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. Pneumovax 23 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 of Pneumovax 23 include:
- injection site reactions (pain, soreness, warmth, redness, swelling, tenderness, hard lump),
- muscle or joint aches or pain,
- stiffness of the arm or the leg where the vaccine was injected,
- fatigue, or
- skin rash.
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 breastfeeding.
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.
Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.
Remember that your health care professional 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 right away if you have any serious side effects, including: unusual weakness, tingling/numbness of the hands/feet, easy bleeding/bruising, swollen glands.
A very serious allergic reaction to this drug is rare. However, get medical help right away 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 the 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 call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.
Read the entire patient information overview for Pneumovax 23 (Pneumococcal Vaccine Polyvalent)
The most common adverse reactions, reported in > 10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials were: injection-site pain/soreness/tenderness (60.0%), injection-site swelling/induration (20.3%), headache (17.6%), injection-site erythema (16.4%), asthenia/fatigue (13.2%), and myalgia (11.9%). [See Clinical Trials Experience]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
In a randomized, double-blind, placebo-controlled crossover clinical trial, subjects were enrolled in four different cohorts defined by age (50-64 years of age and ≥ 65 years of age) and vaccination status (no pneumococcal vaccination or receipt of a pneumococcal polysaccharide vaccine 3-5 years prior to the study). Subjects in each cohort were randomized to receive intramuscular injections of PNEUMOVAX 23 followed by placebo (saline containing 0.25% phenol), or placebo followed by PNEUMOVAX 23, at 30-day (±7 days) intervals. The safety of an initial vaccination (first dose) was compared to revaccination (second dose) with PNEUMOVAX 23 for 14 days following each vaccination.
All 1008 subjects (average age, 67 years; 49% male and 51% female; 91% Caucasian, 4.7% African-American, 3.5% Hispanic, and 0.8% Other) received placebo injections.
Initial vaccination was evaluated in a total of 444 subjects (average age 65 years; 32% male and 68% female; 93% Caucasian, 3.2% African-American, 3.4% Hispanic, and 1.1% Other).
Revaccination was evaluated in 564 subjects (average age 69 years; 53% male and 47% female; 90% Caucasian, 3.5% Hispanic, 6.0% African-American, and 0.5% Other).
Serious Adverse Experiences
In this study, 10 subjects had serious adverse experiences within 14 days of vaccination: 6 who received PNEUMOVAX 23 and 4 who received placebo. Serious adverse experiences within 14 days after PNEUMOVAX 23 included angina pectoris, heart failure, chest pain, ulcerative colitis, depression, and headache/tremor/stiffness/sweating. Serious adverse experiences within 14 days after placebo included myocardial infarction complicated with heart failure, alcohol intoxication, angina pectoris, and edema/urinary retention/heart failure/diabetes.
Five subjects reported serious adverse experiences that occurred outside the 14-day follow-up window: 3 who received PNEUMOVAX 23 and 2 who received placebo. Serious adverse experiences after PNEUMOVAX 23 included cerebrovascular accident, lumbar radiculopathy, and pancreatitis/myocardial infarction resulting in death. Serious adverse experiences after placebo included heart failure and motor vehicle accident resulting in death.4
Solicited and Unsolicited Reactions
Table 1 presents the adverse event rates for all solicited and unsolicited reactions reported in ≥ 1% in any group in this study, without regard to causality.
The most common local adverse reactions reported at the injection site after initial vaccination with PNEUMOVAX 23 were pain/tenderness/soreness (60.0%), swelling/induration (20.3%), and erythema (16.4%). The most common systemic adverse experiences were headache (17.6%), asthenia/fatigue (13.2%), and myalgia (11.9%).
The most common local adverse reactions reported at the injection site after revaccination with PNEUMOVAX 23 were pain/soreness/tenderness (77.2%), swelling (39.8%), and erythema (34.5%). The most common systemic adverse reactions with revaccination were headache (18.1%), asthenia/fatigue (17.9%), and myalgia (17.3%). All of these adverse reactions were reported at a rate lower than 10% after receiving a placebo injection.
Table 1: Incidence of Injection-Site and Systemic
Complaints in Adults ≥ 50 Years of Age Receiving Their First (Initial) or
Second (Revaccination) Dose of PNEUMOVAX 23 (Pneumococcal Polysaccharide
Vaccine, 23 Valent) or Placebo Occurring at ≥ 1% in Any Group
|PNEUMOVAX 23 Initial Vaccination
|PNEUMOVAX 23 Revaccination*
|Number Followed for Safety||438||548||984*|
|AE Rate||AE Rate||AE Rate|
|Upper Respiratory Infection||1.8%||2.6%||1.8%|
|*Subjects receiving their second dose of pneumococcal
polysaccharide vaccine as PNEUMOVAX 23 approximately 3-5 years after their
†Subjects receiving placebo injection from this study combined over periods.
‡The number of subjects receiving placebo followed for injection-site complaints. The corresponding number of subjects followed for systemic complaints was 981.5
§Fever events include subjects who felt feverish in addition to subjects with elevated temperature.
In this clinical study an increased rate of local reactions was observed with revaccination at 3-5 years following initial vaccination.
For subjects aged 65 years or older, injection-site adverse reaction rate was higher following revaccination (79.3%) than following initial vaccination (52.9%). The proportion of subjects reporting injection site discomfort that interfered with or prevented usual activity or injection site induration ≥ 4 inches was higher following revaccination (30.6%) than following initial vaccination (10.4%). Injection site reactions typically resolved by 5 days following vaccination.
For subjects aged 50-64 years, the injection-site adverse reaction rate for revaccinees and initial vaccinees was similar (79.6% and 72.8% respectively).
The rate of systemic adverse reactions was similar among both initial vaccinees and revaccinees within each age group. The rate of vaccine-related systemic adverse reactions was higher following revaccination (33.1%) than following initial vaccination (21.7%) in subjects 65 years of age or older, and was similar following revaccination (37.5%) and initial vaccination (35.5%) in subjects 50-64 years of age. The most common systemic adverse reactions reported after PNEUMOVAX 23 were as follows: asthenia/fatigue, myalgia and headache.
Regardless of age, the observed increase in post vaccination use of analgesics ( ≤ 13% in the revaccinees and ≤ 4% in the initial vaccinees) returned to baseline by day 5.
The following list of adverse reactions includes those identified during post approval use of PNEUMOVAX 23. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or their causal relationship to product exposure.
General Disorders And Administration Site Conditions
Fever ( > 102°F)
Warmth at the injection site
Decreased limb mobility
Peripheral edema in the injected extremity
Hypersensitivity Reactions Including
Increased serum C-reactive protein
3. Kelton, J.G.: Vaccination-associated relapse of immune thrombocytopenia, JAMA. 245(4): 369-371, 1981.
Read the entire FDA prescribing information for Pneumovax 23 (Pneumococcal Vaccine Polyvalent)