Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood culture negative
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 16 weeks old male patient with no medical history, was vaccinated on 16-FEB-2012 with a dose of ROTATEQ, (lot # 670481/0677AA), "by mouth". Concomitant vaccines given on the same date included a dose of PREVNAR 13, (lot # 916978), I.M, in the right leg, a dose of PENTACEL, (lot # C3892BA/C4044AB), I.M, in the left leg. Concomitant therapy included TRI-VI-SOL with iron. On 03-MAR-2012, the patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process. Received intravenous (IV) fluids and IV antibiotics and was admitted to the hospital for observation. Cultures remained negative and there was high clinical suspicion for intussusception. The following information was obtained through follow-up and/or provided by the government. 22-MAR-2012 hospital records received for date of service (DOS) 03-MAR-2012 to 04-MAR-2012 with diagnosis (Dx): vomiting. The patient (Pt) presented with sudden onset copious emesis (milk, then bile), large green watery stool, extreme pallor/grayness, quiet ill-appearing behavior, lethargy, upper respiratory infection (URI) for 3 weeks (wks). Physician examination (PE): Brown mole to leg, slightly cloudy tympanic membranes (TMs), nose congested, liver palpable right costal margin (RCM). Pt admitted for observation. Most likely etiology was intussusception that spontaneously resolved. Condition improved with hydration, the patient was discharged home with care and follow-up (f/u) instructions. Laboratory tests performed included: Blood and urine cultures negative. Abdominal ultrasound and upper gastrointestinal (GI) normal. The following information was obtained through follow-up and/or provided by the government. 22-MAR-2012 lab/diagnostic records received fro date of service (DOS) 04-MAR-2012. Blood: White blood cell count (WBC) 24.3 (H), neutrophils 11.08 (H) and 46% (l), lymphocytes 46% and 11.51 (H), platelets (Plt) 775 (H), AST 83 U/L (H), alanine aminotransferase (ALT) 63 (H), albumin 3.6 (L), protein 5.6 (L). Upper gastrointestinal (GI) and abdominal ultrasound (US), chest x-ray (CXR) unremarkable. Kidney, Ureter and Bladder (KUB): Air filled bowel loops, no evidence of obstruction. Guaiac fecal occult blood test (Guaiac), blood culture (cx) (-). This report was considered serious, immediately life threatening for all the events and patient was hospitalized. It required emergency room/doctor visit. The original reporting source was not provided. 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. The VAERS ID # is 451391. No further information is available. This report was filed with the FDA. The ISR number is 451391-1.