Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Nerve injury, Neurodevelopmental disorder, Neurological symptom, Psychomotor hyperactivity, Reaction to preservatives
Clinical narrative: This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix B, DTPa-Hib, Polio vaccine, MMR II for prophylaxis. The subject was vaccinated with Engerix B on 23 September 1992, 02 November 1992, and 30 March 1993. On 30 March 1993 the subject received third dose of Engerix B. 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." Additionally, the subject experienced a neurodevelopmental disorder. Approximately two years after the third vaccination with Engerix B, in December 1995, the subject was diagnosed with autism and attention deficit hyperactivity disorder. In December 1996, a diagnosis of autism was again made. In April 1998, the subject was diagnosed with mental retardation and mixed receptive-expressive language disorder. This case was assessed as medically serious by manufacturer. The following information was received on 30 March 2007 via medical records. In November 1994, the subject's pediatrician noted he exhibited a limited vocabulary for his age and had not started putting words together. According to pediatrician's notes dated 27 September 1995, the subject had been recently diagnosed with pervasive developmental disorder, and was enrolled in speech therapy at that time. He was later diagnosed with autism. On 04 December 1995, the subject underwent a comprehensive developmental pediatric evaluation. According to his mother, the subject rolled over at three months, and crawled and walked alone at 10 months. He reportedly had a "social smile at one month, said "mama" at 7 months, and then it went away". Concerns at the time of examination included short attention span and occasional aggression. Examination revealed normal extremity strength and tone. The subject was found to meet the diagnostic criteria for autism. On 06 December 1995, he underwent a psychological evaluation for problems including poor language skills and inability to initiate toilet training. Cognitive development as assessed by the Bayley Scales of Infant Development fell within the "significantly delayed performance range of functioning". Diagnoses included autistic disorder and attention deficit hyperactivity disorder (ADHD, predominantly hyperactive-impulsive disorder). Moderate psychosocial stressors were also noted, including problems with primary support group and inadequate educational services. A speech and language evaluation was conducted on 17 June 1996 for possible school placement. According to the speech pathologist's report, the subject exhibited language understanding at 6 to 7 month level with some skills scattered to 11 to 12 months, and expressive language skills at a 3 to 4 month level. On 31 December 1996 a developmental neuropsychosocial evaluation was conducted, resulting in confirmation of a diagnosis of autism. Receptive language skills were assessed at the 12 to 17 month level, with expressive language skills at approximately a 10 month level. The evaluating psychologist stated "the extent of autistic behaviors is sufficiently severe to render impossible any efforts at estimating nonverbal intellectual skills". On 20 March 1997, the subject was evaluated by a neurologist who confirmed autism with severe difficulty with language, and initiated a trial of dextromethorphan. Prozac was initiated on 21 May 1997, and upon follow up on 23 July 1997, it was noted that the subject was experiencing increased focus and eye contact. A taper from dextromethorphan was started at that time. On 17 November 1997, a pediatric neurologist expressed the impression of pervasive developmental disability compatible with autism, stating " I find no other neurologic abnormality and did not feel that any further psychosocial testing needs to be performed." Recommendations included enrollment in a structured autism treatment program. By 11 December 1997, all medications had been stopped. In March 1998, the subject experienced improvement, including following directions and sleeping well, while receiving Luvox. Speech therapy was ongoing. Psychological and neurodevelopmental evaluations were performed on 30 April 1998. Physical examination revealed diffusely low tone especially in the upper extremities. The subject was diagnosed with encephalopathy characterized by autistic behavior and very low-average cognitive functioning (mental retardation, unspecified), mixed receptive and expressive language disorder, and current adaptive functioning within the "moderate" range. On 07 October 1998 the subject underwent a psychological evaluation which revealed cognitive functioning to be at the 13-Month level and speech/ language skills ranging from the 9-month to 18-month level. In December 1998, it was noted that the subject was receiving Luvox to help him concentrate. On 23 November 1999, he was provided with an augmentative communication device. According to neurologist's note dated 03 October 2001, the subject remained nonverbal. He was experiencing increased hyperactivity and aggression while on Paxil, and a taper off of the medication was initiated on that date. On 05 November 2001, the subject was referred for intellectual testing which showed cognitive functioning and adaptive skills in the deficient range, and he was assessed to be operating at a level of mental retardation. The subject was evaluated by a neurologist on 10 April 2002. At the time he was receiving no medications, and it was noted that he "did not respond well to Paxil or others used previously". He remained nonverbal with few exceptions, and attention span was "somewhat" improved. On 12 August 2003 the subject was seen for augmentative communication follow-up. He did not use functional words or word approximations during the course of evaluation, and a voice-output augmentative communication system was recommended. A speech pathology examination on 17 March 2004 showed "scattered growth in overall communication skills", noting improved social skills. At that time, the subject maintained use of a "low tech" structured communication system. A school assessment on 08 June 2004 indicated functional, fine motor, and visual skills in the 3 and a half to 4-year range and solid performance skills in the 2 and a half to 3 year range. He was assessed to have made "minimal" progress since the previous assessment in the fall of 2001. Occupational therapy was ongoing. He experienced a weight gain over approximately one year, increasing from the 50th percentile to the 90th percentile, which was possible attributable to nutritional supplements. In January 2005, diagnosis included borderline hypertension. On 10 March 2005, the subject was evaluated by an ophthalmologist for complaints of squinting and crossing eyes. Impression included esotropia, astigmatism, hyperopia. These were considered to be  incidental findings upon medical record review.