December 20, 2024

Pneumococcal Vaccine Safety

Pneumococcal disease is a serious infection caused by pneumococcus, which can cause many illnesses including pneumonia.
You can protect against serious pneumococcal disease with vaccination.
CDC monitors the safety of pneumococcal vaccines using several different safety systems.

Overview

Pneumococcal disease is a serious 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. You can protect against serious pneumococcal infections with vaccination. CDC, working with U.S. Food and Drug Administration (FDA) and other federal agencies, monitors pneumococcal vaccines using several safety systems.

Available vaccines

There are two types of pneumococcal vaccines for use in the United States: pneumococcal conjugate and pneumococcal polysaccharide.

Pneumococcal conjugate vaccines (PCV)

FDA has approved four conjugate pneumococcal vaccines for use in different groups:

Prevnar13 (PCV13) in 2010 for use in children and in 2011 for use in adults. PCV13 helps protect against 13 types of pneumococcal bacteria that cause the most severe illness among children and adults. PCV13 replaced a previous pneumococcal vaccine, PCV7.
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.
Prevnar20 (PCV20) in 2023 for use in people 6 weeks and older. PCV20 helps protect against 20 types of pneumococcal bacteria that commonly cause severe illness among adults.
Capvaxive (PCV21) in 2024 for use in adults 19 and older. PCV21 helps protect against eight new types of pneumococcal bacteria that commonly cause severe illness in adults and are not included in other licensed vaccines.

Keep Reading: Vaccine Information Statement

Pneumococcal polysaccharide vaccine (PPSV)

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

Keep Reading: Vaccine Information Statement

Who should and should not get the vaccine

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

Keep Reading: Who should and should not get which vaccine(s)

Common side effects

Vaccines, like any medical product, can have side effects. The most common side effects reported after pneumococcal vaccination are mild and last for 1 or 2 days. These include:

Feeling drowsy
Loss of appetite
Soreness or swelling at injection site
Fever
Headache

When to call 911

Severe allergic reactions following vaccination are rare but can be life threatening. If someone shows signs of a severe allergic reaction — such as hives, swelling or difficulty breathing — call 911 immediately.

Very rarely, severe (anaphylactic) allergic reactions may occur after vaccination.

A closer look at the safety data

A 2004 study of VAERS data found that most adverse events reported during the first two years after licensure of 7-valent pneumococcal conjugate vaccine (PCV7) were minor. Known side effects included fever, rash, and local reactions.1
Two large studies conducted in 2013 compared PCV13 with PPSV23. These studies took place in the United States and Europe among adults ages 50 years and older. Common adverse events reported with PCV13 included 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. Adults who received PPSV23 experienced similar adverse events.2 3
A 2012 study showed that children who received both the 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 FDA are committed to monitoring the safety of vaccines. Once vaccines are licensed or authorized by FDA for use in the United States, CDC, FDA, and other federal agencies work together to monitor them using several safety systems.

Keep Reading: About CDC's Vaccine Safety Monitoring Program

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 to report specific 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, including those listed by the manufacturer as a contraindication (a reason not to get more doses of a vaccine). Patients and caregivers can also submit reports to VAERS.

Submitting a Vaccine Adverse Event Reporting System (VAERS) Report and Using VAERS Data

Resources

Pneumococcal Vaccination

Young children, older adults, and people with certain risk conditions need pneumococcal vaccines.

Contraindications and Precautions

Contraindications and Precautions: General Best Practice Guidelines for Immunization. Advisory Commi...

Vaccines & Immunizations | Vaccines & Immunizations | CDC

Stay up –to date on getting recommended vaccines. Here are immunization schedules for people of all ages. Feb. 9, 2023

Vaccine & Immunization Information for Health Care Providers

CDC vaccine and vaccination information for U.S. health care providers.

December 20, 2024

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References

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
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
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
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

Sources

Centers for Disease Control and Prevention. Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. MMWR. 2012 Jun 1;61(21):394-5.
Hak E, Grobbee DE, Sanders EA, et al. Rationale and design of CAPITA: A RCT of 13-valent conjugated pneumococcal vaccine efficacy among older adults. Neth J Med. 2008;66:378–83.
Jackson LA, Gurtman A, van Cleeff M, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. Vaccine. 2013;31:3577–84.
Jackson LA, Gurtman A, Rice K, et al. 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. 2013;31:3585–93.
Kobayashi M, Farrar JL, Gierke R, Britton A, Childs L, Leidner AJ, Campos-Outcalt D, Morgan RL, Long SS, Talbot HK, Poehling KA, Pilishvili T. Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR. 2022;71(4);109–117.
Kobayashi M, Farrar JL, Gierke R, Leidner AJ, Campos-Outcalt D, Morgan RL, Long SS, Poehling KA, Cohen AL. Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR. 2022;71(37);1174–1181.
Tomczyk S, Bennett NM, Stoecker C, Gierke R, Moore MR, Whitney CG, et al. Use of PCV-13 and PPSV-23 vaccine among adults aged 65 and older: Recommendations of the ACIP. MMWR. 2014;63(37);822-825.
Tse A, Tseng HF, Greene SK, Vellozzi C, Lee GM; VSD Rapid Cycle Analysis Influenza Working Group. 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. 2012 Mar 2;30(11):2024-31.
Wise RP, Iskander J, Pratt RD, Campbell S, Ball R, et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA. 2004 Oct 13;292(14):1702-10.