Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Skin discolouration, Ultrasound abdomen normal, Vomiting, X-ray gastrointestinal tract normal, X-ray normal
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. An 8 weeks old female patient with no medical history, no previous illnesses and no known drug allergies was vaccinated on 19-DEC-2011 with the first dose of ROTATEQ (thimerosal free, lot # 670481/0677AA), "by mouth", (dose not reported). Secondary suspect vaccine given on the same date included a dose of RECOMBIVAX HB (lot # 670230/1156AA), I.M, in the left leg, (dose not reported). Concomitant vaccines given on the same date included the first dose of PREVNAR 13, (batch # 916921), I.M, in the left leg and the first dose of PENTACEL, (batch # C3834AA), I.M, in the right leg. Concomitant therapy included TRI-VI-SOL. On 31-DEC-2011, the patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change. The patient was treated emergently with antibiotics and intravenous (IV) fluids for possible sepsis and admitted to intensive care unit for observation. There was high clinical suspicion for self-resolved intussusception. The following information was obtained through follow-up and/or provided by the government. 28-MAR-2012. Hospital records date of service (DOS) 30-DEC-2011, 01-JAN-2012. Diagnosis (DX): abdominal (abd) distension; dehydration; sinus tach. Chief Complaint (CC): severe fussiness; rhinorrhea; nasal congestion; colour change (pink to dusky purple); eyes rolled back briefly; abd distension/tenderness; green mucoid stool; vomiting; cough; clamminess and mottling. Physical examination (PE): tachycardic to 240 "s" not responsive to vagal maneuvers; poor perfusion; erythematous patch noted on lower left quadrant (LLQ) developed and subsequently resolved; delayed cap refill; pale. Admitted to intensive care unit (ICU). Improved. Discharged (DC) in stable condition to f/u c primary care physician (PCP). Laboratory tests performed included: Blood, urine, and cerebrospinal fluid (CSF) cultures negative. Abdominal x-ray, upper gastrointestinal (GI), and abdominal ultrasound normal. The following information was obtained through follow-up and/or provided by the government. 28-MAR-2012. Labs/diagnostics, CSF red blood cells (RBC) 712 (H), CSF neutrophils (neuts) 54 (H), CSF lymphocytes (lymphs) 22 (L), CSF white blood cell count (WBC) 50 (H), potassium, (K) 5.8 (H), sodium (Na) 132 (L), platelets (Plt) 633 (H), WBC 13 (N), neutrophil count (neuts) 29% (L), lymphocyte count (lymphs) 63 (H). Chest X-ray (CXR): negative. Kidney, Ureter and Bladder (KUB): negative. Abdomen ultrasound (abd US): negative. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. 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 (670481/0677AA) 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 # 451390. No further information is available. This report was filed with the FDA. The ISR number is 451390-1.