42 U.S.C. § 300aa–14: Vaccine Injury Table

Summary

Creates a Vaccine Injury Table that lists certain vaccines, the kinds of injuries or deaths linked to them, and how soon the first symptom must appear after the shot for a person to seek compensation. For DTP or other whole-cell pertussis vaccines, anaphylaxis must start within 24 hours, encephalopathy within 3 days, shock-collapse within 3 days, and a lasting seizure disorder within 3 days; related acute complications or deaths have no fixed time limit. For measles, mumps, rubella (or vaccines that include any of those), anaphylaxis must start within 24 hours and encephalopathy or a lasting seizure disorder within 15 days; for DT, Td, or tetanus toxoid those two conditions must start within 3 days. For live (oral) polio vaccine, paralytic polio must start within 30 days for people without immune problems and within 6 months for people with immune deficiency. For inactivated polio vaccine (IPV), anaphylaxis must start within 24 hours. If an acute complication follows a listed condition, the table does not set a time limit. Gives short one-line meanings for key medical terms: encephalopathy = a serious brain injury or malfunction; shock-collapse/hypotonic-hyporesponsive collapse = sudden limpness, pale color, unresponsiveness, or breathing/heart failure; residual seizure disorder = repeated seizures after vaccination that meet the timing and fever rules (for MMR the first seizure must be within 15 days and there must be 2+ seizures in one year; for other vaccines the first seizure must be within 3 days and there must be 2+ seizures in one year); seizure/convulsion covers many seizure types. Allows the Health Secretary to change the table by regulation, but requires public notice, a hearing, and at least 180 days for public comment. Anyone can petition to change the table and petitions are sent to the Advisory Commission; the Secretary must start rulemaking or explain why not after the Commission acts or 180 days. Changes apply only to claims filed after the rule takes effect. The Secretary must give the Commission at least 90 days to review any proposed change unless the Commission made the recommendation. By August 1, 1995 the Secretary must add vaccines the CDC recommended before August 1, 1993 for routine childhood use; vaccines recommended after August 1, 1993 must be added within 2 years of the CDC recommendation; vaccines the CDC recommends for pregnant women must also be added through the same process.

Title 42, §300aa–14

The Public Health and Welfare, Source: USLM XML via OLRC

(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, or condition covered: | Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration:

| A. Anaphylaxis or anaphylactic shock | 24 hours

| B. Encephalopathy (or encephalitis) | 3 days

| C. Shock-collapse or hypotonic-hyporesponsive collapse | 3 days

| D. Residual seizure disorder in accordance with subsection (b)(2) | 3 days

| E. 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. | Measles, mumps, rubella, or any vaccine containing any of the foregoing as a component; DT; Td; or Tetanus Toxoid. |

| A. Anaphylaxis or anaphylactic shock | 24 hours

| B. Encephalopathy (or encephalitis) | 15 days (for mumps, 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 in accordance with subsection (b)(2) | 15 days (for mumps, rubella, measles, or any vaccine containing any of the foregoing as a component). 3 days (for DT, Td, or tetanus toxoid).

| D. 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. | Polio Vaccines (other than Inactivated Polio Vaccine). |

| 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. 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. | Inactivated Polio Vaccine. |

| A. Anaphylaxis or anaphylactic shock | 24 hours

(b)Qualifications and aids to interpretation

The following qualifications and aids to interpretation shall apply to the Vaccine Injury Table in subsection (a):

(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), 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) 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) 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) 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

(3)Vaccines recommended for use in pregnant women

The Secretary shall revise the Vaccine Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and the information described in subparagraphs (B) and (C) of paragraph (2) with respect to such vaccines.

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 300aa–14, act

July 1, 1944, § 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

2016—Subsec. (e)(3). Pub. L. 114–255 added par. (3). 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, § 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, § 6601(k)(2), substituted “300aa–11 of this title” for “300aa–11(b) of this title”.

Statutory Notes and Related Subsidiaries

Effective Date

of 1989 AmendmentFor 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 TableThe Vaccine Injury Table as modified by

Regulations

promulgated by the Secretary of Health and Human Services is set out at 42 CFR 100.3. Pub. L. 103–66, title XIII, § 13632(a)(3), Aug. 10, 1993, 107 Stat. 646, 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)).”

§300aa–14 Vaccine Injury Table

Summary

Title 42, §300aa–14

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Amendments

Regulations

Effective Date

Citations & Metadata