The Vaccine Injury Program

U.S. Congress passed the National Childhood Vaccine Injury Act in 1986 and the Vaccine Compensation Amendments in 1987 and 1995. The Act establishes a compensation system for those persons who may be injured by routine vaccinations. The system is intended to be expeditious and fair. It is also intended to compensate persons with vaccine injuries without requiring the difficult individual determination of causation of injury and without a demonstration that a manufacturer was negligent or that a vaccine was defective H.R. Rep. 99-908, 99th Cong., (1986).

The Process

A claim may be made for any injury or death thought to be the result of a covered vaccine. Claims may be filed by the injured individual; or a parent, legal guardian, or trustee may file on behalf of a child or an incapacitated person. Compensable injuries are either those listed in the Vaccine Injury Table, which is found in the Code of Federal Regulations, Section 2114 of the Act, or those which petitioners can demonstrate were caused by the vaccine.

The Program is administered jointly by the Department of Health and Human Services (HHS), the U.S. Court of Federal Claims (the Court), and the Department of Justice (DOJ). The process is as follows:

First, if there is a reasonable basis for the claim, Conway, Homer & Chin-Caplan, P.C. will file a petition for compensation with the Court. Next, a physician at the Division of Vaccine Injury Compensation, HHS, reviews each petition to determine whether it meets the criteria for compensation and makes a recommendation on compensability. This recommendation is provided to the Court through a report filed by DOJ, although it is not binding. The HHS position is represented by an attorney from DOJ in hearings before a “special master” who makes the initial decision for compensation under the Program. A special master is an attorney appointed by the judges of the Court. Decisions may be appealed to the Court, then to the Federal Circuit Court of Appeals, and then to the Supreme Court.

No petition may be filed under this Program if a civil action is pending for damages related to the vaccine injury, or if damages were awarded by a court or in a settlement of a civil action against the vaccine manufacturer or administrator.

It is not a requirement to have attorney representation during this process; however, because the Rules of the Court are very specific and must be strictly followed, many petitioners have made the decision to have an attorney represent them. The Act provides for the payment of reasonable attorneys’ fees and costs, regardless of the Court’s decision on compensability, providing the case is brought in good faith and there is a reasonable basis for the claim. An attorney who files a petition must be admitted to the U.S. Court of Federal Claims Bar.


COMPENSATION THAT MAY BE AWARDED

Vaccine-Related Injury

  • Reasonable compensation for past and future unreimbursable medical, custodial care, and rehabilitation costs.
  • $250,000 cap for actual and projected pain and suffering, emotional distress.
  • Lost earnings.
  • Reasonable attorneys’ fees and costs.
  • Deadline for filing: Within 36 months after the first symptoms appeared.

Vaccine-Related Death

  • $250,000 for the estate of the deceased.
  • Reasonable attorneys’ fees and costs.
  • Deadline for filing: Within 24 months of death and within 48 months after the onset of the vaccine-related injury from which the death occurred.



What Vaccines are covered?

  • Diphtheria, pertussis, tetanus (DTP, DtaP, Tdap, DT, Td, or TT)
  • Haemophilis influenzae type b (Hib)
  • Hepatitis A (HAV)
  • Hepatitis B (HBV)
  • Trivalent influenza (TIV, LAIV)(given each year during flu season)
  • Measles-mumps-rubella (MMR, MR. M, R)
  • Meningoccal (conjugate & polysaccharide)(MCV4, MPSV4)(meningitis)
  • Polio (IPV, OPV)
  • Pneumococcal conjugate( PCV) (Streptococcus pneumoniae bacteria, cause bacterial meningitis, deaths, ear infections in children)
  • Rotovirus (RV)
  • varicella (VZV)(chickenpox)
  • Papillomavirus (HPV)(STD, cervical cancer) any combination of above vaccines

Vaccine Injury Table

The Vaccine Injury Table (Table) makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found. For example, if you received the tetanus vaccines and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found.

If your injury/condition is not on the Table or if your injury/condition did not occur within the time period on the Table, you must prove that the vaccine caused the injury/condition. Such proof must be based on medical records or opinion, which may include expert witness testimony.

Vaccine Injury Table a
Vaccine
Adverse Event Time Interval
I. Tetanus toxoid-containing vaccines (e.g., DTaP, Tdap, DTP-Hib, DT, Td,  TT)
A.  Anaphylaxis or anaphylactic shock 1 0-4 hours
B.  Brachial neuritis 6 2-28 days
C.  Any acute complication or sequela (including death) of above events 4 Not applicable
II. Pertussis antigen-containing vaccines (e.g., DTaP, Tdap, DTP, P, DTP-Hib)
A.  Anaphylaxis or anaphylactic shock 1 0-4 hours
B.  Encephalopathy (or encephalitis) 2 0-72 hours
C.  Any acute complication or sequela (including death) of above events 4 Not applicable
III. Measles, mumps and rubella virus-containing vaccines in any combination (e.g., MMR, MR, M, R)
A.  Anaphylaxis or anaphylactic shock 1 0-4 hours
B.  Encephalopathy (or encephalitis) 2 5-15 days
C.  Any acute complication or sequela (including death) of above events 4 Not applicable
IV. Rubella virus-containing vaccines (e.g., MMR, MR, R)
A.  Chronic arthritis 5 7-42 days
B.   Any acute complication or sequela (including death) of above event 4 Not applicable
V. Measles virus-containing vaccines (e.g., MMR, MR, M)
A.   Thrombocytopenic purpura 7 7-30 days
B.  Vaccine-Strain Measles Viral Infection in an immunodeficient recipient 8 0-6 months
C.    Any acute complication or sequela (including death) of above events 4 Not applicable
VI. Polio live virus-containing vaccines (OPV)
A. Paralytic polio
  • in a non-immunodeficient recipient
0-30 days
  • in an immunodeficient recipient
0-6 months
  • in a vaccine associated community case
Not applicable
B. Vaccine-strain polio viral infection 9
  • in a non-immunodeficient recipient
0-30 days
  • in an immunodeficient recipient
0-6 months
  • in a vaccine associated community case
Not applicable
C.  Any acute complication or sequela (including death) of above events 4 Not applicable
VII. Polio inactivated-virus containing vaccines (e.g., IPV)
A   Anaphylaxis or anaphylactic shock 1 0-4 hours
B.  Any acute complication or sequela (including death) of above event 4 Not applicable
VIII. Hepatitis B antigen-containing vaccines
A.  Anaphylaxis or anaphylactic shock 1 0-4 hours
B.  Any acute complication or sequela (including death) of above event 4 Not applicable
IX. Hemophilus influenzae (type b polysaccharide conjugate vaccines)
A.  No condition specified for compensation

Not applicable
X. Varicella vaccine
A.  No condition specified for compensation

Not applicable
XI. Rotavirus vaccine
A.  No condition specified for compensation

Not applicable
XII. Pneumococcal conjugate vaccines
A.  No condition specified for compensation Not applicable
XIII. Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by Secretary, HHS of a notice of coverageb c
A.  No condition specified for compensation

Not applicable

aEffective date: November 10, 2008
bAs of December 1, 2004, hepatitis A vaccines have been added to the Vaccine Injury Table (Table) under this Category.
As of July 1, 2005, trivalent influenza vaccines have been added to the Table under this Category. Trivalent influenza vaccines are given annually during the flu season either by needle and syringe or in a nasal spray.  All influenza vaccines routinely administered in the U.S. are trivalent vaccines covered under this Category.  See Federal Register Notice: April 12, 2005

c As of February 1, 2007, meningococcal (conjugate and polysaccharide) and human papillomavirus (HPV) vaccines have been added to the Table under this Category.

 Qualifications and Aids to Interpretation

(1) Anaphylaxis and anaphylactic shock mean an acute, severe, and potentially lethal systemic allergic reaction. Most cases resolve without sequelae. Signs and symptoms begin minutes to a few hours after exposure. Death, if it occurs, usually results from airway obstruction caused by laryngeal edema or bronchospasm and may be associated with cardiovascular collapse. Other significant clinical signs and symptoms may include the following: Cyanosis, hypotension, bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or trachea and/or larynx with stridor and dyspnea. Autopsy findings may include acute emphysema which results from lower respiratory tract obstruction, edema of the hypopharynx, epiglottis, larynx, or trachea and minimal findings of eosinophilia in the liver, spleen and lungs. When death occurs within minutes of exposure and without signs ofrespiratory distress, there may not be significant pathologic findings.

(2) Encephalopathy. For purposes of the Vaccine Injury Table, a vaccine recipient shall be considered to have suffered an encephalopathy only if such recipient manifests, within the applicable period, an injury meeting the description below of an acute encephalopathy, and then a chronic encephalopathy persists in such person for more than 6 months beyond the date of vaccination.

(i) An acute encephalopathy is one that is sufficiently severe so as to require hospitalization (whether or not hospitalization occurred).

(A) For children less than 18 months of age who present without an associated seizure event, an acute encephalopathy is indicated by a “significantly decreased level of consciousness” (see “D” below) lasting for at least 24 hours. Those children less than 18 months of age who present following a seizure shall be viewed as having an acute encephalopathy if their significantly decreased level of consciousness persists beyond 24 hours and cannot be attributed to a postictal state (seizure) or medication.

(B) For adults and children 18 months of age or older, an acute encephalopathy is one that persists for at least 24 hours and characterized by at least two of the following:

(1) A significant change in mental status that is not medication related; specifically a confusional state, or a delirium, or a psychosis;
(2) A significantly decreased level of consciousness, which is independent of a seizure and cannot be attributed to the effects of medication; and
(3) A seizure associated with loss of consciousness.

(C) Increased intracranial pressure may be a clinical feature of acute encephalopathy in any age group.

(D) A “significantly decreased level of consciousness” is indicated by the presence of at least one of the following clinical signs for at least 24 hours or greater (see paragraphs (2)(I)(A) and (2)(I)(B) of this section for applicable timeframes):

(1) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli);
(2) Decreased or absent eye contact (does not fix gaze upon family members or other individuals); or
(3) Inconsistent or absent responses to external stimuli (does not recognize familiar people or things).

(E) The following clinical features alone, or in combination, do not demonstrate an acute encephalopathy or a significant change in either mental status or level of consciousness as described above: Sleepiness, irritability (fussiness), high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanelle. Seizures in themselves are not sufficient to constitute a diagnosis of encephalopathy. In the absence of other evidence of an acute encephalopathy, seizures shall not be viewed as the first symptom or manifestation of the onset of an acute encephalopathy.

(ii) Chronic encephalopathy occurs when a change in mental or neurologic status, first manifested during the applicable time period, persists for a period of at least 6 months from the date of vaccination. Individuals who return to a normal neurologic state after the acute encephalopathy shall not be presumed to have suffered residual neurologic damage from that event; any subsequent chronic encephalopathy shall not be presumed to be a sequela of the acute encephalopathy. If a preponderance of the evidence indicates that a child’s chronic encephalopathy is secondary to genetic, prenatal or perinatal factors, that chronic encephalopathy shall not be considered to be a condition set forth in the Table.
(iii) An encephalopathy shall not be considered to be a condition set forth in the Table if in a proceeding on a petition, it is shown by a preponderance of the evidence that the encephalopathy was caused by an infection, a toxin, a metabolic disturbance, a structural lesion, a genetic disorder or trauma (without regard to whether the cause of the infection, toxin, trauma, metabolic disturbance, structural lesion or genetic disorder is known). If at the time a decision is made on a petition filed under section 2111(b) of the Act for a vaccine-related injury or death, it is not possible to determine the cause by a preponderance of the evidence of an encephalopathy, the encephalopathy shall be considered to be a condition set forth in the Table.
(iv) In determining whether or not an encephalopathy is a condition set forth in the Table, the Court shall consider the entire medical record.

(3) Seizure and convulsion. For purposes of paragraphs (b)(2) of this section, the terms, “seizure” and “convulsion” include myoclonic, generalized tonic-clonic (grand mal), and simple and complex partial seizures. Absence (petit mal) seizures shall not be considered to be a condition set forth in the Table. Jerking movements or staring episodes alone are not necessarily an indication of seizure activity.

(4) Sequela. The term “sequela” means a condition or event which was actually caused by a condition listed in the Vaccine Injury Table.

(5) Chronic Arthritis. For purposes of the Vaccine Injury Table, chronic arthritis may be found in a person with no history in the 3 years prior to vaccination of arthropathy (joint disease) on the basis of:

(A) Medical documentation, recorded within 30 days after the onset, of objective signs of acute arthritis (joint swelling) that occurred between 7 and 42 days after a rubella vaccination;
(B) Medical documentation (recorded within 3 years after the onset of acute arthritis) of the persistence of objective signs of intermittent or continuous arthritis for more than 6 months following vaccination:
(C) Medical documentation of an antibody response to the rubella virus.

For purposes of the Vaccine Injury Table, the following shall not be considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective tissue diseases (including but not limited to rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis/dermatomyositis, fibromyalgia, necrotizing vasculitis and vasculopathies and Sjogren’s Syndrome), degenerative joint disease, infectious agents other than rubella (whether by direct invasion or as an immune reaction), metabolic and endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and cartilage disorders and arthritis associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter’s syndrome, or blood disorders.

Arthralgia (joint pain) or stiffness without joint swelling shall not be viewed as chronic arthritis for purposes of the Vaccine Injury Table.

(6) Brachial neuritis is defined as dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords) without involvement of other peripheral (e.g., nerve roots or a single peripheral nerve) or central (e.g., spinal cord) nervous system structures. A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is followed in days or weeks by weakness and atrophy in upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. The neuritis, or plexopathy, may be present on the same side as or the opposite side of the injection; it is sometimes bilateral, affecting both upper extremities. Weakness is required before the diagnosis can be made. Motor, sensory, and reflex findings on physical examination and the results of nerve conduction and electromyographic studies must be consistent in confirming that dysfunction is attributable to the brachial plexus. The condition should thereby be distinguishable from conditions that may give rise to dysfunction of nerve roots (i.e., radiculopathies) and peripheral nerves (i.e., including multiple mononeuropathies), as well as other peripheral and central nervous system structures (e.g., cranial neuropathies and myelopathies).

(7) Thrombocytopenic purpura is defined by a serum platelet count less than 50,000/mm3. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with other causes such as hypersplenism, autoimmune disorders (including alloantibodies from previous transfusions) myelodysplasias, lymphoproliferative disorders, congenital thrombocytopenia or hemolytic uremic syndrome. This does not include cases of immune (formerly called idiopathic) thrombocytopenic purpura (ITP) that are mediated, for example, by viral or fungal infections, toxins or drugs. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with disseminated intravascular coagulation, as observed with bacterial and viral infections. Viral infections include, for example, those infections secondary to Epstein Barr virus, cytomegalovirus, hepatitis A and B, rhinovirus, human immunodeficiency virus (HIV), adenovirus, and dengue virus. An antecedent viral infection may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing. Bone marrow examination, if performed, must reveal a normal or an increased number of megakaryocytes in an otherwise normal marrow.

(8) Vaccine-strain measles viral infection is defined as a disease caused by the vaccine-strain that should be determined by vaccine‑specific monoclonal antibody or polymerase chain reaction tests.

(9) Vaccine-strain polio viral infection is defined as a disease caused by poliovirus that is isolated from the affected tissue and should be determined to be the vaccine-strain by oligonucleotide or polymerase chain reaction. Isolation of poliovirus from the stool is not sufficient to establish a tissue specific infection or disease caused by vaccine-strain poliovirus.

This information reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This information is not legal advice and does not create or confer any rights for or on any person and does not operate to bind the Department or the public. The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims, which is responsible for resolving claims for compensation under the VICP.



The proceeding information provided by Conway, Homer & Chin-Caplan, 16 Shawmut Street, Boston, MA 02116, Phone: 617-695-1990, Fax: 617-695-0880

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