Applies to pneumococcal 23-polyvalent vaccine: injection injectable.

Serious side effects

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Other side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain, redness, or swelling where the shot was given.
• Headache.
• Feeling tired or weak.
• Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to pneumococcal 23-polyvalent vaccine: injectable solution.

General

The most common adverse events were fever and injection site reactions.^[Ref]

Local

Very common (10% or more): Pain/soreness/tenderness (77.2%), swelling/induration (39.8%), erythema (34.5%)

Common (1% to 10%): Pruritus, ecchymosis

Rare (less than 0.1%): Injection site cellulitis

Postmarketing reports: Warmth at injection site, decreased limb mobility, peripheral edema in injected extremity^[Ref]

Nervous system

Very common (10% or more): Headache (18.1%)

Frequency not reported: Cerebrovascular accident, lumbar radiculopathy

Postmarketing reports: Paresthesia, radiculoneuropathy, Guillain-Barre syndrome, febrile convulsion^[Ref]

Other

Very common (10% or more): Asthenia/fatigue (17.9%)

Common (1% to 10%): Fever

Frequency not reported: Alcohol intoxication

Postmarketing reports: Malaise, increased C-reactive protein^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (17.3%)

Common (1% to 10%): Chills, neck pain

Uncommon (0.1% to 1%): Back pain

Postmarketing reports: Arthralgia, arthritis^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dyspepsia, diarrhea

Frequency not reported: Ulcerative colitis, pancreatitis

Postmarketing reports: Vomiting^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory infection, pharyngitis^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactoid reactions, serum sickness, angioneurotic edema^[Ref]

Hematologic

Postmarketing reports: Lymphadenitis, lymphadenopathy, thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura, hemolytic anemia in patients who have had other hematologic disorders, leukocytosis^[Ref]

Dermatologic

Postmarketing reports: Cellulitis, rash, urticaria, cellulitis-like reactions, erythema multiforme^[Ref]

Cardiovascular

Frequency not reported: Angina pectoris, heart failure, chest pain, myocardial infarction resulting in death^[Ref]

Metabolic

Frequency not reported: Edema, diabetes^[Ref]

Genitourinary

Frequency not reported: Urinary retention^[Ref]