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Administered by: Private Purchased by: Public
Life Threatening? No
Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline) given on 25 March 2009 and ROTATEQ (manufacturer unspecified) given on 15 May 2009. Concurrent vaccination included PENTACEL (manufacturer unspecified), ACTHIB (manufacturer unspecified), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 July 2009. There were no concurrent medications. On 17 July 2009 at 11:09 the subject received 2nd dose of ROTARIX (oral). This was actually the 3rd dose of rotavirus vaccine as ROTATEQ was given to the subject inbetween doses of ROTARIX. An extra dose was administered. It was noted that the lot number for the ROTARIX diluent given with dose 2 was A41DA860A with an expiration date of 25 September 2011. On 18 August 2009, in the evening, 1 month after vaccination with ROTARIX, the subject experienced intussusception with pain, fever, abdominal mass and lethargy. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was seen by his physician and administered a barium enema as treatment which seemed to straighten everything out. At the time of reporting, the subject was at home resting and was reportedly improved. The subject''s physician did not think the events were caused by ROTARIX. 9/23/09 PCP records received dated 8/18/09-9/17/09 with DX: Intussusception. Pt presented 8/18/09 with vomiting, watery stool and excessive drooling. T''=99.2''F. Abd mass palpated in LLQ. Sent for outpt US which was (+) for IS. Barium Enema done with reduction of the IS. Observed in pcp office and d/c home doing well. Returned 9/13 09 after episode of vomiting. Abd exam WNL. (+) R OM.
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