In the U.S.—

In Canada—

• Immunizing agent, active

Pneumococcal (NEU-mo-KOK-al) vaccine polyvalent is an active immunizing agent used to prevent infection by pneumococcal bacteria. It works by causing your body to produce its own protection (antibodies) against the disease.

The following information applies only to the polyvalent 23 pneumococcal vaccine. Other polyvalent pneumococcal vaccines may be available in countries other than the U.S.

Pneumococcal infection can cause serious problems, such as pneumonia, which affects the lungs; meningitis, which affects the brain; bacteremia, which is a severe infection in the blood; and possibly death. These problems are more likely to occur in older adults and persons with certain diseases or conditions that make them more susceptible to a pneumococcal infection or more apt to develop serious problems from a pneumococcal infection.

Unless otherwise contraindicated, immunization against pneumococcal disease is recommended for all adults and children 2 years of age and older, especially:

• Older adults, especially those 65 years of age and older.
• Adults and children 2 to 64 years of age with chronic illnesses.
• Adults and children 2 to 64 years of age with sickle cell disease, those with spleen problems or without spleens, and those who are to have their spleens removed.
• Adults and children 2 to 64 years of age who are at increased risk for pneumococcal disease because of other illness (e.g., heart disease, lung disease, diabetes, alcoholism, and liver disease).
• Adults and children 2 to 64 years of age who are living in special environments or social settings (e.g., Alaskan Natives and certain American Indian populations) and residents of nursing homes and other long-term-care facilities.
• Adults and children 2 to 64 years of age with decreased disease-fighting ability (e.g., those with human immunodeficiency virus (HIV) infection, organ or bone marrow transplantations, and cancer).

Immunization against pneumococcal infection is not recommended for infants and children younger than 2 years of age, because these persons cannot produce enough antibodies to the vaccine to protect them against a pneumococcal infection.

Pneumococcal vaccine usually is given only once to each person. Additional injections are not given, except in special cases, because of the possibility of more frequent and more severe side effects.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pneumococcal vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pneumococcal vaccine. Also tell your health care professional if you are allergic to any other substances, such as preservatives (especially thimerosal).

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. However, if the vaccine is needed, it should be given after the first 3 months of pregnancy and only to women who have certain diseases or conditions that make them more susceptible to a pneumococcal infection or more likely to develop serious problems from a pneumococcal infection.

Breast-feeding—It is not known whether pneumococcal vaccine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are receiving this vaccine and who wish to breast-feed should discuss this with their doctor.

Children—Use of pneumococcal vaccine is not recommended in infants and children younger than 2 years of age. In children 2 years of age and older, this vaccine is not expected to cause different side effects or problems than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pneumococcal vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Severe illness with fever—The symptoms of the illness may be confused with possible side effects of the vaccine

• Previous severe reaction to the vaccine or
• Thrombocytopenic purpura (blood disorder)—Use of pneumococcal vaccine may make the condition worse

Dosing—

The dose of pneumococcal vaccine will be different for different patients. The following information includes only the average doses of pneumococcal vaccine.

• For injection dosage form:
  • For prevention of pneumococcal pneumonia:
    • Adults and children 2 years of age and older—One dose injected under the skin or into a muscle.
    • Children up to 2 years of age—Use is not recommended.

If you have more than one doctor, be sure they all know that you have received pneumococcal vaccine polyvalent 23 so that they can put the information into your medical records. This vaccine usually is given only once to each person, except in special cases.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

• Symptoms of allergic reaction
  • Difficulty in breathing or swallowing;  hives;  itching, especially of feet or hands;  reddening of skin, especially around ears;  swelling of eyes, face, or inside of nose;  unusual tiredness or weakness (sudden and severe) 
  
  

Check with your doctor as soon as possible if the following side effect occurs:

• Rare
  • Fever over 102.2 °F (39 °C) 
  
  

Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Redness, soreness, hard lump, swelling, or pain at place of injection  
  
  

• Less common or rare
  • Aches or pain in joints or muscles;  fever of 101 °F (38.3 °C) or less;  skin rash ;  swollen glands;  unusual tiredness or weakness;  vague feeling of bodily discomfort  
  
  

Side effects may be more common and more severe if this is not the first time you have received pneumococcal vaccine. Check with your doctor as soon as possible if you do have a severe reaction. Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.