. The subject's apgar assess were ? and ? as one and 5 minutes?, respectively. The subject experienced hypoventilation and was taken to a special care unit nursery. He experienced transient respiratory distress, apnea and bradycardia of prematurity, anemia of prematurity, jaundice (max total bilirubin concentration, 12.7 mg/dL), slow feeding, gastroesophageal reflux, bilateral hydrocele, and moniliesis in the groin. Neurological development exams were "normal throughout hospitalization." He was treated w/caffeine, multivitamins w/iron, clotrimazole (Lotrimin), and phototherapy. A cranial ultrasound was performed at 2 wks of age. This revealed no hemorrhage or hydroephalus. The subject was discharged to home 5 wks after birth. Subsequently, an inguinal hernia was noted. The subject had 2 episodes of otitis media at 9 and 10 mts of age, respectively. Developmental history revealed that "Motor milestones appear to have been met w/in normal limits." Specifically, the subject smiled in response to adult of his voice, exhibited eye and head control, handled toys w/his hands, and made sounds at 3 mts (1 mt adjusted for prematurity), sat w/out support at 8 mts (6 mts adjusted); crawled and pulled to a standing position at 9 mts (7 mts adjusted); and stood w/out support, walked, and finger fed himself by 12 mts (10 mts adjusted). The subject reportedly never pointed at objects. Around 14 mts, the subject "very loosely" said single and 2 syllables such as "da", "ba", "da-da", and "ba-ba". Around 14 mts, the subject could say the alphabet and asked for juice. His mother reported that he communicated via screaming. The subject received an injections of Engerix B on 1/13/99, 2/15/99, and 6/30/99. He also received *DTaP vax 4/28/99, 6/30/99, and 3/10/00, Haemophilus influenzae type B conjugate vax 2/15/99, 4/28/99, 6/30/99,, and 3/10/00, oral poliomyelitis virus vax 2/15/99 and 4/28/99, IPOL 3/10/00, MMRII 3/10/00, varicella virus vax 12/29/00, and rotavirus vax 2/15/95, 4/28/99, and 6/30/99. He also received palivirumab on 1/12/99, 2/15/99 and 3/15/99. In the spring of 2000, the subject "suffered neurologic damage as a result of exposure to thimerosol and mercury contained in the various vaccines which were administered, [the subject] to a reasonable degree of medical certainty has suffered injury and is autistic." Treatment and outcome* were not specified. The mother alleged that "the infants who were administered the vax earlier in life were more profoundly affected w/autism." *F/UP report on 11/5/02: The following info was received from medical records. The subject was treated by his pediatrician from 2/15/99 thru at least 1/15/01. During this time, the MD prescribed nyatasin and fluconazole for unspecified indications. Urine peptide analysis were performed on 1/2/01. Please see Lab Data section. The laboratory recommended a "gluten/casein free" diet and/or "peptidase supplementation". The Lab also suggested supplementation w/folic acid, reduced glutathione, n-acetylcysteine, lipoic acid, riboflavin, co-enryme Q10, and ascorbic acid. On 5/18/99, the subject was evaluated by a neonatologist in a developmental clinic. He was 5 mts of age (adjusted age 3.5 mts). The results of the evaluation were "Fine motor: 4.5-5 mts, Gross motor: 5 mts, Social: 4-5 mts, Feeding: 3-4 mts, Language: 3.5-4 mts." The neonatologist wrote, "[The subject] is doing well developmentally." The subject returned to this MD on 12/14/99, he was 12 mts of age (adjusted age 10 mts). The results of the evaluation were "Fine motor: 11-12 mts, Gross motor: 13 mts, Social: 12-13 mts, Feeding: 10-11 mts, Language: 8 mts." The neonatologist stated, "(The subject" is doing well developmentally in all areas except language development. This language delay is possibly due to prematurity plus his family tring to anticipate his needs along w/his brothers." On 8/22/00, the subject was again evaluated by this MD; he was 20 mts (adjusged age, 18 mts). The results of this evaluation were "Fine motor: 20 mts, Gross motor: 20 mts; Social: 18-20 mts; Feeding: 20 mts; Language: expressive: 9 mts, receptive: 10 mts." The neonatalogist stated, "According to his parents, [he] is not saying any words at this time. [His] delay could be his personality versus a minor developmental / speech problem. I recommend that he receive a full speech evaluation." The subject was evaluated by an early interventionist using the Caroline Curriculum, Second edition on 9/20/00. He was "referred by his mother because of developmental delays. [The mother] feels that [the subject] is doing well." The evaluator summarized the assessments as follows. "[The subject[ scored approx at a 12-15 mt level in cognition, with scattered some scores below 12 mts. He scored less than a 12-month level in communication. [The subject] scored approx at a 13-mt level in social adaptation w/scattered scores less than 12 mts up to 20 mts. [He] scored approx at a 13-month level in fine motor w/scattered scores in all areas. W/his gross motor, [he] scored approx at age equivalent. Speech therapy is recommended to address communication needs. Possibly day care is recommended to help [his] speech and social skills. Behavior modifications are recommended to help work on getting [him] to become more interactive. Special instruction is recommended to work on appropriate play skills." The subject was evaluated by a speech pathologist on 9/29/00 "because of some concerns about developmental delay." At that time, his mother reported that the subject "likes to sit on the couch w/his blanket, sucking on something. [He] displays a tendency to bang his head against the sofa cushions while watching TV or resting; reportedly he does this in bed as well. He reportedly likes buckles and tends to put things in his mouth." The subject's speech was "characterized by grunting and screaming w/some consonant sounds, but no words, to get his needs met or to remark / point out." Using the Preschool Language Scale, the subject's auditory comprehension was assessed at 11 mts, expressive communication at 12 mts, and total language at 12 mts. The evaluator's assessments were "1) Moderate delay in receptive language skills, 2) Moderate delay in expressive language skills." He added, "Prognosis for improved communication skills is excellent w/initiation of intervention and involvement of parents in carryover suggestions, speech therapy on a regular basis is strongly recommended to provide extra stimulation of [the subject's] communication skills. The subject was evaluated by a psychologist on 10/9/00 "to determine strengths and weaknesses related to early intervention needs." The psychologist noted that the subject "did not respond well to social interaction. [He] reportedly rocks back and forth and bangs his head a great deal. He also maintained rather poor eye contact w/this examiner. He was referred by his mother because of possible developmental delays." Assessments included Bayley Scales of Infant Development 2nd Edition and Vineland Adaptive Behavior Scales Interview Edition. Using Bayley scales of Infant Development 2nd Edition, the subject exhibited a mental developmental age of 13.5 mts, a psychomotor developmental age of 13 mts, a cognitive developmental age of 15.5 mts, a language developmental age of 11 mts, a cognitive developmental age of 15.5 mts, a language developmental age of 11 mts, a social developmental age of 10 mts, and a motor developmental age of 15 mts. Using the Vineland Adaptive Behavior Scale, communication was graded on a 7-mt level, daily living skills at an 11-mt level, socialization at a 10-mt level, and motor skills at a 12-mt level. The psychologist's Dx was "Features of Pervasive Developmental Disorder." He recommended speech therapy; an early intervention program focusing on cognitive, language, and social stimulation; and behavioral training in regard to self-injury. The subject was evaluated by a neurologist on 12/8/00 "for pervassive developmental disorder of autism." At that time, his mother reported that the subject "often rocks. He does have considerable screaming. He does not play well w/other children (although at times he will interact w/2 of his 3 siblings). He has a lot of odd habits w/rocking and sucking behavior. He does not point to objects or bring them to his prents. He makes poor eye contact. He has very little speech." The neurologist noted, "Physical exam shows a very active youngster. Coordiantion was poor for age. Sensory exam was hard to evaluate. He made poor eye contact and was resistive to being touched." The neurologist's impression was, "In summary, this youngster probably has pervasive developmental disorder." The subject was evaluatd by a 2nd psychologist on 1/4/01 at the autism resource center of a tertiary care center. At that time, it was reported that "His parents first became concerned about his development at around 17 mts because he was purposely banging his head. They were also concerned that he was not using language to communicate by 18 mts." The subject was evaluated "to determine if [his] behavior and development are due to a Pervassive Developmental Disorder." The subject was evaluated w/the Autism Diagnostic Interview - Revised, Autism Diagnostic Observation Schedule Module X, Childhood Autism Rating Scale, and Vineland Adaptive Behavior Scales. The psychologist note,d "[The subject] currently says the alphabet and counts to 10 respectively, but uses less than 5 words communicatively." The psychologist also noted that the subject "shows limited responses to social approaches from others, and he is even less likely to initiate an interaction on his own. During the evaluation it was difficult to catch his eye unless he was highly motivated to obtain an obuject. He responded to his name on the first attempt, but then did not orient towards a person calling him throughout the remainder of the session. His parents reported that [he] does not approach other children or look at them, but that if he is approached by another child he will become very excited. During the evaluation, he smiled several times during activities he enjoyed, and his parents reported that he is drawn to activities in which other people are energetic and excited. However, [he] seems to be more interested in other people's actions rather than in having a social interaction. His parents reported that if he is upset he will seek comfort from them, but that he does not offer comfort to others in distress. [He] says a few words such as "ball", "mama", and "nannas" for banana. He also babbles. [He] did not use other strategies to compensate for his limited verbalizations. Observations during the evaluation and parent report indicate he does not use pointing, gestures, or headshaking to communicate. [His] play skills are also limited. His mother reported that she believed his social play had dramatically decreased during the last few weeks. During the evaluation he allowed some hand-over-hand prompting to demonstrate how toys worked, and did some rudimentary imaginative play (e.g., fed a doll one bite of food) after several prompts and encouragement. During the evaluation, he engaged in some simple functional play such as pushing cars, and putting balls thru basketball hoops. His parents reported that at home he likes to complete puzzles, and explore the house. They reported that he actively resists structured activities, preferring to lie on the floor w/his toys (e.g., looking at the underside of toy cars). He also repetitively opened and shut doors on the cars.. [He] also demonstrated some stereotyped hand mannerisms, and he walked w/an unusual gait (i.e., feet facing out). His level of adaptive behavior was assessed as being in the "Impaired range relative to other children his age." His domain scores were as follows: Communication: 6 mts, Daily living skills: 12 mts, Socialization: 11 mts, Motor skills: 21 mts. The psychologist concluded, "According to the info gathered in this evaluation, [the subject] meets criteria for a DSM-IV Dx of Autistic Disorder." The psychologist recommended "intensive intervention", speech therapy, structured interactions w/"typical peers", toilet training, parent training, a behavioral plan for self-injury, and a hearing exam. The subject was evaluated by an occupational therapist on 1/11/01. The therapist noted that "General health had been good until last summer when he turned 18 mts. He began to develop colds and had pneumonia one time. Then he began to experience ear infections in the fall. It was during this time that [his] parents began to see changes in development and booans? concerned." Assessments included chart review, parent interview / questionnaire, clinical observations, the Peabody Developmental Fine Motor Scales (PDMS), the self-care portion of the Pediatric Evaluation Disabilities Inventory (PDEI) and the Response to Sensory Input. The occupational therapist concluded that the subject "appears to be functioning at the 16 mt level according to the fine motor portion of the PDMS. Self care skills appear to be functioning at the 16 mt level according to the fine motor portion of the PDMS. Self care skills appear to be the below average range according to the PDI. Using the Response to Sensory Input as a guide to assessing sensory processing indicated a wide range of responses. He appears to be underactive to some auditory, tactile and visual input and more sensitive to movement input." Occupational therapy was recommended. Following the reported onset of autism, the subject experienced diarrhea, yeast infection, "minor" colds, pneumonia, four episodes of otitis media, reactive airway disease, and underwent a hernia repair in March 99. These events were not reported as adverse events due to vax admin, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info received on 10/15/02 did not provide the outcomes of the reported events. Info received on 9/30/02 indicated that the autism persisted on that date. This report of autism or pervasive developmental disorder is considered GSK medically serious. (OMIC)* The most recent info. was received on 10/4/02. The autism persisted as of 9/30/02. Aht outcome of the mercury toxicity was not provided.* This report of autism is considered medically serious.  On 05 May 2003, the patient was noted to have poor mobility. On 21 July 2003, the patient was diagnosed with conductive hearing loss with chronic serious otitis media, sustachian tube dysfunction, and possible adenoidal hypertrophy. The patient underwent therapy evaluation on 17 Nov 2003 for low tons and delayed gross motor skills. Following the reported onset of autism, the subject experienced diarrhea, yeast infection, "minor" colds pneumonia, four episodes of otitis media, reactive airway disease, chronic rhinitis, dark circles under the eyes, pressure in ears, bronchitis, herpes zoster antibody status positive, and underwent a hernia repair in march 1999. These events were not reported as adverse events due to vaccine administration, but were found during the course of reveiw of the subject's medical records. Therefore, they are not listed as adverse events. The most recent information received on 26 February 2004 indicated taht the autism persisted as of 17 November 2003. This report of autism or pervasive developmental disorder is considered by the manufacturer medically serious.