Hepatitis B written on a page. Medical concept.

Hepatitis B Vaccine Side Effects

There are two Hepatitis B vaccines, Engerix-B® and Recombivax HB®. The most common side effects of these vaccines are injection-site soreness and mild fever. The risk is slightly higher for adults.

Table of Contents for Hepatitis B Vaccine Side Effects

What are Hepatitis B vaccine names?

Engerix-B Hepatitis B VaccineThe first hepatitis B vaccine was approved in the United States in 1982, but it is no longer used. In 1986 and 1989, two other hepatitis B vaccines were created using recombinant DNA technology:

There are also a few other combination vaccines against Hepatitis B that also contain vaccines against other diseases, including:

  • Pediarix® (HepB-DTaP/IPV)
  • Twinrix® (HepB-HepA) 
  • Comvax® (discontinued in 2014)

How is the vaccine given?

Engerix-B® and Recombivax HB® are given in 3 or 4 shots over a 6-month period. Infants should get their first dose at birth and usually complete the series by 6 months of age. Older children and teenagers who were not vaccinated as infants should also be vaccinated, as well as unvaccinated adults who are at risk of infection with hepatitis B.

Can the vaccine cause Hepatitis B?

No. Engerix-B® and Recombivax HB® are recombinant vaccines. That means they only contain parts of the hepatitis B virus and they can’t cause an infection. They are made by putting the gene for hepatitis B into a common yeast and harvesting pieces of the virus.

Is the hepatitis B vaccine safe?

Yes. Since 1982, at least 50 million infants and over 70 million teenagers and adults have received at least one Hepatitis B vaccine. The risk of serious side effects is very low and most children who get the hepatitis B vaccine do not have any side effects at all.

What are common side effects?

Of the children who have side effect of the hepatitis B vaccine, the most common is mild soreness where the shot was injected or a low fever. Adults are slightly more likely to experience these side effects.

The common side effects of Engerix-B® and Recombivax HB® include:

  • Injection-site soreness, swelling, redness, or lump
  • Fatigue
  • Fever
  • Irritability
  • Diarrhea
  • Loss of appetite
  • Runny nose

What are rare side effects?

Hepatitis B vaccination may cause apnea (temporarily stop breathing) in infants who are premature, low birth weight, or sick. Delayed vaccination may be recommended on a case-by-case basis.

Shoulder Injury Related to Vaccine Administration (SIRVA) occurs when the vaccine needle accidentally hits the shoulder bursa, ligaments, or tendons, resulting in pain and limited range of motion.

What are severe side effects?

Severe allergic reactions (anaphylaxis) from hepatitis B vaccines are estimated to occur after fewer than 1 in a million doses, usually within a few minutes or hours of vaccination. Symptoms may include:

  • Hives
  • Swelling of the face and throat
  • Difficulty breathing
  • Fast heartbeat
  • Dizziness
  • Weakness

What other side effects have been reported?

The following side effects have been reported in patients who received Engerix-B, but it is known if they were actually caused by the vaccine:

  • Abnormal liver function tests
  • Allergic reaction
  • Anaphylaxis
  • Apnea (temporarily stop breathing)
  • Arthritis
  • Asthma-like symptoms
  • Bell’s palsy
  • Bronchospasm
  • Conjunctivitis
  • Earache
  • Eczema
  • Encephalitis
  • Encephalopathy
  • Erythema multiforme
  • Erythema nodosum
  • Facial paralysis
  • Fainting
  • Fever
  • Guillain-Barre Syndrome
  • Hair loss
  • Heart palpitations
  • Herpes zoster
  • Hypersensitivity syndrome
  • Hypoesthesia
  • Indigestion (dyspepsia)
  • Injection-site reaction
  • Keratitis
  • Lichen planus
  • Migraine headache
  • Meningitis (brain inflammation)
  • Multiple sclerosis
  • Muscular weakness
  • Neuritis
  • Neuropathy
  • Numbness
  • Optic neuritis
  • Paralysis
  • Paresis
  • Seizures
  • Serum sickness-like symptoms
  • Stevens-Johnson Syndrome
  • Tinnitus
  • Transverse myelitis
  • Vasculitis
  • Vertigo
  • Visual disturbances

The following side effects have been reported in patients who received Recombivax HB, but it is unknown if they were caused by the vaccine:

  • Agitation
  • Allergic reaction
  • Alopecia
  • Anaphylaxis
  • Arthritis
  • Asthma-like symptoms
  • Autoimmune diseases
  • Bell’s Palsy
  • Breathing problems
  • Bronchospasm
  • Conjunctivitis
  • Constipation
  • Eczema
  • Elevation of liver enzymes
  • Encephalitis (brain inflammation)
  • Erythema multiforme
  • Exacerbation of multiple sclerosis
  • Facial paralysis
  • Febrile seizure
  • Fever
  • Guillain-Barré Syndrome
  • Heart problems
  • Herpes zoster
  • Hypesthesia
  • Increased erythrocyte sedimentation rate
  • Irritability
  • Joint pain
  • Lupus like syndrome
  • Migraine
  • Multiple sclerosis
  • Muscle weakness
  • Myelitis
  • Nerve damage
  • Optic neuritis
  • Pain in the extremity
  • Peripheral neuropathy
  • Petechiae
  • Polyarteritis nodosa
  • Radiculopathy
  • Seizures
  • Serum sickness symptoms
  • Sleepiness
  • Skin reactions
  • Stevens Johnson Syndrome
  • Systemic Lupus Erythematosus (SLE)
  • Tachycardia
  • Thrombocytopenia
  • Transverse myelitis
  • Uveitis
  • Vasculitis
  • Visual disturbances

Where can I get more information?

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