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Write-up: Information has been received from a physician concerning a 4 month old male, with no reported medical history, who on 9/28/06 was vaccinated with a first 2 ml oral dose of Rotavirus vaccine (lot 654970/0777F). Concomitant vaccines administered on the same day included a dose of Prevnar, a dose of Hib and a dose of Pediarix. It was reported that, on approx 9/30/06, the pt initially presented with edpsodic excruciating abdominal pain and was diagnosed with colic at the ER of the hospital. The next day the pt presented with bilious emesis and bloody diarrhea. No treatment was given, the pt was sent directly to the tertiary care hospital. The physician didn''t know the exact date, but he thought 10/2/06 sounded right. The physician reported that the pt had 2 days of signs of symptoms prior to going to the hospital. The pt had an air contrast enema which revealed the intussusception. He stated that the pt spent 12 hours at the hospital prior to the study being performed. It was reported that the pt developed intussusception with perforation. It was noted that at the time of report the pt was recovering, but had not been released from the hospital. The pts mother told the reporter that the pt was receiving his second blood transfusion. The reporter noted that since the pt received two blood transfusions, he thought that the pt possibly had surgery and was planning on contacting the physician at the hospital No product quality complaint was involved. No other information was provided. Additional information has been requested. 10/26/06 Received medical records from hospital which reveal patient admitted to ER with fever, vomiting & blood in stool for 1-2 day. Patient failed an air enema & underwent open laparotomy, open reduction & incidental appendectomy on 10/2/06. Intussusception of sigmoid colon was reduced only to mid transverse colon. Findings at surgery included difficult to reduce intussussception, markedly edematous distal ileum & serosal tears of cecum. Had transient respiratory distress & was in PICU from 10/3-10/5, no vent support needed. Continued to have persistent fever, elevated CRP, severely elevated WBC & anemia. Treated with multiple antibiotics. Blood c/s from 10/2 grew micrococcus which was considered to be a contaminant. Continued to have frequent loose stools but no blood. Consult on 10/9 revealed WBC of 42,550 w/53 segs & no bands, 21 monos. H&H 5.6 & 17.2. CMP was WNL CRP max was 35.4 & was slowly decreasing. CT scan of abd done 10/10 as w/u for persistent fever revealed min fluid accumulation along the lateral aspect of the liver, with a few more loculated-appearing areas & infected fluid could not be excluded; tiny bubbles of intraperitoneal air related to recent abd surgery; bowel wall thickening in RLQ, likely the cecum & distal ileum; no evidence for recurrent intussusception or bowel obstruction; thickening of right hemidiaphragm w/very small right pleural effusion & area of probable atelectasis in RLL. A PICC line was placed on 10/11. PMH: uneventful. SVD w/birth wt of 6 lbs 14 oz. No problems during pregnancy. G&D have been normal. No D/C summary included with med records. T/C to ROI. Patient was d/c home on 10/18 but no d/c summary available. Will send progress notes./ss 10/27/06 Received progress notes from hospital which reveal patient had an expected post op ileus s/p surgical reduction of intussusception on 10/2. Transferred to PICU on 10/3 due to resp distress even on blowby O2 w/grunting & markedly distended abdomen w/o NGT output. Temp on admit to PICU was 101.5. Dx: Restrictive lung disease secondary to distended but soft abdomen. Progressed well in PICU & was on RA by 10/5. Continued to spike temps of <102 on multi antibiotics. By 10/9, although clinically improving continued to spike temps & have significantly elevated WBCs & anemia. Continued on parenteral nutrition. ID consult requested & done on 10/9. Transfused on 10/10. PICC line inserted 10/11 for
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