IMPORTANT SAFETY INFORMATION FOR Prevnar 13^®

Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13^®, Prevnar^®, or any diphtheria toxoid–containing vaccine is a contraindication to the use of Prevnar 13^®
Prevnar 13^® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes. Protection against otitis media is expected to be substantially lower than protection against invasive disease
Immunocompromised children or children with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to active immunization
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13^®, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
The most commonly reported serious adverse events were bronchiolitis (0.9%, 1.1%), gastroenteritis (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13™ and Prevnar^®, respectively
The most commonly reported solicited adverse reactions (≥20%) in US clinical trials with Prevnar 13^® were redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep

These documents are in PDF (portable document format).
PDF files require Adobe Reader; click here to download this free program.

IMPORTANT SAFETY INFORMATION FOR Prevnar 13®