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

(a) Initial table This subsection lists vaccines, the injuries and deaths linked to them, and the time window in which the first symptom must appear to qualify for compensation under the Program. Group I — DTP, P, DTP/Polio combination vaccines, or any vaccine containing whole-cell, extracted or partial-cell pertussis bacteria, or specific pertussis antigens: anaphylaxis or anaphylactic shock, within 24 hours; encephalopathy (a brain injury or inflammation), within 3 days; shock-collapse or a hypotonic-hyporesponsive collapse, within 3 days; a residual seizure disorder, as described in subsection (b)(2), starting within 3 days; and any acute complication or after-effect of one of these (including death), with no separate time limit, as long as the original condition arose within its own time window. Group II — measles, mumps, or rubella vaccines, or any vaccine containing one of them, plus DT, Td, or tetanus toxoid: anaphylaxis, within 24 hours; encephalopathy, within 15 days for measles/mumps/rubella-containing vaccines, or within 3 days for DT, Td, or tetanus toxoid; a residual seizure disorder, on the same 15-day or 3-day schedule; and any acute complication or after-effect (including death), with no separate time limit, as long as the original condition arose within its own time window. Group III — polio vaccines other than inactivated polio vaccine: paralytic polio, within 30 days for someone with a normal immune system, or within 6 months for someone with a weakened immune system, or with no time limit for someone who caught it from a person who was vaccinated; and any acute complication or after-effect (including death), with no separate time limit. Group IV — inactivated polio vaccine: anaphylaxis, within 24 hours; and any acute complication or after-effect (including death), with no separate time limit. (b) Qualifications and aids to interpretation A shock-collapse or hypotonic-hyporesponsive collapse can show up as reduced or lost muscle tone, partial or complete paralysis, turning pale or blue, not responding to surroundings, reduced or lost consciousness, an unusually long sleep that's hard to wake from, or the heart or lungs stopping. A person can be treated as having a residual seizure disorder if they had no seizure before the vaccine (or only one with a fever under 102°F), and afterward: for measles, mumps, or rubella vaccines, the first seizure came within 15 days and at least two more seizures — with no fever or a fever under 102°F — came within a year; for any other vaccine, the first seizure came within 3 days and at least two more (under the same fever rule) came within a year. "Encephalopathy" means any significant new abnormality of, injury to, or impaired function of the brain. Common signs include localized or widespread neurological problems, increased pressure inside the skull, or at least 6 hours of altered consciousness, with or without seizures. It may fully resolve or leave lasting impairment. High-pitched or unusual screaming, inconsolable crying, and a bulging soft spot on an infant's skull are consistent with encephalopathy, but do not by themselves prove it; it is usually confirmed by slow-wave activity on an EEG. If the evidence shows, by a preponderance, that an encephalopathy was actually caused by infection, toxins, trauma, or a metabolic problem, it does not count as a condition listed on the Table. But if the cause cannot be determined by a preponderance of the evidence at the time of judgment, it is treated as a condition on the Table — and the court must consider the entire medical record in deciding. "Seizure" and "convulsion" include grand mal, petit mal, absence, myoclonic, tonic-clonic, and focal motor seizures and signs. If a Table provision covered by these interpretation rules is later revised, the rules stop applying to that provision after the revision takes effect, unless the revision says otherwise. (c) Administrative revision of table The Secretary may issue regulations to change the Vaccine Injury Table, after providing notice and an opportunity for a public hearing, and at least 180 days of public comment. Anyone — including the Advisory Commission on Childhood Vaccines — may petition the Secretary to propose a Table change. Unless the petition is clearly frivolous or was started by the Commission itself, it must be referred to the Commission for recommendations. After receiving the Commission's recommendation, or 180 days after the referral (whichever comes first), the Secretary must either conduct a rulemaking on the proposal or publish reasons for not doing so. A Table modification may add or remove injuries, disabilities, illnesses, conditions, and deaths, or change the required time periods. Any modification applies only to petitions filed after the new regulation takes effect. (d) Role of Commission Except for a regulation the Advisory Commission on Childhood Vaccines itself recommends, the Secretary cannot propose any Table regulation or revision without first giving the Commission a copy, asking for its recommendations and comments, and giving it at least 90 days to respond. (e) Additional vaccines By August 1, 1995, the Secretary had to revise the Table to add any vaccine the Centers for Disease Control and Prevention recommended, before August 1, 1993, for routine administration to children, along with the associated injuries, disabilities, illnesses, conditions, and deaths, and the time periods for their first symptoms. For any vaccine the CDC recommends for routine administration to children after August 1, 1993, the Secretary must make the same kind of update within 2 years of that recommendation. The Secretary must also revise the Table, following the process in subsection (c), for any vaccine the CDC recommends for routine administration to pregnant women, including the same kind of injury and timing information.