- Hepatitis A Vaccine
- Hepatitis A VIS
- Why get vaccinated?
- Hepatitis A vaccine
- Some people should not get this vaccine
- Risks of a vaccine reaction
- What if there is a serious problem?
- The National Vaccine Injury Compensation Program
- How can I learn more?
- Hepatitis A Adult Vaccine
- Your Child’s Immunizations: Hepatitis A Vaccine (HepA)
- Hepatitis A Vaccines
- Hepatitis A Disease and How to Protect Against It
- Hepatitis A Vaccine Side Effects
- Available Hepatitis A Vaccines
- How CDC Monitors the Hepatitis A Vaccine Safety
- A Closer Look at the Safety Data
- More Resources
- Related Scientific Articles
- Hepatitis A vaccine
- What is hepatitis A vaccine?
- Who should be vaccinated against hepatitis A?
- Examples of hepatitis A vaccines
- Possible side effects
- Where can I get vaccinated?
- Learn more
- What are Hepatitis A vaccines?
- Can the vaccine cause Hepatitis A?
- What are common side effects?
- What are rare side effects?
- What are severe side effects?
- What is SIRVA?
- Can Hepatitis A vaccines cause a Shoulder Injury Related to Vaccine Administration (SIRVA)?
- Can I file a Hepatitis A vaccine lawsuit?
- Where can I get more information?
- Hepatitis a adult vaccine Side Effects
- For the Consumer
- For Healthcare Professionals
- Further information
- More about hepatitis a adult vaccine
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.
The safety of HAVRIX has been evaluated in 61 clinical trials involving more than 34,000 individuals receiving doses of 360 EL.U., 720 EL.U., or 1440 EL.U.
Of solicited adverse events in clinical trials of adults, who received HAVRIX 1440 EL.U., and children (2 years of age and older), who received either HAVRIX 360 EL.U. or 720 EL.U., the most frequently reported was injection-site soreness (56% of adults and 21% of children); less than 0.5% of soreness was reported as severe. Headache was reported by 14% of adults and less than 9% of children. Other solicited and unsolicited events occurring during clinical trials are listed below.
Incidence 1% to 10% of Injections
Metabolism and Nutrition Disorders: Anorexia.
Gastrointestinal Disorders: Nausea.
General Disorders and Administration Site Conditions: Fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site; malaise.
Incidence < 1% of Injections
Infections and Infestations: Pharyngitis, upper respiratory tract infections.
Blood and Lymphatic System Disorders: Lymphadenopathy.
Psychiatric Disorders: Insomnia.
Nervous System Disorders: Dysgeusia, hypertonia.
Eye Disorders: Photophobia.
Ear and Labyrinth Disorders: Vertigo.
Gastrointestinal Disorders: Abdominal pain, diarrhea, vomiting.
Skin and Subcutaneous Tissue Disorders: Pruritus, rash, urticaria.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia.
General Disorders and Administration Site Conditions: Injection site hematoma.
Investigations: Creatine phosphokinase increased.
Studies of HAVRIX 720 EL.U./0.5 mL in Children 11 to 25 Months of Age
In the largest of these studies (HAV 231) conducted in the US, 1,241 children 15 months of age were randomized to receive: Group 1) HAVRIX alone; Group 2) HAVRIX concomitantly with measles, mumps, and rubella (MMR) vaccine (manufactured by Merck and Co.) and varicella vaccine (manufactured by Merck and Co.); or Group 3) MMR and varicella vaccines. Subjects in Group 3 who received MMR and varicella vaccines received the first dose of HAVRIX 42 days later. A second dose of HAVRIX was administered to all subjects 6 to 9 months after the first dose of HAVRIX. Solicited local adverse reactions and general events were recorded by parents/guardians on diary cards for 4 days (days 0 to 3) after vaccination. Unsolicited adverse events were recorded on the diary card for 31 days after vaccination. Telephone follow-up was conducted 6 months after the last vaccination to inquire about serious adverse events, new onset chronic illnesses and medically significant events. A total of 1,035 children completed the 6-month follow-up. Among subjects in all groups combined, 53% were male; 69% of subjects were white, 16% were Hispanic, 9% were black and 6% were other racial/ethnic groups.
Percentages of subjects with solicited local adverse reactions and general adverse events following HAVRIX administered alone (Group 1) or concomitantly with MMR and varicella vaccines (Group 2) are presented in Table 1. The solicited adverse events from the 3 additional coadministration studies conducted with HAVRIX were comparable to those from Study HAV 231.
Table 1: Solicited Local Adverse Reactions and General Adverse Events Occurring Within 4 Days of Vaccinationa in Children 15 to 24 Months of Age With HAVRIX Administered Alone or Concomitantly With MMR and Varicella Vaccines (TVC)
Serious Adverse Events in Children 11 to 25 Months of Age
Among these 4 studies, 0.9% (29/3,152) of subjects reported a serious adverse event within the 31-day period following vaccination with HAVRIX. Among subjects administered HAVRIX alone 1.0% (13/1,332) reported a serious adverse event. Among subjects who received HAVRIX concomitantly with other childhood vaccines, 0.9% (8/909) reported a serious adverse event. In these 4 studies, there were 4 reports of seizure within 31 days post-vaccination: these occurred 2, 9, and 27 days following the first dose of HAVRIX administered alone and 12 days following the second dose of HAVRIX. In one subject who received INFANRIX and Hib conjugate vaccine followed by HAVRIX 6 weeks later, bronchial hyperreactivity and respiratory distress were reported on the day of administration of HAVRIX alone.
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for HAVRIX since market introduction of this vaccine are listed below. This list includes serious adverse events or events which have a suspected causal connection to components of HAVRIX or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Infections and Infestations: Rhinitis.
Blood and Lymphatic System Disorders: Thrombocytopenia.
Immune System Disorders: Anaphylactic reaction, anaphylactoid reaction, serum sickness-like syndrome.
Nervous System Disorders: Convulsion, dizziness, encephalopathy, Guillain-Barre syndrome, hypoesthesia, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope.
Vascular Disorders: Vasculitis.
Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea.
Hepatobiliary Disorders: Hepatitis, jaundice.
Skin and Subcutaneous Tissue Disorders: Angioedema, erythema multiforme, hyperhidrosis.
Congenital, Familial, and Genetic Disorders: Congenital anomaly.
Musculoskeletal and Connective Tissue Disorders: Musculoskeletal stiffness.
General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site reaction, local swelling.
Read the entire FDA prescribing information for Havrix (Hepatitis A Vaccine, Inactivated)
Hepatitis A Vaccine
Side effects vary between the different types of hepatitis A vaccine, but can include the following:
Very common (affecting more than 1 in 10 people at each dose):
- pain at the injection site
- redness and hardness at the injection site
- feeling tired, irritable, weak or generally unwell
- loss of appetite or feeling sick
- upset stomach or diarrhoea
Common (affecting up to 1 in 10 people at each dose):
- a slightly raised temperature (fever)
- swelling or a small lump at the injection site
- itchy skin
- aching muscles
- feeling drowsy
Uncommon (affecting up to 1 in 100 people at each dose):
- feeling dizzy
- stomach pain or being sick
For rarer side effects (affecting fewer than 1 in 1000 people), ask to see the Patient Information Leaflet for the vaccine you are offered.
As with any vaccine, medicine or food, there is a very small chance of a severe allergic reaction (anaphylaxis). Anaphylaxis is different from less severe allergic reactions because it causes life-threatening breathing and/or circulation problems. It is always extremely serious but can be treated with adrenaline. Health care workers who give vaccines know how to do this. In the UK between 1997 and 2003 there were a total of 130 reports of anaphylaxis following ALL immunisations. Around 117 million doses of vaccines were given in the UK during this period. This means that the overall rate of anaphylaxis is around 1 in 900,000.
More information on side effects
Reactions listed under ‘possible side effects’ or ‘adverse events’ on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.
If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card Scheme . You can also contact the MHRA to ask for data on Yellow Card reports for individual vaccines . See more information on the Yellow Card scheme and monitoring of vaccine safety.
Hepatitis B vaccine
Hepatitis B was previously referred to as “serum hepatitis” because it usually is spread by the transfer of infected blood or serum (for example, through needle sticks, blood transfusions, hemodialysis, and childbirth). Hepatitis B also is spread through sexual intercourse and may be passed from mother to child. Inadvertent exposure to infected blood or body fluids may occur during tattooing, body piercing, or when sharing razors or toothbrushes with an infected person. Persons infected with hepatitis B may be asymptomatic or may develop fatigue, jaundice, and weight loss. Rarely – though more commonly than with hepatitis A – acute infection with hepatitis B can cause liver failure and death.
Most infected adults are able to clear the hepatitis B virus from their body and become immune to further infections with hepatitis B. However, some people are not able to clear the hepatitis B virus and it progresses to chronic (persistent) infection and inflammation of the liver. Most infants infected at birth and 25% to 50% of infected children aged 1–5 years have chronic persistent infection.
Chronic infection may be mild or may damage the liver. The majority of individuals with chronic hepatitis B who clear the virus and are “cured” still have detectable virus in the liver. However, the importance of this fact is unclear since there is no evidence of consequences to the presence of the virus except that it can be reactivated with immunosuppression. Individuals with hepatitis B virus only in the liver are not infectious. Some people with chronic hepatitis B infection have their lives shortened by complications of liver disease, cirrhosis, or liver cancer.
Vaccination has reduced the number of new cases of hepatitis B by more than 75% in the United States. The hepatitis B vaccine contains a protein (antigen) that stimulates the body to make protective antibodies. Examples of hepatitis B vaccines available in the United States include hepatitis B vaccine-injection (Engerix-B and Recombivax-HB). Three doses (given at 0, 1, and 6 months) are necessary to assure protection.
There are also combination vaccines on the market that provide protection against hepatitis B and other diseases. For example:
- hepatitis-b-hepatitis-a-vaccine injection (Twinrix), which provides protection against both hepatitis A and hepatitis B;
- Haemophilus B/hepatitis B vaccine – injection (Comvax) provides protection against hepatitis B and Haemophilus influenzae type b (a cause of meningitis); and
- Pediarix provides protection against hepatitis B, tetanus, pertussis and polio.
Hepatitis B vaccines are effective and safe. Most vaccinated individuals develop protective antibodies when they get the vaccine and are protected from infection with hepatitis B. Among individuals at high risk for infection with hepatitis B include:
- health care workers,
- intimate and household contacts of patients with chronic hepatitis B infection,
- public safety workers who may be exposed to blood products,
- men who have sex with men,
- individuals with multiple sexual partners,
- dialysis patients,
- injection drug users,
- persons with chronic liver disease,
- residents and staff in institutions that care for persons with developmental disabilities,
- persons infected with human immunodeficiency virus (HIV), and
- persons who require repeated transfusions or blood products.
Centers that serve high-risk individuals are encouraged to provide the vaccine to their clients. Such centers include:
- dialysis units,
- drug treatment facilities,
- sexually transmitted diseases clinics and correctional facilities.
A blood test for hepatitis B antibodies is recommended after vaccination to ensure that antibodies have been produced. For the few who do not form antibodies, revaccination may improve the response, especially in infants. However, a small proportion of individuals will never respond to hepatitis B vaccination. Side effects from the vaccine usually are mild, primarily soreness at the site of injection. The risk of serious allergic reactions (anaphylaxis) is less than one per million doses.
In the United States, hepatitis B vaccination is recommended for all infants at birth. Older children and adolescents should receive the vaccine if they did not receive it at birth. Adults in high risk situations also are advised to receive hepatitis B vaccine.
Some countries have a high prevalence of hepatitis B in their population. Travelers who visit these countries for a prolonged period of time (usually 6 months or longer) and those who may be exposed to blood or semen should consider vaccination.
Unvaccinated individuals who are exposed to a known case of hepatitis B or to a person at high risk for hepatitis B should be evaluated by a physician. Examples of such exposures include needle stick injuries in health care workers or sexual intercourse with an infected person. If the exposure is significant, the physician will recommend vaccination and may also recommend an injection of hepatitis B immune globulin (HBIG). HBIG is prepared from the plasma of blood donors and contains antibodies to hepatitis B. Vaccination and HBIG can substantially reduce the risk of disease in persons exposed to hepatitis B if given within one week of a needle stick or two weeks of sexual intercourse.
Vaccination provides long-term immunity in people who respond to the vaccine. There is no need for HBIG if an exposure occurs to a vaccinated person who is known to have responded to the vaccine; however, a blood test might be drawn to verify that the person did respond to the vaccine and form antibodies.
Infected mothers can pass hepatitis B to their newborn infants. All pregnant women should have blood drawn to determine if they are infected. Infants born to infected mothers should receive HBIG and hepatitis B vaccine at birth. This is 85% to 95% effective in eliminating the risk of hepatitis B infection in the infant.
Hepatitis A VIS
Current Edition Date: 7/20/2016
- VIS in other languagesExternal
- More information about hepatitis A vaccination
What You Need to Know
Why get vaccinated?
Hepatitis A is a serious liver disease. It is caused by the hepatitis A virus (HAV). HAV is spread from person to person through contact with the feces (stool) of people who are infected, which can easily happen if someone does not wash his or her hands properly. You can also get hepatitis A from food, water, or objects contaminated with HAV.
Symptoms of hepatitis A can include:
- fever, fatigue, loss of appetite, nausea, vomiting, and/or joint pain
- severe stomach pains and diarrhea (mainly in children), or
- jaundice (yellow skin or eyes, dark urine, clay-colored bowel movements).
These symptoms usually appear 2 to 6 weeks after exposure and usually last less than 2 months, although some people can be ill for as long as 6 months. If you have hepatitis A you may be too ill to work.
Children often do not have symptoms, but most adults do. You can spread HAV without having symptoms.
Hepatitis A can cause liver failure and death, although this is rare and occurs more commonly in persons 50 years of age or older and persons with other liver diseases, such as hepatitis B or C.
Hepatitis A vaccine can prevent hepatitis A. Hepatitis A vaccines were recommended in the United States beginning in 1996. Since then, the number of cases reported each year in the U.S. has dropped from around 31,000 cases to fewer than 1,500 cases.
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Hepatitis A vaccine
Hepatitis A vaccine is an inactivated (killed) vaccine. You will need 2 doses for long-lasting protection. These doses should be given at least 6 months apart.
Children are routinely vaccinated between their first and second birthdays (12 through 23 months of age). Older children and adolescents can get the vaccine after 23 months. Adults who have not been vaccinated previously and want to be protected against hepatitis A can also get the vaccine.
You should get hepatitis A vaccine if you:
- are traveling to countries where hepatitis A is common,
- are a man who has sex with other men,
- use illegal drugs,
- have a chronic liver disease such as hepatitis B or hepatitis C,
- are being treated with clotting-factor concentrates,
- work with hepatitis A-infected animals or in a hepatitis A research laboratory, or
- expect to have close personal contact with an international adoptee from a country where hepatitis A is common
Ask your healthcare provider if you want more information about any of these groups.
There are no known risks to getting hepatitis A vaccine at the same time as other vaccines.
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Some people should not get this vaccine
Tell the person who is giving you the vaccine:
- If you have any severe, life-threatening allergies.
If you ever had a life-threatening allergic reaction after a dose of hepatitis A vaccine, or have a severe allergy to any part of this vaccine, you may be advised not to get vaccinated. Ask your health care provider if you want information about vaccine components.
- If you are not feeling well.
If you have a mild illness, such as a cold, you can probably get the vaccine today. If you are moderately or severely ill, you should probably wait until you recover. Your doctor can advise you.
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Risks of a vaccine reaction
With any medicine, including vaccines, there is a chance of side effects. These are usually mild and go away on their own, but serious reactions are also possible.
Most people who get hepatitis A vaccine do not have any problems with it.
Minor problems following hepatitis A vaccine include:
- soreness or redness where the shot was given
- low-grade fever
If these problems occur, they usually begin soon after the shot and last 1 or 2 days.
Your doctor can tell you more about these reactions.
Other problems that could happen after this vaccine:
- People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your provider if you feel dizzy, or have vision changes or ringing in the ears.
- Some people get shoulder pain that can be more severe and longer lasting than the more routine soreness that can follow injections. This happens very rarely.
- Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.
As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.
The safety of vaccines is always being monitored. For more information, visit the vaccine safety site.
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What if there is a serious problem?
What should I look for?
- Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would usually start a few minutes to a few hours after the vaccination.
What should I do?
- If you think it is a severe allergic reaction or other emergency that can’t wait, call 9-1-1 and get to the nearest hospital. Otherwise, call your clinic.Afterward, the reaction should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS websiteExternal, or by calling 1-800-822-7967.
VAERS does not give medical advice.
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The National Vaccine Injury Compensation Program
The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.
Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP websiteExternal. There is a time limit to file a claim for compensation.
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How can I learn more?
- Ask your healthcare provider. He or she can give you the vaccine package insert or suggest other sources of information.
- Call your local or state health department.
- Contact the Centers for Disease Control and Prevention (CDC):
- Call 1-800-232-4636 (1-800-CDC-INFO) or
- Visit CDC’s vaccines website
Many Vaccine Information Statements are available in español and other languages. See http://www.immunize.org/visExternal.
Hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite http://www.immunize.org/vis/vis_spanish.aspExternal
Vaccine Information Statement
Hepatitis A Vaccine (7/20/2016)
42 U.S.C. § 300aa-26
Office Use Only
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Hepatitis A Adult Vaccine
Hepatitis is a serious disease caused by a virus. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.
Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.
The hepatitis A adult vaccine is used to help prevent this disease in adults.
This vaccine works by exposing you to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.
Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.
Like any vaccine, the hepatitis A vaccine may not provide protection from disease in every person.
You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if you are allergic to neomycin.
Hepatitis A pediatric vaccine will not protect against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis A if you are already infected with the virus, even without showing symptoms.
You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if you are allergic to neomycin.
Before receiving this vaccine, tell your doctor if you have:
- an allergy to latex rubber; or
- a weak immune system (caused by disease or by using certain medicine).
You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with hepatitis A.
It is not known if hepatitis A vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Hepatitis A vaccine is not approved for use by anyone younger than 12 months old.
Your Child’s Immunizations: Hepatitis A Vaccine (HepA)
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What Is Hepatitis A?
The hepatitis A virus (HAV) causes fever, nausea, vomiting, and jaundice, and can lead to community-wide epidemics. Childcare centers are a common site of outbreaks.
HepA Immunization Schedule
The vaccine is recommended for children 12–23 months old, followed by a second dose 6–18 months later.
HepA can be given as early as 6 months of age if a baby will travel to a place where hepatitis A is common (the baby will still need routine vaccination after the first birthday). It’s also recommended for older kids and adults who are at high risk for the disease. This includes:
- people who live in, travel to, or adopt children from locations with high rates of hepatitis A
- people with clotting disorders
- people with chronic liver disease
- homeless people
- drug users
It also can be given to anyone who wants immunity to the disease.
HepA also is useful for staff of childcare facilities or schools where they may be at risk of exposure. If you plan to travel, talk to your doctor in advance so you and your family have time to get any needed immunizations.
Why Is HepA Recommended?
Besides protecting the individual child, vaccination against the hepatitis A virus can help prevent epidemics. Some infected kids do not have any symptoms, but can still spread the virus to others. Having many young kids vaccinated against hepatitis A can limit the spread of the disease in a community.
Possible Risks of the HepA Vaccine
Side effects are usually mild fever; and tenderness, swelling, and redness at the site of the injection. Allergic reactions to the vaccine are rare.
When to Delay or Avoid HAV Immunization
The HepA vaccine is not recommended if your child:
- is currently sick, although simple colds or other minor illnesses should not prevent immunization
- had a severe allergic reaction to the first dose of hepatitis A vaccine or has a latex allergy
Caring for Your Child After HAV Immunization
Your child may have fever, soreness, and some swelling and redness in the area where the shot was given. For pain and fever, check with your doctor to see if you can give either acetaminophen or ibuprofen, and to find out the appropriate dose.
When Should I Call the Doctor?
- Call if you aren’t sure if the vaccine should be postponed or avoided.
- Call if there are problems after the immunization.
Reviewed by: Elana Pearl Ben-Joseph, MD Date reviewed: March 2019
Hepatitis A Vaccines
Hepatitis A Disease and How to Protect Against It
The Hepatitis A virus causes liver disease that can last from a few weeks to several months. People become infected by close personal contact with someone who is infected or by drinking or eating contaminated food or drinks. You can protect against Hepatitis A with safe, effective vaccination.
Hepatitis A Vaccine Side Effects
The Hepatitis A vaccine is very safe, and it is effective at preventing the Hepatitis A disease. Vaccines, like any medicine, can have side effects. About half of the people who get the Hepatitis A vaccine have no side effects at all. In the other half of people, most report having very mild side effects, like a sore arm from the shot for a day or two. The most common side effects are usually mild and last 1 or 2 days.
Common Side Effects of Hepatitis A Vaccine:
- Sore arm from the shot
- Loss of appetite
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Available Hepatitis A Vaccines
There are three Hepatitis A vaccines approved for use in the United States:
- Havrix pdf iconexternal icon: The Food and Drug Administration (FDA) approved this vaccine in 1995. It is approved for people 1 year of age and older, travelers to other countries, and others at risk.
- Vaqta pdf iconexternal icon: FDA approved this vaccine in 1996. It is approved for people 1 year of age and older, travelers to other countries, and others at risk.
- Twinrix pdf iconexternal icon: FDA approved this vaccine in 2001 for protection against Hepatitis A and Hepatitis B disease. It is approved for people 18 years of age and older, travelers to other countries, and others at risk.
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How CDC Monitors the Hepatitis A Vaccine Safety
CDC and FDA continuously monitor the safety of vaccines after they are approved. If a problem is found with a vaccine, CDC and FDA will inform health officials, health care providers, and the public.
CDC uses three systems to monitor vaccine safety:
- The Vaccine Adverse Event Reporting System (VAERS): an early warning system that helps CDC and FDA monitor problems following vaccination. Anyone can report possible vaccine side effects to VAERS.
- The Vaccine Safety Datalink (VSD): a collaboration between CDC and nine health care organizations which allows ongoing monitoring and proactive searches of vaccine-related data.
- The Clinical Immunization Safety Assessment (CISA) Project: a partnership between CDC and several medical centers that conducts clinical research on vaccine-associated health risks.
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A Closer Look at the Safety Data
- A 2-year reviewexternal icon of Hepatitis A vaccine safety using VAERS data, found no safety problems when the vaccine began to be used as part of the routine immunization schedule in the United States
- A 2004 studyexternal icon of Vaqta among a large group of California patients showed no health problems linked to vaccination. More than 49,000 doses of Hepatitis A vaccine were given to the patients; 15,000 were given to children younger than 18 years of age.
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- Hepatitis A Vaccine Information Statement
- Hepatitis A Vaccine: Who Should Not Be Vaccinated
- Hepatitis A Information for the Public
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Related Scientific Articles
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Hepatitis A vaccine
Easy-to-read medicine information about hepatitis A vaccine – what it is, when it is given and possible side effects.
|Type of medicine||Also called|
What is hepatitis A vaccine?
Hepatitis A vaccine gives protection against infection from the hepatitis A virus. The vaccine works by causing your body to produce antibodies against the virus responsible for hepatitis A infection and in this way protects (or provides immunity) against the disease.
The hepatitis A virus is carried in the faeces (poo) of an infected person. You can come into contact with this when you drink contaminated water, eat food prepared by someone with hepatitis A virus who did not wash their hands after going to the toilet or have sexual contact with someone with the virus. Read more about hepatitis A.
Who should be vaccinated against hepatitis A?
Hepatitis A is uncommon in New Zealand but the vaccine is funded for people at risk of severe infection, such as:
- transplant patients
- children with chronic liver disease
- people who live in close contact with someone infected with hepatitis A.
Immunisation is recommended but not funded for the following groups:
- adults with chronic liver disease including chronic hepatitis B or chronic hepatitis C
- men who have sex with men
- some occupational groups (ie, healthcare workers exposed to faeces/poo, employees of early childhood services, particularly where there are children too young to be toilet trained, sewage workers, those who work with non-human primates (eg, zoos, research laboratories)
- food handlers during community outbreaks
- military personnel who are likely to be deployed to high-risk areas.
Vaccination can be considered in others at higher risk, such as injecting drug users. Hepatitis A vaccine is not routinely recommended for all children in New Zealand, although it may be considered during community outbreaks.
If you are planning to travel to a developing country, you may be at risk of hepatitis A infection and should consider getting immunised.
- High-risk areas include Africa, Asia, Central and South America and the Middle East.
- Moderate-risk areas include the Mediterranean, Eastern Europe (including Russia) and parts of the Pacific.
The vaccine should be given at least 2 weeks before departure so that your body has time to respond to the vaccine.
Examples of hepatitis A vaccines
Havrix and Havrix Junior® are vaccines that protect against hepatitis A.
- Havrix is the higher strength vaccine, used in people 16 years and older.
- Havrix Junior is the lower strength vaccine used in children 1 to 15 years.
These vaccines are given intra-muscularly (injected into the muscle) of the upper arm muscle in adults and older children, and into the thigh muscle in infants.
To get the full benefit of the hepatitis A vaccine, two doses of the injection are needed.
- After one dose of hepatitis A vaccine, protection from hepatitis A lasts for at least 1 year.
- A second boostering dose, given 6 to 12 months after the first dose, gives longer term protection. It is predicted that protection could last for 20 years.
Possible side effects
Like all medicines, vaccines can cause side effects, although not everyone gets them.
|Side effects||What should I do?|
Where can I get vaccinated?
The best place to go for vaccinations is your family medical clinic. They have your medical records and can check to see if you’ve already had a particular vaccination. Either your doctor or a nurse can give the vaccination.
If you don’t have a family doctor, you can go to one of the after-hour medical clinics. Ring them first to make sure they can help you with the vaccination you need.
You can find a clinic near you on the Healthpoint website. Put in your address and region, and under Select a service, click on GPs/Accident & Urgent Medical Care.
Vaccines on the National Immunisation Schedule are free. Other vaccines are funded only for people at particular risk of disease. You can choose to pay for vaccines that you are not eligible to receive for free.
The following links have more information on hepatitis A vaccines:
- The New Zealand National Immunisation Schedule
- Tips following immunisation Ministry of Health, NZ
- Havrix Medsafe Consumer Information
- Twinrix Medsafe Consumer Information
- Hepatitis A Ministry of Health, NZ, 2018
- Hepatitis A Immunisation Handbook, NZ
- Hepatitis A The Immunisation Advisory Centre, NZ
- Havrix The Immunisation Advisory Centre, NZ
- Hepatitis A vaccine New Zealand Formulary
Havrix and Vaqta are two vaccines against Hepatitis A. The risk of severe side effects is low, but Vaqta is more likely to cause fevers in children under 2 years old. Side effects are more likely when HepA vaccines are given with MMR and pneumococcal vaccines.
What are Hepatitis A vaccines?
Havrix and Vaqta
Two vaccines against Hepatitis A are approved in the United States:
Can the vaccine cause Hepatitis A?
No. Havrix and Vaqta can’t cause Hepatitis A because they do not have a live virus. The vaccine contain an inactivated (dead) whole virus from a strain of Hepatitis A that was proven to be weak.
What are common side effects?
- Injection-site reactions (pain, redness, swelling, lump)
- Eye irritation
- Low fever
- Stomach pain
- Loss of appetite
- Joint pain
- Sore throat
What are rare side effects?
Hepatitis A vaccines sometimes cause temporary side effects like fainting, dizziness, vision changes, numbness, tingling, or seizure-like movements. Tell your doctor right away if you have these symptoms. The vaccine is also linked to rare reports of severe side effects.
Both vaccines contain latex and the antibiotic neomycin. People who are sensitive to these ingredients can suffer severe allergic reactions.
What are severe side effects?
- Allergic reaction
- Back pain or stiffness
- Cerebellar ataxia
- Encephalopathy (brain inflammation)
- Enlarged lymph nodes
- Erythema multiforme
- Fever over 100ºF
- Flu-like symptoms
- Febrile seizure
- Guillain-Barré Syndrome (GBS)
- Hematoma (blood pocket)
- Hepatitis (non-viral liver inflammation)
- Latex hypersensitivity reaction
- Lung infection
- Serum sickness-like syndrome
- Shoulder Injury Related to Vaccine Administration (SIRVA)
- Viral infection
What is SIRVA?
Shoulder Injury Related to Vaccine Administration (SIRVA) occurs when the person giving the vaccine accidentally hits nerves, tendons, ligaments, or punctures the bursa in the shoulder. This can result in chronic pain and limited range of movement in the arm.
Can Hepatitis A vaccines cause a Shoulder Injury Related to Vaccine Administration (SIRVA)?
Yes. As with all injection vaccines, there is a risk of a Shoulder Injury Related to Vaccine Administration (SIRVA) with Hepatitis A vaccines. This side effect is more likely when the needle is injected improperly into the shoulder, typically too high or too deep. SIRVA symptoms may include chronic pain, limited mobility, poor flexibility, and weakness.
Can I file a Hepatitis A vaccine lawsuit?
Our lawyers are evaluating Hepatitis A vaccine lawsuits for anyone who suffered a shoulder injury (SIRVA) after receiving the vaccine.
Where can I get more information?
- Hepatitis A Vaccine Lawsuits & Vaccine Injury Compensation Program
- HAVRIX Package Insert (PDF)
- VAQTA Package Insert (PDF)
Hepatitis a adult vaccine Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 3, 2018.
- Side Effects
For the Consumer
Applies to hepatitis a adult vaccine: intramuscular solution, intramuscular suspension
Along with its needed effects, hepatitis a adult vaccine 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:
- Fever more than 99.5 degrees F
- general feeling of discomfort or illness
- unusual tiredness or weakness
- Body aches or pain
- difficulty with breathing or swallowing
- dryness or soreness of the throat
- ear congestion
- 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
- 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
Incidence not known
- Abdominal or stomach pain
- 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
- dark urine
- difficulty controlling your bladder or bowels
- difficulty with walking
- fast heartbeat
- feeling of discomfort
- feeling sad or depressed
- flu-like symptoms
- 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
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- 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
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:
- Pain, redness, swelling, or lumps at the injection site
- weight loss
- 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
- 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
- trouble with sleeping
- unable to sleep
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
The most common adverse events were injection site reactions, irritability, drowsiness, loss of appetite and headache.
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
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
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
Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Abdominal pain, diarrhea, vomiting
Very common (10% or more): Loss of appetite (19.9%)
Common (1% to 10%): Anorexia
Uncommon (0.1% to 1%): Pruritus, rash, urticaria
Postmarketing reports: Angioedema, erythema multiforme, hyperhidrosis
Uncommon (0.1% to 1%): Arthralgia, myalgia
Postmarketing reports: Musculoskeletal stiffness, chills
Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia
Uncommon (0.1% to 1%): Pharyngitis, upper respiratory tract infection
Postmarketing reports: Rhinitis
Postmarketing reports: Anaphylactic reaction, anaphylactoid reaction, serum sickness-like syndrome
Very common (10% or more): Irritability (33.3%)
Uncommon (0.1% to 1%): Insomnia
Postmarketing reports: Hepatitis, jaundice
Postmarketing reports: Vasculitis
Postmarketing reports: Dyspnea
Uncommon (0.1% to 1%): Photophobia
1. “Product Information. Havrix (hepatitis A vaccine).” SmithKline Beecham, Philadelphia, PA.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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- Dosage Information
- Drug Interactions
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