(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 of respiratory
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.