Dengvaxia Side Effects

Generic name: dengue vaccine

Medically reviewed by Drugs.com. Last updated on Nov 1, 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.

Precautions

It is very important that you receive the second and third dose of the vaccine series at the right times and that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Children without a previous laboratory-confirmed dengue infection should not receive the vaccine. Dengue tetravalent vaccine, live may increase your child's risk for severe dengue disease when vaccinated and later infected with the dengue virus. Your child's doctor should check for this information in your child's medical records.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

This vaccine may case syncope (fainting). Talk with your doctor if you have concerns.

Side effects from this vaccine could occur within 14 days after you receive a shot. Be sure to tell your doctor about any serious side effects that occur during that time.

This vaccine may not protect everyone completely. It is very important that you use precautions to reduce the risk of mosquito bites. Use insect repellents and mosquito nets, wear protective clothing, and stay indoors during twilight and after dark.

Make sure any doctor or dentist who treats you knows that you are receiving this medicine. This medicine may affect the results of certain medical tests, including tuberculin purified protein derivative (PPD) test sensitivity. Tuberculin testing should be done before or at least 1 month after receiving the vaccine.

Tell your doctor if you are using medicine that weakens the immune system, including cancer medicine, steroids, or radiation treatment.

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:

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:

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]

See also:

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