Japanese encephalitis virus vaccine Side Effects

Please note - some side effects for Japanese encephalitis virus vaccine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: subcutaneous powder for injection

General

The majority of adverse effects associated with Japanese encephalitis vaccine have been local and mild systemic effects. In some studies, less than 1% of adverse events were classified as severe. Side effects reportedly decrease with subsequent injections; however, in some cases reactions have occurred with second or third doses, after uneventful prior doses.

Any allergic and unusual adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (USA) and to the manufacturer.

Local

Local side effects have included tenderness, redness, swelling in <1% up to 31% of vaccinees. Local soreness and redness reportedly decreases with subsequent injections.

Dermatologic

Dermatologic side effects have included rash and urticaria. Some vaccinees had generalized itching without evidence of a rash. Refractory urticaria requiring intravenous steroids has also been reported.

Hypersensitivity

Hypersensitivity or hypersensitivity-like reactions have included hives (0.2%), facial swelling (0.1%), generalized urticaria, angioedema of the extremities, and face, especially the lips and oropharynx, erythema multiforme, erythema nodosum, joint swelling, respiratory distress, hypotension, and collapse.

Nervous system

Nervous system side effects have rarely included encephalitis, encephalopathy, seizures, peripheral neuropathy, transverse myelitis, cranial nerve paresis, cerebellar ataxia, behavior disorder, acute disseminated encephalomyelitis, and Bell's palsy.

Cardiovascular

Cardiovascular side effects have included fatal myocarditis in a patient who received Japanese encephalitis vaccine and meningococcal vaccine, and sudden death in a patient with a history of hypersensitivity and possible anaphylaxis who also received plague vaccine. Hypotension has been reported in conjunction with allergic-like symptoms.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and abdominal pain in 10% of vaccinees.

Ocular

Ocular side effects have included optic neuritis in a patient who received Japanese encephalitis vaccine concurrently with multiple other vaccines.

Respiratory

Respiratory side effects have included dyspnea and wheezing in conjunction with allergic-like symptoms.

Other

Other systemic side effects have included fever, dizziness, flu-like symptoms, headache, myalgia, malaise, and chills in 5% to 10% of vaccinees. Headache and febrile episodes were reported in 15.2% and 5.5%, respectively.

Other

Serious adverse events have included Guillain-Barre syndrome in a patient who had mononucleosis; one case of urticaria, hepatitis, respiratory failure, eosinophilia, and pulmonary effusion and infiltrate; respiratory and renal failure in a patient with acid fast bacilli in sputum and pulmonary infiltrate; and hypertension of unknown etiology in a patient who developed a headache several hours after the first dose. Causality has not been determined.

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