Tick-borne encephalitis (inactivated) pediatric vaccine Side Effects

Applies to tick-borne encephalitis (inactivated) pediatric vaccine: intramuscular suspension.

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 shot caused any side effects.

Becoming infected with tick-borne encephalitis is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is low.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• pain and tenderness where the vaccine was given;

• headache;

• fever;

• restlessness; or

• weakness.

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 vaccine side effects to the US Department of Health and Human Services at 1 800 822 7967.

For Healthcare Professionals

Applies to tick-borne encephalitis (inactivated) pediatric vaccine: intramuscular suspension.

Cardiovascular

Postmarketing reports: Tachycardia^[Ref]

Dermatologic

Postmarketing reports: Dermatitis, erythema, hyperhidrosis, pruritus, rash (erythematous, maculopapular, vesicular), urticaria^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting^[Ref]

General

The most common side effects in children 1 through 15 years of age were local tenderness, local pain, headache, fever, and restlessness. The most common side effects in patients at least 16 years of age were local tenderness, local pain, fatigue, headache, and muscle pain.^[Ref]

Hematologic

Uncommon (0.1% to 1%): Swelling of lymph nodes, swelling of axillary/inguinal lymph nodes^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction, hypersensitivity^[Ref]

Immunologic

Postmarketing reports: Precipitation or aggravation of autoimmune disorders (e.g., multiple sclerosis)^[Ref]

Local

Very common (10% or more): Injection site pain (up to 14.7%), tenderness (up to 29.9%)

Common (1% to 10%): Injection site reactions (e.g., erythema, induration, swelling)

Uncommon (0.1% to 1%): Hematoma

Rare (0.01% to 0.1%): Ecchymosis, itching

Postmarketing reports: Injection site joint movement impairment, injection site joint pain, injection site inflammation, injection site nodule^[Ref]

Metabolic

Common (1% to 10%): Loss of appetite^[Ref]

Musculoskeletal

Common (1% to 10%): Joint pain, muscle pain

Postmarketing reports: Back pain, joint swelling, musculoskeletal stiffness (including neck stiffness), neck pain, pain in extremity^[Ref]

Nervous system

Very common (10% or more): Headache (11.1%)

Postmarketing reports: Aseptic meningitis, convulsion (including febrile), demyelinating disorders (acute disseminated encephalomyelitis, Guillain-Barré syndrome, myelitis, transverse myelitis), dizziness, encephalitis, meningism, polyneuropathy, sensory abnormalities and motor dysfunction (hemiparesis, hemiplegia, VIIth nerve paralysis/facial paresis, paralysis, paresis, neuritis, neuralgia, optic neuritis)^[Ref]

Ocular

Postmarketing reports: Eye pain, photophobia, visual impairment^[Ref]

Other

Common (1% to 10%): Fatigue, fever, malaise

Postmarketing reports: Asthenia, chills, edema, disturbance, gait, herpes zoster (triggered in pre-exposed individuals), influenza-like illness, tinnitus^[Ref]

Fevers were very common in younger children and common in older children; Lower fever rates were reported after the second and third vaccinations compared to the first vaccination.

Rates of fever reported within 4 days after each dose in clinical trial study:

DOSE 1:

-Children aged 1 to 2 years (n=186): 23.7% (38C to 38.4C [100.4F to 101.1F]); 5.9% (38.5C to 38.9C [101.2F to 102F]); 5.9% (39C to 40C [102.1F to 104F])

-Children aged 3 to 6 years (n=563): 4.6% (38C to 38.4C [100.4F to 101.1F]); 5% (38.5C to 38.9C [101.2F to 102F]); 3% (39C to 40C [102.1F to 104F])

-Children aged 7 to 15 years (n=1668): 3.4% (38C to 38.4C [100.4F to 101.1F]); 2% (38.5C to 38.9C [101.2F to 102F]); 0.3% (39C to 40C [102.1F to 104F])

-Total (n=2417): 5.2% (38C to 38.4C [100.4F to 101.1F]); 3% (38.5C to 38.9C [101.2F to 102F]); 1.4% (39C to 40C [102.1F to 104F])

DOSE 2:

-Children aged 1 to 2 years (n=185): 9.2% (38C to 38.4C [100.4F to 101.1F]); 2.2% (38.5C to 38.9C [101.2F to 102F]); 0.5% (39C to 40C [102.1F to 104F]); 0.5% (greater than 40C [greater than 104F])

-Children aged 3 to 6 years (n=561): 1.2% (38C to 38.4C [100.4F to 101.1F]); 0.4% (38.5C to 38.9C [101.2F to 102F]); 0.5% (39C to 40C [102.1F to 104F])

-Children aged 7 to 15 years (n=1664): 0.8% (38C to 38.4C [100.4F to 101.1F]); 0.4% (38.5C to 38.9C [101.2F to 102F]); less than 0.1% (39C to 40C [102.1F to 104F])

-Total (n=2410): 1.6% (38C to 38.4C [100.4F to 101.1F]); 0.5% (38.5C to 38.9C [101.2F to 102F]); 0.2% (39C to 40C [102.1F to 104F]); less than 0.1% (greater than 40C [greater than 104F])

DOSE 3:

-Children aged 1 to 2 years (n=184): 7.1% (38C to 38.4C [100.4F to 101.1F]); 3.8% (38.5C to 38.9C [101.2F to 102F]); 1.6% (39C to 40C [102.1F to 104F])

-Children aged 3 to 6 years (n=557): 1.4% (38C to 38.4C [100.4F to 101.1F]); 0.4% (38.5C to 38.9C [101.2F to 102F]); 0.7% (39C to 40C [102.1F to 104F]); 0.2% (greater than 40C [greater than 104F])

-Children aged 7 to 15 years (n=1649): 0.6% (38C to 38.4C [100.4F to 101.1F]); 0.3% (38.5C to 38.9C [101.2F to 102F]); 0.2% (39C to 40C [102.1F to 104F])

-Total (n=2390): 1.3% (38C to 38.4C [100.4F to 101.1F]); 0.6% (38.5C to 38.9C [101.2F to 102F]); 0.5% (39C to 40C [102.1F to 104F]); less than 0.1% (greater than 40C [greater than 104F])^[Ref]

Psychiatric

Common (1% to 10%): Changes in sleeping pattern, restlessness^[Ref]

Respiratory

Postmarketing reports: Dyspnea^[Ref]

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.

Medical Disclaimer