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Vaccines

Chickenpox vaccine, tetanus shot, flu shot — odds are we’ve all received or at least heard of these vaccines. Of the one 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.

*Please seek the advice of a medical professional before discontinuing the use of this drug.

Vaccine Syringe and Various Vaccine Pill Forms

After an infection, the body’s immune system remembers what it learned about how to protect the body against that disease. A vaccine is a substance that improves immunity to a particular disease by imitating an infection. It is often made from weakened or killed forms of the bacterium causing disease. The vaccine gets the body’s immune system to recognize the infection, destroy it and remember how to fight that disease in the future.

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.

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.

Woman Testing Chemicals in Lab
The FDA rigorously test vaccines for imperfections

Vaccine Side Effects

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.

Vaccines, like any medication, can cause side effects, according to the CDC.

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. Some of these side effects can be categorized into two groups: shoulder injuries, and autoimmune diseases and other disorders. These include:

Long-Lasting Side Effects

Shoulder Injuries

Brachial neuritis— Inflammation of the network of nerves that originate near the neck and shoulder (brachial plexus) that causes sudden shoulder and arm pain, followed by weakness and/or numbness.

Torn rotator cuff — A tear in the group of four muscles that help to lift and rotate the arm and to stabilize the ball of the shoulder within the joint.

Frozen shoulder (adhesive capsulitis) — A condition that causes pain and stiffness in the shoulder to the point where it becomes very hard to move.

Shoulder bursitis — Inflammation of the large lubricated cushion (bursa) near the top of the shoulder that causes tenderness.

Shoulder tendinitis — Irritation or damage to the rotator cuff that can cause pain and stiffness around the shoulder.

Shoulder impingement syndrome — A condition when the bone on top of the shoulder rubs against the tendon and the bursa, causing irritation and pain.

Chronic pain — Shoulder pain that is present for longer than six months.

Autoimmune Diseases and Other Disorders

Guillain-Barré Syndrome (GBS) — A disorder in which the immune system damages nerve cells, causing muscle weakness and sometimes paralysis.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) — A neurological disorder in which there is progressive weakness and impaired sensory function in the legs and arms.

Acute Disseminated Encephalomyelitis (ADEM) — A neurological disorder that causes prolonged, severe headaches in children and movement and tingling or numbness issues in adults.

Systemic Lupus Erythematosus (SLE), or lupus — An autoimmune disease that causes a chronic inflammatory condition that can affect many organs in the body.

Myositis — Muscle inflammation that can cause muscle weakness and pain, fatigue, difficulty breathing, rash and persistent dry cough.

Cerebellar Ataxia — A disorder that occurs when the area of the brain responsible for muscle coordination (cerebellum) becomes inflamed or damaged.

Bell’s Palsy — A form of temporary facial paralysis caused by damage or trauma to the facial nerves.

Immune Thrombocytopenia (ITP) — A bleeding disorder in which the blood doesn’t clot as it should, which can result in bleeding inside the body (internal bleeding) or underneath or from the skin.

Vasculitis — A group of rare diseases that involve inflammation of the blood vessels.

Optic Neuritis — Swelling of the eye’s optic nerve, which can result in a person’s inability to see clearly.

National Vaccine Injury Compensation Program

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.

Rash at Injection Site
VICP was formed to help those injured by the administration of certain vaccines

In the 1980s, lawsuits against vaccine manufacturers and healthcare providers threatened to cause vaccine shortages and lower vaccine rates, which 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 in instances in which such a finding is not made, people may receive compensation through a settlement.

The U.S. government defines VICP’s objectives as:

  1. To ensure an adequate supply of vaccines
  2. To stabilize vaccine costs
  3. To establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines

VICP began accepting claims in 1988, and by 2015, more than 18,072 petitions had been filed with the program. In that time, 16,289 petitions were decided — 5,353 of which resulted in compensation and 10,936 were dismissed. In total, the program has paid out more than $3.6 billion.

Between 2006 and 2015 alone, more than 2.8 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, the court decided 4,426 petitions — 65 percent (2,884) of which resulted in compensation. In other words, for every 1 million doses of vaccine that were distributed, 1 person received compensation.

People injured by vaccines may receive compensation for:

  • 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)
  • Past lost wages and future loss of earning capacity
  • Any out-of-pocket medical expenses not covered by insurance
  • 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.

Those involved in the VICP petition process include:

  • Petitioners — injured parties, many of whom are represented by private attorneys who are members of the Vaccine Injured Petitioners Bar Association.
  • U.S. Department of Health and Human Services — defends all vaccine-related claims.
  • U.S. Department of Justice —represents the U.S. Department of Health and Human Services in court.
  • U.S. Court of Federal Claims – handles vaccine-related claims (The court is made up of eight special masters collectively known as the Office of Special Masters, who are appointed by Court of Federal Claims judges).

VICP-Covered Vaccines

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.

Elderly Man Getting a Shot from Nurse
VICP covers most vaccines given routinely in the U.S.

The vaccine injury table is essentially a one-stop location to determine which vaccines are covered by VICP. Unless another cause if 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.

Vaccines currently covered by VICP

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 (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.

Vasovagal syncope: ≤ 1 hour

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

Hepatitis: Hepatitis A Vaccine (HAV) or Hepatitis B Vaccine (HBV)

Anaphylaxis ≤4 hours

Shoulder Injury Related to Vaccine Administration:≤48 hours.

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

Pneumonia: Prevnar (PCV7), Synflorix (PCV10), Prevnar 13 (PCV13)

Shoulder Injury Relatedto Vaccine Administration: ≤48 hours.

Vasovagal syncope: ≤1 hours.

Influenza: Seasonal influenza vaccines

Shoulder Injury Related to Vaccine Administration:≤48 hours

Vasovagal syncope ≤1 hour

Meningitis: Menactra, Menveo, and MenHibrix

Anaphylaxis, Brachial Neuritis: ≤4 hours

Shoulder Injury Related to Vaccine Administration ≤48 hours.

Vasovagal syncope ≤1 hour

Human Papillomavirus (HPV): Gardasil, Gardasil 9, Cervarix

Anaphylaxis, Brachial Neuritis: ≤4 hours

Shoulder Injury Related to Vaccine Administration: ≤48 hours.

Vasovagal syncope ≤1 hour

Whooping Cough (Pertussis): DTap, DTP, Tdap, P, DTP-Hib

Anaphylaxis, Brachial Neuritis: ≤ 4 hours

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

Rotavirus: RV

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

Filing a Petition

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 name of the person who received the vaccine
  • The date and place of the vaccination
  • A specific description of the injury alleged
  • Whether the injury claimed is contained within the Vaccine Injury Table

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.”

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.

VICP Petition Steps

  • Step 1

    A person files a petition with the U.S. Court of Federal Claims.

  • Step 2

    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.

  • Step 3

    The U.S. Justice Department generates and submits a report to the court that includes the medical recommendation and legal analysis.

  • Step 4

    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.

  • Step 5

    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.

Vaccine Settlements

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.

Author

Emily is a former journalist with experience in health care writing. She graduated from the University of Florida with a bachelor’s degree in journalism.

View Sources
  1. World Health Organization. (n.d.). Vaccines. Retrieved from http://www.who.int/topics/vaccines/en/
  2. CDC.gov. (2013, February). Understanding How Vaccines Work. Retrieved from https://www.cdc.gov/vaccines/hcp/conversations/downloads/vacsafe-understand-color-office.pdf
  3. CDC.gov. (2017, March 10). Possible Side-effects from Vaccines. Retrieved from https://www.cdc.gov/vaccines/vac-gen/side-effects.htm
  4. FDA.gov. (2016, December 30). Vaccines. Retrieved from https://www.fda.gov/biologicsbloodvaccines/vaccines/default.htm
  5. American Academy of Orthopaedic Surgeons. (2001, January). Frozen Shoulder. Retrieved from http://orthoinfo.aaos.org/topic.cfm?topic=a00071
  6. American Academy of Orthopaedic Surgeons. (2017, March). Rotator Cuff Tears. Retrieved from http://orthoinfo.aaos.org/topic.cfm?topic=a00064
  7. American Academy of Orthopaedic Surgeons. (2011, February). Shoulder Impingement/Rotator Cuff Tendinitis. Retrieved from http://orthoinfo.aaos.org/topic.cfm?topic=a00032
  8. Cleveland Clinic. (2015, March 27). Shoulder Tendinitis. Retrieved from https://my.clevelandclinic.org/health/articles/shoulder-tendinitis
  9. Burbank, K.M. (2008, February 15). Chronic Shoulder Pain: Part I. Evaluation and Diagnosis. Retrieved from http://www.aafp.org/afp/2008/0215/p453.html
  10. CDC.gov. (2015, October 16). Guillain-Barré syndrome and Flu Vaccine. Retrieved from https://www.cdc.gov/flu/protect/vaccine/guillainbarre.htm
  11. National Institute of Neurological Disorders and Stroke. (n.d.). Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Retrieved from https://www.ninds.nih.gov/disorders/all-disorders/chronic-inflammatory-demyelinating-polyneuropathy-cidp-information-page
  12. Cleveland Clinic. (2014, August 22). Acute Disseminated Encephalomyelitis (ADEM). Retrieved from https://my.clevelandclinic.org/health/articles/acute-disseminated-encephalomyelitis
  13. University of Maryland Medical Center. (2013, March 14). Systemic lupus erythematosus. Retrieved from http://www.umm.edu/health/medical/reports/articles/systemic-lupus-erythematosus
  14. The Myositis Association. (2015, January). Types of Myositis. Retrieved from http://www.myositis.org/learn-about-myositis/types-of-myositis
  15. National Institute of Neurological Disorders and Stroke. (2003, April). What is Bell’s Palsy? Retrieved from https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Bells-Palsy-Fact-Sheet
  16. National Heart, Lung, and Blood Institute. (2012, March 14). What Is Immune Thrombocytopenia? Retrieved from https://www.nhlbi.nih.gov/health/health-topics/topics/itp
  17. American College of Rheumatology. (2015, May). Vasculitis. Retrieved from http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Vasculitis
  18. Boyd, K. (2017, March 1). What Is Optic Neuritis? Retrieved from https://www.aao.org/eye-health/diseases/what-is-optic-neuritis
  19. U.S. Department of Health and Human Services Health Resources and Services Administration. (2017, March). What is a countermeasure? Retrieved from https://www.hrsa.gov/cicp/
  20. U.S. Department of Health and Human Services Health Resources and Services Administration. (2017, January). Frequently Asked Questions. Retrieved from https://www.hrsa.gov/vaccinecompensation/FAQ/index.html
  21. U.S. Department of Health and Human Services Health Resources and Services Administration. (n.d.). Vaccine Injury Table. Retrieved from https://www.hrsa.gov/vaccinecompensation/vaccineinjurytable.pdf
  22. CDC.gov. (2017, March 10). Six Things YOU Need to Know about Vaccines. Retrieved from https://www.cdc.gov/vaccines/vac-gen/vaxwithme.html
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