From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]

[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
 
-HEAD-
    Sec. 300aa-14. Vaccine Injury Table
 
-STATUTE-
    (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,   Time period for
                            injury, or             first symptom or
                            condition covered:     manifestation of
                                                   onset or of
                                                   significant
                                                   aggravation after
                                                   vaccine
                                                   administration:
                           A. Anaphylaxis or      24 hours
                            anaphylactic shock
                           B. Encephalopathy       3 days
                            (or encephalitis)
                           C. Shock-collapse or    3 days
                            hypotonic-
                           hyporesponsive
                            collapse
                           D. Residual seizure     3 days
                            disorder in
                            accordance with
                            subsection (b)(2)
                           E. Any acute           Not applicable
                            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
    II.                    Measles, mumps,
                            rubella, or any
                            vaccine containing
                            any of the
                            foregoing as a
                            component; DT; Td;
                            or Tetanus Toxoid.
                           A. Anaphylaxis or      24 hours
                            anaphylactic shock
                           B. Encephalopathy      15 days (for mumps,
                            (or 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    15 days (for mumps,
                            disorder in            rubella, measles,
                            accordance with        or any vaccine
                            subsection (b)(2)      containing any of
                                                   the foregoing as a
                                                   component). 3 days
                                                   (for DT, Td, or
                                                   tetanus toxoid).
                           D. Any acute           Not applicable
                            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
    III.                   Polio Vaccines
                            (other than
                            Inactivated Polio
                            Vaccine).
                           A. Paralytic polio
                            - in a non-           30 days
                           immunodeficient
                            recipient
                            - in an                6 months
                            immunodeficient
                            recipient
                            - in a vaccine-       Not applicable
                           associated community
                            case
                           B. Any acute           Not applicable
                            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
    IV.                    Inactivated Polio
                            Vaccine.
                           A. Anaphylaxis or      24 hours
                            anaphylactic shock
                           B. Any acute           Not applicable
                            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
                     -------------------------------
    (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.
 
-SOURCE-
    (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.)
 
-MISC1-
                              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)).''
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in sections 300aa-25, 300aa-33 of
    this title.