Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Anaemia, Blood albumin decreased, Blood sodium decreased, C-reactive protein increased, Clostridium difficile colitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old male with egg allergy, a history of eczema and no previous illness, on 08-JUL-2010, was vaccinated orally with the third dose of ROTATEQ (lot # 665259/0202Z). Concomitant therapy included a first dose of PREVNAR 13 IM in the right leg (lot # E49135), a third dose of PEDIARIX IM in the left leg (lot # AC21B213AA), a third dose of ACTHIB (unspecified carrier) IM in the right leg (lot # UF880AA) and hydrocortisone ointment 1%. On 16-JUL-2010, the patient developed fever. On 18-JUL-2010, 19-JUL-2010 and 20-JUL-2010, the patient was seen in the clinic for fever with rash, vomiting and diarrhea. It was presumed that it was a viral syndrome with erythema multiforme. The patient continued to have fever for 5 days, so was admitted for rule out Kawasaki disease from 22-JUL-2010 to 25-JUL-2010. At that time, laboratories showed normal white blood cell, hemoglobin and platelets and serum C-reactive protein greater than 27. Eventually, the patient also developed albumin 2.8 and hemoglobin 9.3. A stool culture performed was positive for Clostridium difficile. The patient was discharged with 10 day course of oral FLAGYL. The discharge summary from 22-JUL-2010 to 25-JUL-2010 was : diagnosis of diarrhea C. difficile, patient admitted for fever and diarrhea for 5 days. Dry cough, vomiting and conjunctivitis. Infectious gastroenteritis. IV fluids administered. The patient was treated with FLAGYL. The patient had lacy macular erythema on abdomen and was discharged. The patient continued to have low grade fever, so was readmitted for rule out incomplete Kawasaki disease. At this admission, laboratories showed normal white blood cell 30K, erythrocyte sedimentation rate 95, CRP 17, hemoglobin 9.4, platelets greater than 450K, albumin 3.0, sodium 133. The patient received Intravenous High Dose Human Immunoglobulin (IVIG) and started on aspirin. An echocardiogram performed was with proximal coronary aneurysm. The discharge summary from 29-JUL-2010 to 02-AUG-2010 was: diagnosis of Kawasaki disease, C. difficile diarrhea, mild hyponatremia. The patient continued to spike low grade fever. IVIG was administered. Erythematous papular pruritic rash improved. Conjunctivitis, cough, congestion, rhinorrhea, anemia, infections enteritis, lips dry hyponatremia hypoalbumnemia. On 24-AUG-2010, multiple consultant medical records were received. Additional information from 22-JUL-2010 to 30-JUL-2010, assessment: Kawasaki disease, ongoing fevers, pruritic erythematous papules on chest, back and diaper area; nasal congestion and rhinorrhea. Progress notes from 08-JUL-2010 to 09-AUG-2010, were received from the Primary Care Physician, assessment: incompletely manifested Kawasaki disease. The patient presented with fever, erythematous rash, sore throat, cough, vomiting, dry mouth, erythema multiforme, gastroenteritis and was admitted to hospital. In a Post hospital follow up cardiac consultation incompletely manifested Kawasaki disease was diagnosed. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. A lot check was requested. The original reporting source was not provided. The VAERS ID # is 385064. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.