Pneumococcal Vaccine Safety

Key points

You can protect against pneumococcal disease with vaccination.

Overview

Pneumococcal disease is an infection caused by Streptococcus pneumoniae bacteria, sometimes referred to as pneumococcus. Pneumococcus can cause many types of illnesses, including ear and sinus infections, pneumonia, and bloodstream infections.

Available vaccines & manufacturer package inserts

Pneumococcal conjugate vaccines (PCV)

  • The FDA approved Prevnar13 (PCV13) in 2010 for use in children and in 2011 for use in adults. PCV13 replaced a previous pneumococcal vaccine, PCV7. PCV13 helps protect against 13 types of pneumococcal bacteria that cause the most severe illness among children and adults.
  • FDA approved Vaxneuvance (PCV15) in 2021 for use in adults and in 2022 for use in children. PCV15 helps protect against 15 types of pneumococcal bacteria that commonly cause severe illness among adults.
  • FDA approved Prevnar20 in 2023 for use in individuals ages 6 weeks and older. PCV20 helps protect against 20 types of pneumococcal bacteria that commonly cause severe illness among adults.

Pneumococcal polysaccharide vaccine (PPSV)

  • FDA approved Pneumovax 23 (PPSV23) in 1983. It helps protect against serious infections caused by 23 types of pneumococcal bacteria.

Who should get the vaccine

There are people who should and should not get each type of pneumococcal vaccine.

Common side effects

  • Feeling drowsy.
  • Loss of appetite.
  • Sore or swollen arm from the shot.
  • Fever.
  • Headache.

When to call 911‎

Severe allergic reactions following vaccination are rare, but can be life threatening. If someone experiences symptoms of a severe allergic reaction, which can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

Vaccines, like any medicine, can have side effects. The most common side effects from pneumococcal vaccines are mild and last for 1 or 2 days. Very rarely, severe (anaphylactic) allergic reactions may occur after vaccination.

Report possible adverse events to VAERS‎

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.

A closer look at the safety data

  • A 2004 study found most VAERS reports in the first 2 years after licensure of 7-valent pneumococcal conjugate vaccine (PCV7) were minor known side effects.1
  • Two large 2013 studies conducted in the United States and Europe in adults ages 50 years and older compared PCV13 with PPSV23. Common adverse events reported with PCV13 were pain, redness, and swelling at the injection site; limited movement of the injected arm; tiredness; headache; chills; decreased appetite; generalized muscle pain; and joint pain. Similar reactions were observed in adults who received PPSV23.23
  • A 2012 study showed that children who received both 2010-2011 trivalent influenza (flu) vaccine and PCV13 at the same doctor visit had a higher risk of febrile seizures.4

How CDC monitors vaccine safety

CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.

Resources

  1. Wise, R. P., Iskander, J., Pratt, R. D., Campbell, S., Ball, R., Pless, R. P., & Braun, M. M. (2004). Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA, 292(14), 1702–1710. https://doi.org/10.1001/jama.292.14.1702
  2. Jackson, L. A., Gurtman, A., van Cleeff, M., Jansen, K. U., Jayawardene, D., Devlin, C., Scott, D. A., Emini, E. A., Gruber, W. C., & Schmoele-Thoma, B. (2013). Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. Vaccine, 31(35), 3577–3584. https://doi.org/10.1016/j.vaccine.2013.04.085
  3. Jackson, L. A., Gurtman, A., Rice, K., Pauksens, K., Greenberg, R. N., Jones, T. R., Scott, D. A., Emini, E. A., Gruber, W. C., & Schmoele-Thoma, B. (2013). Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine, 31(35), 3585–3593. https://doi.org/10.1016/j.vaccine.2013.05.010
  4. Tse, A., Tseng, H. F., Greene, S. K., Vellozzi, C., Lee, G. M., & VSD Rapid Cycle Analysis Influenza Working Group (2012). Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011. Vaccine, 30(11), 2024–2031. https://doi.org/10.1016/j.vaccine.2012.01.027