Applies to pneumococcal 15-valent conjugate vaccine: intramuscular suspension.

Serious side effects

Along with its needed effects, pneumococcal 15-valent conjugate vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking pneumococcal 15-valent conjugate vaccine:

Less common

• Fever

Other side effects

Some side effects of pneumococcal 15-valent conjugate vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• decreased appetite
• difficulty in moving
• headache
• joint pain or swelling
• muscle aches, cramps, pains, or stiffness
• unusual tiredness or weakness

For Healthcare Professionals

Applies to pneumococcal 15-valent conjugate vaccine: intramuscular suspension.

Dermatologic

Frequency of rash was common in infants.

Common (1% to 10%): Rash, urticaria

Gastrointestinal

Common (1% to 10%): Nausea, vomiting

Vomiting was more common in infants.

General

The most common adverse events were injection site pain, myalgia, fatigue, injection site swelling and erythema, and arthralgia.^[Ref]

Hypersensitivity

Hypersensitivity reactions were reported in adults.

Rare (0.01% to 0.1%): Hypersensitivity reaction (including tongue edema, flushing, and throat tightness)

Local

Very common (10% or more): Pain (66.8% to 75.8%), erythema (10.9% to 15.1%)

Common (1% to 10%): Injection site bruising/hematoma, pruritus

Uncommon (0.1% to 1%): Injection-site urticaria, warmth

Frequency not reported: Induration, swelling^[Ref]

Metabolic

Very common (10% or more): Decreased appetite

Decrease in appetite was very common in infants aged less than 2 years than children of greater than 2 years of age.

Musculoskeletal

Very common (10% or more): Arthralgia (7.7% to 12.7%), myalgia (26.9% to 28.8%)^[Ref]

Nervous system

Very common (10% or more): Headache (18.9% to 26.5%)

Uncommon (0.1% to 1%): Dizziness

Frequency not reported: Somnolence^[Ref]

Somnolence was very common in infants.^[Ref]

Other

Very common (10% or more): Fatigue (21.5% to 34.3%)

Common (1% to 10%): Fever

Uncommon (0.1% to 1%): Chills^[Ref]

Psychiatric

Irritability was very common in infants aged less than 2 years of age.

Very common (10% or more): Irritability