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Vaccine adverse event
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Vaccine adverse event
A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. The World Health Organization (WHO) refers to Adverse Events Following Immunization (AEFI).
AEFIs can be related to the vaccine itself (product or quality defects), to the vaccination process (administration error or stress related reactions) or can occur independently from vaccination (coincidental).
Most vaccine adverse events are mild. Serious injuries and deaths caused by vaccines are very rare, and the idea that severe events are common has been classed as a "common misconception about immunization" by the WHO. Some claimed vaccine injuries are not, in fact, caused by vaccines; for example, there is a subculture of advocates who attribute their children's autism to vaccine injury, despite the fact that vaccines do not cause autism.
Claims of vaccine injuries appeared in litigation in the United States in the latter part of the 20th century. Some families have won substantial awards from sympathetic juries, even though many public health officials have said that the claims of injuries are unfounded. In response, several vaccine makers stopped production, threatening public health, resulting in laws being passed at several points to shield makers from liabilities stemming from vaccine injury claims.
According to the U.S. Centers for Disease Control and Prevention, while "any vaccine can cause side effects", most side effects are minor, primarily including sore arms or a mild fever. Unlike most medical interventions vaccines are given to healthy people, where the risk of side effects is not as easily outweighed by the benefit of treating existing disease. As such, the safety of immunization interventions is taken very seriously by the scientific community, with constant monitoring of a number of data sources looking for patterns of adverse events.
As the success of immunization programs increases and the incidence of disease decreases, public attention shifts away from the risks of disease to the risk of vaccination. Concerns about immunization safety often follow a pattern. First, some investigators suggest that a medical condition of increasing prevalence or unknown cause is due to an adverse effect of vaccination. The initial study, and subsequent studies by the same investigators, have inadequate methodology, typically a poorly controlled or uncontrolled case series. A premature announcement is made of the alleged adverse effect, which resonates with individuals who have the condition and which underestimates the potential harm of not being vaccinated. The initial study is not reproduced by other investigators. Finally, it takes several years before the public regains confidence in the vaccine.
Controversies in this area revolve around the question of whether the risks of adverse events following immunization outweigh the benefits of preventing infectious disease. In rare cases immunizations can cause serious adverse effects, such as gelatin measles-mumps-rubella vaccine (MMR) causing anaphylaxis, a severe allergic reaction. Allegations particularly focus on disorders claimed to be caused by the MMR vaccine and thiomersal, a preservative used in vaccines routinely given to U.S. infants prior to 2001. Current scientific evidence does not support claims of vaccines causing various disorders.
The debate is complicated by misconceptions around the recording and reporting of adverse events by anti-vaccination activists. According to authorities, anti-vaccination websites greatly exaggerate the risk of serious adverse effects from vaccines and falsely describe conditions such as autism and shaken baby syndrome as vaccine injuries, leading to misconceptions about the safety and effectiveness of vaccines. This has had the result of stigmatizing autistic people and the parents who had them immunized.
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Vaccine adverse event
A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. The World Health Organization (WHO) refers to Adverse Events Following Immunization (AEFI).
AEFIs can be related to the vaccine itself (product or quality defects), to the vaccination process (administration error or stress related reactions) or can occur independently from vaccination (coincidental).
Most vaccine adverse events are mild. Serious injuries and deaths caused by vaccines are very rare, and the idea that severe events are common has been classed as a "common misconception about immunization" by the WHO. Some claimed vaccine injuries are not, in fact, caused by vaccines; for example, there is a subculture of advocates who attribute their children's autism to vaccine injury, despite the fact that vaccines do not cause autism.
Claims of vaccine injuries appeared in litigation in the United States in the latter part of the 20th century. Some families have won substantial awards from sympathetic juries, even though many public health officials have said that the claims of injuries are unfounded. In response, several vaccine makers stopped production, threatening public health, resulting in laws being passed at several points to shield makers from liabilities stemming from vaccine injury claims.
According to the U.S. Centers for Disease Control and Prevention, while "any vaccine can cause side effects", most side effects are minor, primarily including sore arms or a mild fever. Unlike most medical interventions vaccines are given to healthy people, where the risk of side effects is not as easily outweighed by the benefit of treating existing disease. As such, the safety of immunization interventions is taken very seriously by the scientific community, with constant monitoring of a number of data sources looking for patterns of adverse events.
As the success of immunization programs increases and the incidence of disease decreases, public attention shifts away from the risks of disease to the risk of vaccination. Concerns about immunization safety often follow a pattern. First, some investigators suggest that a medical condition of increasing prevalence or unknown cause is due to an adverse effect of vaccination. The initial study, and subsequent studies by the same investigators, have inadequate methodology, typically a poorly controlled or uncontrolled case series. A premature announcement is made of the alleged adverse effect, which resonates with individuals who have the condition and which underestimates the potential harm of not being vaccinated. The initial study is not reproduced by other investigators. Finally, it takes several years before the public regains confidence in the vaccine.
Controversies in this area revolve around the question of whether the risks of adverse events following immunization outweigh the benefits of preventing infectious disease. In rare cases immunizations can cause serious adverse effects, such as gelatin measles-mumps-rubella vaccine (MMR) causing anaphylaxis, a severe allergic reaction. Allegations particularly focus on disorders claimed to be caused by the MMR vaccine and thiomersal, a preservative used in vaccines routinely given to U.S. infants prior to 2001. Current scientific evidence does not support claims of vaccines causing various disorders.
The debate is complicated by misconceptions around the recording and reporting of adverse events by anti-vaccination activists. According to authorities, anti-vaccination websites greatly exaggerate the risk of serious adverse effects from vaccines and falsely describe conditions such as autism and shaken baby syndrome as vaccine injuries, leading to misconceptions about the safety and effectiveness of vaccines. This has had the result of stigmatizing autistic people and the parents who had them immunized.