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.

Medications such as cyclosporine and tacrolimus that weaken the immune system should not be used with Pneumovax 23 because they reduce the effects of Pneumovax 23.

During pregnancy, Pneumovax 23 should be used only when clearly needed. It is unknown if Pneumovax 23 enters breast milk. Consult your doctor before breastfeeding.

What are the important side effects of Pneumovax 23 (pneumococcal vaccine)?

Common side effects of pneumococcal vaccine are:

  • Injection site pain
  • Redness
  • Soreness
  • Tenderness

Other side effects include:

Severe allergic reactions may occur.

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

Serious adverse experiences within 14 days after placebo included myocardial infarction complicated with

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

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
N=444
Pneumovax 23 Revaccination*
N=564
Placebo Injection†
N=1008
Number Followed for Safety 438 548 984*
  AE Rate AE Rate AE Rate
Injection-Site Complaints
Solicited Events
  Pain/Soreness/ Tenderness 60.0% 77.2% 7.7%
  Swelling/ Induration 20.3% 39.8% 2.8%
  Erythema 16.4% 34.5% 3.3%
Unsolicited Events
  Ecchymosis 0% 1.1% 0.3%
  Pruritus 0.2% 1.6% 0.0%
Systemic Complaints
Solicited Events
  Asthenia/Fatigue 13.2% 17.9% 6.7%
  Chills 2.7% 7.8% 1.8%
  Myalgia 11.9% 17.3% 3.3%
  Headache 17.6% 18.1% 8.9%
Unsolicited Events
  Fever§ 1.4% 2.0% 0.7%
  Diarrhea 1.1% 0.7% 0.5%
  Dyspepsia 1.1% 1.1% 0.9%
  Nausea 1.8% 1.8% 0.9%
  Back Pain 0.9% 0.9% 1.0%
  Neck Pain 0.7% 1.5% 0.2%
  Upper Respiratory Infection 1.8% 2.6% 1.8%
  Pharyngitis 1.1% 0.4% 1.3%
*Subjects receiving their second dose of pneumococcal polysaccharide vaccine as Pneumovax 23 approximately 3-5 years after their first dose.
†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.

Post-Marketing Experience

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

Cellulitis Malaise
Fever ( > 102°F)
Warmth at the injection site
Decreased limb mobility
Peripheral edema in the injected extremity

Digestive System

Nausea
Vomiting

Hematologic/Lymphatic

Lymphadenitis
Lymphadenopathy
Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura
Hemolytic anemia in patients who have had other hematologic disorders
Leukocytosis

Hypersensitivity Reactions Including

Anaphylactoid reactions
Serum Sickness
Angioneurotic edema

Musculoskeletal System

Arthralgia
Arthritis

Nervous System

Paresthesia
Radiculoneuropathy
Guillain-Barré syndrome
Febrile convulsion

Skin

Rash
Urticaria
Cellulitis-like reactions
Erythema multiforme

Investigations

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.

Treatment & Diagnosis

Medications & Supplements

FDA Logo

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.

Medically Reviewed on 7/15/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.