Age: 0.3
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: Initial report received on 27 June 2011 from another manufacturer, report # WAES 1106USA03158. Verbatim from the report: "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 April 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 with pneumothorax, ASD, bicuspid aortic valve an no known drug allergies who on 01 April 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 # E0330-1) and PREVNAR 13 (Lot #915373) all given IM. Concomitant medications included TYLENOL. On 07 April 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 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 current jelly stools were noted. The patient was transferred to a higher level facility. On 10 April 2011, the patient was diagnosed with intussusception secondary to Meckel diverticulim, sepsis, and pertionitis was ruled out. The patient was post status post repair of coarctation of aorta. A computed tomography (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 the operating room (OR). An 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 and temperature spikes. The patient was treated with IV antibiotics. The patient was discharged from in stable condition to follow up with primary care physician and specialists. Abdominal x-ray performed on 09 May 2011, showed dilated small bowel, probably represented ileus although distal obstruction was not excluded. Diagnostic laboratory tests performed on the same date included: platelets 536 (high), Hb 8.3, Hct 265, 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 events were considered serious due to hospitalization, life threatening and ER visit. The original reporting source was not provided. The VAERS ID # was 422292. No further information was available". It is noted that the Sanofi Pasteur SA lot number for ACTHIB is G1169-1. Documents held by sender: None.