§ 100.3 Vaccine injury table.
(a) In accordance with section 312(b) of the National Childhood Vaccine Injury Act of 1986, title III of Public Law 99–660, 100 Stat. 3779 (42 U.S.C. 300aa–1 note) and section 2114(c) of the Public Health Service Act, as amended (PHS Act) (42 U.S.C. 300aa–14(c)), 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. Paragraph (b) of this section sets forth additional provisions that are not separately listed in this Table but that constitute part of it. Paragraph (c) of this section sets forth the qualifications and aids to interpretation for the terms used in the Table. Conditions and injuries that do not meet the terms of the qualifications and aids to interpretation are not within the Table. Paragraph (d) of this section sets forth a glossary of terms used in paragraph (c).
Vaccine Injury Table
| Vaccine | Illness, disability, injury or condition covered | Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration |
|---|---|---|
| I. Vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or TT) | A. Anaphylaxis B. Brachial Neuritis | ≤4 hours. 2–28 days (not less than 2 days and not more than 28 days). |
| C. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| D. Vasovagal syncope | ≤1 hour. | |
| II. Vaccines containing whole cell pertussis bacteria, extracted or partial cell pertussis bacteria, or specific pertussis antigen(s) (e.g., DTP, DTaP, P, DTP-Hib) | A. Anaphylaxis | ≤4 hours. |
| B. Encephalopathy or encephalitis | ≤72 hours. | |
| C. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| D. Vasovagal syncope | ≤1 hour. | |
| III. Vaccines containing measles, mumps, and rubella virus or any of its components (e.g., MMR, MM, MMRV) | A. Anaphylaxis B. Encephalopathy or encephalitis | ≤4 hours. 5–15 days (not less than 5 days and not more than 15 days). |
| C. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| D. Vasovagal syncope | ≤1 hour. | |
| IV. Vaccines containing rubella virus (e.g., MMR, MMRV) | A. Chronic arthritis | 7–42 days (not less than 7 days and not more than 42 days). |
| V. Vaccines containing measles virus (e.g., MMR, MM, MMRV) | A. Thrombocytopenic purpura | 7–30 days (not less than 7 days and not more than 30 days). |
| B. Vaccine-Strain Measles Viral Disease in an immunodeficient recipient | ||
| —Vaccine-strain virus identified | Not applicable. | |
| —If strain determination is not done or if laboratory testing is inconclusive | ≤12 months. | |
| VI. Vaccines containing polio live virus (OPV) | 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. Vaccine-Strain Polio Viral Infection | ||
| —in a non-immunodeficient recipient | ≤30 days. | |
| —in an immunodeficient recipient | ≤6 months. | |
| —in a vaccine associated community case | Not applicable. | |
| VII. Vaccines containing polio inactivated virus (e.g., IPV) | A. Anaphylaxis | ≤4 hours. |
| B. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| C. Vasovagal syncope | ≤1 hour. | |
| VIII. Hepatitis B vaccines | A. Anaphylaxis | ≤4 hours. |
| B. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| C. Vasovagal syncope | ≤1 hour. | |
| IX. Haemophilus influenzae type b (Hib) vaccines | A. Shoulder Injury Related to Vaccine Administration | ≤48 hours. |
| B. Vasovagal syncope | ≤1 hour. | |
| X. Varicella vaccines | A. Anaphylaxis | ≤4 hours. |
| B. Disseminated varicella vaccine-strain viral disease | ||
| —Vaccine-strain virus identified | Not applicable. | |
| —If strain determination is not done or if laboratory testing is inconclusive | 7–42 days (not less than 7 days and not more than 42 days). | |
| C. Varicella vaccine-strain viral reactivation | Not applicable. | |
| D. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| E. Vasovagal syncope | ≤1 hour. | |
| XI. Rotavirus vaccines | A. Intussusception | 1–21 days (not less than 1 day and not more than 21 days). |
| XII. Pneumococcal conjugate vaccines | A. Shoulder Injury Related to Vaccine Administration | ≤48 hours. |
| B. Vasovagal syncope | ≤1 hour. | |
| XIII. Hepatitis A vaccines | A. Shoulder Injury Related to Vaccine Administration | ≤48 hours. |
| B. Vasovagal syncope | ≤1 hour. | |
| XIV. Seasonal influenza vaccines | A. Anaphylaxis | ≤4 hours. |
| B. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| C. Vasovagal syncope | ≤1 hour. | |
| D. Guillain-Barré Syndrome | 3–42 days (not less than 3 days and not more than 42 days). | |
| XV. Meningococcal vaccines | A. Anaphylaxis | ≤4 hours. |
| B. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| C. Vasovagal syncope | ≤1 hour. | |
| XVI. Human papillomavirus (HPV) vaccines | A. Anaphylaxis | ≤4 hours. |
| B. Shoulder Injury Related to Vaccine Administration | ≤48 hours. | |
| C. Vasovagal syncope | ≤1 hour. | |
| XVII. Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children and/or pregnant women, after publication by the Secretary of a notice of coverage | A. Shoulder Injury Related to Vaccine Administration B. Vasovagal syncope | ≤48 hours. ≤1 hour. |
(b) Provisions that apply to all conditions listed. (1) Any acute complication or sequela, including death, of the illness, disability, injury, or condition listed in paragraph (a) of this section (and defined in paragraphs (c) and (d) of this section) qualifies as a Table injury under paragraph (a) except when the definition in paragraph (c) requires exclusion.
(2) In determining whether or not an injury is a condition set forth in paragraph (a) of this section, the Court shall consider the entire medical record.
(3) An idiopathic condition that meets the definition of an illness, disability, injury, or condition set forth in paragraph (c) of this section shall be considered to be a condition set forth in paragraph (a) of this section.
(c) Qualifications and aids to interpretation. The following qualifications and aids to interpretation shall apply to, define and describe the scope of, and be read in conjunction with paragraphs (a), (b), and (d) of this section:
(1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially lethal systemic reaction that occurs as a single discrete event with simultaneous involvement of two or more organ systems. Most cases resolve without sequela. 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. There are no specific pathological findings to confirm a diagnosis of anaphylaxis.