How is the VICP funded? Federal tax dollars allocated by Congress at $110 million per year. Vaccine Injury Compensation Trust Fund, funded from an excise tax of $. 75 on every dose of covered vaccine that is purchased.

What is National Vaccine Injury Compensation Program? The National Vaccine Injury Compensation Program (VICP) is a Federal “no-fault” system designed to compensate individuals, or families of individuals, who have been injured by childhood vaccines, whether administered in the private or public sector.

The National Childhood Vaccine Injury Act of 1986 (the Act) established the National Vaccine Injury Compensation Program (VICP) as a federal “no-fault” compensation system for individuals who may have been injured by specific covered vaccines.

As a general rule, for an injury, claims must be filed within 3 years after the first symptom of the vaccine injury.

Common side effects of Fluarix include injection site reactions that may last for up to 1-2 days (soreness, redness, swelling, bruising, pain, or a lump), fever, chills, muscle aches, joint pain, headache, tired feeling, weakness, fussiness or crying (in children).

National Childhood Vaccine Injury Act (NCVIA) In response to NCVIA, CDC and FDA established VAERS in 1990. NCVIA was enacted to compensate individuals of all ages who have been injured by vaccines that are listed in the vaccine injury table.

Compensations

Currently, 16 vaccines – some requiring multiple doses at specific ages and times – are recommended from birth to 18 years old. Recommended vaccines include: Influenza (annual flu shot) Diphtheria, tetanus and pertussis (DTaP)

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Section 2: How to Search VAERS Public Data….

1. Step 1: Organize table layout.
2. Step 2: Select symptoms.
3. Step 3: Select vaccine characteristics.
4. Step 4: Select location, age, gender.
5. Step 5: Select other event characteristics.
6. Step 6: Search text fields.
7. Step 7: Select report completed dates.
8. Step 8: Select report received dates.

Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is not designed to determine if a vaccine caused or contributed to an adverse event. A report to VAERS does not mean the vaccine caused the event. VAERS is a passive surveillance system, meaning it relies on people sending in reports of their experiences after vaccination.

An adverse event is a health problem that happens after vaccination that may or may not be caused by a vaccine. These events may require further investigation. By definition, a side effect has been shown to be linked to a vaccine by scientific studies.

If the sponsor determines that the adverse event is serious, unexpected, and that there is a reasonable possibility that the event was caused by the drug, they must submit a case report to FDA that is attached to the drug’s investigational new drug (IND) application.

The 5 Ws of Adverse Events. Who is responsible for reporting serious adverse events (SAEs)? Manufacturers are under mandatory requirements to report serious adverse events related to their products to the US Food and Drug Administration (FDA).

Investigators are required to report promptly “to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately” (21 CFR 312.64[b]).

Reports from consumers, health professionals, and manufacturers can be made by mail, telephone, or on-line. Adverse event reports are entered into the AERS database. Adverse events in AERS are coded to terms in the Medical Dictionary for Regulatory Activities terminology (MedDRA).

Overview of adverse events Adverse events include side effects to medicines and vaccines, and problems or incidents involving medical devices. Examples of adverse events are any unfavourable and unintended sign, symptom or disease associated with the use of a therapeutic good.

Physicians’ professional commitment to advance scientific knowledge and make relevant information available to patients, colleagues, and the public carries with it the responsibility to report suspected adverse events resulting from the use of a drug or medical device.

Submitting Adverse Event Reports to FDA

1. Report Online.
2. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission.
3. Call FDA at 1-800-FDA-1088 to report by telephone.
4. Reporting Form FDA 3500 commonly used by health professionals. View Instructions for Form FDA 3500.

Note that adverse experiences include reports of failure to produce the expected pharmacologic action, i.e., ”lack of effect.” 2.

Examples of such adverse drug reactions include rashes, jaundice, anemia, a decrease in the white blood cell count, kidney damage, and nerve injury that may impair vision or hearing. These reactions tend to be more serious but typically occur in a very small number of people.

The FDA maintains MedWatch, a Web-based reporting system that allows consumers and health professionals to voluntarily report serious adverse events and other serious problems that they suspect are associated with the use of an FDA-regulated product.

Grades 3 are severe and undesirable adverse events (e.g., significant symptoms requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation).

An adverse event is any undesirable experience associated with the use of a medical product in a patient.

Grade 3 Severe AE. Grade 4 Life-threatening or disabling AE. Grade 5 Death related to AE.

To many people, adverse events and side effects mean the same thing and are used interchangeably, which is incorrect. Adverse events are unintended pharmacologic effects that occur when a medication is administered correctly while a side effect is a secondary unwanted effect that occurs due to drug therapy.

Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have.

Common side effects include upset stomach, dry mouth, and drowsiness. A side effect is considered serious if the result is: death; life-threatening; hospitalization; disability or permanent damage; or exposure prior to conception or during pregnancy caused birth defect.