AAP News TODAY 2016 - Sunday, October 23, 2016 - 11
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Not an actual patient.
Selected Safety Information
No safety or efficacy data are available for
administration of RotaTeq to infants with a history
of gastrointestinal disorders.
Reference: 1. Vesikari T, Matson DO, Dennehy P, et al; for Rotavirus
Efficacy and Safety Trial (REST) Study Team. Safety and efficacy
of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.
N Engl J Med. 2006;354(1):23-33.
Vaccine virus transmission from vaccine recipient to
nonvaccinated contacts has been reported. Caution
is advised when considering whether to administer
RotaTeq to individuals with immunodeficient contacts.
In clinical trials, the most common adverse events
included diarrhea, vomiting, irritability, otitis media,
nasopharyngitis, and bronchospasm.
In post-marketing experience, intussusception
(including death) and Kawasaki disease have been
reported in infants who have received RotaTeq.
RotaTeq may not protect all vaccine recipients
Please see the adjacent Brief Summary of the