Applies to dengue vaccine: subcutaneous powder for suspension.

Serious side effects of Dengue vaccine

Along with its needed effects, dengue 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 dengue vaccine:

Rare

• Bleeding in the mouth
• cough
• high fever
• noisy breathing
• persistent vomiting
• redness of the skin
• restlessness
• severe stomach pain or tenderness
• sleepiness or drowsiness
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• trouble breathing

Incidence not known

• Difficulty swallowing
• dizziness
• fast heartbeat
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Other side effects of Dengue vaccine

Some side effects of dengue 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 the 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
• difficulty in moving
• general feeling of discomfort or illness
• headache
• joint pain or swelling
• lack or loss of strength
• muscle pains, cramps, or stiffness

Rare

• Collection of blood under the skin
• deep, dark purple bruise
• stomach pain
• vomiting

For Healthcare Professionals

Applies to dengue vaccine: subcutaneous powder for injection.

General

The most common adverse events after dose 1 were headache, injection site pain and myalgia.^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Generalized erythema, pruritus, urticaria^[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Abdominal pain, vomiting^[Ref]

Hematologic

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

Hypersensitivity

Postmarketing reports: Anaphylactic reactions^[Ref]

Immunologic

Postmarketing reports: Severe dengue infection^[Ref]

Local

Very common (10% or more): Injection site pain (up to 32.4%)

Common (1% to 10%): Erythema (up to 7.9%), swelling (up to 5.5%)

Uncommon (0.1% to 1%): Induration, injection site anesthesia, injection site discoloration, injection site hematoma, injection site pain (after 7 days following any dose), injection site pruritus^[Ref]

Injection site pain occurred in 32.4% of patients after dose 1, 26.5% of patients after dose 2, and 23.1% of patients after dose 3.

Erythema occurred in 7.9% of patients after dose 1, 4.7% of patients after dose 2, and 5.6% of patients after dose 3. swelling occurred in 5.5% of patients after dose 1, 4% of patients after dose 2, and 3.2% of patients after dose 3.^[Ref]

Musculoskeletal

Myalgia occurred in 29% of patients after dose 1, 21% after dose 2, and 20% after dose 3.^[Ref]

Very common (10% or more): Myalgia (up to 29.2%)^[Ref]

Nervous system

Very common (10% or more): Headache (up to 40%)

Uncommon (0.1% to 1%): Acute disseminated encephalomyelitis, convulsion, dizziness, vertigo^[Ref]

Acute disseminated encephalomyelitis occurred 7 days after dose 1.

Convulsion occurred the day of dose 1.

Headache occurred in 40% of patients after dose 1, and 30% after dose 2 and 3.^[Ref]

Other

Asthenia occurred in 25% of patients after dose 1, 18% after dose 2, and 16.3% after dose 3.

Malaise occurred in 25% of patient after dose 1, 21% after dose 2, and 19.3% after dose 3.

Fever occurred in 8.3% of the patients after dose 1, 9.1% after dose 2, and 7.3% after dose 3.^[Ref]

Very common (10% or more): Asthenia (up to 25%), malaise (up to 25%)

Common (1% to 10%): Fever (up to 8.3%)

Frequency not reported: Death^[Ref]

Respiratory

Uncommon (0.1% to 1%): Asthma attack, asthma crisis, dyspnea^[Ref]