Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Constipation, Decreased appetite, Febrile convulsion, Laboratory test abnormal
Clinical narrative: Seriousness criteria other medically significant (OMIC), Initial report received from another manufacturer, report number WAES0511USA00146, on 11/9/2005. A nine month old female patient received in the left thigh a second dose of Fluzone SV 2004-2005, lot number U1381AA, on 4/29/2005. The patient had a history of facial rash and eye discharge, and her mother was vaccinated varicella virus vaccine, while pregnant. One month post vaccination, on 5/29/2005, the patient developed a fever, runny nose and sneezing. She was treated with acetaminophen. On 6/01/2005, the patient developed a rash on her body which was sparse and erythemous on the trunk. On 6/02/2005, the patients appetite was slightly decreased. On 9/22/2005, the patient developed a fever of 102 deg F, and on 9/28/2005, the patient experienced a febrile seizure and urinary tract infection. C reactive protein was high and positive at 9.2 mg/dl. Microscopic urine analysis showed bacteria to be many. Urine culture from a catheterized specimen showed greater than 100,000 cfu/ml of Escherichia coli. The patient was treated with cephalexin, acetaminophen, and ibuprofen. The patient was directed to be examined by her physician the following day. On Oct 1 2005, it was noted that the patient had not had a fever for more then 24 hours, she was urination well, and her activity was normal, On Oct 2 2005, a urine culture was repeated, although results were not reported. Imaging was to be done in one month. On Oct 11 2005, it was reported that the patient had been constipated for one day. She was afebrile and had completed the cephalexin. On Oct 26 2005, it was noted that the patient was constipated and had developed a fever on and off for four days. The patient's vaccination history included, on Oct 29 2004, a first dose of IPOL, lot number X1006, given in the right thigh, a first dose of Daptacel, lot number C1996AA, given in the left thigh, a first dose of Prevenar , lot number 495721, given in the left thigh and a first dose of Comvax, lot number 648422/0091P, given in the right thigh. Vaccinations received on 12/10/2005  include a second dose of Daptacel, lot number C2104AA, given in the right thigh, a second dose of ACTHIB (dose one was a different product), lot number UE335AC given in the left thigh, and a second dose of Prevnar, lot number A7400E, given in the right thigh. Vaccinations received on Jan 28 2005 include a third dose of Daptacel, lot number C2131AA, in the left thigh a second dose of IPOL, lot number X1189, given in the left thigh, a second dose of Comvax, lot number 6481423/0128P, given in the right thigh, and a third dose of Prevnar, lot number A557562B given in the right thigh. Vaccination received on Mar 29 2005 include a third dose of Hepatitis B virus vaccine dose one and two were Comvax, lot number 647593/0465P, given in the left thigh and a first does of Fluzone SV 2004-2005, lot number U1381AA, given in the right thigh. Following these events, the patient was subsequently vaccinated with a left thigh injection of Fluzone SV 2005-2006, lot number U1754AA, On 10/11/2005. Adverse events experienced by the patient after this vaccine are reported in non serious case 200502514. At the time of this report, the patients recovery status was unknown.