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Life Threatening? No
Write-up: Information has been received from health professionals concerning a 7 month old male who received his first dose on 17-APR-2007, second dose 20-JUN-2007, and a third dose, 2 ml oral 21-AUG-2007, of Rotateq (lot #655866/1110F; 56385/0030U; 656381/0875U respectively). Concomitant vaccines included Hib conj vaccine (lot#''s53523/0063U and 654679/1126F respectively), PREVNAR (lot #''s B08691F; B08690H; and B58845F respectively), and PEDIARIX (lot #''s AC21B096A; AC21B114CA; and AC21B124AA respectively). On 11-SEP-2007, the patient''s mother phoned the office reporting that the patient had developed a fever, loose stools, was gassy, and was screaming every 1 1/2 hours at night. He was seen in the office and stool samples on 12-SEP-2007 were negative for Rota virus. The reporter stated that he continued to experience symptoms "on and off over the next couple of weeks." He was seen in the office again on 04-OCT-2007, after developing loose stools with mucous and low grade fever "on and off". On 05-OCT-2007, he was hospitalized and underwent an x-ray with barium enema "which cleared the intussusception". He was seen in the office in follow up to his hospitalization and reportedly was "doing fine". The reporter stated "the admission to the hospital and enema administration was intervention to prevent serious criteria". No product quality complaint was reported. The patients experiences were considered to be other important medical events by the reporter. This is one of two reports from the same source. Additional information has been requested. 10/23/07 Patient demographics provided by CDC. 10/23/07 Recieved contrast enema report from CDC which reveals patient had ileocolic IS at hepatic flexure & was successfully reduced. 10/23/07 Received vax record from pcp & VAERS database updated w/same. 12/4/07 Received ER medical records which reveal patient experienced irritability, fever & distended abdomen. BE reduced IS but transferred to higher level of care for continued observation. FINAL ER DX: Intussusception. Records faxed to CDC. 12/7/07 Reviewed hospital medical records which reveal patient experienced abdominal discomfort for approx 1 month starting w/ulcerations in mouth & throat & progressed to nightly abdominal pain, large amounts of gas, low grade fever intermittently. PCP tested for rotavirus which was neg. Initially had increased WBC. GI consult done as outpatient 1 week prior to admit who dx GERD, tx w/antacid & antibiotic. Transferred from outlying ER s/p BE revealed IS. Admitted 10/6 & d/c same day. To f/u w/PCP & have GI small bowel series done as outpatient. FINAL DX: abdominal pain, possible formula intolerance, unlikely intussusception. Records faxed to CDC.
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