Age: 1.3
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Autism spectrum disorder, Bruxism, Diarrhoea, Flatulence
Clinical narrative: Initial report was received from a consumer, who is the patient's parent. A 16-month-old female patient developed a fever and bulls-eye rash, 21 days after she had received an injection of ACTHIB, lot number UE577AA (route and site not reported), (corresponding sanofi pasteur SA lot number Y0404-2). The patient had received concomitant injections of MMR (dose one), lot number 11869 (manufacturer Merck, route and site not reported), and VARIVAX, lot number 0446P (manufacturer Merck, route and site not reported) and PREVNAR, lot number A65653C (manufacturer Wyeth, route and site not reported). According to the reporter, the patient had no medical history and had not experienced any reactions after previous immunizations received. On 28 April 2005, 21 days after she had received the vaccines, the patient developed a fever of 103 degrees Fahrenheit and was administered Ibuprofen. The patient woke in the AM with approximately 15 areas of a bulls-eye rash throughtout her body. Her fever increased to 104.7 degrees Fahrenheit and she was screaming and had an arched back. The patient's mother stated she felt the patient may have had a seizure. Approximately one week later, the patient began to grind her teeth, spin in circles, seemed to lose eye contact and stopped interacting with family members. Chronic diarrhea and gas were reported to have started at that time. The reporter provided the patients past immunization history. On 26 January 2004, the patient received RECOMBIVAX (manufacturer Merck, lot number not reported). On 08 March 2004, the patient received TRIPEDIA, lot number U1028CA, IPOL, lot number X01462, COMVAX (Merck, lot number 0367N), and PREVNAR (manufacturer Wyeth, lot number 495-033). On 08 June 2004, the patient received an injection of RECOMBIVAX (manufacturer Merck, lot number not reported). On 19 April 2004, the patient received an injection of TRIPEDIA, lot number U1028CA, IPOL, lot number X05542, PEDVAX HIB (manufacturer Merck, lot number 0656N), and PREVNAR (manufacturer Wyeth, lot number 495-033). On 08 June 2004, the patient received TRIPEDIA, lot number U1028CA, IPOL, lot number X05542, RECOMBIVAX (Merck, lot number 0218N), and PEDVAX HIB (manufacturer Merck, lot number 0656N). The patient has also received a dose of PREVNAR on 09 September 2004 (manufacturer Wyeth, lot number A57560C). According to the reporter, who is the patient's mother, the patient had not experienced any adverse events after receipt of these vaccines. On 26 August 2005, subsequent to the reported event, the patient received DAPTACEL, lot number C2253AA and PREVNAR (manufacturer Wyeth, lot number A94451K). The patient received a medical exemption following vaccination on 26 August 2005 and had not received any immunizations since that time. According to the reporter, the patient was subsequently diagnosed as having Autism Spectrum Disorder (captured in case 2005-01988). On 10 August 2006, the patient was subsequently diagnosed with an immune dysfunction (captured in case 2008-01478). No further information was provided. This patient had two additional serious adverse events which have been captured in case numbers 2005-01988 and 2008-01478.