Sex: M
Vaccine: HEP
Symptoms: Mental retardation severity unspecified, Mixed receptive-expressive language disorder, Musculoskeletal stiffness, Nerve injury, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of nerve injury in a male subject of unspecified age who was vaccinated with Engerix, DTaP, Polio, MMR, and Hib for prophylaxis. The subject was vaccinated with Engerix-B on 13 April 1995, 18 May 1995, and 18 January 1996. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "serious and permanent neurological injuries" which were "alleged to be caused by Thimerosal." Follow up information was received on 30 March 2007 via medical records. It was noted that the subject's father was a "head banger and had temper tantrums" as a child. Other family history was significant for Down Syndrome. On 27 October 1996, the subject was involved in a motor vehicle accident; it was noted that he was in the "rear seat with a belt, rolled over five times", but was uninjured. The subject reportedly sat at 6 months, stood at 12 months, walked at 14 months and was "bubbly and talkative" at 15 months. On 11 April 1997, the subject was seen for a two year old "well visit". At that time, the subject experienced slightly delayed speech, with progress notes indicating "five to six words, understands well". An educational evaluation on 24 April 1997 revealed "only a slight delay in expressive language", and speech/language therapy was not recommended at that time. The subject had an expressive vocabulary of 15 to 20 words, and speech sound development was assessed to be age-appropriate. As early as September 1997, the subject's parents expressed concern about a "probability of a diagnosis of autism". On 12 September 1997, recommendation was made for weekly speech and language therapy. A pediatrician's progress note dated 23 October 1997 indicated delayed speech with a question of regression at approximately 18 months of age. At that time, the subject was reportedly interacting with other children better, and exhibited occasional temper tantrums. On 06 February 1998, the subject's problem list included recent aggression and temper tantrums, separation anxiety, and decreased vocabulary ("down to four words"). The parents questioned the subject's pediatrician about a "special school for autism". A fine motor skill assessment was performed on 26 January 1999, and revealed delays in the development of fine motor skills, with delays considered most likely related to mild hypotonia and difficulty processing proprioceptive information. On an unknown date, the subject was diagnosed with pervasive developmental disorder (PDD). Pediatric audiological evaluation on 03 April 2000 showed mild hearing impairment. On 18 October 2000, the subject underwent a comprehensive developmental pediatric evaluation for revision of the current diagnosis of developmental delay. Observations included difficulties with social skills, poor eye contact, and language delays. He was non-dysmorphic, with height in the 75th percentile and weight in the 95th percentile. He was diagnosed with autistic disorder, "rule out seizure disorder, rule out cognitive impairment". A follow-up evaluation by a speech pathologist on 19 October 2000 confirmed diagnoses of autistic disorder and mixed receptive-expressive language disorder. A psychological evaluation to assess personality and intellectual ability was performed between 21 March 2000 and 28 March 2000. According to the parent's report, the subject rarely exhibited temper tantrums; the mother "believes that any such occurrences are related to ingestion of milk or wheat products". Observed behaviors included staring for at least five seconds, pinching fingers together in front of his eyes, and licking inedible objects. He continued to exhibit poor social skills, and expressive language skills were at the two and a half year old to three and a half year old level. Provisional diagnosis was mild to moderate autism, and continued speech and language therapy was recommended. The subject scored an autism quotient of 96 on the Gilliam Autism Rating Scale (GARS), placing him in the 39th percentile. A psychological evaluation was performed on 18 October 2000 and 08 November 2000. According to the history provided by his parents, the subject experienced "seizure-like convulsions" beginning at two to three years of age. He experienced approximately six episodes of these convulsions, which were approximately thirty seconds in duration and were characterized by neck stiffness, arm vibration, and utterance of "distress signals". He had not experienced any convulsive episodes since approximately 1998. Medications at the time of evaluation in October and November 2000 included Secretin, "DMG", acidophilus and vitamin therapy "to address symptoms of pervasive developmental disorder". Developmental assessment showed abilities according to the Bayley Scales of Infant Development (second edition) at the 27-month level, with significant delays in communication, play, and social interaction. Diagnostic impressions included autistic disorder, moderate mental retardation, and indicated "rule out" seizure disorder. In 2001, treatment included occupational and speech therapy for "autism spectrum disorder".  In April 2002, the subject continued to experience gross motor skills that were in the "very poor" range for his age. A diagnostic evaluation for school purposes was performed on 08 April 2005. According to the evaluating nurse's report, diagnostic testing on an unknown date had revealed elevated levels of lead, arsenic, tin, and mercury. In approximately 2003, the subject underwent chelation therapy, which was interrupted due to "high level of years".  It was also noted that the subject developed a "high fever and screaming reaction after his first MMR vaccine and has a medical contraindication to receive additional boosters". At the time of examination the subject's writing, reading, and math skill were at kindergarten level, and he was noted to have made progress with his behavior, but continued to experience difficulty paying attention. The subject was enrolled in special education instruction, speech therapy, social skills groups, occupational therapy, adapted physical education, and behavioral specialist intervention. In April 2005, chelation resumption was recommended. Medications at that time included Sporanox and Culturelle. In June 2005, a letter written by the subject's allergies noted a primary diagnosis of Autism Spectrum Disorder, and he was described as "a very big ten year old with hypotonia and limited stamina...For medical necessity [subject] will require a special stroller." The report, including events of aggression, autism/autistic spectrum disorder, pervasive developmental disorder, and convulsions, was assessed to be medically significant by manufacturer.