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Je-Vax

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Je-Vax

Je-Vax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Je-Vax (Japanese Encephalitis Virus Vaccine Inactivated) is a vaccine used to help prevent Japanese encephalitis virus disease in adults and children who are at least 12 months old. Common side effects include redness, pain, or swelling where the shot was given, low fever, chills, flu symptoms, headache, tired feeling, muscle pain, nausea, vomiting, stomach pain, mild itching or skin rash.

For persons 3 years of age and older, a single dose is 1.0 mL of vaccine. For children 1 year to 3 years of age, a single dose is 0.5 mL of vaccine. Je-Vax may interact with steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you use and other vaccines you have recently received. Vaccines may be harmful to a fetus. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide if you should receive this vaccine, especially if you have a high risk of infection with the Japanese encephalitis virus. Consult your doctor before breastfeeding.

Our Je-Vax (Japanese Encephalitis Virus Vaccine Inactivated) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Je-Vax in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction (which may occur up to 17 days after you receive the shot): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • high fever;
  • behavior changes; or
  • seizures (black-out or convulsions).

Less serious side include:

  • redness, pain, or swelling where the shot was given;
  • low fever, chills, flu symptoms;
  • headache, tired feeling;
  • muscle pain;
  • nausea, vomiting, stomach pain; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Je-Vax (Japanese Encephalitis Virus Vaccine Inactivated) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Je-Vax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

JE vaccine is associated with a moderate frequency of local and mild systemic adverse effects.3,4,5,9,10,11,12 Tenderness, redness, swelling and other local effects have been reported in about 20% of vaccinees ( < 1% to 31%). Systemic side effects, principally fever, headache, malaise, rash, and other reactions, such as chills, dizziness, myalgia, nausea, vomiting and abdominal pain have been reported in approximately 10% of vaccinees.

In a study conducted by the CDC less than 5% of the 1,756 US travelers immunized with a three-dose regimen of the vaccine reported headache, flu-like symptoms, fever, and other systemic complaints. Hives and facial swelling were reported in 0.2% and 0.1% of vaccinees, respectively. Local soreness occurred in 5.9% and local redness in 2.9%. There was no increase in the number or severity of reactions with increasing numbers of doses.8

The US Army studied 4,034 personnel from 1987 to 1989.11 Using a two- or three-dose regimen of JE vaccine, arm soreness was described in 22.7%, local redness in 4.8%, headache in 15.2%, and a febrile episode in 5.5%. In another trial evaluating the safety and immunogenicity of a three-dose immunizing series (Day 0, 7, and 30 or Day 0, 7, and 14), performed in 538 adult volunteers in 1990, the Army determined that local soreness and redness occurred in 21% of vaccinees after the first dose, then decreased with subsequent injections (p < 0.0001, Chi-square for downward trend). Systemic symptoms including feverishness, headache and rash occurred in 5% of vaccinees after the first dose, then decreased with subsequent injections (p < 0.001, Chi-square for downward trend).5 Participants who received the third dose on Day 14 reported more side effects than those who received the injection on Day 30. Among these volunteers, 252 received a booster injection of vaccine one year after receiving the first dose of the primary series. Side effects reported after the booster injection included local symptoms of soreness (24.5%) and redness (6.1%) at the injection site and systemic complaints of headache (4.9%), fever (1.6%), and rash (0.8%). Less than 1% of all reported symptoms was graded as severe. No generalized urticaria or anaphylaxis was reported.

Since 1989, an apparently new pattern of adverse reactions has been reported among vaccinees in Europe, North America, and Australia.12,13,14 The reactions have been characterized by urticaria, often in a generalized distribution, or angioedema of the extremities, face, especially of the lips and oropharynx. Three vaccine recipients developed respiratory distress. Distress or collapse due to hypotension or other causes led to hospitalization in several cases. Most reactions were treated successfully with antihistamines or oral steroids; however some patients were hospitalized for parenteral steroid therapy. Three patients developed an erythema multiforme or erythema nodosum and some patients have had joint swelling. Some vaccinees complained of generalized itching without objective evidence of a rash.

An important feature of the reactions has been the interval between vaccination and onset of symptoms. Reactions after a first vaccine dose occurred after a median of 12 hours after immunization (88% of reactions occurred within 3 days). The interval between administration of a second dose and onset of symptoms generally was longer, (median 3 days and possibly as long as 2 weeks). Reactions have occurred after a second or third dose, when preceding doses were received uneventfully.

Between November 1991 and May 1992, the US Navy immunized 35,253 US personnel (marines, other military and dependents) with JE-VAX (japanese encephalitis virus vaccine inactivated) on Okinawa. The overall reaction rate, 62.4 per 10,000 vaccinees (95% confidence interval 54.2 to 70.6) includes persons reporting urticaria, angioedema, generalized itching and wheezing. The reaction rate per 10,000 vaccinees was 26.7 (95% confidence interval 21.3 to 32.1), 30.8 (95% confidence interval 24.6 to 37.0) or 12.2 (95% confidence interval 7.9 to 16.5) after the first, second or third dose, respectively.6 These reactions were generally mild to moderate in severity. Nine out of 35,253 persons immunized were hospitalized (2.6 per 10,000 vaccinees) primarily to allow administration of intravenous steroids for refractory urticaria. None of these reactions were considered life-threatening.

A case-control study conducted as part of the JE immunization campaign in Okinawa found that persons developing these reactions after JE vaccination were more likely to have had a past history of urticaria after hymenoptera envenomation, drugs, physical or other provocations or of idiopathic origins (relative risk 9.1, 95% confidence interval 1.8 to 50.9).6 The vaccine constituents responsible for these adverse reactions have not been identified.

Other serious adverse events reported following vaccination include (1) one case of Guillain-Barré syndrome after JE vaccination has been reported in the United States since 1984 (this patient was diagnosed as having mononucleosis three weeks before the onset of weakness); (2) one case of urticaria, hepatitis and respiratory failure one week after dose 2 (this person showed effusion and infiltrate on chest x-ray and eosinophilia); (3) one case of respiratory and renal failure one week after a dose (this 26-month-old male had infiltrate on chest x-ray and acid fast bacilli in sputum); and (4) one case of newly diagnosed hypertension in a young adult male presenting with a headache several hours after receiving dose one. The relationship of JE-VAX (japanese encephalitis virus vaccine inactivated) to the etiology of these adverse events is unknown.

Optic neuritis has been reported for one patient. In addition to JE-VAX (japanese encephalitis virus vaccine inactivated) , this patient concurrently received a number of other vaccines.15

Fatal myocarditis has been reported in a patient who had recently been given meningococcal vaccine and at least one dose of JE vaccine. Any causal role for the vaccines is unclear.15

Sudden death occurred approximately 60 hours after receiving the first dose of JE vaccine in a 21-year-old US military person with a history of recurrent hypersensitivity and an episode of possible anaphylaxis. This person also received the third dose of plague vaccine approximately 12 to 15 hours prior to the death. There was no evidence of urticaria or angioedema. Cause of death was not established at autopsy.

Surveillance of JE vaccine related complications in Japan from 1965 to 1973 disclosed neurologic events (primarily encephalitis, encephalopathy, seizures, and peripheral neuropathy) in 1 to 2.3 per million vaccinees.16,17 Very rarely, deaths occurred with vaccine-associated encephalitis. Between 1987 and 1989, two cases of neurologic dysfunction were reported from Japan; one of these was a transverse myelitis, while the second included seizures, cranial nerve paresis, cerebellar ataxia, and behavior disorder.17 In 1992, two cases of acute disseminated encephalomyelitis were reported from Japan; one occurred 14 days after the second dose and the second occurred 17 days after a booster dose of JE vaccine. Both cases recovered.18 One case of Bell's Palsy was reported from Thailand.

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine.19,20,21

Reporting by parents and patients of all adverse events occurring after antigen administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.19,20,21

Health-care providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

Read the entire FDA prescribing information for Je-Vax (Japanese Encephalitis Virus Vaccine Inactivated) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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