Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Kawasaki's disease, Pyrexia, Rash maculo-papular, Red blood cell abnormality, Red blood cell sedimentation rate increased
Clinical narrative: Information regarding Prevnar was received from a physician regarding a 5 month old male patient who experienced Kawasaki's disease. At 5 months of age, the patient received a dose on 2/17/04. The patient also received a dose of diphtheria/tetanus toxoids/acellular pertussis vaccine, a dose of IPOL, and a dose of Pedvax-HIB on 2/17/04. The infant was reported to be healthy. Indication for Prevnar was immunization. Product was administered on 2/17/04. Dose regimen was 1 dose (IM). Concomitant medications were not reported. On 2/17/04, the infant developed a fever of 104-105 degrees F rectally for about 48 hours. On 2/19/04, the infant was seen by a physician for a rectal temperature of 104 degrees F. The infant had developed a generalized macular-papular rash. Laboratory tests revealed an elevated erythrocyte sedimentation rate. The infant was hospitalized and treated with gamma globulin. The physician reported that the infant had Kawasaki's disease. The fever reduced and the rash disappeared following treatment with gammaglobulin. Information regarding this event has been forwarded to the manufacturers of the two vaccines. No additional information was available at the time of this report. Follow-up information received from the physician provided the patient's name, revised event onset date, revised vaccination information and lot numbers, and a hospital summary with laboratory results. On 18-Feb-2004, the infant developed a fever of 104-105 deg F. rectally. He was seen in an emergency room and subsequently discharged. on 19-Feb-2004, the infant was seen by a physician for a rectal temperature of 104 deg. F. On examination, red eyes without exudates were noted. The infant had also developed edematous eruptions all over the body and some papules. There was no mucous involvment other thatn the conjuctiva. The infant was seen home from the physician's office; however, he was seen in an emergency room again that night. Laboratory tests performed on 19-Feb-2004 revealed an elevated erythrocyte sedimentation rate (ESR) of 53 mm and C-reactive protein (CRP) of 9.1 mg/dL. A complete blood count (CBC) showed low whte blood cells of 4.9 10 X 3/ul with decreased neutrophils at 40.1%. A blood culture performed showed no growth. On 20-Feb-2004, the infant was again seen in the physician's office for spiking fevers, and it was then decided that the infant should be hospitalized. On examination, the infant had conjunctival injection and some hyperemia of the oral mucosa. There was brawny discoloration of the palms and soles, and a fine rash all over the body. There was no lympadenopathy. The infant's temperature was 102 deg. F and he was tachycardiac. Treatment with gamma globulin and aspirin was initiated. Laboratory tests performed on 21-Feb-2004 revealed a CRP of 17.6 mg/dL and an ESR of 67 mm. Viral tests for enterovirus, rotavirus, arbovirus, and herpes simplex types I an II DNA were all negative. A viral culture of the cerebrospinal fluid was negative. A chest x-ray showed bilateral hilar and perihilar as well as right lower lobe infiltrates. A urinalysis results were as follows: yellow, cloudy, specific gravity of 1.030 (high); 2 + ketones; 1 + protein; pH of 6.0; urobilinogen of 0.2 EU/dl; white blood cells of 3-5/hpf; few epithelial cell; moderate bacteria; glucose, bilirubin, nitrate, and occult blood were all negative. An EKG perfmed on an unspecified date was unremarkable except for the septal ST changes. The infant was subsequently diagnosed with Kawasaki mucocutaneous lymph node syndrome (Kawasaki's disease). On 27-Fen-2004, laboratory tests revealed an ESR of 42 mm and a CRP of 0.4 mg/dL. A CBC was within normal limits with the exception of a low hematocrit (31.1%), high lymphocytes (7.8 10 X3/ul), and low neutrophils (22.4%). His condition improved following treatment with gamma globulin. The fever reduced and the rash disappeared. On 12-Mar-2004, laboratory tests revealed an ESR of 17 mm, a CRP of 0.1 mg/dL, and a CBC that was within normal limits with the exception of low neutrophils and high lymphocytes. The infant was dischaged from the hospital; however the discharge date was not specified.