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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of invagination of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical condition included treated congenital toxoplasmosis (NOS). The subject had no past medical condition of intestinal malformation and intestinal invagination. There was a family functional colopathy. In February 2008, the subject received a 1st dose of ROTARIX (batch number not available). On 17 February 2008, 14 days after vaccination with ROTARIX, the subject was hospitalized. At the echography, a diagnosis of ileocaecal invagination of intestine with mesenteric ganglions was made. The subject was treated with enema and the subject recovered. The hospital physicians evoked a possible relation between toxoplasmosis and mesenteric ganglions. The physician considered the events were unrelated to vaccination with ROTARIX (temporal association but non causal). Follow up received on 12 March 2008: The subject had no past medical history of intestinal invagination, abdominal surgery and intestinal malformation. There was no family history of intestinal invagination. Medical condition included congenital toxoplasmosis (maternal antibodies became positive during the pregnancy), treated with ADIAZINE and pyrimethamine since birth. On 12 February 2008, the subject received a first dose of ROTARIX (batch number A41CA526A) and a dose of INFANRIX QUINTA (batch number A20CA391B, right gluteal, subcutaneous). Five days later, on 17 February 2008, the subject developed moderate occlusive syndrome (intestinal obstruction) with vomiting and cessation of feces and flatus. Diagnosis of acute intestinal (ileocaecum) invagination was made on echography. No abdominal scan and X-ray was performed. The intestinal invagination was reduced by gastrografin enema, controlled on post reduction echography. ROTARIX has not been readministered. The reporter considered that the events were possibly related to vaccination with ROTARIX. Upon follow-up received from the agency (PB20080160) on 02 April 2010: Concurrent medication included ADIAZINE (500 mg/kg/day), MALOCIDE (2/5 mg/kg/day) and FOLINORAL (50 mg/kg/day) since birth. These drugs have not been stopped following the events. On 17 February 2008, the subject was admitted at hospital due to apathy and refusal to eat during more than 12 hours. Clinical course was favorable after enema. The subject recovered without sequelae in 48 hours. According to the foreign method of assessment, the causal relationship, between the reported events and vaccination with ROTARIX was dubious. This case has been closed; no more information will be available.
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