Safety And Adverse Events
Common and local adverse events
HA vaccine is well tolerated. Reactions are generally mild and transient, and are usually limited to soreness and redness at the injection site. Other less frequent reactions include headache, irritability, malaise, fever, fatigue and gastrointestinal symptoms. Injection site reactions occur less frequently in children than in adults as do mild, systemic events . No significant difference in reactions is evident between initial and subsequent doses of vaccine or in the presence of pre-existing immunity.
Refer to Hepatitis B Vaccine in Part 4 for information about HAHB vaccine.
Injection site reactions following receipt of standard human Ig include tenderness, erythema and stiffness of local muscles, which may persist for several hours. Mild fever or malaise may occasionally occur.
Less common and serious or severe adverse events
Less common side effects following receipt of standard human Ig include flushing, headache, chills and nausea. Urticaria, angioedema and anaphylactic reactions may occur rarely.
Guidance on reporting Adverse Events Following Immunization
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI.
Contraindications and precautions
Why It Is Used
Hepatitis B virus causes a liver infection that can lead to serious complications, including liver cancer. It is common in people throughout the world, particularly in Asia and sub-Saharan Africa.
The Canadian National Advisory Committee on Immunization recommends hepatitis B immunization for all children. Pregnant women and other adults who do not have immunity and who have a high chance of exposure should be vaccinated.
How Hepatitis Is Spread
Hepatitis A: About 20,000 people in the U.S. contract hepatitis A each year. The hepatitis A virus is found in the stool of the infected person. It is spread through contaminated food or water or by certain types of sexual contact.
Children who get hepatitis A often don’t have symptoms, so they can have the virus and not know it. However, they can still spread it easily. Fortunately, children are now routinely vaccinated against hepatitis A.
Most people who get hepatitis A recover completely within two weeks to six months and don’t have any liver damage. In rare cases, hepatitis A can cause liver failure and even death in older adults or people with underlying liver disease.
Hepatitis B: Every year, about 40,000 people in the U.S. become infected with hepatitis B. Acute hepatitis lasts from a few weeks to several months. Many infected people are able to clear the virus and remain virus-free after the acute stage. However, for others, the virus remains in the body, and they develop chronic hepatitis B infection, which is a serious, lifelong condition. About 1.2 million people in the U.S. have chronic hepatitis B. Of these, 15% to 25% will develop more serious health problems, such as liver damage, cirrhosis, liver failure, and liver cancer, and some people die as a result of hepatitis B-related disease.
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How Does Hepatitis A Spread
Contaminated food or water is the most common source of hepatitis A infection. Contamination can happen at any point in the food growing, processing or cooking process. Travelers are at an increased risk. Take extra precautions in developing countries with poor sanitary conditions.
It is possible for the disease to spread through close contact with an infected person. This includes sex or caring for an infected person.
Vaccination is the best form of protection.
Vaccine For Hepatitis B
Hepatitis B Vaccine
It takes only a few shots to protect yourself and your loved ones against hepatitis B for a lifetime.
The hepatitis B vaccine is a safe and effective vaccine that is recommended for all infants at birth and for children up to 18 years. The hepatitis B vaccine is also recommended for adults living with diabetes and those at high risk for infection due to their jobs, lifestyle, living situations, or country of birth. Since everyone is at some risk, all adults should seriously consider getting the hepatitis B vaccine for a lifetime protection against a preventable chronic liver disease.
The hepatitis B vaccine is also known as the first anti-cancer vaccine because it prevents hepatitis B, the leading cause of liver cancer worldwide.
You cannot get hepatitis B from the vaccine. All hepatitis B vaccines that have been used since 1986 are made synthetically meaning the hepatitis B vaccines do not contain any blood products. Learn more.
If you have a current HBV infection or have recovered from a past HBV infection, the hepatitis B vaccine series will not benefit you or clear the virus. However, the vaccine can provide a lifetime of protection for loved ones who do not have hepatitis B and get the vaccine as soon as possible. Testing is the only way to know if you or your loved ones have a current infection or have recovered from a past infection.
Hepatitis B Vaccine Recommendations
Three-Dose Hepatitis B Vaccine Schedule
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What Is Hepatitis B Virus
Hepatitis B virus attacks the liver. Hepatitis B virus infections are known as the “silent epidemic” because many infected people don’t experience symptoms until decades later when they develop hepatitis , cirrhosis , or cancer of the liver . Every year in the United States about 22,000 new hepatitis B infections occur and about 2,000 people die from their infections.
Symptoms Of Hepatitis B
Many people with hepatitis B will not experience any symptoms and may fight off the virus without realising they had it.
If symptoms do develop, they tend to happen 2 or 3 months after exposure to the hepatitis B virus.
Symptoms of hepatitis B include:
- flu-like symptoms, including tiredness, a fever, and general aches and pains
- loss of appetite
- tummy pain
- yellowing of the skin and eyes
These symptoms will usually pass within 1 to 3 months , although occasionally the infection can last for 6 months or more .
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Prevent Hepatitis B Infections In Newborns
If you are pregnant and have hepatitis B, talk with your doctor about lowering the risk that the infection will spread to your baby. Your doctor will check your virus levels during pregnancy. If virus levels are high, your doctor may recommend treatment during pregnancy to lower virus levels and reduce the chance that hepatitis B will spread to your baby. Your doctor may refer you to a liver specialist to find out if you need hepatitis B treatment and to check for liver damage.
When it is time to give birth, tell the doctor and staff who deliver your baby that you have hepatitis B. A health care professional should give your baby the hepatitis B vaccine and HBIG right after birth. The vaccine and HBIG will greatly reduce the chance of your baby getting the infection.
What To Think About
If you are exposed to HBV before you have received all three shots in the vaccination series, a dose of hepatitis B immune globulin usually will prevent infection until the vaccine takes effect.
If you have already had hepatitis B and have developed protective antibodies to the virus, you do not need the vaccine because you have lifetime protection against the infection. If you are not sure whether you have had hepatitis B, you can be tested, or you can be vaccinated without testing. The vaccine is not harmful for you if you are already immune.
If you have chronic HBV infection, the vaccine will be ineffective, although it is not harmful.
The vaccine is safe for women who are pregnant or breastfeeding.
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What Are Clinical Trials For Hepatitis B
Clinical trialsand other types of clinical studiesare part of medical research and involve people like you. When you volunteer to take part in a clinical study, you help doctors and researchers learn more about disease and improve health care for people in the future.
Researchers are studying many aspects of hepatitis B, such as
- progression of hepatitis B and long-term outcomes
- new treatments for hepatitis B
- prevention of reactivated or worsening hepatitis B in people receiving cancer treatment
How Do Doctors Treat Hepatitis B
Doctors typically dont treat hepatitis B unless it becomes chronic. Doctors may treat chronic hepatitis B with antiviral medicines that attack the virus.
Not everyone with chronic hepatitis B needs treatment. If blood tests show that hepatitis B could be damaging a persons liver, a doctor may prescribe antiviral medicines to lower the chances of liver damage and complications.
Medicines that you take by mouth include
A medicine that doctors can give as a shot is peginterferon alfa-2a .
The length of treatment varies. Hepatitis B medicines may cause side effects. Talk with your doctor about the side effects of treatment. Tell your doctor before taking any other prescription or over-the-counter medicines.
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Concurrent Administration Of Vaccines
HB-containing vaccines may be administered concomitantly with other vaccines or with HBIg. Different injection sites and separate needles and syringes must be used for concurrent parenteral injections.
Refer to Timing of Vaccine Administration in Part 1 for additional information about concurrent administration of vaccines.
Outlook For Hepatitis B
The vast majority of people infected with hepatitis B in adulthood are able to fight off the virus and fully recover within 1 to 3 months.
Most will then be immune to the infection for life.
Babies and children with hepatitis B are more likely to develop a chronic infection.
Chronic hepatitis B affects around:
- 90% of babies with hepatitis B
- 20% of older children with hepatitis B
- 5% of adults with hepatitis B
Page last reviewed: 30 January 2019 Next review due: 30 January 2022
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What Are The Side Effects
The most common of the hepatitis B vaccine are mild and include:
- Low fever or,
- Sore arm from the shot.
Prepare for your child’s vaccine visit and learn about how you can:
- Research vaccines and ready your child before the visit
- Comfort your child during the appointment
- Care for your child after the shot
Hepatitis A Vaccine And International Travel
Who should get the hepatitis A vaccine before traveling internationally?
All unvaccinated people, along with those who have never had hepatitis A, should be vaccinated before traveling to countries where hepatitis A is common. Travelers to urban areas, resorts, and luxury hotels in countries where hepatitis A is common are still at risk. International travelers have been infected, even though they regularly washed their hands and were careful about what they drank and ate. Those who are too young or cant get vaccinated because of a previous, life-threatening reaction to the hepatitis A vaccine or vaccine component should receive immune globulin. Travelers to other countries where hepatitis A does not commonly occur are not recommended to receive hepatitis A vaccine before travel.
How soon before travel should I get the hepatitis A vaccine?
You should get the first dose of hepatitis A vaccine as soon as you plan international travel to a country where hepatitis A is common. The vaccine will provide some protection even if you get vaccinated closer to departure. For older adults , people who are immunocompromised, and people with chronic liver disease or other chronic medical conditions the health-care provider may consider, based on several factors, giving an injection of immune globulin at the same time in different limbs.
What should I do if I am traveling internationally but cannot receive hepatitis A vaccine?
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What Is The Hepatitis A Vaccine
The hepatitis A vaccine is a dose of inactive virus that stimulates your natural immune system. After the hepatitis A vaccine is given, your body makes antibodies that will protect you against the hepatitis A virus.
Vaccination for hepatitis A requires 2 shots, 6 months apart. The vaccine is given with an injection, into the muscle of the upper arm. If for some reason the second injection doesn’t take place at 6 months, you can receive the second dose at a later time.
If you need hepatitis B vaccination in addition to hepatitis A, you can do these individually or as a combined vaccine that covers both. The combination vaccine is given as 3 injections over a 6-month period–an initial dose, followed by a second dose 1 month later, and then a third dose 5 months after the second.
Why Is The Hepb Vaccine Recommended
People who dont know they’re infected can spread the hepatitis B virus. So it cant be avoided just by being careful. That’s why health experts recommend that all babies get the vaccine right from birth.
The HepB injection usually creates long-term immunity. Most infants who get the HepB series are protected from hepatitis B infection beyond childhood, into their adult years.
Eliminating the risk of infection also decreases risk for cirrhosis of the liver, chronic liver disease, and liver cancer.
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If I Already Have Hepatitis B Can The Vaccine Treat It
No. The hepatitis vaccine prevents hepatitis, but doesnt cure it if you already have it. If you have hepatitis B, there are other treatment options.
However, if you recently got exposed to the hepatitis B virus and you havent had the vaccine yet, tell your doctor right away. The vaccine and possibly other treatment can reduce your chances of getting hepatitis B if you get it within 2 weeks after you came into contact with the virus. The sooner you seek care after being exposed to hepatitis B, the better, so try to get there right away.
Who Should Not Get The Vaccine
Speak with your health care provider if you have had a life-threatening reaction to a previous dose of hepatitis A vaccine, or any component of the vaccine including neomycin, or to latex.
There is no need to delay getting immunized because of a cold or other mild illness. However, if you have concerns speak with your health care provider.
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Who Should Get The Hbv Vaccine
The Centers for Disease Control and Prevention recommends that children should get their first hepatitis B vaccine at birth and complete the doses by 6 to 18 months of age. However, the HBV vaccine is still recommended for all children if they havent already gotten it, from infanthood up to 19 years old. Most U.S. states require a hepatitis B vaccine for school admittance, however.
Its also recommended for adults at an increased risk of catching the HBV infection, or anyone who fears they have or will be exposed to it in the near future.
The HBV vaccine is even safe to administer to pregnant women.
Who Is The Vaccine Recommended For
The HBV vaccine is recommended for adults who:
- Are sexually active with or live in the same house as a person with HBV
- Are sexually active with more than one partner
- Seek care in a clinic for sexually transmitted diseases, HIV testing or treatment, or drug treatment
- Men who have sex with other men
- People who inject drugs or have a job that involves contact with human blood
- People who are on the staff of or a client in an institution for the developmentally disabled
- Hemodialysis patients or those with end-stage renal disease
- People with HIV
- Dialysis patients
- Those with chronic liver disease
- Those who live or travel for more than six months a year in countries where Hepatitis B is common
- Prisoners in a correctional facility
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What Is Hepatitis A & B
Hepatitis A and B are two viruses that affect your livers ability to function. Hepatitis A is usually spread through the ingestion of contaminated food or water or close contact including sexual relations with someone who is already infected. Hepatitis B is spread through contact with the blood or other body fluids of an infected person, including contact with objects that could have blood or body fluids on them such as toothbrushes and razors.
The hepatitis A virus can cause a flu-like illness, a yellowing of the skin or eyes , along with severe stomach pains and diarrhea. The hepatitis B virus can cause a short-term flu-like illness, or long-term infection that can lead to liver damage, liver cancer or death. Babies and young children infected with hepatitis B are more likely to get this chronic form of the disease.
What Are Dosages Of Hepatitis B Vaccine
Dosages of Hepatitis B Vaccine:
- 40 mcg/ml
- 5 mcg/0.5 ml
- 10 mcg/0.5 mg
Dosage Considerations Should be Given as Follows:
- Engerix B: 1 mL intramuscularly at 0, 1, and 6 months
- Recombivax HB: 1 mL intramuscularly at 0, 1, and 6 months
- Adults receiving dialysis or other immunocompromising conditions
- Recombivax HB : 40 mcg intramuscularly at 0, 1, and 6 months, OR
- Engerix-B : 40 mcg intramuscularly at 0, 1, and 6 months
- Unvaccinated children should complete a 3-dose series
- Children aged 11-15 years: 2-dose series of adult formulation Recombivax HB is licensed for use in children aged 11 through 15 years
- low blood pressure
- pain when urinating
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System , 1-800-822-7967
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
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