Age: 0.21
Sex: M
Vaccine: DTAP, HBPV, HEP, IPV
Symptoms: Reaction to preservatives, Regressive behaviour, Repetitive speech, Speech disorder, Speech disorder developmental
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with Engerix B and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis b vaccine. 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." The following information was received via medical records: On an unspecified date the subject received the 1st dose of hepatitis b vaccine, on 25 June 1999 the subject received the 2nd dose of Engerix B. The subject received doses 1, 2, and 3 of Acel-Imune on 25 June 1999, 13 August 1999, and 29 October 1999 respectively and 4th dose of Tripedia on 11 October 2000. The subject received doses 1, 2, and 3 of Ipol on 25 June 1999, 13 August 1999, and 29 October 1999 respectively. The subject received doses 1, 2, 3, and 4 of Hib vaccine on 25 June 1999, 13 August 1999, 29 October 1999, and 11 October 2000 respectively. On 09 May 2000 the subject received a dose of Varivax and a dose of MMR II. On an unspecified date in January 2001, approximately 19 months after the 2nd dose of Engerix B, the subject was diagnosed with pervasive developmental disorder. On an unspecified date in February 2001, approximately 20 months after the 2nd dose of Engerix B, the subject was diagnosed with autism. On an unspecified date, the subject was diagnosed with neurodevelopmental disorder. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer. Follow-up was received via medical records on 29 March 2007. Medical history included frequent ear infections, bilateral ear tub placement and reflux, The subject's concurrent conditions and concurrent medications were not reported. In December 2000, the subject was enrolled in early intervention services. On 11 January 2001, the subject was assessed for interventional therapy due to "a delay of at least 25 percent in at least one area of development." Medical records from this assessment noted that the subject played alone, was repetitive, communicated by grunting and was overwhelmed by new situations. As a result of the assessment, the subject received interventions with educational services, speech therapy, behavioral therapy and occupational therapy to develop age appropriate behaviors, reduce inappropriate behaviors that interfered with his ability to learn and play appropriately, learn to understand receptive and expressive language, develop safety awareness skills, develop the ability to dress himself, develop gross motor skills, and develop age appropriate attending skills including eye contact. On 03 March 2001, the subject underwent a functional assessment. Medical records from this assessment noted that the subject experienced tantrums "most likely due to the inability to communicate." Behaviors of primary concern were noted to be restricted social interactions, tantrums, motor planning difficulties, restricted expressive and receptive language, and limited play skills. Review of medical records from an initial assessment on 05 March 2001 for an education program for discrete trial teaching indicated that the parents of the subject expressed concerns regarding recent regression in the subject's ability to play and speak. They reported that the subject "seemingly lost the ability" to play with common household objects and his emerging verbal ability had been lost and clear regression had occurred. Therapy with one on one behavior analysis using discrete trial teaching was initiated in Marcy 2001. Medical records dated 23 July 2001 indicated that the subject was "on a gluten free diet" and "displays sensitivity to light." On 15 January 2002, at 33 months of age, results of speech-language assessment indicated that the subject's ability for receptive language was in the 15 to 18 month age level, expressive language was in the 15 to 29 month level, development of sounds and intelligibility was in the 7 to 15 month level and communication through rhythm was in the 18 to 23 month level. An occupational therapy progress report dated 21 January 2002 indicated that the subject was functioning at the 18 to 24 month age level in gross motor skills, social skills, fine motor skills, communication skills, and showed abnormal sensory processing.