PART 100—VACCINE INJURY COMPENSATION Authority: Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); and sec. 13632(a)(3) of Public Law 103-66. § 100.1 Applicability. This part applies to the National Vaccine Injury Compensation Program (VICP) under subtitle 2 of title XXI of the Public Health Service (PHS) Act. [60 FR 7693, Feb. 8, 1995] § 100.2 Average cost of a health insurance policy. For purposes of determining the amount of compensation under the VICP, section 2115(a)(3)(B) of the PHS Act, 42 U.S.C. 300aa-15(a)(3)(B), provides that certain individuals are entitled to receive an amount reflecting lost earnings, less certain deductions. One of the deductions is the average cost of a health insurance policy, as determined by the Secretary. The Secretary has determined that the average cost of a health insurance policy is $363.12 for 2006. This figure is calculated periodically (generally on an annual basis) using the most recent Medical Expenditure Panel Survey-Insurance Component (MEPS-IC) data available as the baseline for the average monthly cost of a health insurance policy. This baseline is adjusted by the annual percentage increase/decrease obtained from the most recent annual Kaiser Family Foundation and Health Research and Educational Trust (KFF/HRET) Employer Health Benefits survey or other authoritative source that may be more accurate or appropriate in the future. The revised amount will be effective upon its delivery by the Secretary to the United States Court of Federal Claims, and the amount will be published as a notice in the Federal Register [72 FR 36612, July 5, 2007] § 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., A. Anaphylaxis ≤4 hours. 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., 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., A. Anaphylaxis ≤4 hours. C. Shoulder Injury Related to Vaccine Administration ≤48 hours. D. Vasovagal syncope ≤1 hour. IV. Vaccines containing rubella virus ( e.g., A. Chronic arthritis 7-42 days (not less than 7 days and not more than 42 days). V. Vaccines containing measles virus ( e.g., 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., 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 ≤48 hours. (b) Provisions that apply to all conditions listed. (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. (1) Anaphylaxis. (2) Encephalopathy. (i) Acute encephalopathy. ( 1 ( 2 (B) For adults and children 18 months of age or older, an acute encephalopathy is one that persists at least 24 hours and is characterized by at least two of the following: ( 1 ( 2 ( 3 (C) The following clinical features in themselves do not demonstrate an acute encephalopathy or a significant change in either mental status or level of consciousness: Sleepiness, irritability (fussiness), high-pitched and unusual screaming, poor feeding, persistent inconsolable crying, bulging fontanelle, or symptoms of dementia. (D) Seizures in themselves are not sufficient to constitute a diagnosis of encephalopathy and in the absence of other evidence of an acute encephalopathy seizures shall not be viewed as the first symptom or manifestation of an acute encephalopathy. (ii) Exclusionary criteria for encephalopathy. (A) An underlying condition or systemic disease shown to be unrelated to the vaccine (such as malignancy, structural lesion, psychiatric illness, dementia, genetic disorder, prenatal or perinatal central nervous system (CNS) injury); or (B) An acute event shown to be unrelated to the vaccine such as a head trauma, stroke, transient ischemic attack, complicated migraine, drug use (illicit or prescribed) or an infectious disease. (3) Encephalitis. (i) Acute encephalitis. (A) Evidence of neurologic dysfunction consists of either: ( 1 ( 2 (B) Evidence of an inflammatory process in the brain (central nervous system or CNS inflammation) must include cerebrospinal fluid (CSF) pleocytosis (>5 white blood cells (WBC)/mm 3 ( 1 ( 2 ( 3 (ii) Exclusionary criteria for encephalitis. (A) An underlying malignancy that led to a paraneoplastic encephalitis; (B) An infectious disease associated with encephalitis, including a bacterial, parasitic, fungal or viral illness (such as herpes viruses, adenovirus, enterovirus, West Nile Virus, or human immunodeficiency virus), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing; or (C) Acute disseminated encephalomyelitis (ADEM). Although early ADEM may have laboratory and clinical characteristics similar to acute encephalitis, findings on MRI are distinct with ADEM displaying evidence of acute demyelination (scattered, focal, or multifocal areas of inflammation and demyelination within cerebral subcortical and deep cortical white matter; gray matter involvement may also be seen but is a minor component); or (D) Other conditions or abnormalities that would explain the vaccine recipient's symptoms. (4) Intussusception. (ii) For purposes of paragraph (a) of this section, the following shall not be considered to be a Table intussusception: (A) Onset that occurs with or after the third dose of a vaccine containing rotavirus; (B) Onset within 14 days after an infectious disease associated with intussusception, including viral disease (such as those secondary to non-enteric or enteric adenovirus, or other enteric viruses such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing; (C) Onset in a person with a preexisting condition identified as the lead point for intussusception such as intestinal masses and cystic structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or duplication cysts); (D) Onset in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or (E) Onset in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease). (5) Chronic arthritis. (i) Chronic arthritis may be found in a person with no history in the 3 years prior to vaccination of arthropathy (joint disease) on the basis of: (A) Medical documentation recorded within 30 days after the onset of objective signs of acute arthritis (joint swelling) that occurred between 7 and 42 days after a rubella vaccination; and (B) Medical documentation (recorded within 3 years after the onset of acute arthritis) of the persistence of objective signs of intermittent or continuous arthritis for more than 6 months following vaccination; and (C) Medical documentation of an antibody response to the rubella virus. (ii) The following shall not be considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective tissue diseases (including but not limited to rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis/determatomyositis, fibromyalgia, necrotizing vasculitis and vasculopathies and Sjogren's Syndrome), degenerative joint disease, infectious agents other than rubella (whether by direct invasion or as an immune reaction), metabolic and endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and cartilage disorders, and arthritis associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's Syndrome, blood disorders, or arthralgia (joint pain), or joint stiffness without swelling. (6) Brachial neuritis. i.e., (i) Pain in the affected arm and shoulder is a presenting symptom and occurs within the specified time-frame; (ii) Weakness; (A) Clinical diagnosis in the absence of nerve conduction and electromyographic studies requires weakness in muscles supplied by more than one peripheral nerve. (B) Nerve conduction studies (NCS) and electromyographic (EMG) studies localizing the injury to the brachial plexus are required before the diagnosis can be made if weakness is limited to muscles supplied by a single peripheral nerve. (iii) Motor, sensory, and reflex findings on physical examination and the results of NCS and EMG studies, if performed, must be consistent in confirming that dysfunction is attributable to the brachial plexus; and (iv) No other condition or abnormality is present that would explain the vaccine recipient's symptoms. (7) Thrombocytopenic purpura. 3 (8) Vaccine-strain measles viral disease. (9) Vaccine-strain polio viral infection. (10) Shoulder injury related to vaccine administration (SIRVA). e.g. (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient's symptoms ( e.g. (11) Disseminated varicella vaccine-strain viral disease. (12) Varicella vaccine-strain viral reactivation disease. (13) Vasovagal syncope. (14) Immunodeficient recipient. (15) Guillain-Barré Syndrome (GBS). (ii) The most common subtype in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP), which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and nerve roots. Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are typically characterized by symmetric motor flaccid weakness, sensory abnormalities, and/or autonomic dysfunction caused by autoimmune damage to peripheral nerves and nerve roots. The diagnosis of AIDP, AMAN, and AMSAN requires: (A) Bilateral flaccid limb weakness and decreased or absent deep tendon reflexes in weak limbs; (B) A monophasic illness pattern; (C) An interval between onset and nadir of weakness between 12 hours and 28 days; (D) Subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse; however, death may occur without a clinical plateau); and, (E) The absence of an identified more likely alternative diagnosis. (iii) Fisher Syndrome (FS), also known as Miller Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and AIDP may be seen with limb weakness. The diagnosis of FS requires: (A) Bilateral ophthalmoparesis; (B) Bilateral reduced or absent tendon reflexes; (C) Ataxia; (D) The absence of limb weakness (the presence of limb weakness suggests a diagnosis of AIDP, AMAN, or AMSAN); (E) A monophasic illness pattern; (F) An interval between onset and nadir of weakness between 12 hours and 28 days; (G) Subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse; however, death may occur without a clinical plateau); (H) No alteration in consciousness; (I) No corticospinal track signs; and (J) The absence of an identified more likely alternative diagnosis. (iv) Evidence that is supportive, but not required, of a diagnosis of all subtypes of GBS includes electrophysiologic findings consistent with GBS or an elevation of cerebral spinal fluid (CSF) protein with a total CSF white blood cell count below 50 cells per microliter. Both CSF and electrophysiologic studies are frequently normal in the first week of illness in otherwise typical cases of GBS. (v) To qualify as any subtype of GBS, there must not be a more likely alternative diagnosis for the weakness. (vi) Exclusionary criteria for the diagnosis of all subtypes of GBS include the ultimate diagnosis of any of the following conditions: chronic immune demyelinating polyradiculopathy (CIDP), carcinomatous meningitis, brain stem encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, spinal cord infarct, spinal cord compression, anterior horn cell diseases such as polio or West Nile virus infection, subacute inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, cauda equina compression, metabolic conditions such as hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy (such as vincristine, platinum compounds, or nitrofurantoin), porphyria, critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, organophosphate poisoning, botulism, critical illness myopathy, polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above list is not exhaustive. (d) Glossary for purposes of paragraph (c) of this section Chronic encephalopathy. (ii) Individuals who return to their baseline neurologic state, as confirmed by clinical findings, within less than 6 months from the first symptom or manifestation of onset or of significant aggravation of an acute encephalopathy or encephalitis shall not be presumed to have suffered residual neurologic damage from that event; any subsequent chronic encephalopathy shall not be presumed to be a sequela of the acute encephalopathy or encephalitis. (2) Injected (3) Sequela (4) Significantly decreased level of consciousness (i) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli); (ii) Decreased or absent eye contact (does not fix gaze upon family members or other individuals); or (iii) Inconsistent or absent responses to external stimuli (does not recognize familiar people or things). (5) Seizure (e) Coverage provisions. (2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X of the Table) are included in the Table as of August 6, 1997. (3) Rotavirus vaccines (Item XI of the Table) are included in the Table as of October 22, 1998. (4) Pneumococcal conjugate vaccines (Item XII of the Table) are included in the Table as of December 18, 1999. (5) Hepatitis A vaccines (Item XIII of the Table) are included on the Table as of December 1, 2004. (6) Trivalent influenza vaccines (Included in item XIV of the Table) are included on the Table as of July 1, 2005. All other seasonal influenza vaccines (Item XIV of the Table) are included on the Table as of November 12, 2013. (7) Meningococcal vaccines and human papillomavirus vaccines (Items XV and XVI of the Table) are included on the Table as of February 1, 2007. (8) Other new vaccines (Item XVII of the Table) will be included in the Table as of the effective date of a tax enacted to provide funds for compensation paid with respect to such vaccines. An amendment to this section will be published in the Federal Register [82 FR 6299, Jan. 19, 2017, as amended at 86 FR 68427, Dec. 2, 2021]