Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Eye discharge, Pyrexia, Rash macular, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old Caucasian male with no past medical history and no known drug allergies who on 6/17/02 was vaccinated with the first dose of MMR II (lot 640792/1381L), SC in the right arm. Concomitant therapy that day included the first dose of varicella virus vaccine live (lot 641597/1299L), SC in the left arm. There was no other concomitant medication or illness at the time of vaccination. On 6/22/02 (initially reported as the night of 6/17/02 and also as "the day after" vaccination) the pt developed a fever of 102-105.4 F. Also reported, was a "fever rising to 106 rectally." The pt also developed a "rash over entire body, hives, measles type rash, diarrhea, mucous in eyes (x 2 days only)." The pt's rash was also described as a "severe red rash over entire body with hundreds of spots on trunk." The pt had been taken to the ER and had been treated with Tylenol and Motrin. On 7/1/02 lab work done at the hospital included CBC and SED rate, results follow: WBC 4.7k/ul, RBC 3.63L, HGB 10.2L, HCT 28.9L, MCV 79.6fL, MCH 28.2pg, MCHC 35.4g/dL, RDW 12.6%, platelet 286K/uL, MPV 6.9L and a sed rate of 39H. On 7/2/02 the pt was seen for a pediatric cardiology consultation and echodiagram for possibility of Kawasaki's disease. At examination, the cardiologist reported that there was no swelling of the hadns and feet, no cervical lymphadenopathy and the fever had stopped. The ESR was 39. The physical examination showed a well-developed and well-nourished infant in no distress. There was a macular skin rash over the chest and face. There was no swelling of the extremities and no peeling. The pt's heart rate was 90. The chest was symmetrical with clear breath sounds and no murmurs. The femoral pulses were palpable and the abdomen was soft with no liver enlargement. The echocardiogram two-dimentional and color Doppler showed normal cardiac anatomy with normal ventricular contractility. There were no anatomic defects seen. The right and left coronary arteries were reportedly "seen and appeared normal in size with no dilatation." There was no pericardial effusion. The Doppler study of the aorta, pulmonary, mitral and tricuspid valves showed normal flow patterns. The pt had no coronary artery abnormalities and in the opinion of the reporting cardiologist was "not consistent with Kawasaki's disease." The cardiologist had reportedly reassured the pt's family that "there was no need for cardiology follow-up unless new findings developed." It was reported that the fever lasted greater than 10 days and the rash lasted greater than 2 weeks, from 6/22/02 to 7/6/02. On 7/5/02, the rash was reported as resolving, described as "now with purple brown marks." The pt reportedly recovered on 7/6/02. It was also noted that the pt had developed a fever of 102 F at 5 months of age when vaccinated with Prevnar. The pt's sibling had no adverse events following prior vaccinations. The adverse event of "fever rising to 106 rectally" was considered to be an other important medical events. It was also reported that two other pts approsimately 13 months old (WAES0208USA02718 and 0208USA02719) had similar symptoms following vaccination. No further info is expected.