Pneumovax 23 Side Effects

Please note - some side effects for Pneumovax 23 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Pneumovax 23 - for the Consumer

Pneumovax 23

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pneumovax 23:

Fever; redness, soreness, swelling, or a lump at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using Pneumovax 23:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Pneumovax 23 Side Effects - for the Professional

Pneumovax 23

The most common adverse experiences reported with Pneumovax 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 23 include:

General disorders and administration site conditions
Cellulitis
Asthenia
Malaise
Fever (> 102°F)
Chills
Pain
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{38}
Hemolytic anemia in patients who have had other hematologic disorders
Leukocytosis

Hypersensitivity reactions including
Anaphylactoid reactions
Serum Sickness
Angioneurotic edema

Musculoskeletal System
Arthralgia
Arthritis
Myalgia

Nervous System
Headache
Paresthesia
Radiculoneuropathy
Guillain-Barré syndrome
Febrile convulsion

Skin
Rash
Urticaria

Investigations
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 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.

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Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions, serum sickness, and angioneurotic edema.

Hematologic

Hematologic side effects have included lymphadenitis, thrombocytopenia in patient with stabilized idiopathic thrombocytopenic purpura, and hemolytic anemia in patients who have had other hematologic disorders.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, and myalgia.

Nervous system

Nervous system side effects have included headache, paresthesia, radiculoneuropathy, and Guillain-Barre syndrome.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Dermatologic

Dermatologic side effects have included rash and urticaria.

Local

Local side effects have included soreness, warmth, erythema, swelling, and induration.

General

General side effects have included cellulitis, asthenia, malaise, and fever.

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