The Johnson & Johnson vaccine has been linked to an increased risk of rare blood clots combined with low levels of blood platelets, especially in women ages 30 to 49. The CDC has also noted that most patients who were treated “responded well to medicine and rest and felt better quickly.” Early evidence suggests these myocarditis cases are less severe than typical ones. Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks.
The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults.īased on data collected through August 2021, the reporting rates of either condition in the U.S. Also, those who shouldn’t receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, according to the CDC. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. history.”Ī small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. As the Centers for Disease Control and Prevention has said, these vaccines “have undergone and will continue to undergo the most intensive safety monitoring in U.S.
The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain - or no side effects at all. and only a few, very rare, safety concerns have emerged. More than half a billion doses of COVID-19 vaccines have now been administered in the U.S. The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events.įor more, see “ How safe are the vaccines? ” In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks. to identify adverse events related to vaccination in near real time. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.Īnother monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”Īnyone can submit a report to VAERS for any health problem that occurs after an immunization. One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA.
#Pfizer adverse event free#
In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants.
No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects.
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