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Life Threatening? No
Write-up: This case was reported by a regulatory authority (PL-URPL-OCM-20100323027) and described the occurrence of suspected intussusception in a 9-week-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA and PREVNAR (non-gsk). On 6 January 2010 the subject received unspecified dose of ROTARIX (oral), unspecified dose of INFANRIX HEXA (intramuscular, unknown), unspecified dose of PREVNAR (intramuscular, unknown). On 11 January 2010, 5 days after vaccination with INFANRIX HEXA, PREVNAR and ROTARIX, the subject experienced merging maculo-papular rash and hypotonic-hyporesponsive episode. Subsequently, the child was hospitalised. On admission, the child had decreased body temperature (35.9 deg. C). An ultrasonography showed dilated intestinal loops, intestinal hypomotility and traces of fluid in the peritoneum. The child was referred to the Infectious Disease Clinic because of suspected sepsis. During the first days of admission, the child was in a serious condition and experienced hematochezia, hard abdomen and intestinal hypomotility. No pathological flora was isolated from the blood culture. Because of the vaccination with ROTARIX, the possibility of spontaneously resolved intussusception was considered. The subject was hospitalised. At the time of reporting the events were improved. The regulatory Authority has provided GSK with all the available information at this time, any further information received by the regulatory authority will be forwarded to GSK.
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