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Epidemics and pandemics have always been squeezing the world from time to time. Especially the disadvantaged and immunocompromised populations.
Thanks a bunch to Edward Jenner, the modern age of vaccines began in 1796. Vaccination is the administration of a killed or weakened microbe into the body to trigger the immune response thereby helping the immune system develop protection from disease.
Vaccines are by far the well-received clinical advent of the modern era. It protects the human race from once-common childhood illnesses to emerging threats. Vaccines used all over the world to prevent various diseases come under the following types. The classification is based on the microbial preparation in the vaccines.
- Inactivated vaccines
- Live-attenuated vaccines
- Toxoid vaccines
- Subunit, recombinant, polysaccharide, and conjugate vaccines
- Messenger RNA (mRNA) vaccines
- Viral vector vaccines
A study indicates that every year childhood vaccination saves up to 3 million lives. As per the Centers for Disease Control and Prevention (CDC), vaccines had prevented more than 21 million hospitalizations and 732,000 deaths among children within the last 20-years.
Here we are about to hash over on the darker side of the lifesaving vaccinations. It’s about the vaccine injury or Vaccine Adverse Event (VAE). World Health Organization refers it as Adverse events following immunization (AEFI).
Vaccine injury can be simply defined as the adverse effects of vaccination. The effects may be minor or severe. An effective vaccination will minimize even minor reactions and induce the maximum positive immune response in the body. However, there are several controversies around the globe related to the usage of vaccines to battle deadly diseases versus the risks of adverse events following immunization.
Although uncommon, some vaccine injuries can even result in severe health problems in both adults and children. Vaccine injuries need not occur due to the vaccine itself. It may also involve human errors.
Adverse events following immunization are categorized as follows
- Vaccine product-related reaction
- Vaccine quality defect-related reaction
- Immunization error- related reaction
- Immunization anxiety-related reaction
- Coincidental event
The reactions related to vaccine product and vaccine quality is very crucial in vaccine injury cases. Any error in vaccine components or manufacture may trigger adverse immune reactions in the individual. Effects may range from minor reactions like swelling and soreness to severe reactions like disability and death. Minor reactions appear within minutes of vaccination. However, it may resolve in a short period. However, severe reactions may pose disability and may be life-threatening in some rare instances.
Immunization errors may occur anywhere in the vaccination stages like vaccine preparation, handling, storage or administration. Non-sterile injections, reconstitution errors, injections at the incorrect site, improper vaccine transportation and storage are some examples. AEFI for immunization errors are toxic shock syndrome, sepsis, local abscess, sciatic nerve damage etc.
Immunization anxiety-related reactions have nothing to do with vaccine preparation or administration. It includes certain signs and symptoms associated with anxiety. The following are the common immunization anxiety-related reactions.
- Acute stress response- Difficulty in breathing, hyperventilation, palpitation and increase in heart rate.
- Vasovagal reaction- Decreased heart rate, sweating, nausea, dizziness, and loss of consciousness.
- Dissociative neurological symptom reactions- Weakness or paralysis, speech difficulties, abnormal limb posturing, gait irregularities, and non-epileptic seizures
Types of Vaccine Injuries
Vaccine injuries occur as a result of the immune response of the individual towards the vaccine components, product defect or may be due to an improper administration of the vaccine.
Let’s get into types of vaccine injuries reported worldwide.
- Allergic reactions
Allergic reactions may extend from itching and soreness at the vaccination area to severe anaphylactic shocks. Anaphylactic shock leads cause oxygen deprivation. This mainly happens within seconds or minutes of vaccination.
- Shoulder injuries
Shoulder injuries are associated with vaccine injuries in adults as well as children. Some examples are as follows
Shoulder Injury Related to Vaccine Administration (SIRVA)
When a vaccine is injected too high or too deep into the shoulder, it leads to Shoulder Injury Related to Vaccine Administration. It occurs when an intramuscular deltoid injection is administered incorrectly into the shoulder joint.
It is a type of peripheral neuropathy which causes damage to the brachial plexus. These nerves carry signals to and from the spinal cord.
Bursae are small, fluid-filled sacs that serve as cushions between bones and soft tissues. Certain vaccines may lead to inflammation of bursae causing bursitis in the shoulder.
Rotator cuff injuries
Rotator cuff is a group of tendons that holds your arm in the shoulder socket. Vaccines may cause these tendons to tear, thereby causing pain and weakness in the shoulder. Tendons that form the rotator cuff may also get damaged causing tendonitis.
- Autoimmune Disorders
An autoimmune disorder occurs when the immune system mistakenly attacks healthy body cells and tissues considering them as foreign antigens. Guillain-Barré syndrome (GBS) also called acute inflammatory demyelinating polyneuropathy, is an autoimmune disorder associated with certain vaccines. In this condition, the immune system mistakenly attacks the protective myelin sheath that covers the peripheral nerves.
Guillain-Barré syndrome is reported to be the adverse effect of some vaccinations like the flu vaccine, Hepatitis A or hepatitis B vaccine, Human papillomavirus –HPV vaccine and Tetanus- Tdap or DTaP vaccines.
- Brain Disorders
Certain vaccines are reported to affect the brain leading to conditions like Encephalitis, Encephalopathy and Vasovagal syncope.
- Bowel Problems
Bowel problems are rarely associated with some vaccines. Intussusception is one such bowel disorder reported as a vaccine injury due to rotavirus vaccines. It occurs in children where one part of the intestine slides inside another section.
- Blood Disorders
Idiopathic thrombocytopenic purpura is a blood disorder developed rarely in some individuals after the measles, mumps, and rubella (MMR) vaccines. It is a condition where the bone marrow fails to produce enough platelets. Platelet deficiency causes a delay in the blood clotting process which may cause lethal effects.
Vaccine Injury Claims
Having discussed vaccine injuries and how gravely it could affect an individual, let’s now check out if the law protects a citizen victimized in a vaccine injury. Is it a yes or no? A BIG YES.
If you are suffering from any damages due to a vaccination, you could undoubtedly proceed with a claim. But it is rarely claimed against the pharmaceutical company or the medical professional. In the US, vaccine injury claims are filed and processed via National Vaccine Injury Compensation Program (VICP).
What is VICP?
VICP was established by the National Childhood Vaccine Injury Act of 1986, title III of Public Law 99-660. The program was amended when lawsuits against vaccine manufacturers and healthcare providers was found to cause vaccine shortages and a decline in vaccination rates.
How VICP works?
VICP provides compensation to individuals who get injured by a VICP-covered vaccine. It covers all vaccines listed on the Vaccine Injury Table maintained by the Secretary of the US Department of Health and Human Services (HHS).
Compensation and legal fees for a vaccine injury claim are paid by the Vaccine Injury Compensation Trust Fund. The funds are raised from tax on vaccines that are recommended by the Centers for Disease Control and Prevention (CDC). Adverse events associated with vaccines are monitored and reported by a passive surveillance program named the Vaccine Adverse Event Reporting System (VAERS).
Who can file a vaccine injury claim?
Any individual who is injured by a vaccine covered by the VICP could file the claim. If the victim is a child, parents could file the claim. If the vaccine injury cause’s death of an individual, his legal representatives could file the claim. The good news is that you don’t have to be a US citizen to file a vaccine injury claim.
How to file a claim in VICP?
- The claim should be filed in the United States Court of Federal Claims with the Secretary of the US Department of Health and Human Services as the Respondent.
- The petition is reviewed and the medical ground of the claim is analyzed.
- A report is developed by The U.S. Department of Justice which is submitted to the court.
- The report is presented to a court-appointed special master who hears both the parties in the claim. After analyzing the evidence presented, a final decision would be made.
- Compensation if granted, would be provided by U.S. Department of Health and Human Services.
To establish any vaccine injury, the symptoms should have been presented in the victim within a time period after the vaccination. For instance, if a child develops intussusception between 1-21 days after receiving the rotavirus vaccine, it is considered as a vaccine injury. For it to be vaccine-related, any other cause for the condition should be eliminated.
As per the US Department of Health and Human Services, the effect of the vaccination injury should have
- Lasted for more than six months after the vaccination or
- Caused a hospital stay and surgery; or
- Resulted in the death of the individual.
It should be noted that the claim must be filed within three years of the first symptoms of the vaccine injury.
What are the damages covered in a VICP claim?
The damages covered in a vaccine injury claim are ongoing and future medical expenses, lost earnings, loss of quality of life, disability and pain and suffering. The compensation amount would depend upon the extent of damage and disability caused by the vaccination. For pain and suffering and death, up to $250,000 may be awarded.
Can I file a vaccine injury claim outside NICP?
After filing a claim in NICP, you may proceed with a civil lawsuit against the pharmaceutical company or the medical professional who gave you the vaccine shot. However, it is not legally necessary.
Vaccination injuries though rare cannot be overlooked as vaccines have become a key component of our lives. Those hundreds of claimants who file claims with the National Vaccine Injury Compensation Program epitomize only a small section of the vaccine injury victims. Vaccine injury claims can be effectively pursued by any individual through NICP. A knowledgeable vaccine injury attorney could assist the victim in acquiring a deserving compensation.