Home > Important Safety Information

Important Safety Information

IMPORTANT SAFETY INFORMATION FOR PREVNAR 13^®

• Prevnar 13^® should not be given to anyone with a severe allergic reaction to any component of Prevnar 13^®, Prevnar^® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) or any diphtheria toxoid–containing vaccine.
• Prevnar 13^® may not protect all individuals receiving the vaccine.
• Protection against ear infections is expected to be less than that for invasive disease.
• Children with weakened immune systems may have a reduced immune response to Prevnar 13^®.
• A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
• The most commonly reported serious adverse events include bronchiolitis (an infection of the lungs) (0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13^® and Prevnar^®, respectively.
• The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Any side effects associated with the vaccination should be reported to your child's health care provider.
• Ask your child's health care provider about the risks and benefits of Prevnar 13^®. Only a health care provider can decide if Prevnar 13^® is right for your child.

Please see Prescribing Information for Prevnar 13^® 

INDICATION FOR PREVNAR 13^®

• Prevnar 13^® is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday).
• Prevnar 13^® is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
• Prevnar 13^® is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.