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

Serious side effects

Along with its needed effects, tick-borne encephalitis (inactivated) vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tick-borne encephalitis (inactivated) vaccine:

Less common

• Trouble sleeping

Incidence not known

• Back pain, sudden and severe
• blindness
• blue-yellow color blindness
• blurred vision
• chest tightness
• confusion
• cough
• decreased vision
• difficulty seeing at night
• difficulty swallowing
• dizziness
• eye pain
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives, itching, skin rash
• hoarseness
• inability to move the arms and legs
• increased sensitivity of the eyes to sunlight
• irritability
• joint pain, stiffness, or swelling
• muscle weakness, sudden and progressing
• nausea
• nerve pain
• numbness, tingling, pain, or weakness in the hands or feet
• pain in the arms or legs
• painful blisters on the trunk of the body
• paralysis of one side of the body
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• seizures
• stiff neck or back
• sudden numbness and weakness in the arms and legs
• trouble breathing
• unusual tiredness or weakness
• vomiting

Other side effects

Some side effects of tick-borne encephalitis (inactivated) vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Muscle pain
• pain or tenderness at the injection site

Less common

• Loss of appetite
• redness, swelling, or lumps at the injection site

Rare

• Bruising or itching at the injection site
• swollen lymph glands in the neck, armpit, or groin

Incidence not known

• Blistering, crusting, irritation, itching, or reddening of the skin
• continuing ringing or buzzing or other unexplained noise in the ears
• cracked, dry, or scaly skin
• hearing loss
• increased sweating
• lack or loss of strength

For Healthcare Professionals

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

General

The most common side effects in patients at least 16 years of age were local tenderness, local pain, fatigue, headache, and muscle pain. The most common side effects in children 1 through 15 years of age were local tenderness, local pain, headache, fever, and restlessness. In children 1 to 15 years of age, rates of systemic side effects observed after the second and third vaccination were lower than after the first vaccination; comparable rates of injection site reactions were observed after the first, second, and third vaccination.^[Ref]

Local

Very common (10% or more): Local tenderness (up to 29.9%), injection site pain (up to 14.7%), local pain (up to 13.5%); injection site reactions (e.g., injection site pain)

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

Uncommon (0.1% to 1%): Injection site hemorrhage

Rare (0.01% to 0.1%): Local hematoma, injection site pruritus, injection site reactions (e.g., pruritus, paresthesia, warmth)

Frequency not reported: Local ecchymosis, local itching, injection site warmth

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

Nervous system

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

Rare (0.01% to 0.1%): Sensory abnormalities, dizziness, vertigo, somnolence

Postmarketing reports: Convulsion (including febrile), demyelinating disorders (acute disseminated encephalomyelitis, Guillain-Barre syndrome, myelitis, transverse myelitis), encephalitis, sensory abnormalities and motor dysfunction (hemiparesis, hemiplegia, seventh nerve paralysis/facial paresis/facial palsy, paralysis, paresis, neuritis, neuralgia, optic neuritis, hypoesthesia, paresthesia), polyneuropathy, meningism, dizziness, aseptic meningitis, tinnitus^[Ref]

Other

Fevers were very common in younger children and common in older children; fever rates after the second and third vaccinations were generally lower than after the first vaccination. Fever was measured rectally in children up to 3 years of age and orally in children 3 years of age and older; the analysis included any fever temporally associated with vaccination whether or not causally related. Fever was age dependent and decreased with the number of vaccinations.

Rates of fever reported within 4 days after each dose in 1 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])

In a safety study and dose finding studies, the fever rates observed after the first vaccination were as follows:

-Children aged 1 to 2 years (n=262): Mild fever (38C to 39C) in 27.9%; moderate fever (39.1C to 40C) in 3.4%; no severe fever (greater than 40C)

-Children aged 3 to 15 years (n=2519): Mild fever in 6.8%; moderate fever in 0.6%; no severe fever (greater than 40C)

Fever rates reported after the second vaccination were generally lower compared to those after the first vaccination:

-Children aged 1 to 2 years: 15.6% (41/263)

-Children aged 3 to 15 years: 1.9% (49/2522)^[Ref]

Common (1% to 10%): Fever/pyrexia, fatigue, malaise

Uncommon (0.1% to 1%): Chills

Postmarketing reports: Influenza-like illness, chills, gait disturbance, asthenia, edema^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle pain/myalgia, joint pain/arthralgia

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

Gastrointestinal

Common (1% to 10%): Nausea, vomiting

Uncommon (0.1% to 1%): Abdominal pain

Rare (0.01% to 0.1%): Diarrhea, dyspepsia^[Ref]

Psychiatric

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

Metabolic

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

Hematologic

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

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity

Postmarketing reports: Anaphylactic reaction, hypersensitivity^[Ref]

Dermatologic

Rare (0.01% to 0.1%): Urticaria

Postmarketing reports: Herpes zoster (triggered in pre-exposed patients), urticaria, rash (erythematous, maculopapular, vesicular), pruritus, dermatitis, erythema, hyperhidrosis^[Ref]

Cardiovascular

Postmarketing reports: Tachycardia^[Ref]

Respiratory

Postmarketing reports: Dyspnea^[Ref]

Ocular

Postmarketing reports: Visual impairment, photophobia, eye pain^[Ref]

Immunologic

Frequency not reported: Higher local reactogenicity profile

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

In a small comparative study on immune response after IM and subcutaneous administration in healthy adults, the subcutaneous route resulted in higher local reactogenicity profile (especially in women).^[Ref]