Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Deafness, Decreased eye contact, Developmental delay, Diarrhoea, Disturbance in social behaviour
Clinical narrative: Information has been downloaded from data (US-EMA-20170729-rpatevhp-131840864). Information has been received from a consumer regarding to a 16 month old female patient with otitis media. Medical history included: 3 doses of TRIPEDIA at ages 2, 4, and 6 months. Patient showed signs of Autism at 7-months. At 12-months hearing was checked because she was ignoring her mom and dad. The patient's hearing was good. The patient received measles, mumps, and rubella (manufacturer unknown) dose one at 12 months of age and experienced crying, fever and listlessness which was never reported. Family history: Great grandmother with tics. On 08-JUN-2004, the patient was vaccinated with TRIPEDIA batch/lot number U1028C and with poliovirus vaccine inactivated (vero) (IPOL) batch/lot number X0554 (strengths, doses, dose numbers, and expiration dates were not reported), both by unknown administration route, as prophylactic vaccination. On 04-APR-2005, the patient had no illnesses at the physician visit. On 07-APR-2005, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number reported as 11869, expiration date and strength were not reported), VARIVAX by unknown administration route, lot number reported as "0446P"; PREVNAR intramuscularly, batch/lot number A65653C; and with ACTHIB intramuscularly batch/lot number Y0404, (strengths, doses, dose numbers, and expiration dates were not reported) all for prophylactic vaccination. Concomitant therapy included amoxicillin. On 28-APR-2005, the patient experienced screaming, "may had a seizure", arching back (opisthotonos), 15 areas of bull eyes rash throughout the body and fever. On 26-AUG-2005, she received PREVNAR batch/lot number A94451K; and DAPTACEL Batch/lot number C2253A, (strengths, doses, dose numbers, and expiration dates were not reported) both intramuscularly, for prophylactic vaccination. On 27-AUG-2005 the patient experienced inconsolable crying and facial tics. On 30-AUG-2005, the patient experienced "spinning in circles"  and easily frustrated. On an unknown date, the patient experienced delayed fine motor and developmental play skills, staring spells, poor sleep, gas, hearing loss, delayed language/speech skills, seemed to loose eye contact, autism spectrum disorder, poor regulation of sensory input, diarrhea, stopped interacting with family members, delayed self care skills and grinding teeth. The outcome of screaming, seizure, rash and pyrexia was unknown. At the time of the report, the patient had not recovered from psychomotor skills impaired, opisthotonos, staring, poor quality sleep, emotional distress, tic, flatulence, deafness, speech disorder developmental, disturbance in attention, abnormal behaviour, autism spectrum disorder, crying, sensory integrative dysfunction, diarrhoea, disturbance in social behaviour, impaired self-care and bruxism. The reporter considered the aforementioned events as medically significant.; Sender's Comments: 2008-01478: 2005-01988: US-009507513-1812USA011068: