Japanese enceph vacc sa14-14-2, inactivated Side Effects
Medically reviewed by Drugs.com. Last updated on Jun 13, 2022.
For the Consumer
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%)
More about japanese enceph vacc sa14-14-2, inactivated
Patient resources
- Drug Information
- Japanese Encephalitis Virus Vaccine (Inactivated)
- Japanese Encephalitis Virus Vaccine (Live/Attenuated)
- Other brands
- Ixiaro
Professional resources
Related treatment guides
References
1. "Product Information. Ixiaro (Japanese encephalitis virus vaccine SA14-14-2)." Valneva USA, Gaithersburg, MD.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.