Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine, intussusception, uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception, or Severe Combined Immunodeficiency Disease (SCID)

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Safety Profile for ROTARIX

Solicited Adverse Events

Total vaccinated cohort = all vaccinated infants for whom safety data were available.
n = number of infants for whom at least one symptom sheet was completed.
a Defined as crying more than usual.
b Data not collected in 1 of 7 studies. Dose 1: ROTARIX (n=2853); placebo (n=1897);
Dose 2: ROTARIX (n=2522); placebo (n=1863).
c Defined as temperature ≥100.4°F (≥38.0°C) rectally or ≥99.5°F (≥37.5°C) orally.
d Defined as eating less than usual.

Unsolicited Adverse Events

622801R0 July 2016