| Vaccine | Rate of Serious | Rate of Death | Dosage Pattern |
| ANTH (Anthrax) | Very High | Very High | Short-lived: 1998 to 2001 |
| DTP (Diphtheria, Tetanus, Pertussis) | Medium | High | Phased-out: ended in 2001 |
| LYME | Very High | High | Short-lived: 1999 to 2001 |
| MEA (Measles) | Low | High | Phased-out: ended in 2008 |
| MU (Mumps) | High | Very High | Short-lived: 2003 to 2008 |
| RAB (Rabies) | High | Very High | Current |
| RV (Rotavirus) | Very High | Very High | Short-lived: 1999 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Symptoms | ||
| Vaccine | Events | Percent |
| MMR | 1437 | 64.44% |
| HIBV | 446 | 20.00% |
| DTAP | 353 | 15.83% |
| HEP | 338 | 15.16% |
Vaccine
|
Illness, disability, injury or condition covered
|
Time period for first symptom or manifestation of onset or of
significant aggravation after vaccine administration
|
|---|---|---|
| I. Vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or TT) | A. Anaphylaxis or anaphylactic shock | 4 hours. |
| B. Brachial Neuritis | 2-28 days. | |
| C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable. | |
| II. Vaccines containing whole cell pertussis bacteria, extracted or partial cell pertussis bacteria, or specific pertussis antigen(s) (e.g., DTP, DTaP, P, DTP-Hib) | A. Anaphylaxis or anaphylactic shock | 4 hours. |
| B. Encephalopathy (or encephalitis) | 72 hours. | |
| C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable. | |
| III. Measles, mumps, and rubella vaccine or any of its components (e.g., MMR, MR, M, R) | A. Anaphylaxis or anaphylactic shock | 4 hours. |
| B. Encephalopathy (or encephalitis) | 5-15 days (not less than 5 days and not more than 15 days). | |
| C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable. | |
| IV. Vaccines containing rubella virus (e.g., MMR, MR, R) | A. Chronic arthritis | 7-42 days. |
| B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable. | |
| V. Vaccines containing measles virus (e.g., MMR, MR, M) | A. Thrombocytopenic purpura | 7-30 days. |
| B. Vaccine-Strain Measles Viral Infection in an immunodeficient recipient | 6 months. | |
| C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable. | |
| VI. Vaccines containing polio live virus (OPV) | A. Paralytic Polio | |
| —in a non-immunodeficient recipient | 30 days. | |
| —in an immunodeficient recipient | 6 months. | |
| —in a vaccine associated community case | Not applicable. | |
| B. Vaccine-Strain Polio Viral Infection | ||
| —in a non-immunodeficient recipient | 30 days. | |
| —in an immunodeficient recipient | 6 months. | |
| —in a vaccine associated community case | Not applicable. | |
| C. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable. | |
| VII. Vaccines containing polio inactivated virus (e.g., IPV) | A. Anaphylaxis or anaphylactic shock | 4 hours |
| B. Any acute complication or sequela (including death of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed. | Not applicable. | |
| VIII. Hepatitis B. vaccines | A. Anaphylaxis or anaphylactic shock | 4 hours. |
| B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable. | |
| IX. Hemophilus influenzae type b polysaccharide conjugate vaccines | No Condition Specified | Not applicable. |
| X. Varicella vaccine | No Condition Specified | Not applicable. |
| XI. Rotavirus vaccine | No Condition Specified | Not applicable. |
| XII. Pneumococcal conjugate vaccines | No Condition Specified | Not applicable. |
| XIII. Hepatitis A vaccines | No Condition Specified | Not applicable. |
| XIV. Trivalent influenza vaccines | No Condition Specified | Not applicable. |
| XV. Meningococcal vaccines | No Condition Specified | Not applicable. |
| XVI. Human papillomavirus (HPV) vaccines | No Condition Specified | Not applicable. |
| XVII. Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage* | No Condition Specified | Not applicable. |
*Now includes all vaccines against seasonal
influenza (except trivalent influenza vaccines, which are already covered),
effective November 12, 2013.
(b) Qualifications and aids to
interpretation. The following qualifications and aids to interpretation
shall apply to the Vaccine Injury Table to paragraph (a) of this section:
(1) Anaphylaxis and anaphylactic shock. For
purposes of paragraph (a) of this section, 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
trchea and minimal findings of eosinophilia in the liver, spleen and lungs. When
death occurs within minutes of exposure and without signs of respiratory
distress, there may not be significant pathologic findings.
(2) Encephalopathy. For purposes of paragraph
(a) of this section, 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 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 (b)(2)(i)(A) and
(b)(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.
(3) [Reserved]
(4) 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.
(5) Sequela. The term “sequela” means a
condition or event which was actually caused by a condition listed in the
Vaccine Injury Table.
(6) Chronic Arthritis. (i) For purposes of
paragraph (a) of this section, 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; and
(C) Medical documentation of an antibody response to
the rubella virus.
(ii) For purposes of paragraph (a) of this section,
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/determatomyositis, fibromyalgia, necrotizing vascultitis and
vasculopathies and Sjögren'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.
(iii) Arthralgia (joint pain) or stiffness without
joint swelling shall not be viewed as chronic arthritis for purposes of
paragraph (a) of this section.
(7) Brachial neuritis. (i) This term 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.
(ii) 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 monoeuropathies), as well as other peripheral and
central nervous system structures (e.g., cranial neuropathies and
myelopathies).
(8) Thrombocytopenic purpura. This term 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.
(9) Vaccine-strain measles viral infection.
This term is defined as a disease caused by the vaccine-strain that should be
determined by vaccine-specific monoclonal antibody or polymerase chain reaction
tests.
(10) Vaccine-strain polio viral infection.
This term 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.
(c) Coverage provisions. (1) Except as
provided in paragraph (c)(2), (3), (4), (5), (6), or (7) of this section, the
revised Table of Injuries set forth in paragraph (a) of this section and the
Qualifications and Aids to Interpretation set forth in paragraph (b) of this
section apply to petitions for compensation under the Program filed with the
United States Court of Federal Claims on or after March 24, 1997. Petitions for
compensation filed before such date shall be governed by section 2114(a) and (b)
of the Public Health Service Act as in effect on January 1, 1995, or by §100.3
as in effect on March 10, 1995 (see 60 FR 7678, et seq., February 8,
1995), as applicable.
(2) Hepatitis B, Hib, and varicella vaccines (Items
VIII, IX, and X of the Table) are included in the Table as of August 6,
1997.
(3) Rotavirus vaccines (Item XI of the Table) are
included in the Table as of October 22, 1998.
(4) Pneumococcal conjugate vaccines (Item XII of the
Table) are included in the Table as of December 18, 1999.
(5) Hepatitis A vaccines (Item XIII of the Table)
are included on the Table as of December 1, 2004.
(6) Trivalent influenza vaccines (Item XIV of the
Table) are included on the Table as of July 1, 2005.
(7) Meningococcal vaccines and human papillomavirus
vaccines (Items XV and XVI of the Table) are included on the Table as of
February 1, 2007.
(8) Other new vaccines (Item XVII of the Table) will
be included in the Table as of the effective date of a tax enacted to provide
funds for compensation paid with respect to such vaccines. An amendment to this
section will be published in the Federal Register to announce the effective date
of such a tax.