Note: This document contains side effect information about hepatitis a adult vaccine. Some dosage forms listed on this page may not apply to the brand name Havrix.

Applies to hepatitis a adult vaccine: intramuscular solution, intramuscular suspension.

Serious side effects of Havrix

Along with its needed effects, hepatitis a adult vaccine (the active ingredient contained in Havrix) 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 hepatitis a adult vaccine:

More common

• Fever more than 99.5 degrees F
• general feeling of discomfort or illness
• unusual tiredness or weakness

Rare

• Body aches or pain
• chills
• congestion
• cough
• difficulty with breathing or swallowing
• dryness or soreness of the throat
• ear congestion
• headache
• hives
• hoarseness
• itching, especially of the feet or hands
• loss of voice
• nasal congestion
• reddening of the skin, especially around the ears
• runny nose
• shortness of breath
• sneezing
• sore throat
• swelling of the eyes, face, or inside of the nose
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tender, swollen glands in the neck
• tightness in the chest
• unusual tiredness or weakness (sudden and severe)
• voice changes
• wheezing

Incidence not known

• Abdominal or stomach pain
• agitation
• back pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs
• clay-colored stools
• coma
• confusion
• dark urine
• diarrhea
• difficulty controlling your bladder or bowels
• difficulty with walking
• dizziness
• drowsiness
• fainting
• fast heartbeat
• feeling of discomfort
• feeling sad or depressed
• flu-like symptoms
• forgetful
• hallucinations
• inability to move the arms and legs
• increased sweating
• inflammation of the joints
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle aches or cramps
• nausea
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red, irritated eyes
• seizures
• sensation of pins and needles
• shakiness and unsteady walk
• slurred speech
• sores, ulcers, or white spots in the mouth or on the lips
• stabbing pain
• stiff neck
• sudden numbness and weakness in the arms and legs
• swollen lymph glands
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• vomiting of blood
• yellow eyes or skin

Other side effects of Havrix

Some side effects of hepatitis a adult 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

• Pain, redness, swelling, or lumps at the injection site
• weight loss

Less common

• Arm pain
• bleeding between periods
• change in the amount of bleeding during periods
• change in the pattern of monthly periods
• lack or loss of strength
• tenderness or warmth at the injection site
• unusual stopping of menstrual bleeding

Rare

• Change in color vision
• change in taste
• collection of blood under the skin
• deep, dark purple bruise
• difficulty seeing at night
• difficulty with moving
• dizziness or lightheadedness
• excessive muscle tone
• feeling of constant movement of self or surroundings
• increased sensitivity of the eyes to sunlight
• loss of taste
• muscle tension or tightness
• sensation of spinning
• sleeplessness
• trouble with sleeping
• unable to sleep
• welts

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to hepatitis a adult vaccine: intramuscular suspension.

General

The most common adverse events were injection site reactions, irritability, drowsiness, loss of appetite and headache.^[Ref]

Local

Very common (10% or more): Injection site soreness (56%), injection site pain (24.3%), injection site redness (22.8%)

Common (1% to 10%): Induration and swelling of the injection site

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

Postmarketing reports: Injection site reaction^[Ref]

Nervous system

Very common (10% or more): Drowsiness (22.3%), headache (14%)

Uncommon (0.1% to 1%): Dysgeusia, hypertonia, vertigo, seizure

Postmarketing reports: Convulsion, dizziness, encephalopathy, Guillain-Barre syndrome, hypoesthesia, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope^[Ref]

Other

Common (1% to 10%): Fatigue, fever over 99.5F, malaise

Uncommon (0.1% to 1%): Creatine phosphokinase increased

Postmarketing reports: Congenital anomaly, influenza-like symptoms^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea

Uncommon (0.1% to 1%): Abdominal pain, diarrhea, vomiting^[Ref]

Metabolic

Very common (10% or more): Loss of appetite (19.9%)

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

Dermatologic

Uncommon (0.1% to 1%): Pruritus, rash, urticaria

Postmarketing reports: Angioedema, erythema multiforme, hyperhidrosis^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, myalgia

Postmarketing reports: Musculoskeletal stiffness, chills^[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy

Postmarketing reports: Thrombocytopenia^[Ref]

Immunologic

Uncommon (0.1% to 1%): Pharyngitis, upper respiratory tract infection

Postmarketing reports: Rhinitis^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction, anaphylactoid reaction, serum sickness-like syndrome^[Ref]

Psychiatric

Very common (10% or more): Irritability (33.3%)

Uncommon (0.1% to 1%): Insomnia^[Ref]

Hepatic

Postmarketing reports: Hepatitis, jaundice^[Ref]

Cardiovascular

Postmarketing reports: Vasculitis^[Ref]

Respiratory

Postmarketing reports: Dyspnea^[Ref]

Ocular

Uncommon (0.1% to 1%): Photophobia^[Ref]