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Administered by: Private Purchased by: Other
Life Threatening? Yes
Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 21 February 2014 the subject received a dose of ROTARIX (oral). On 25 February 2014, 4 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was taken to the emergency room on 25 February 2014 and "had surgery to correct" the intussusception on 26 February 2014. No further details were available at the time of reporting. The subject was hospitalised and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). GSK considered this case medically serious. On 26 February 2014, the event was resolved. Follow up was received from the physician on 26 February 2014. The physician reported the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline) as the second dose in the rotavirus series. Concurrent vaccination included Hib; manufacturer unspecified; intramuscular; unknown given on 21 February 2014; DTaP-IPV/HepB; GlaxoSmithKline; intramuscular; unknown given on 21 February 2014; pneumococcal vaccines (non-gsk); manufacturer unspecified; intramuscular; unknown given on 21 February 2014. There was no history of alcohol or tobacco use per the physician. The physician confirmed that the subject received ROTARIX on 21 February 2014. On 25 February 2014, the subject experienced intussusception, vomiting, and screaming. On 26 February 2014, the outcome of the events were unresolved. The physician reported that the subject had surgery as treatment. The physician considered the events to be serious. Follow-up received on 17 July 2014 from physician via the targeted follow-up questionnaire. As previously reported the ROTARIX vaccine was administered correctly along with concomitant vaccinations. ROTARIX was administered by a nurse at the physician''s office. The subject experienced intussusception on 25 February 2014 and resolved on 27 February 2014 (previously reported as 26 February 2014). At the time of this report the subject had completed the ROTARIX vaccination series. No other information was provided.
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