Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Respiratory failure, Sepsis, Small intestinal obstruction, Somnolence, Systemic inflammatory response syndrome
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. On 01-APR-2011, a 16 weeks old male patient with heart murmur II/VI (coarctation of aorta), SP repair, PDA, intermittent bouts of cold/congestion x 1 month, nasolacrimal duct obstruction, gastroesophageal reflux disease, torticollis, recurrent thrush, meconium aspiration at birth c pneumothorax, ASD, bicuspid aortic valve and no known drug allergies who on 01-APR-2011, was vaccinated orally with the second dose of ROTATEQ (Lot # 669083/1450Z). Secondary suspect vaccinations included the second doses of: DAPTACEL (Lot # C3577BA), ACTHIB (Lot # UH288AA), IPOL (Lot # E03301) and PREVNAR 13 (Lot # 915373) all given IM. Concomitant medications included TYLENOL. On 07-APR-2011, 6 days after vaccinations, the patient became irritable, fussy, had multiple episodes of emesis with bilious and some projectile vomiting. The patient had decreased urine output. On 09-APR-2011, the patient presented to the ER with vomiting, ileus, dehydration, increase in nasal congestion. He was vomiting bilious material and was experiencing sleepiness, had decreased oral intake, and decreased urine output, he had dry cough, fussiness. A physical exam was performed, the patient was found tachycardic, had slight abdominal distension and currant jelly stools were noted. The patient was transferred to a higher level facility. On 10-APR-2011, the patient was diagnosed with intussusception secondary to Meckel diverticulim, sepsis and peritonitis were ruled out. The patient's was status post repair of coarctation of aorta. CT of abdomen was consistent with small bowel obstruction. The transferred was accepted. The patient was evaluated and admitted. Attempts of enema reduction of intussusception showed persistent filling defect in the patient's ileum. Thus, the patient was taken to Operation Room (OR). E-lap with segmental ileal resection with anastomosis including Meckels diverticulectomy and appendectomy were performed. Post-operative course was complicated by peritonitis, sepsis; systemic inflammatory response syndrome; respiratory insufficiency; episodic bradycardia et temp spikes. The patient was treated with IV antibiotics. The patient was discharged home in stable condition to follow up with primary care physician and specialists. Abdominal X-ray performed on 09-MAY-2011, showed dilated loops of small bowel, probably represented ileus although distal obstruction was not excluded. Diagnostic laboratory tests performed on the same date included: platelets: 536 (high); Hg: 8.3; Hct: 26%; WBC: 7; neutr: 35%; bands: 29%; CRP: 27. An echocardiogram showed no evidence of recurrent obstruction. Chest x-ray showed opacity in retrocardiac region of left lower lobe suggesting atelectasis. A CT of abdomen was suspicious for distal mechanical small bowel obstruction; the small bowel appeared distended diffusely and the colon appeared collapsed. An ultrasound of abdomen was recurrent/unre. The patient's outcomes were not reported. The   [Due to memory limitations, the remainder of this text could not be compared.]  d. The events were considered serious due to hospitalization, life threatening and ER visit. The original reporting source was not provided. The VAERS ID # was 422292. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. No further information is available.