
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300aa-14]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                        SUBCHAPTER XIX--VACCINES
 
          Part 2--National Vaccine Injury Compensation Program
 
                     subpart a--program requirements
 
Sec. 300aa-14. Vaccine Injury Table


(a) Initial table

    The following is a table of vaccines, the injuries, disabilities, 
illnesses, conditions, and deaths resulting from the administration of 
such vaccines, and the time period in which the first symptom or 
manifestation of onset or of the significant aggravation of such 
injuries, disabilities, illnesses, conditions, and deaths is to occur 
after vaccine administration for purposes of receiving compensation 
under the Program:

                          VACCINE INJURY TABLE



I.             DTP; P; DTP/Polio Combination;  .........................
                or Any Other Vaccine
                Containing Whole Cell
                Pertussis Bacteria, Extracted
                or Partial Cell Bacteria, or
                Specific Pertussis
                Antigen(s).
               Illness, disability, injury,    Time period for first
                or condition covered:           symptom or manifestation
                                                of onset or of
                                                significant aggravation
                                                after vaccine
                                                administration:
               A. Anaphylaxis or anaphylactic  24 hours
                shock........................
               B. Encephalopathy (or            3 days
                encephalitis)................
               C. Shock-collapse or hypotonic-  3 days
                hyporesponsive collapse......
               D. Residual seizure disorder     3 days
                in accordance with subsection
                (b)(2).......................
               E. Any acute complication or    Not applicable
                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.......
II.            Measles, mumps, rubella, or     .........................
                any vaccine containing any of
                the foregoing as a component;
                DT; Td; or Tetanus Toxoid.
               A. Anaphylaxis or anaphylactic  24 hours
                shock........................
               B. Encephalopathy (or           15 days (for mumps,
                encephalitis)................   rubella, measles, or any
                                                vaccine containing any
                                                of the foregoing as a
                                                component). 3 days (for
                                                DT, Td, or tetanus
                                                toxoid).
               C. Residual seizure disorder    15 days (for mumps,
                in accordance with subsection   rubella, measles, or any
                (b)(2).......................   vaccine containing any
                                                of the foregoing as a
                                                component). 3 days (for
                                                DT, Td, or tetanus
                                                toxoid).
               D. Any acute complication or    Not applicable
                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.......
III.           Polio Vaccines (other than
                Inactivated Polio Vaccine).
               A. Paralytic polio              .........................
                 --in a non-immunodeficient    30 days
                  recipient..................
                 --in an immunodeficient        6 months
                  recipient..................
                 --in a vaccine-associated     Not applicable
                  community case.............
               B. Any acute complication or    Not applicable
                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.......
IV.            Inactivated Polio Vaccine.      .........................
               A. Anaphylaxis or anaphylactic  24 hours
                shock........................
               B. Any acute complication or    Not applicable
                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.......


(b) Qualifications and aids to interpretation

    The following qualifications and aids to interpretation shall apply 
to the Vaccine Injury Table in subsection (a) of this section:
        (1) A shock-collapse or a hypotonic-hyporesponsive collapse may 
    be evidenced by indicia or symptoms such as decrease or loss of 
    muscle tone, paralysis (partial or complete), hemiplegia or 
    hemiparesis, loss of color or turning pale white or blue, 
    unresponsiveness to environmental stimuli, depression of 
    consciousness, loss of consciousness, prolonged sleeping with 
    difficulty arousing, or cardiovascular or respiratory arrest.
        (2) A petitioner may be considered to have suffered a residual 
    seizure disorder if the petitioner did not suffer a seizure or 
    convulsion unaccompanied by fever or accompanied by a fever of less 
    than 102 degrees Fahrenheit before the first seizure or convulsion 
    after the administration of the vaccine involved and if--
            (A) in the case of a measles, mumps, or rubella vaccine or 
        any combination of such vaccines, the first seizure or 
        convulsion occurred within 15 days after administration of the 
        vaccine and 2 or more seizures or convulsions occurred within 1 
        year after the administration of the vaccine which were 
        unaccompanied by fever or accompanied by a fever of less than 
        102 degrees Fahrenheit, and
            (B) in the case of any other vaccine, the first seizure or 
        convulsion occurred within 3 days after administration of the 
        vaccine and 2 or more seizures or convulsions occurred within 1 
        year after the administration of the vaccine which were 
        unaccompanied by fever or accompanied by a fever of less than 
        102 degrees Fahrenheit.

        (3)(A) The term ``encephalopathy'' means any significant 
    acquired abnormality of, or injury to, or impairment of function of 
    the brain. Among the frequent manifestations of encephalopathy are 
    focal and diffuse neurologic signs, increased intracranial pressure, 
    or changes lasting at least 6 hours in level of consciousness, with 
    or without convulsions. The neurological signs and symptoms of 
    encephalopathy may be temporary with complete recovery, or may 
    result in various degrees of permanent impairment. Signs and 
    symptoms such as high pitched and unusual screaming, persistent 
    unconsolable crying, and bulging fontanel are compatible with an 
    encephalopathy, but in and of themselves are not conclusive evidence 
    of encephalopathy. Encephalopathy usually can be documented by slow 
    wave activity on an electroencephalogram.
        (B) If in a proceeding on a petition it is shown by a 
    preponderance of the evidence that an encephalopathy was caused by 
    infection, toxins, trauma, or metabolic disturbances the 
    encephalopathy shall not be considered to be a condition set forth 
    in the table. If at the time a judgment is entered on a petition 
    filed under section 300aa-11 of this title 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. In determining whether or not an encephalopathy is a 
    condition set forth in the table, the court shall consider the 
    entire medical record.
        (4) For purposes of paragraphs (2) and (3), the terms 
    ``seizure'' and ``convulsion'' include grand mal, petit mal, 
    absence, myoclonic, tonic-clonic, and focal motor seizures and 
    signs. If a provision of the table to which paragraph (1), (2), (3), 
    or (4) applies is revised under subsection (c) or (d) of this 
    section, such paragraph shall not apply to such provision after the 
    effective date of the revision unless the revision specifies that 
    such paragraph is to continue to apply.

(c) Administrative revision of table

    (1) The Secretary may promulgate regulations to modify in accordance 
with paragraph (3) the Vaccine Injury Table. In promulgating such 
regulations, the Secretary shall provide for notice and opportunity for 
a public hearing and at least 180 days of public comment.
    (2) Any person (including the Advisory Commission on Childhood 
Vaccines) may petition the Secretary to propose regulations to amend the 
Vaccine Injury Table. Unless clearly frivolous, or initiated by the 
Commission, any such petition shall be referred to the Commission for 
its recommendations. Following--
        (A) receipt of any recommendation of the Commission, or
        (B) 180 days after the date of the referral to the Commission,

whichever occurs first, the Secretary shall conduct a rulemaking 
proceeding on the matters proposed in the petition or publish in the 
Federal Register a statement of reasons for not conducting such 
proceeding.
    (3) A modification of the Vaccine Injury Table under paragraph (1) 
may add to, or delete from, the list of injuries, disabilities, 
illnesses, conditions, and deaths for which compensation may be provided 
or may change the time periods for the first symptom or manifestation of 
the onset or the significant aggravation of any such injury, disability, 
illness, condition, or death.
    (4) Any modification under paragraph (1) of the Vaccine Injury Table 
shall apply only with respect to petitions for compensation under the 
Program which are filed after the effective date of such regulation.

(d) Role of Commission

    Except with respect to a regulation recommended by the Advisory 
Commission on Childhood Vaccines, the Secretary may not propose a 
regulation under subsection (c) of this section or any revision thereof, 
unless the Secretary has first provided to the Commission a copy of the 
proposed regulation or revision, requested recommendations and comments 
by the Commission, and afforded the Commission at least 90 days to make 
such recommendations.

(e) Additional vaccines

           (1) Vaccines recommended before August 1, 1993

        By August 1, 1995, the Secretary shall revise the Vaccine Injury 
    Table included in subsection (a) of this section to include--
            (A) vaccines which are recommended to the Secretary by the 
        Centers for Disease Control and Prevention before August 1, 
        1993, for routine administration to children,
            (B) the injuries, disabilities, illnesses, conditions, and 
        deaths associated with such vaccines, and
            (C) the time period in which the first symptoms or 
        manifestations of onset or other significant aggravation of such 
        injuries, disabilities, illnesses, conditions, and deaths 
        associated with such vaccines may occur.

            (2) Vaccines recommended after August 1, 1993

        When after August 1, 1993, the Centers for Disease Control and 
    Prevention recommends a vaccine to the Secretary for routine 
    administration to children, the Secretary shall, within 2 years of 
    such recommendation, amend the Vaccine Injury Table included in 
    subsection (a) of this section to include--
            (A) vaccines which were recommended for routine 
        administration to children,
            (B) the injuries, disabilities, illnesses, conditions, and 
        deaths associated with such vaccines, and
            (C) the time period in which the first symptoms or 
        manifestations of onset or other significant aggravation of such 
        injuries, disabilities, illnesses, conditions, and deaths 
        associated with such vaccines may occur.

(July 1, 1944, ch. 373, title XXI, Sec. 2114, as added Pub. L. 99-660, 
title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3764; amended Pub. L. 
101-239, title VI, Sec. 6601(k), Dec. 19, 1989, 103 Stat. 2290; Pub. L. 
103-66, title XIII, Sec. 13632(a)(2), Aug. 10, 1993, 107 Stat. 645.)


                            Prior Provisions

    A prior section 300aa-14, act July 1, 1944, Sec. 2115, was 
successively renumbered by subsequent acts and transferred, see section 
238l of this title.
    A prior section 2114 of act July 1, 1944, was successively 
renumbered by subsequent acts and transferred, see section 238k of this 
title.


                               Amendments

    1993--Subsec. (e). Pub. L. 103-66 amended heading and text of 
subsec. (e) generally. Prior to amendment, text read as follows: ``The 
Secretary may recommend to Congress revisions of the table to change the 
vaccines covered by the table.''
    1989--Subsec. (a). Pub. L. 101-239, Sec. 6601(k)(1), substituted 
``(b)(2)'' for ``(c)(2)'' in items I.D. and II.C. in table.
    Subsec. (b)(3)(B). Pub. L. 101-239, Sec. 6601(k)(2), substituted 
``300aa-11 of this title'' for ``300aa-11(b) of this title''.


                    Effective Date of 1989 Amendment

    For applicability of amendments by Pub. L. 101-239 to petitions 
filed after Dec. 19, 1989, petitions currently pending in which the 
evidentiary record is closed, and petitions currently pending in which 
the evidentiary record is not closed, with provision for an immediate 
suspension for 30 days of all pending cases, see section 6601(s)(1) of 
Pub. L. 101-239, set out as a note under section 300aa-10 of this title.


                    Revisions of Vaccine Injury Table

    The Vaccine Injury Table as modified by regulations promulgated by 
the Secretary of Health and Human Services is set out at 42 CFR 100.3.
    Section 13632(a)(3) of Pub. L. 103-66 provided that: ``A revision by 
the Secretary under section 2114(e) of the Public Health Service Act (42 
U.S.C. 300aa-14(e)) (as amended by paragraph (2)) shall take effect upon 
the effective date of a tax enacted to provide funds for compensation 
paid with respect to the vaccine to be added to the vaccine injury table 
in section 2114(a) of the Public Health Service Act (42 U.S.C. 300aa-
14(a)).''

                  Section Referred to in Other Sections

    This section is referred to in sections 300aa-25, 300aa-33 of this 
title.
