Note: This document contains side effect information about japanese enceph vacc sa14-14-2, inactivated. Some dosage forms listed on this page may not apply to the brand name Ixiaro.

Applies to japanese enceph vacc sa14-14-2, inactivated: parenteral suspension for im use.

Side effects include:

Infants and children 2 months through 11 years of age: Fever, irritability, flu-like symptoms, diarrhea, vomiting, loss of appetite, rash, injection site reactions (pain, tenderness, erythema).

Adults and adolescents ≥12 years of age: Headache, myalgia, fatigue, influenza-like illness, nausea, injection site reactions (pain, tenderness, erythema, induration).

For Healthcare Professionals

Applies to japanese enceph vacc sa14-14-2, inactivated: intramuscular suspension.

General

The most common adverse events in adults were injection site reactions, headache, and myalgia. The most common adverse events in adolescents (12 to under 18 years) were injection site pain and tenderness. The most common adverse event in children (1 to under 12 years) was fever. The most common adverse events in infants (2 months to under 1 year) were injection site redness, fever, irritability, and diarrhea.^[Ref]

Local

Very common (10% or more): Redness (17.6%), pain (15%)

Common (1% to 10%): Tenderness, swelling, hardening, induration, edema, pruritus^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (11.5%)

Common (1% to 10%): Vomiting, nausea

Frequency not reported: Rectal hemorrhage^[Ref]

Other

Very common (10% or more): Fever over 99.9F (23.7%), flu-like symptoms (13.3%), fatigue (11.3%)

Common (1% to 10%): Excessive fatigue

Frequency not reported: Chest pain, orthopedic injuries

Musculoskeletal

Very common (10% or more): Myalgia (15.6%)

Common (1% to 10%): Back pain^[Ref]

Nervous system

Febrile convulsions only occurred in patients under 3 years of age, onset was 2 days to over 5 months after vaccination with no apparent temporal clustering.

One case of multiple sclerosis was reported in adult clinical trials.^[Ref]

Common (1% to 10%): Headache

Frequency not reported: Febrile convulsions, multiple sclerosis

Postmarketing reports: Paresthesia, neuritis^[Ref]

Respiratory

Common (1% to 10%): Pharyngolaryngeal pain, cough^[Ref]

Immunologic

Common (1% to 10%): Nasopharyngitis, rhinitis, upper respiratory tract infection

Frequency not reported: Appendicitis, limb abscess contralateral to injected arm

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Dermatomyositis^[Ref]

Hematologic

Disseminated intravascular coagulation after suspected bacterial meningitis leading to death occurred in a 12 year old male patient 4 months after the second dose of this vaccine.

Frequency not reported: Disseminated intravascular coagulation

Cardiovascular

Myocardial infarction (MI) occurred in one adult patient with a history of MI, 3 weeks after receiving the second vaccine dose

Frequency not reported: Myocardial infarction

Genitourinary

Frequency not reported: Ovarian torsion

Metabolic

Common (1% to 10%): Loss of appetite

Psychiatric

Very common (10% or more): Irritability (15.3%)