Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, RV5, DTAP, HIBV, RV5
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Contusion, Echocardiogram normal
Clinical narrative: Information has been received from a physician concerning a 16-week-old female with no pertinent medical history and no drug reactions/allergies who on 17-JUL-2007 was vaccinated PO with a dose of Rotateq (Lot # 656384/0237U). Concomitant therapy that day included a dose of DTaP and a dose of ActHIB. On 14-AUG-2007, the patient was vaccinated with a dose of Prevnar and Engerix B. On 04-SEP-2007 the patient had a puffy bruise on the posterior neck. On 05-SEP-2007, the patient had a fever of 101 degrees Fahrenheit and was cranky, but no rash was seen. On 07-SEP-2007, the patient had red, swollen feet and hands and scattered macularpapular rash over the trunk and limbs. The patient was admitted to the hospital on 07-SEP-2007 and was diagnosed with Kawasaki's disease. The patient was given IVIG (intravenous immunoglobulin) and baby aspirin. Lab studies included: complete blood count, erythrocyte sedimentation rate, liver function tests, and an echocardiogram. At the time of the report, the patient was recovering. There was no other information to report. The event was considered to be an other important medical event by the reporter. Additional information has been requested. This is a follow-up report (s) previously submitted on 10/12/2007; 12/03/2007.  Information has been received from a physician concerning a 16-week-old female who weighed 7 lbs 9 oz. at birth, with no siblings, nor pertinent medical history and no drug reactions/allergies who on 17-Jul-2007 was vaccinated PO with a dose of ROTATEQ (Lot # 656384/0237u). Concomitant therapy that day included an intraqmuscular dose of PEDVAXHIB (Lot # UF112AA), and TRIPEDIA (Lot # C2606AA). On 14-Aug-2007, the patient was vaccinated with an intramuscular dose of PREVNAR (Lot # B265108), ENGERIX-B, and an intramuscular dose of HAVRIX. There was no illness at the time of vaccination and no adverse events follwoing prior vaccination. On 04-Sep-2007 the patient had a puffy bruise on the posterior neck. On 05-Sep-2007, the patient had a fever of 101 degree Fahrenheit and was cranky, but no rash was seen. On 07-Sep-2007, the patient had red, swollen feet and hand and scattered macularpapular rash over the trunk and limbs. The patient was admitted to the hospital on 07-Sep-2007 and was diagnosed with Kawasaki's Disease. The patient was given intravenous immunoglobulin and baby aspirin. The patient was hospitalized for 4 days. Lab studies included: complete blood count, erythrocyte sedimentation rate, liver function tests, and an echocardiogram. The echocardiogram was reported as "ok". As of 10-Sep-2007, the patient had recovered. There was no other information to report. Additional information has been received from a pediatric cardiologist concerning a 15 week old female, who he evaluated for a three day history of fever up to 102 degrees with hand and feet swelling. The physician reports that she developed a rash more on the extremities then centrally, a slight cough, and was irritable. On physical examination her heart rate was 130 and respiratory rate was 20. Sclera was reddened but without discharge. Her extremities revealed a trivvial pericardial effusion without cardiac temponade, normal left ventricle function, normal sized left ventricle, and small parent foramen. Her sedentantion rate was reported as 90. The physician's clinical impression was that she had the critiea for mucocutaneous lymph node syndrome and was discharged. A follow-up echocardiogram for (MCLNC) on 25-Sep-2007 revealed, normal left ventricular systolic function, normal sized left ventricle, and normal coronaries. On 25-Oct-2007, she underwent an echocardiogram to assess her coronaries, rule out a pericardial effusion, and evaluation in any of the major coronary arteries, no pericardial effusion, and no valvular regurgitation, normal left ventricular systolic function, normal right and left main coronary arteries, and a normal sized left ventricle. Current patient status was not reported. Kawaski's disease was considered to have been a life threatening illness. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory.The lot met the requirements of the Center for Biologics and Research and was released. Addtional information is not expected. All available medical records will be provided upon request.