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Does Havrix, Vaqta (Hepatitis A vaccine) cause side effects?
Havrix, Vaqta (Hepatitis A vaccine) is an immunization used to prevent hepatitis A, a type of liver disease that is caused by the hepatitis A virus (HAV), in persons 12 months of age and older. Common side effects of hepatitis A vaccine include soreness where the shot was given, headache, loss of appetite, and tiredness.
Drug interactions of hepatitis A vaccine include fingolimod, belimumab, anakinra, adalimumab, infliximab, antineoplastic agents (anti-cancer medications), and other drugs that suppress the immune system.
There are no adequate or well-controlled trials of hepatitis A vaccine use in pregnant women.
Hepatitis A vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if the hepatitis A vaccine is excreted into human milk after administration to the mother. The manufacturer recommends caution when given it to nursing mothers.
What are the important side effects of Havrix, Vaqta (hepatitis A vaccine)?
Mild side effects include:
- Soreness where the shot was given
- Loss of appetite
Other reported side effects include:
Havrix, Vaqta (hepatitis A vaccine) side effects list for healthcare professionals
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
Gastrointestinal Disorders: Nausea.
Incidence < 1% of Injections
Blood and Lymphatic System Disorders: Lymphadenopathy.
Psychiatric Disorders: Insomnia.
Nervous System Disorders: Dysgeusia, hypertonia.
Eye Disorders: Photophobia.
Skin and Subcutaneous Tissue Disorders: rash.
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 4 studies, 3,152 children 11 to 25 months of age received at least one dose of HAVRIX 720 EL.U. administered alone or concomitantly with other routine childhood vaccinations. The studies included HAV 210 (N = 1,084), HAV 232 (N = 394), HAV 220 (N = 433), and HAV 231 (N = 1,241).
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)
|Group 1 HAVRIX Dose 1 %||Group 2 HAVRIX+ MMR+Vb Dose 1 %||Group 1 HAVRIX Dose 2 %||Group 2 HAVRIX Dose 2 %|
|Local (at injection site for HAVRIX)|
|Irritability, grade 3||0.3||1.9||1.5||0.3|
|Drowsiness, grade 3||1.0||2.2||1.1||0.0|
|Loss of appetite, any||18.3||26.1||19.9||20.5|
|Loss of appetite, grade 3||1.0||1.4||0.4||0.3|
|Fever ≥ 100.6°F (38.1°C)||3.0||4.8||3.3||2.7|
|Fever ≥ 101.5°F (38.6°C)||2.0||2.6||1.8||1.6|
|Fever ≥ 102.4°F (39.1°C)||0.7||0.7||0.4||1.1|
|Total vaccinated cohort (TVC) = all subjects who received at least one dose of vaccine.|
N = number of subjects who received at least one dose of vaccine and for whom diary card information was available.
Grade 3: drowsiness defined as prevented normal daily activities; irritability/fussiness defined as crying that could not be comforted/prevented normal daily activities; loss of appetite defined as no eating at all.
a Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b MMR = measles, mumps, and rubella vaccine; V = varicella vaccine.
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.
Vascular Disorders: Vasculitis.
Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea.
Hepatobiliary Disorders: Hepatitis, jaundice.
Congenital, Familial, and Genetic Disorders: Congenital anomaly.
Musculoskeletal and Connective Tissue Disorders: Musculoskeletal stiffness.
What drugs interact with Havrix, Vaqta (hepatitis A vaccine)?
Concomitant Administration With Vaccines And Immune Globulin
In clinical studies HAVRIX was administered concomitantly with the following vaccines:
- INFANRIX (DTaP);
- Hib conjugate vaccine;
- pneumococcal 7-valent conjugate vaccine;
- MMR vaccine;
- varicella vaccine.
HAVRIX may be administered concomitantly with immune globulin.
When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. Do not mix HAVRIX with any other vaccine or product in the same syringe or vial.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to HAVRIX.
Havrix, Vaqta (Hepatitis A vaccine) is an immunization used to prevent hepatitis A, a type of liver disease that is caused by the hepatitis A virus (HAV), in persons 12 months of age and older. Common side effects of hepatitis A vaccine include soreness where the shot was given, headache, loss of appetite, and tiredness. Other reported side effects of hepatitis A vaccine include allergic reactions, belly pain, taste changes, nausea, vomiting, sensitivity to light, seizures, dizziness, and difficulty sleeping. Drug interactions of hepatitis A vaccine include fingolimod, belimumab, anakinra, adalimumab, infliximab, antineoplastic agents (anti-cancer medications), and other drugs that suppress the immune system. There are no adequate or well-controlled trials of hepatitis A vaccine use in pregnant women.
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Related Disease Conditions
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Hepatitis A (HAV, Hep A)
Hepatitis means inflammation of the liver. Hepatitis A (HAV, Hep A) is one type of liver disease caused by a virus. Since hepatitis A is a virus, it can pass from person to person from eating or drinking contaminated food or coming into contact with contaminated materials containing the virus. Symptoms of hepatitis A include stomach pain, diarrhea, dark yellow urine, jaundice, and more. There is a vaccine to prevent contracting hepatitis A.
Hepatitis B (HBV, Hep B)
The hepatitis B virus (HBV, hep B) is a unique, coated DNA virus belonging to the Hepadnaviridae family of viruses. The course of the virus is determined primarily by the age at which the infection is acquired and the interaction between the virus and the body's immune system. Successful treatment is associated with a reduction in liver injury and fibrosis (scarring), a decreased likelihood of developing cirrhosis and its complications, including liver cancer, and a prolonged survival.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like: fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by persons sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Hepatitis A and B Vaccinations
Hepatitis A and hepatitis B are the two most commnon viruses that infect the liver. Hepatitis A and Hepatitis B can be prevented and treated with immunizations (vaccinations) such as Havrix, Vaqta, Twinrix, Comvax, Pediarix, and hepatitis b immune globulin (HBIG).
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
Is Hepatitis B Contagious?
Hepatitis B is a type of liver infection. Hepatitis B is spread through person-to-person contact or through personal items like razors, toothbrushes, etc. Symptoms of hepatitis B include fever, yellowish skin (jaundice), dark urine, fatigue, nausea, and vomiting. There is no drug to cure hepatitis B; however, there is a hepatitis B vaccine available.
Hepatitis C Cure (Symptoms, Transmission, Treatments, and Cost)
Hepatitis is inflammation of the liver. There are a variety of toxins, diseases, illicit drugs, medications, bacterial and viral infections, and heavy alcohol use can case inflammation of the liver. Hepatitis C viral infection (HCV) is one type of hepatitis. According to the CDC, in 2014 there were an estimated 30,500 cases of acute hepatitis C infections in the US. An estimated 2.7-3.9 million people in the US have chronic hepatitis C. The virus is spread from person-to-person via blood-to-blood contact. Symptoms of HCV infection include joint pain, jaundice, dark urine, nausea, fatigue, fever, loss of appetites, clay colored stool. Hepatitis C can be cured with medications in most people. There is no vaccine against the hepatitis C virus.
Is Hepatitis A Contagious?
Hepatitis means inflammation of the liver. Hepatitis A is one type of hepatitis. Hepatitis is transmitted through person to person contact, contaminated ice, vegetables, fruits, and untreated water. Hepatitis A can be prevented by the hepatitis A vaccine. Symptoms of hepatitis A may include nausea and/or vomiting, fever, loss of appetite, abdominal pain, dark urine, clay-colored stools, jaundice (yellowish color to skin and/or eyes, or joint pain.
Hepatitis E Viral Infection
Hepatitis E (hep E) is a type of hepatitis viral infection that includes hepatitis A, B, C, D, F, which is caused by the hepatitis E virus. Usually, you get (transmitted) hepatitis E from eating or drinking dirty or contaminated water. Hepatitis E can be very serious, especially if a woman is pregnant. Up to ¼ of women who are pregnant with the hep E virus can die from the infection. The signs and symptoms of hepatitis E infection are nausea and vomiting, brown or dark urine, stool changes jaundice (yellow eyes and skin), pain in the right side of the abdomen, dark or brown urine, and light-colored stool. Some people with hep E don’t have any symptoms so they don’t know that they are contagious. It takes about 6 weeks to recover from hep E. A person who has any type of hepatitis, including hepatitis E, should not drink any alcohol. Hep E complications are rare, but when they do occur they include severe (“fulminant”) hepatitis, liver failure, and death. Currently, no specific drugs or treatments are available for hepatitis E. Moreover, the only hepatitis E vaccine currently is available in China. Avoid alcohol, keep hydrated, and getting rest are home remedies for hepatitis E. Talk to your doctor before taking any over-the-counter (medications), especially those containing acetaminophen (Tylenol and others). Usually, the prognosis and life expectancy for hepatitis E after recovery is good. Most people do not have long term liver problems from the infection.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.