VAERS
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VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine. VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA monitor vaccine safety to fulfill their duty as regulatory agencies charged with protecting the public. As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution, underreporting, and inconsistent data quality. Raw, unverified data from VAERS has often been used by the anti-vaccine community to justify misinformat ...
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COVID-19 Vaccine Misinformation And Hesitancy
Anti-vaccination activists and other people in many countries have spread a variety of unfounded conspiracy theories and other misinformation about COVID-19 vaccines based on misunderstood or misrepresented science, religion, exaggerated claims about side effects, a story about COVID-19 being spread by 5G, misrepresentations about how the immune system works and when and how COVID-19 vaccines are made, and other false or distorted information. This misinformation has proliferated and may have made many people averse to vaccination. This has led to governments and private organizations around the world introducing measures to incentivize/coerce vaccination, such as lotteries, mandates and free entry to events, which has in turn led to further misinformation about the legality and effect of these measures themselves. Misinformation Various false theories have spread in different parts of the world regarding the COVID-19 vaccines. COVID-19 and variant related claims Pr ...
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Anti-vaccine
Vaccine hesitancy is a delay in acceptance, or refusal, of vaccines despite the availability of vaccine services and supporting evidence. The term covers refusals to vaccinate, delaying vaccines, accepting vaccines but remaining uncertain about their use, or using certain vaccines but not others. The scientific consensus that vaccines are generally safe and effective is overwhelming. Vaccine hesitancy often results in disease outbreaks and deaths from vaccine-preventable diseases. Therefore, the World Health Organization characterizes vaccine hesitancy as one of the top ten global health threats. "Anti-vaccinationism" refers to total opposition to vaccination; in more recent years, anti-vaccinationists have been known as "anti-vaxxers" or "anti-vax". Vaccine hesitancy is complex and context-specific, varying across time, place and vaccines. It can be influenced by factors such as lack of proper scientifically based knowledge and understanding about how vaccines are made or wor ...
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Vaccine Hesitancy
Vaccine hesitancy is a delay in acceptance, or refusal, of vaccines despite the availability of vaccine services and supporting evidence. The term covers refusals to vaccinate, delaying vaccines, accepting vaccines but remaining uncertain about their use, or using certain vaccines but not others. The scientific consensus that vaccines are generally safe and effective is overwhelming. Vaccine hesitancy often results in disease outbreaks and deaths from vaccine-preventable diseases. Therefore, the World Health Organization characterizes vaccine hesitancy as one of the top ten global health threats. "Anti-vaccinationism" refers to total opposition to vaccination; in more recent years, anti-vaccinationists have been known as "anti-vaxxers" or "anti-vax". Vaccine hesitancy is complex and context-specific, varying across time, place and vaccines. It can be influenced by factors such as lack of proper scientifically based knowledge and understanding about how vaccines are made or wo ...
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COVID-19 Vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. In January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by March 2020, the global pharmaceutical industry announced a major commitment to address COVID19. In 2020, the first COVID19 vaccines were developed and made available to the public through emergency authorizations and conditional approvals. Initially, most COVID19 vaccines were two ...
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Centers For Disease Control And Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgia. The agency's main goal is the protection of public health and safety through the control and prevention of disease, injury, and disability in the US and worldwide. The CDC focuses national attention on developing and applying disease control and prevention. It especially focuses its attention on infectious disease, food borne pathogens, environmental health, occupational safety and health, health promotion, injury prevention and educational activities designed to improve the health of United States citizens. The CDC also conducts research and provides information on non-infectious diseases, such as obesity and diabetes, and is a founding member of the International Association of National Public Health Institutes.
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Jim Laidler
James R. Laidler is an American anesthesiologist in Portland, Oregon, who is known both for his activism for, and later his opposition to, alternative autism therapies. Education Laidler obtained his bachelor's degree from Pacific Lutheran University in biochemistry in 1981. He completed his residency in anesthesiology, as well as a fellowship in pain medicine, in Chicago and began treating autistic children in 2000. Laidler is an adjunct professor at Portland State University. Autism activism Originally, Laidler was not only an outspoken advocate of alternative autism therapies, and often spoke at Defeat Autism Now! conferences, but had used many of them on his own sons, including chelation therapy, secretin, and a number of dietary supplements such as dimethylglycine. However, he had a change of heart after his son, who was on a gluten-free diet for his autism, ate a waffle at a buffet while his parents were distracted. Laidler says his son's doctors had told him that his son w ...
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National Childhood Vaccine Injury Act
The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was signed into law by United States President Ronald Reagan as part of a larger health bill on November 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters. Background In the 1970s and 1980s, a controversy erupted related to the question of whether the whole-cell pertussis component of the DPT vaccine caused permanent brain injury known as pertussis vaccine encephalopathy, in rare cases. No studies showed a causal con ...
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Vaccine Safety Datalink
The Vaccine Safety Datalink Project (VSD) was established in 1990 by the United States Centers for Disease Control and Prevention (CDC) to study the adverse effects of vaccines. Four large health maintenance organizations, including Kaiser Permanente, were initially recruited to provide the CDC with medical data on vaccination histories, health outcomes, and subject characteristics. The VSD database contains data compiled from surveillance on more than seven million people in the United States, including about 500,000 children from birth through age six years (2% of the U.S. population in this age group). The VSD data-sharing program is now being administered by the National Center for Health Statistics Research Data Center. The data sharing guidelines have been revised to include comments from interested groups as well as recommendations from the Institute of Medicine (IOM). The Vaccine Adverse Event Reporting System (VAERS), the VSD, and the Clinical Immunization Safety Asses ...
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Adverse Event Reporting System
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery (such as need for retraining to prevent prescribing errors). The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012. Background Reporting of adverse events from the point of care is voluntary in the United States. The FDA receives some adverse event and medicati ...
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Risk–benefit Ratio
A risk–benefit ratio (or benefit-risk ratio) is the ratio of the risk of an action to its potential benefits. Risk–benefit analysis (or benefit-risk analysis) is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our lives is accepted as necessary to achieve certain benefits. For example, driving an automobile is a risk most people take daily, also since it is mitigated by the controlling factor of their perception of their individual ability to manage the risk-creating situation. When individuals are exposed to involuntary risk (a risk over which they have no control), they make risk aversion their primary goal. Under these circumstances, individuals require the probability of risk to be as much as one thousand times smaller than for the same situation under their perceived control (a notable example being the common bias in the perception of risk in flying v ...
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Thimerosal
Thiomersal (INN), or thimerosal (USAN, JAN), is an organomercury compound. It is a well-established antiseptic and antifungal agent. The pharmaceutical corporation Eli Lilly and Company gave thiomersal the trade name Merthiolate. It has been used as a preservative in vaccines, immunoglobulin preparations, skin test antigens, antivenins, ophthalmic and nasal products, and tattoo inks. In spite of the scientific consensus that fears about its safety are unsubstantiated, its use as a vaccine preservative has been called into question by anti-vaccination groups. Due to this public pressure the substance was phased out of routine childhood vaccines in the United States, the European Union, and a few other countries in response to popular fears. It remains in use as a preservative for annual flu vaccines. History Morris Kharasch, a chemist then at the University of Maryland filed a patent application for thiomersal in 1927; Eli Lilly later marketed the compound under the trade ...
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Vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or Antigen, killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future. Vaccines can be prophylaxis, prophylactic (to prevent or ameliorate the effects of a future infection by a natural or "wild" pathogen), or therapeutic vaccines, therapeutic (to fight a disease that has already occurred, such as cancer vaccine, cancer).
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