Does Pneumovax 23 (pneumococcal vaccine) cause side effects?
Pneumovax 23 (pneumococcal vaccine) is an immunization used to prevent pneumonia. This pneumococcal vaccine contains chemicals (polysaccharides) extracted from 23 types of Streptococcus pneumonia bacteria.
Upon injecting pneumococcal vaccine, the body recognizes these chemical as foreign and produces antibodies to destroy the chemicals. Antibodies are blood protein that help the body fight infection and destroy other harmful substances.
Once produced, these antibodies destroy injected Streptococcus pneumonia chemicals but the antibodies remain active in the body and can detect the same chemicals from live Streptococcus pneumonia in the future. If a vaccinated person comes in contact with Streptococcus pneumonia the antibodies will destroy the bacteria and prevent pneumonia or reduce its severity.
Pneumovax 23 should not be confused with pneumococcal conjugate vaccine (PCV13) used in special conditions (children under 5 years old, for example) because often in the medical literature the non-specific term "pneumococcal vaccine" is used.
Common side effects of Pneumovax 23 include
Serious side effects of Pneumovax 23 include severe allergic reactions.
Drug interactions of Pneumovax 23 include zoster vaccine live (Zostavax) administered at the same time. When they are given concurrently, Pneumovax 23 reduces the response of zoster vaccine compared to those who received both vaccines 4 weeks apart.
Pneumovax 23 (pneumococcal vaccine) side effects list for healthcare professionals
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%).
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
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:
- myalgia and
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
Hypersensitivity Reactions Including
Increased serum C-reactive protein
What drugs interact with Pneumovax 23 (pneumococcal vaccine)?
Concomitant Administration With Other Vaccines
In a randomized clinical study, a reduced immune response to Zostavax as measured by gpELISA was observed in individuals who received concurrent administration of Pneumovax 23 and Zostavax compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.
Limited safety and immunogenicity data from clinical trials are available on the concurrent administration of Pneumovax 23 and vaccines other than Zostavax.
Multimedia: Slideshows, Images & Quizzes
Related Disease Conditions
Pneumonia is inflammation of the lungs caused by fungi, bacteria, or viruses. Symptoms and signs include cough, fever, shortness of breath, and chills. Antibiotics treat pneumonia, and the choice of the antibiotic depends upon the cause of the infection.
Is Pneumonia Contagious?
Pneumonia is inflammation of the lung usually caused by bacterial or viral infection (rarely, also by fungi) that causes the air sacs to fill with pus. If inflammation affects both lungs, the infection is termed double pneumonia. If it affects one lung, it is termed single pneumonia. If it affects only a certain lobe of a lung it's termed lobar pneumonia. Most pneumonias are caused by bacteria and viruses, but some pneumonias are caused by inhaling toxic chemicals that damage lung tissue.
Second Source article from WebMD
Second Source article from Government
Interstitial Lung Disease (Interstitial Pneumonia)
Interstitial lung disease refers to a variety of diseased that thicken the tissue between the lungs' air sacks. Symptoms of interstitial lung disease include shortness of breath, cough, and vascular problems, and their treatment depends on the underlying cause of the tissue thickening. Causes include viruses, bacteria, tobacco smoke, environmental factors, cancer, and heart or kidney failure.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.