A vaccine is a substance that boosts protection against a particular disease by imitating an infection. It is often made from weakened or killed forms of the disease-causing bacteria. The vaccine gets the body’s immune system to recognize the infection, destroy it and remember how to fight that disease in the future.
Chickenpox vaccine, tetanus shot, flu shot — odds are we’ve all received or at least heard of these vaccines. Of the 1 billion doses of vaccines manufactured worldwide each year, the vast majority are given to healthy babies, children and adults as a way to prevent diseases.
There are 81 vaccines licensed for use in the U.S., according to the U.S. Food and Drug Administration (FDA). The FDA along with the Centers for Disease Control and Prevention (CDC) take many steps to make sure vaccines are very safe and effective. In fact, every vaccine approved for use in the U.S. undergoes years of careful testing. Highly trained scientists and doctors at the FDA analyze the results of these clinical studies, and the FDA inspects the locations where vaccines are made to make sure they adhere to strict manufacturing procedures. Even after a vaccine is licensed, the agencies continue to monitor its use and work to make sure there are no safety issues.
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When determining whether to approve a vaccine, the FDA takes all of the ingredients of a vaccine into account. Some licensed vaccines, such as DTaP vaccines, the pneumococcal conjugate vaccine and hepatitis B vaccines, contain aluminum salts, which are used to enhance the immune response of vaccinated people. Other common ingredients found in vaccines include: antibiotics, used to help prevent bacterial contamination during manufacturing; formaldehyde, used to inactivate viruses so that they don’t cause disease; sugars, amino acids and proteins, used to help protect the vaccine from adverse conditions such as the freeze-drying process; preservatives, used to prevent the growth of bacteria or fungi that may be introduced into the vaccine during its use; and fetal calf/bovine serum, used in some instances to provide nutrition to viruses grown in cells during the manufacturing of vaccines.
Vaccines, like any medication, can cause side effects, according to the CDC. However, the agency advises that a decision not to immunize could put people at risk of contracting potentially deadly diseases. Vaccines have reduced preventable infectious diseases to a record low and now only a small number of people suffer the devastating effects of measles, whooping cough and other illnesses, regulators say.
In rare cases, vaccines can cause serious, life-altering injuries.
In most cases, vaccine side effects are mild and go away within a few days. Examples include soreness where the shot was given, low fever, headache and fatigue. Though very rare, severe, long-lasting side effects from vaccines do occur. These can include shoulder injury related to vaccine administration, autoimmune diseases, neurological disorders, inflammatory disorders and bleeding disorders.
If the body’s immune system reacts adversely to one or more components of a vaccine, the patient may experience several types of shoulder-related injuries. Such injuries are known as shoulder injuries related to vaccine administration, or SIRVA.
SIRVA can also occur if a vaccine is injected into the arm too high or too deep and causes an injury to the musculoskeletal structures of the shoulders, such as tendons, ligaments or bursa.
Symptoms of SIRVA generally emerge within 48 hours of injection with a vaccine. The most common symptoms of SIRVA are severe, persistent shoulder pain and limited range of motion.
Doctors may choose to treat SIRVA with an anti-inflammatory or other pain medication. Some patients may also receive corticosteroid injections. Physical therapy is another treatment option and may reduce swelling and improve range of motion. Unfortunately, many patients who undergo treatment continue to suffer from pain, and severe cases may require surgery to repair shoulder damage.
Not only can SIRVA cause continued pain and discomfort, but also it can be expensive. Although a vaccine, such as the flu shot, may be free of charge, it could result in tens of thousands of dollars in medical expenses, including MRIs and visits to an orthopedic surgeon’s office. Patients with insurance may only pay about 20 percent of the cost out-of-pocket; however, there are thousands of uninsured people receiving annual vaccinations at clinics and pharmacies across the U.S.
Vaccines are associated with certain rare but serious medical conditions. These conditions can be life-altering and even life-threatening. The measles, mumps and rubella (MMR) vaccine, for example, is associated with inflammation of the brain and brain disease that alters brain function or structure. And case reports have documented an association between tetanus vaccination and the immune-system disorder Guillain-Barré syndrome.
In very rare instances in which vaccines cause life-altering problems, the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to people who file vaccine-related injury or death petitions and who are found to have been injured by certain vaccines administered on or after October 1, 1988.
In the 1980s, lawsuits against vaccine manufacturers and healthcare providers threatened to cause vaccine shortages and lower vaccine rates. This could have caused a revival of vaccine-preventable diseases. As a result, the National Childhood Vaccine Injury Act of 1986 created the VICP as a no-fault alternative to the traditional legal system for resolving vaccine injury claims.
Under the no-fault system, the person who claims injury is responsible for showing that the vaccine caused the injury, regardless of who is to blame. In other words, the person is asked to prove causation rather than fault. The program provides compensation to people found to be injured by certain vaccines. Even if the causation isn’t found, a settlement may provide compensation.
VICP began accepting claims in 1988, and by January 2018, more than 19,021 petitions had been filed with the program. In that time, 16,938 petitions were decided. The program awarded compensation in 5,825 cases and 11,113 petitions. In total, the program has paid out about $3.8 billion.
Between 2006 and 2016, more than 3.1 billion doses of vaccines covered by VICP were distributed in the U.S., according to the CDC. Of the injury claims filed during that time, about 3,583 cases had been compensated: 634 by concession, 293 by court decision and 2,649 by settlement. The majority are regarding Influenza vaccines.
In 2017, people filed 1,243 claims. This surpassed the 1,120 claims filed in 2016. As of Jan. 3, 2018, vaccine patients had filed 339 injury claims for the fiscal year that began Oct. 1, 2018.
1. Pain & Suffering
Pain and suffering (under the Vaccine Act, there is a statutory cap of $250,000 on pain and suffering claims, regardless of the injury’s severity)
2. Lost Wages
Past lost wages and future loss of earning capacity
3. Medical Expenses
Any out-of-pocket medical expenses not covered by insurance
4. Medical Care
Future medical care
The VICP is funded through the Vaccine Injury Compensation Trust Fund. The U.S. Department of Treasury collects a 75-cent excise tax on vaccines recommended by the CDC for routine administration to children. The tax is based on the number of diseases that a vaccine prevents. For example, trivalent influenza vaccine prevents one disease and is therefore taxed 75 cents. The measles-mumps-rubella vaccine, however, prevents three diseases and is consequently taxed $2.25.
The Division of Injury Compensation Programs, Healthcare Systems Bureau, and Health Resources and Services Administration administer the VICP. The U.S. Department of Health and Human Services (HHS) is responsible for hosting the program as well as conducting medical reviews of petitions and making court-ordered compensation payments. The U.S. Department of Justice represents HHS in court, and the U.S. Court of Federal Claims in Washington, D.C. decides whether a person receives compensation and determines the type and amount of compensation given.
VICP covers most vaccines given routinely in the U.S. For a vaccine to be covered, the CDC must recommend the category of vaccine for routine administration to children or pregnant women. The category of vaccine must also be subject to an excise tax by federal law.
The U.S. Department of Health and Human Services Health Resources and Services Administration provides a vaccine injury table that lists the injuries and/or conditions associated with some VICP covered vaccines.
The vaccine injury table is essentially a one-stop location to determine which vaccines are covered by VICP. Unless another cause is proven, it is presumed that the vaccine caused the injury or condition if the injury meets the definition in the table and the first symptom of the injury and/or condition emerged within the listed time period. This presumption remains even if a vaccine included in the table is administered “off-label” or against CDC or Advisory Committee for Immunization Practices recommendations.
In the event a person’s injury and/or condition is not on the table or it does not meet the table requirements, he or she must use expert witness testimony, medical records, medical opinion or other evidence to prove the vaccine caused the injury and/or condition. Additional vaccines may be added to the table in the future.
VICP currently covers 17 vaccines. The following shows the covered illnesses, disabilities, injuries, conditions and deaths for each vaccine as well as the time period in which they are to occur for a person to receive compensation.
Tetanus & Whooping Cough (Pertussis): DTaP, DTP, DT, Td Tdap or TT
Anaphylaxis, Brachial Neuritis: ≤ 4 hours. 2-28 days (not less than 2 days and not more than 28 days).
Shoulder Injury Related to Vaccine Administration: ≤ 48 hours.
Shoulder Injury Related to Vaccine Administration: ≤ 48 hours.
Measles, Mumps, and Rubella: MMR, MR, M, R
Anaphylaxis: ≤ 4 hours
Encephalopathy or encephalitis: ≤ 72 hours
Shoulder Injury Related to Vaccine Administration: ≤ 48 hour
Vasovagal syncope: ≤ 1 hour
Chickenpox: Varicella (VZV)
Anaphylaxis, Brachial Neuritis: ≤4 hours
Disseminated varicella vaccine-strain viral disease: N/A
Vaccine-strain virus identified: N/A
If strain determination is not done or if laboratory testing is inconclusive: 7-42 days (not less than 7 days and not more than 42 days)
Varicella vaccine-strain viral reactivation: N/A
Shoulder Injury Related to Vaccine Administration: ≤48 hours
Vasovagal syncope: ≤1 hour
Polio: OPV and IPV
Anaphylaxis, Brachial Neuritis: ≤ 4 hours
Shoulder Injury Related to Vaccine Administration: ≤ 48 hours.
Vasovagal syncope: ≤ 1 hour
Intussusception: 1-21 days (not less than 1 day and not more than 21 days).
* Information show describes Illness, disability, injury or condition covered as well as Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration
To receive compensation from VICP, you must file a legal document known as a petition with the U.S. Court of Federal Claims. A petition is usually only a few pages long and it lays out the facts of the claim. You can prepare the petition yourself or hire a lawyer to prepare and file one for you. Most people hire a lawyer because this is a legal process.
Any person who received a VICP-covered vaccine and believes he or she was injured as a result can file a petition, regardless of age. Parents, legal guardians and legal representatives can file a petition on behalf of infants, children, disabled adults and deceased persons. You do not need to be a U.S. citizen to file a petition.
According to the Vaccine Rules of the U.S. Court of Federal Claims, the petition must include:
The VICP has severity requirements for filing a petition. A person can file a petition when the effects of the injury lasted for more than six months after the vaccination; resulted in inpatient hospitalization and surgical intervention; or resulted in death.
The timeframe for filing a petition is different for an injury claim and for a death claim. If a person chooses to file an injury claim, he or she must do so within three years after “the first symptom or manifestation of onset or of the significant aggravation of the injury.” Death claims must be filed within two years of the death and within four years of “the first symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted.”
Officials changed some of the requirements in 2017 to make it easier to obtain compensation in two kinds of cases. One of those involves people who develop Guillian-Barre syndrome (GBS) between three and 42 days after receiving a flu vaccine. When that happens, the program will presume that GBS was caused by the vaccine. This saves the claimant from having to provide proof of causation.
The other change relates to people who suffer a SIRVA injury within 48 hours of any covered vaccine. The program will also presume causation in those cases.
The changes relax the statute of limitations for some people who may not have been able to file under the previous rules. People who qualify under the new rule may file petitions for these injuries caused by covered vaccinations if the injuries happened after March 21, 2009. These petitions must be filed before March 21, 2019, to qualify for the temporarily relaxed deadlines. This applies to petitions that were previously rejected or were not filed. If they were filed and formally decided under the program, they cannot be filed again.
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Besides meeting the filing deadlines, you must prove in your petition that: the injury or condition allegedly caused by the covered vaccine meets the requirements of the Vaccine Injury Table; the vaccine caused the injury or condition; or the vaccine significantly aggravated an existing illness or condition causing it to get worse. In addition, the court must not find that the injury or death was caused by something else.
People who believe they have been injured after receiving vaccines covered by the VICP and also the Countermeasures Injury Compensation Program (CICP) may file a petition with either program or with both programs. The CICP was created in case someone suffers a serious injury from a covered vaccine recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat. For example, a person who suffered serious injury after receiving both the seasonal flu vaccine (covered under VICP) and the 2009 H1N1 vaccine (covered under CICP) could file a petition with both programs.
A person files a petition with the U.S. Court of Federal Claims.
Medical staff with the U.S. Department of Health and Human Services reviews the petition, determines if it meets the medical criteria for compensation and makes a preliminary recommendation.
The U.S. Justice Department generates and submits a report to the court that includes the medical recommendation and legal analysis.
A court-appointed special master receives the report and decides whether the petitioner should be compensated. The court typically holds a hearing in which both parties can present evidence. If the special master awards compensation, he or she determines the amount and type.
The court orders the U.S. Department of Health and Human Services to pay the compensation. The court may order the department to pay attorneys' fees and costs even if the petition is dismissed as long as certain requirements are met.
More than 80 percent of all compensation the VICP awards comes as a result of negotiated settlement in which the U.S. Department of Health and Human Services has not concluded that a vaccine caused the alleged injury.
The person allegedly injured by a vaccine and HHS may decide to settle in order to minimize loss, time and the expense of litigating a case. A settlement may also come out of a desire to resolve a petition quickly.
Please seek the advice of a medical professional before making health care decisions.
Emily Miller is an award-winning writer who has held editorial positions with reputable print and online publications around the U.S. As the editor of Drugwatch.com, Emily draws on her background as both a patient and a journalist to ensure her team of writers provides consumers with the latest and most accurate information on drugs, medical devices, procedures and related lawsuits. Emily holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science, the Society of Professional Journalists and the Society for Technical Communication.