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.
Refer to Reporting Adverse Events Following Immunization in Canada and Adverse events following immunization in Part 2 for additional information about AEFI reporting.
For Adults At High Risk Of Exposure
Adults who have not received the hepatitis B vaccine series should be immunized when they have an increased risk of exposure. Job, travel, health condition, or lifestyle all may increase a person’s risk of contracting hepatitis B.
People who live or work where there is risk of exposure include:
- Health care and public safety workers who are likely to be exposed to blood or blood products.
- Clients and staff of institutions or residential settings with known or potential HBV carriers.
- People planning extended travel to China, Southeast Asia, Africa, and other areas where hepatitis B infection is high.
People who have health conditions that put them at high risk for exposure or a severe infection include:
- People who have a severe kidney disease that requires them to have their blood filtered through a machine .
- People who have chronic liver disease.
- People who have hemophilia and other conditions in which they need to have blood products on an ongoing basis.
- People who had a stem cell transplant.
People whose lifestyle puts them at high risk for exposure include:
- People who inject illegal drugs.
- Men who have sex with men.
- People who have had more than one sex partner in the past 6 months or who have a history of sexually transmitted infection.
- Household contacts and sex partners of hepatitis B carriers.
- Prison inmates.
What Drugs Interact With Twinrix
Concomitant Administration With Vaccines And Immune Globulin
- Do not mix Twinrix with any other vaccine or product in the same syringe.
- When concomitant administration of immunoglobulin is required, it should be given with a different syringe and at a different injection site.
- There are no data to assess the concomitant use of Twinrix with other vaccines.
- Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids , may reduce the immune response to Twinrix.
Interference With Laboratory Tests
- Hepatitis B surface antigen derived from hepatitis B vaccines has been transiently detected in blood samples following vaccination. Serum HBsAg detection may not have diagnostic value within 28 days after receipt of a hepatitis B vaccine, including Twinrix.
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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.
More Information On Side Effects
Reactions listed under âpossible side effectsâ or âadverse eventsâ 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 through the Yellow Card Scheme
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Side Effects Requiring Immediate Medical Attention
Along with its needed effects, hepatitis b 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 immediately if any of the following side effects occur while taking hepatitis b adult vaccine:
- pain or discomfort in the arms, jaw, back, or neck
- sudden numbness and weakness in the arms and legs
Persons New To Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals, as necessary. In many countries outside of Canada, HB vaccine is in limited use.
All persons from a country that is endemic for HB should be assessed and vaccinated against HB if not immune and not infected. Individuals born in developing countries are more likely to be carriers of HB, necessitating vaccination of their sexual and household contacts based on review of their serologic test results. HB vaccine is recommended for all household contacts whose families have immigrated to Canada from areas in which there is a high prevalence of HB and who may be exposed to HB carriers through their extended families or when visiting their country of origin.
Children adopted from countries in which there is a high prevalence of HB infection should be screened for HBsAg and, if positive, household or close contacts in the adopting family should be immunized before adoption or as soon as possible thereafter. Adults going to pick-up children from these countries should be vaccinated before departure. Refer to Immunization of Persons New to Canada in Part 3 for additional information.
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Side Effects Of Hepatitis B Vaccines
Immunisations containing components to protect against hepatitis B are effective and safe, although all medication can have unwanted side effects.
Side effects from the vaccine are uncommon and usually mild, but may include:
- Localised pain, redness and swelling at the injection site.
- Low-grade temperature .
- In children being unsettled, irritable, tearful, generally unhappy, drowsy and tired.
- Occasionally, an injection-site lump that may last many weeks, but for which treatment is not needed.
A Look At Each Vaccine: Hepatitis B Vaccine
The hepatitis B vaccine is given to prevent the severe liver disease that can develop when children or adults are infected with hepatitis B virus. The hepatitis B vaccine is given as a series of three shots. The first dose is given within 24 hours of birth. The second dose is given one to two months after the first dose, and the third dose is given between 6 months and 18 months of age.
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How To Get Vaccinated Against Hepatitis B
All babies in the UK born on or after 1 August 2017 are given 3 doses of hepatitis B-containing vaccine as part of the NHS routine vaccination schedule. These doses are given at 8, 12 and 16 weeks of age.
Babies at high risk of developing hepatitis B infection from infected mothers are given additional doses of the hepatitis B vaccine at birth, 4 weeks and 1 year of age.
If you think you’re at risk and need the hepatitis B vaccine, ask your GP to vaccinate you, or visit any sexual health or genitourinary medicine clinic.
If your GP or nurse is unable to offer you the hepatitis B vaccine because of a temporary shortage in supply, you may need to wait longer for the vaccine. For more information, read What to do if you have to wait for a dose of hepatitis B vaccine .
If your job places you at risk of hepatitis B infection, it’s your employer’s responsibility to arrange vaccination for you, rather than your GP. Contact your occupational health department.
How Do You Get Hepatitis B
The Hepatitis B virus is spread when blood, semen, or other body fluid infected with the Hepatitis B virus enters the body of a person who is not infected. Some Hepatitis B causes can include:
- Sex with an infected partner
- Sharing needles, syringes or other drug preparation equipment
- Sharing items such as toothbrushes, razors or medical equipment such as a glucose monitor with an infected person
- Direct contact with the blood or open sores of an infected person
- Exposure to blood from needlesticks or other sharp instruments of an infected person
You CANNOT get Hepatitis B through food or water, sharing eating utensils, breastfeeding, hugging, kissing, hand holding, coughing or sneezing.
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Why Should I Vaccinate My Newborn Child If I Know That I Am Not Infected With Hepatitis B Virus
Before the hepatitis B vaccine, every year in the United States about 18,000 children were infected with hepatitis B virus by the time they were 10 years old. This statistic is especially important because people are much more likely to develop liver cancer or cirrhosis if they are infected early in life, rather than later in life .
About 9,000 of the 18,000 children infected in the first 10 years of life caught the virus from their mother during birth. However, many young children didn’t catch the disease from their mother. They caught it from either another family member or someone else who came in contact with the child. Because hepatitis B can be transmitted by relatively casual contact with items contaminated with blood of an infected person, and because many people who are infected with hepatitis B virus don’t know that they have it, it is virtually impossible to be “careful enough” to avoid this infection.
For these reasons, all young children are recommended to receive the hepatitis B vaccine. The best time to receive the first dose is right after birth. This will ensure that the child will be protected as early as possible from catching hepatitis B from people who dont know that they are infected with the virus.
Listen to Dr. Offit explain why newborns get the hepatitis B vaccine by watching this short video, part of the series Talking About Vaccines with Dr. Paul Offit.
Babies And Hepatitis B Vaccination
Pregnant women have a routine blood test for hepatitis B as part of their antenatal care.
Babies born to mothers infected with hepatitis B need to be given a dose of the hepatitis B vaccine within 24 hours of their birth, followed by further doses at 4, 8, 12 and 16 weeks of age, plus a final dose when they’re 1 year old.
Babies of mothers identified by the blood test as particularly infectious might also be given an injection of HBIG at birth on top of the hepatitis B vaccination to give them rapid protection against infection.
All babies born to mothers infected with hepatitis B should be tested at 1 year of age to check if they’ve become infected with the virus.
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Hepatitis B Vaccine Side Effects
As with any medication, the hepatitis B vaccine may cause some side effects. Most people dont experience any unwanted effects. The most common symptom is a sore arm from the injection site.
When receiving the vaccination, youll likely receive information or a pamphlet regarding the side effects that you might expect, and others that warrant medical attention.
Mild side effects usually last only . Mild side effects of the vaccine include:
- redness, swelling, or itching at the injection site
- a purple spot or lump at the injection site
Does Recombivax Hb Cause Side Effects
Recombivax HB is made from noninfectious parts of HBV using recombinant DNA technology. The vaccine is a sterile preparation for intramuscular injection and contains purified inactive proteins from the surface of HBV.
The proteins can activate the immune system but cannot give rise to a replicating virus. Viral proteins used in Recombivax HB are manufactured in yeast cells using recombinant technology. Recombivax HB works by stimulating the immune system to attack the viral proteins.
When Recombivax HB is administered, the body’s immune system recognizes the viral proteins in the vaccine as foreign, and develops antibodies against them, thus providing immunity from future infections. In the event of HBV exposure following vaccination, the body will already be primed to fight the infection.
Common side effects of Recombivax HB include
Drug interactions of Recombivax HB include fingolimod, belimumab, anakinra, adalimumab, infliximab, antineoplastic agents , and other immunosuppressives, which may decrease the effectiveness of Recombivax HB.
There are no adequate or well-controlled trials of Recombivax HB use in pregnant women. Recombivax HB should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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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 youve already had a particular vaccination. Either your doctor or a nurse can give the vaccination.If you dont 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.
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.
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Concerns About Immunisation Side Effects
If the side effect following immunisation is unexpected, persistent or severe, or if you are worried about yourself or your child’s condition after a vaccination, see your doctor or immunisation nurse as soon as possible or go directly to a hospital.
It is important to seek medical advice if you are unwell, as this may be due to other illness, rather than because of the vaccination.
Immunisation side effects may be reported to SAEFVIC, the Victorian vaccine safety and reporting service. Discuss with your immunisation provider how to report adverse events in other states or territories.
Possible Side Effects From Vaccines
Any vaccine can cause side effects. For the most part these are minor and go away within a few days. Listed below are vaccines licensed in the United States and side effects that have been associated with each of them. This information is copied directly from CDCs Vaccine Information Statements , which in turn are derived from the Advisory Committee on Immunization Practices recommendations for each vaccine.
Remember, vaccines are continually monitored for safety, and like any medication, vaccines can cause side effects. However, a decision not to immunize a child also involves risk and could put the child and others who come into contact with him or her at risk of contracting a potentially deadly disease.
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Side Effects Not Requiring Immediate Medical Attention
Some side effects of hepatitis b 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 at the injection site
- unusual tiredness or weakness
Applies to hepatitis b adult vaccine: intramuscular solution, intramuscular suspension
What Are The Side Effects Of Hepatitis A And Hepatitis B Vaccine
Get emergency medical help if you have any of these signs of an allergic reaction: hives difficulty breathing swelling of your face, lips, tongue, or throat.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Becoming infected with hepatitis is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
You may feel faint after receiving this vaccine. Some people have had seizure like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.
- numbness, tingling, or burning pain
- red or blistering skin rash with burning or tingly feeling
- easy bruising or bleeding or
- unexplained muscle pain, tenderness, or weakness.
Common side effects include:
- redness, tenderness, or a hard lump where the shot was given
- headache or
- tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
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Twinrix 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 with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
Following any dose of Twinrix, the most common solicited injection site reactions were
- injection site soreness and redness
- the most common solicited systemic adverse reactions were
- headache and
- fatigue .
The safety of Twinrix has been evaluated in clinical trials involving the administration of approximately 7,500 doses to more than 2,500 individuals.
- In a U.S. study, 773 subjects were randomized 1:1 to receive Twinrix or concurrent administration of Engerix-B and Havrix .
- Solicited local adverse reactions and systemic adverse events were recorded by parents/guardians on diary cards for 4 days after vaccination.
- Unsolicited adverse events were recorded for 31 days after vaccination.
- Solicited reactions reported following the administration of Twinrix or Engerix-B and Havrix are presented in Table 1.
Table 1: Rates of Local Adverse Reactions and Systemic Adverse Reactions within 4 Days of Vaccinationawith Twinrixb or Engerix-B and Havrixc
Most solicited local adverse reactions and systemic adverse reactions seen with Twinrix were considered by the subjects as mild and self-limiting and did not last more than 48 hours.
Postmarketing Experience With Twinrix