From CDC

Kawasaki Syndrome and RotaTeq Vaccine
The Food and Drug Administration (FDA) approved a revised label for RotaTeq®, a rotavirus vaccine manufactured by Merck, to include information on reports of Kawasaki syndrome occurring before and after the vaccine's licensure in February 2006. FDA has not made any changes to its indications for use of RotaTeq nor has it issued new or revised warnings or precautions. Likewise, the Centers for Disease Control and Prevention (CDC) has not made any changes in its recommendations regarding the use of RotaTeq. Healthcare providers and parents should remain confident in using RotaTeq in infants.

The FDA reports that five cases of Kawasaki syndrome have been identified in children less than 1 year of age who received the RotaTeq vaccine during clinical trials conducted before the vaccine was licensed. Three reports of Kawasaki syndrome were detected following the vaccine's approval in February 2006 through routine monitoring using the Vaccine Adverse Event Reporting System (VAERS). After learning about these Kawasaki syndrome reports, CDC identified one additional unconfirmed case through its Vaccine Safety Datalink (VSD) project. The vaccine label has been revised to notify healthcare providers and the public about the reports of Kawasaki syndrome following RotaTeq vaccination.

The number of Kawasaki syndrome reports does not exceed the number of cases we expect to see based on the usual occurrence of Kawasaki syndrome in children. There is no known cause-and-effect relationship between receiving RotaTeq or any other vaccine and the occurrence of Kawasaki syndrome.

The available data support the safety of the RotaTeq vaccine and its effectiveness in preventing rotavirus infection, a common cause of severe infant diarrhea and hospitalization. CDC and FDA continue to monitor the safety of RotaTeq and all vaccines.

• Kawasaki syndrome is a serious illness in children of unknown cause and characterized by a high fever that lasts several days. Kawasaki syndrome causes inflammation of the walls of the small- and medium-sized arteries (vasculitis) throughout the body, including the coronary arteries. Kawasaki syndrome primarily occurs in young children, most under 5 years of age. It affects approximately 4,000 children in the United States each year. There is no specific test to diagnose Kawasaki syndrome. A doctor diagnoses Kawasaki syndrome based on the presence of typical signs and symptoms. These include a high fever that lasts for five or more days, irritability, red eyes, bright red and cracked lips, a “strawberry” tongue, swollen hands and feet, peeling skin on the fingertips and toes, a rash, and swollen lymph nodes. Prompt recognition of symptoms and appropriate treatment are essential in the care of Kawasaki syndrome.
• Kawasaki syndrome has been seen after a variety of infectious or environmental exposures including a prior respiratory illness, exposure to carpet-cleaning chemicals, use of a humidifier, and living near a body of water. There is no firm evidence that Kawasaki syndrome is caused by any of these factors. Kawasaki syndrome has not been linked to vaccinations.