Hepatitis b adult vaccine Side Effects

Not all side effects for hepatitis b adult vaccine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to hepatitis b adult vaccine: intramuscular suspension

In addition to its needed effects, some unwanted effects may be caused by hepatitis b adult vaccine. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking hepatitis b adult vaccine, check with your doctor or nurse immediately:

More common
  • Fever of 37.7 degrees C (100 degrees F) or higher
Rare
  • Aches or pain in the joints, fever, or skin rash or welts (may occur days or weeks after receiving the vaccine)
  • blurred vision or other vision changes
  • confusion
  • difficulty with breathing or swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • hives
  • itching, especially of the feet or hands
  • muscle weakness
  • numbness or tingling of the arms and legs
  • reddening of the skin, especially around the ears
  • sweating
  • swelling of the eyes, face, or inside of the nose
  • unusual tiredness or weakness (sudden and severe)

Some of the side effects that can occur with hepatitis b adult vaccine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Dizziness
  • headache
  • soreness at the injection site
Less common
  • Hard lump, redness, swelling, pain, itching, purple spot, tenderness, or warmth at the injection site
  • unusual tiredness or weakness
Rare
  • Aches or pain in the muscles
  • agitation
  • back pain or stiffness or pain in neck or shoulder
  • chills
  • constipation
  • diarrhea
  • difficulty with moving
  • feeling of warmth
  • general feeling of discomfort or illness
  • headache (mild), sore throat, runny nose, or fever (mild)
  • increased sweating
  • itching
  • lack of appetite or decreased appetite
  • nausea or vomiting
  • redness of the face, neck, arms, and occasionally, upper chest
  • sleepiness or unusual drowsiness
  • sleeplessness
  • stomach cramps or pain
  • sudden redness of skin
  • swelling of glands in the armpit or neck
  • trouble with sleeping
  • unable to sleep
  • welts
  • weight loss

For Healthcare Professionals

Applies to hepatitis b adult vaccine: intramuscular suspension

General

Hepatitis B vaccine is generally well-tolerated. Most side effects were mild and primarily included injection site reactions and fatigue.

Respiratory

Respiratory side effects have included rhinitis, cough, pharyngitis, upper respiratory tract illness, influenza-like symptoms, and bronchospasm including asthma-like symptoms.

Other

Other side effects have included fatigue, fever, chills, flushing, lightheadedness, sweating, weakness, malaise, tinnitus, and earache.

Ocular

Ocular side effects have included optic neuritis, conjunctivitis, keratitis, and visual disturbances.

Nervous system

Nervous system side effects have included headache, dizziness, vertigo, somnolence, insomnia, irritability, agitation, migraine, syncope, paresis, neuropathy, hypoesthesia, paresthesia, convulsions, encephalitis, Guillain-Barre syndrome, radiculopathy, herpes zoster, muscle weakness, multiple sclerosis, exacerbation of multiple sclerosis, Bell's palsy, optic sclerosis, myelitis, and transverse myelitis.

Musculoskeletal

Musculoskeletal side effects have included arthritis, arthralgia, myalgia, back pain, and pain or stiffness in the arm, shoulder, or neck.

Local

Local side effects have included soreness, redness, swelling, induration, pain, pruritus, warmth, nodule formation, and ecchymosis at the injection site.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, anaphylactoid reactions, rash, pruritus, urticaria, edema, dyspnea, chest discomfort, bronchial spasm, palpitation, hypotension, erythema multiforme, Stevens-Johnson syndrome, angioedema, arthritis, and serum sickness-like syndrome (arthralgia, arthritis, fever, urticaria, erythema multiforme, ecchymoses, and erythema nodosum).

Hepatic

Hepatic side effects have included abnormal liver function tests.

Hematologic

Hematologic side effects have included lymphadenopathy, thrombocytopenia, and increased erythrocyte sedimentation rate.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, vomiting, abdominal pain, cramps, anorexia, constipation, and dyspepsia.

Dermatologic

Dermatologic side effects have included rash, urticaria, petechiae, erythema, hyperhidrosis, angioedema, eczema, herpes zoster, erythema nodosum, purpura, alopecia, and Stevens-Johnson syndrome.

Cardiovascular

Cardiovascular side effects have included syncope, hypotension, tachycardia, and palpitations.

Immunologic

Immunologic side effects including liver transplant rejection, diarrhea infections, pneumonia, and sepsis have been reported in greater than 10% of patients.

Genitourinary

Genitourinary side effects have included dysuria.

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