Initial U.S. Approval: 1983
PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease…
PNEUMOVAX 23 is approved for use in persons 50 years of age or older…
WARNINGS AND PRECAUTIONS
Use caution and appropriate care for individuals with severely compromised cardiovascular and/or pulmonary function…
Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine, is not recommended.
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… angina pectoris, and edema/urinary retention/heart failure/diabetes.
Serious adverse experiences after PNEUMOVAX 23 included cerebrovascular accident, lumbar radiculopathy, and pancreatitis/myocardial infarction resulting in death.
Post-Marketing Experience
– Cellulitis
– Malaise
– Fever (>102°F)
– Warmth at the injection site
– Decreased limb mobility
– Peripheral edema in the injected extremity Injection-site necrosis
– Nausea
– Vomiting
– Lymphadenitis
– Lymphadenopathy
– Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura
– Hemolytic anemia in patients who have had other hematologic disorders Leukocytosis
– Anaphylactoid reactions
– Serum Sickness
– Angioneurotic edema
– Arthralgia
– Arthritis
– Paresthesia
– Radiculoneuropathy
– Guillain-Barré syndrome
– Febrile convulsion
– Rash
– Urticaria
– Cellulitis-like reactions
– Erythema multiforme
– Increased serum C-reactive protein
Post-marketing reports have been received in which some elderly individuals had severe adverse experiences and a complicated clinical course following vaccination. Some individuals with underlying medical conditions of varying severity experienced local reactions and fever associated with clinical deterioration requiring hospital care.