Dengvaxia Side Effects

Generic name: dengue vaccine

Medically reviewed by Drugs.com. Last updated on Aug 13, 2024.

Note: This document provides detailed information about Dengvaxia Side Effects associated with dengue vaccine. Some dosage forms listed on this page may not apply specifically to the brand name Dengvaxia.

Applies to dengue vaccine: subcutaneous powder for suspension.

Common side effects of Dengvaxia

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 side effects

• 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 side effects

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

Serious side effects of Dengvaxia

Along with its needed effects, dengue vaccine (the active ingredient contained in Dengvaxia) 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 side effects

• 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

For healthcare professionals

Applies to dengue vaccine: subcutaneous powder for injection.

General adverse events

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

Dermatologic

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

Gastrointestinal

• Uncommon (0.1% to 1%): Abdominal pain, nausea, vomiting, diarrhea^[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

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

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

• 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]

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]

Respiratory

• Very common (10% or more): Respiratory tract infection
• Common (1% to 10%): Nasopharyngitis, pharyngotonsillitis
• Uncommon (0.1% to 1%): Bronchitis, rhinitis, asthma attack, dyspnea^[Ref]

Frequently asked questions

• Why can't the dengue vaccine Dengvaxia be used in people who haven't already had dengue?

Further information

Dengvaxia side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer