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Hepatitis b adult vaccine Side Effects

In Summary

Commonly reported side effects of hepatitis b adult vaccine include: fatigue, pain at injection site, and tenderness at injection site. Other side effects include: pruritus, fever, dizziness, headache, vertigo, erythema, ecchymoses, inflammation at injection site, swelling at injection site, and induration at injection site. See below for a comprehensive list of adverse effects.

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)

Severity: Minor

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

The most common adverse events were injection site reactions, headache, and fatigue.[Ref]

Local

Very common (10% or more): Injection site pain (33.8%), injection site soreness (22%), injection site redness (15.6%), injection site swelling (11.7%)
Common (1% to 10%): Injection site induration
Uncommon (0.1% to 1%): Injection site ecchymosis, injection site pruritus
Postmarketing reports: Injection site reaction[Ref]

Nervous system

Very common (10% or more): Headache (23.4%)
Common (1% to 10%): Dizziness, drowsiness
Uncommon (0.1% to 1%): Somnolence, tingling, paresthesia
Postmarketing reports: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, Guillain-Barre syndrome and Bell's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis, vertigo, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis[Ref]

Other

Very common (10% or more): Fatigue (33.8%)
Common (1% to 10%): Fever, malaise
Uncommon (0.1% to 1%): Chills, influenza-like symptoms, sweating, achiness, sensation of warmth, lightheadedness, flushing, earache
Postmarketing reports: Tinnitus[Ref]

Hypersensitivity

Apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymosis, and erythema nodosum.[Ref]

Postmarketing reports: Allergic reaction, anaphylactoid reaction, anaphylaxis, apparent hypersensitivity syndrome[Ref]

Metabolic

Common (1% to 10%): Appetite lost
Uncommon (0.1% to 1%): Anorexia[Ref]

Psychiatric

Very common (10% or more): Irritability
Uncommon (0.1% to 1%): Agitation, insomnia[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, upper respiratory infection
Uncommon (0.1% to 1%): Upper respiratory tract illnesses, rhinitis, cough, influenza
Frequency not reported: Pharyngitis
Postmarketing reports: Apnea, bronchospasm including asthma-like symptoms[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck
Postmarketing reports: Arthritis, muscular weakness[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal symptoms
Uncommon (0.1% to 1%): Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting
Postmarketing reports: Dyspepsia[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rate[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythema, petechiae, pruritus, rash, sweating, urticaria
Postmarketing reports: Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing, hypotension
Postmarketing reports: Palpitations, tachycardia, vasculitis, syncope[Ref]

Ocular

Very rare (less than 0.01%): Uveitis
Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritis[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria[Ref]

Hepatic

Postmarketing reports: Abnormal liver function tests[Ref]

Immunologic

Postmarketing reports: Herpes zoster, meningitis[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Recombivax HB (hepatitis B vaccine)." Merck & Company Inc, West Point, PA.

3. "Product Information. Engerix-B (hepatitis B vaccine)." SmithKline Beecham, Philadelphia, PA.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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