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Pneumovax Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Pneumovax 23 (Pneumococcal Vaccine Polyvalent) is a vaccine that helps protect against serious infection, such as ear infection, sinus infection, pneumonia, blood infection (bacteremia), and meningitis (infection of the covering of the brain) due to the bacteria Streptococcus pneumoniae. This vaccine is important for preventing infection in individuals at risk, including those with heart disease, lung disease, liver disease, kidney disease, diabetes, alcoholism, cirrhosis, spleen problems, sickle cell anemia, HIV, certain cancers, adults over 65 years of age. Common side effects include injection site reactions (pain, redness, swelling, hard lump), muscle/joint aches, fever, nausea and vomiting.
A single 0.5 ml dose of Pneumovax 23 vaccine is injected subcutaneously (under the skin) or intramuscularly (in the deltoid muscle or lateral mid-thigh) by a physician or nurse. Pneumovax may interact with steroids, treatment for cancer with chemotherapy (medication), radiation, or x-rays, azathioprine, basiliximab, cyclosporine, etanercept, leflunomide, muromonab-CD3, mycophenolate mofetil, sirolimus, or tacrolimus. Tell your doctor all medications you are taking. During pregnancy, Pneumovax should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Pneumovax 23 (Pneumococcal Vaccine Polyvalent) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Pneumovax in Detail - Patient Information: Side Effects
Getting pneumococcal disease is much riskier than getting pneumococcal polysaccharide vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of pneumococcal polysaccharide vaccine causing serious harm, or death, is extremely small.
Seek emergency medical attention or contact your doctor immediately if any of the following rare but serious side effects from pneumococcal polysaccharide vaccine are experienced:
- a serious allergic reaction including swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; hives; paleness; weakness; dizziness; or a fast heart beat within a few minutes to a few hours after the shot; or
- high fever; or
- behavior changes.
About half of those who get PPV have very mild side effects, such as redness or pain where the shot is given. Less and 1% develop fever, muscle aches, or more severe local reactions.
Your doctor may recommend reducing fever or pain that may occur by taking an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications.
Side effects other than those listed here may also occur. Contact your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Pneumovax (Pneumococcal Vaccine Polyvalent) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Pneumovax Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual weakness, tingling/numbness of the hands/feet, easy bleeding/bruising, swollen glands.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice any other effects not listed, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Pneumovax (Pneumococcal Vaccine Polyvalent)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Pneumovax FDA Prescribing Information: Side Effects
The most common adverse experiences reported with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 in clinical trials were: Local reaction at injection site including soreness, erythema, warmth, swelling and induration Fever ≤ 102°F
Other adverse experiences reported in clinical trials and/or in post-marketing experience with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 include:
General disorders and administration site conditions
Fever ( > 102°F)
Decreased limb mobility
Peripheral edema in the injected extremity
Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura38
Hemolytic anemia in patients who have had other hematologic disorders
Hypersensitivity reactions including
Increased serum C-reactive protein
In post-marketing experience, injection site cellulitis-like reactions were reported rarely; between 1989 and 2002, when approximately 43 million doses were distributed, the annual reporting rate was < 2/100,000 doses. These cellulitis-like reactions occurred with initial and repeat vaccination at a median onset time of 2 days after vaccine administration.
Systemic signs and symptoms including fever, leukocytosis and an increase in the laboratory value for serum C-reactive protein may be associated with local reactions.
In a clinical trial, an increased rate of local reactions has been observed with revaccination at 3-5 years following primary vaccination.
For subjects aged ≥ 65 years, it was reported that the overall injection-site adverse experiences rate was higher following revaccination (79.3%) than following primary vaccination (52.9%). For subjects aged 50-64 years, the reported overall injection-site adverse experiences rate for re-vaccinees and primary vaccinees were similar (79.6% and 72.8% respectively).
In both age groups, re-vaccinees reported a higher rate of a composite endpoint (any of the following: moderate pain, severe pain, and/or large induration at the injection site) than primary vaccinees. Among subjects ≥ 65 years of age, the composite endpoint was reported by 30.6% and 10.4% of revaccination and primary vaccination subjects, respectively, while among subjects 50-64 years of age, the endpoint was reported by 35.5% and 18.9% respectively. The injection site reactions occurred within the 3 day monitoring period and typically resolved by day 5.
The rate of overall systemic adverse experiences was similar among both primary vaccinees and re-vaccinees within each age group. The rate of vaccine-related systemic adverse experiences was higher following revaccination (33.1%) than following primary vaccination (21.7%) in subjects ≥ 65 years of age, and was similar following revaccination (37.5%) and primary vaccination (35.5%) in subjects 50-64 years of age. The most common systemic adverse experiences reported after PNEUMOVAX (pneumococcal vaccine polyvalent) 23 were as follows: asthenia/fatigue, myalgia and headache.
Regardless of age, the observed increase in post vaccination use of analgesics ( ≤ 13% in the re-vaccinees and ≤ 4% in the primary vaccinees) returned to baseline by day 5.
Read the entire FDA prescribing information for Pneumovax (Pneumococcal Vaccine Polyvalent) »
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