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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.
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