Pneumococcal vaccine polyvalent (Intramuscular, Subcutaneous)

Pneumococcal polyvalent vaccine is an active immunizing agent that helps prevent infection by pneumococcal bacteria. It does this by prompting your body to make its own protection (antibodies) against the disease.

The information below is specific to the polyvalent 23 pneumococcal vaccine. Other types of polyvalent pneumococcal vaccines may be available in countries outside the U.S.

Pneumococcal infection can lead to serious issues, including pneumonia, which affects the lungs; meningitis, which affects the brain; bacteremia, a severe blood infection; and potentially death. These issues are more likely to happen in older adults and people with certain diseases or conditions that make them more vulnerable to pneumococcal infection or more likely to experience serious complications from it.

Unless there are specific reasons not to, immunization (vaccination) against pneumococcal disease is recommended for all adults and children aged 2 years and older, especially:

• Older adults, particularly those 65 years of age and older.
• Adults and children aged 2 to 64 years with chronic illnesses.
• Adults and children aged 2 to 64 years with sickle cell disease, those with spleen issues or who do not have spleens, and those who are scheduled to have their spleens removed.
• Adults and children aged 2 to 64 years who are at higher risk for pneumococcal disease due to another illness (e.g., heart disease, lung disease, asthma, diabetes, alcoholism, liver disease, or kidney disease). People who smoke cigarettes should also get the vaccine.
• Adults and children aged 2 to 64 years 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 aged 2 to 64 years with weakened immune systems (e.g., those with human immunodeficiency virus (HIV) infection, organ or bone marrow transplants, and cancer).

Vaccination against pneumococcal infection is not recommended for infants and children younger than 2 years of age, as they cannot produce enough antibodies from the vaccine to protect them against a pneumococcal infection.

This vaccine should only be given by or under the supervision of your doctor or another healthcare professional.

If you see more than one doctor, make sure they all know you have received the pneumococcal vaccine polyvalent 23 so they can update your medical records. This vaccine is typically given only once to each person, except in special situations.

This vaccine can cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Contact your doctor immediately if you or your child has a rash, itching, swelling of the tongue and throat, or trouble breathing after getting the vaccine.

The pneumococcal polyvalent vaccine will not protect you or your child from all types of pneumococcal infections. It also will not treat an active infection.

In deciding to use a vaccine, you and your doctor will weigh the risks of the vaccine against its benefits. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

The pneumococcal polyvalent vaccine is not recommended for infants and children younger than 2 years of age.

Geriatric

Current studies have not shown any specific problems for elderly patients that would limit the usefulness of the pneumococcal polyvalent vaccine. However, older patients are more likely to experience unwanted effects, so caution may be needed for those receiving this vaccine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might occur. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this vaccine. The following interactions have been chosen for their potential importance and are not an exhaustive list.

Using this vaccine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy
• Zoster Vaccine, Live

Using this vaccine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both of the medicines.

• Pneumococcal 20-Valent Vaccine, Diphtheria Conjugate
• Rituximab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect your ability to use this vaccine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Brain disease or
• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as effectively in patients with these conditions.

• Heart or blood vessel disease or
• Lung disease—Use with caution, as it may increase the risk of more serious side effects.

• Moderate to severe acute illness—Patients with this condition should receive the vaccine at a later time.

• Thrombocytopenic purpura (blood disorder)—Use with caution, as it may worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Chills

Less common

• Body aches or pain
• Cough
• Difficulty with breathing
• Ear congestion
• Fever
• Headache
• Loss of voice
• Nasal congestion
• Runny nose
• Sneezing
• Sore throat
• Unusual tiredness or weakness

Rare

• Fever over 102.2 °F (39 °C)

Incidence not known

• Black, tarry stools
• Bleeding gums
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blood in the urine or stools
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Decreased movement of the legs
• Difficulty with breathing or swallowing
• Dizziness
• Eye pain
• Fast heartbeat
• Feeling of discomfort
• General feeling of discomfort or illness
• Headache
• Hives
• Inflammation of the joints
• Itching, especially of the feet or hands
• Itching, pain, redness, swelling, tenderness, or warmth on the skin
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Muscle aches
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Rash
• Shortness of breath
• Swollen lymph glands
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Tightness in the chest
• Tingling of the hands or feet
• Reddish skin, especially around the ears
• Swelling of the eyes, face, or inside of the nose
• Unusual bleeding or bruising
• Unusual tiredness or weakness (sudden and severe)
• Unusual weight gain or loss
• Wheezing

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty with moving
• Lack or loss of strength
• Muscle aching or cramping
• Muscle pains or stiffness
• Redness, soreness, hard lump, swelling, tenderness, or pain at the injection site
• Swollen joints

Less common or rare

• Aches or pain in the joints or muscles
• Fever of 101 °F (38.3 °C) or less
• Swollen glands
• Vague feeling of bodily discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Pneumovax 23
• Pnu-Imune 23

In Canada

• Prevnar

Available Dosage Forms:

• Solution

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of the muscles or under the skin, usually in the thigh or upper arm.

Pneumococcal vaccine is usually given only once to each person. Additional injections are only given for special cases, because of the possibility of more frequent and more severe side effects.