Pfizer is committed to consistently monitoring the safety of PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). In clinical studies, PREVNAR 13® was given to more than 5,000 adults 50 and older. PREVNAR 13® does not contain a live virus or bacteria. It contains the same protein that has been a building block of vaccines for more than 20 years.
Some patients have experienced side effects. But they are generally mild.
Because PREVNAR 13® is given by injection, the common side effects reported in clinical trials were injection site reactions: redness, swelling, pain at the injection site, and limitation of arm movement. There were also systemic side effects: fatigue, headache, muscle pain, joint pain, decreased appetite, chills, and rash.
PREVNAR 13® should not be given to anyone with a severe allergic reaction to any component of PREVNAR 13® or any diphtheria toxoid–containing vaccine. Adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response. In adults, immune responses to PREVNAR 13® were reduced when given with injected seasonal flu vaccine. In adults, the common side effects were pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills, or rash.
If you experience any side effects related to the vaccination, you should report them to your health care provider. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.