Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Liver function test normal, Motor dysfunction, Pyrexia, Varicella post vaccine, Weight decreased
Clinical narrative: Initial report received on 29 March 2012 from a manufacturer (Manufacturer (MFR) report number: A0970857B). The case was reported by a consumer who is the grandmother of a 17-month-old male patient who received a single dose injection of PENTACEL, sanofi pasteur Ltd., (dose number, lot number, route and site not reported) on 23 March 2010. On the same day, he also received single dose injections of the following vaccines: dose one of HEPATITIS A VACCINE, manufacturer unknown; MMR VACCINE, manufacturer unknown; VARICELLA VACCINE, manufacturer unknown and PREVNAR (manufacturer unknown, dose number in series, lot number, route and site not reported). The following is verbatim as per report. "This case was reported by a consumer (subject's grandmother) and described the occurrence of autism in a 17-month-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), PENTACEL (non-gsk), MMR vaccine (non-gsk), varicella virus vaccine (non-gsk) and PREVNAR. A physician or other health care professional has not verified this report. The subject's medical history included constipation, drug reaction and thrush. Concurrent medical conditions included celiac symptoms nos, flour sensitivity and sensitive to chemicals. Historic vaccinations included Haemophilius influenzae type b vaccine; manufacturer unspecified; unknown given on 16 December 2008; diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified; unknown given on 16 December 2008; poliomyelitis vaccine inactivated (non-gsk); non-GSK manufacture; unknown give on 16 December 2008; and live attenuated human rotavirus vaccine; manufacture unspecified; unknown given on 16 December 2008. On 23 March 2010 the subject received 1st dose of Hepatitis A vaccine (unknown), unspecified dose of PENTACEL (Non-GSK) (unknown), unspecified dose of MMR vaccine (Non-GSK) (unknown), unspecified dose of Varicella virus vaccine (Non-GSK) (unknown, unspecified dose of PREVNAR (unknown). In 2010, less than one week after vaccination with PENTACEL, Hepatitis A vaccine, MMR vaccine (Non-GSK), PREVNAR and Varicella virus vaccine (Non-GSK), the subject experienced high grade fever up to 105, not eating properly (loss of appetite). The subject's physician recommended treating the fever with TYLENOL and sponge baths. About 2-3 weeks after vaccination with PENTACEL (Non-GSK), Hepatitis A vaccine, MMR vaccine (Non-GSK), PREVNAR and Varicella virus vaccine (non-GSK), the subject experienced chicken pox and "about" 1 month after, the subject experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The grandmother explained that the subject lost 80 percent of his fine motor skills. According to the grandmother, prior to these vaccinations, at the subject's last physical he was noted as normal growth and development. About 4 months after vaccination with PENTACEL (Non-GSK), Hepatitis A vaccine, MMR vaccine (Non-GSK), PREVNAR and Varicella virus vaccine (Non-GSK), the subject experienced autism. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education students. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. After the next vaccination with Hepatitis A vaccine the events recurred. On 09 March 2012, the subject was vaccinated with HAVRIX and experienced some of the same events plus different events. See case A0970857C for details. Prior to these vaccinations, the subject was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine on 16 December 2008 and experienced some of the same events plus some different events. See case A0970857A for details. The patient's outcome was not recovered. Documents held by sender: None.