Health
Headache, malaise, pain is normal
Americans may experience at least one side effect from the COVID-19 vaccine, but doctors say it is normal and you should still be vaccinated.
In Moderna’s Phase 3 trial The company said The most common side effects were malaise, muscle and pain, arthralgia, headache, pain at the injection site, redness or swelling.
More than half of Moderna’s study participants had side effects from the vaccine in Phase 1 trials. According to a preliminary report published in July in the New England Journal of Medicine.
Pfizer / BioNTech Phase 3 TrialThe probabilities of fatigue and headache were 3.8% and 2%, respectively.
Experts say the U.S. Food and Drug Administration has completed a review of Phase 3 study data for both vaccines and released that information to the public for more information on who is likely to experience what side effects. I will. The earliest time this can happen is December 10.
Doctors emphasize that these side effects are not only normal, but also a sign that the body is responding properly to the vaccine.
Dr. Melanie Swift, an occupational medicine physician helping to lead the COVID-19 vaccination program at the Mayo Clinic, said it was important to educate Americans about the side effects of the vaccine.
“Just because you hurt doesn’t mean that (the vaccine) didn’t work or didn’t work, which means that your body responded as expected,” she said. “It’s important to take both doses. Otherwise, the first doses were all free.”
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Side effects are not adverse events
Companies and institutions tend to exchange the terms “side effects” and “adverse effects,” but experts warn that “adverse events” are a very different experience.
Side effects are common and do not disrupt daily life. Adverse events are the more unexpected effects of drugs. Dr. Renholovitz, a pulmonary specialist at Lenox Hill Hospital, said some adverse events from other vaccines reported over the decades included rare neurological events or vaccine-induced immunopotentiation. ..
However, while about 10% to 15% of patients vaccinated against the flu experience side effects, Swift said adverse events are more likely to occur in less than 0.1% of patients.
“Adverse events are rare … side effects are common, self-limited and benign,” Horowitz said. He added that most side effects can be treated with Tylenol.
For example, if you exercise in the gym and leave it in pain, Swift says it is a common and expected side effect. But if you leave the gym and have pink eyes, it’s a reportable adverse event. And if enough people have pink eyes, there is a problem with the gym.
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According to medical experts, if someone reacts badly to the vaccine, it can occur in the first 6 weeks after vaccination. However, experts are still unaware of the long-term effects of the COVID-19 vaccine, until the trial is complete and researchers monitor real-world participants years later.
Both Pfizer and Moderna’s Pharmaceutical and Safety Oversight Commissions have reported no significant safety concerns for the vaccine. According to Swift, the board is likely to have canceled the trial in the event of an adverse event.
This happened to Johnson & Johnson in October, when a large COVID-19 vaccine trial was suspended after a volunteer unexplained illness. Another study conducted by AstraZeneca was discontinued on September 8 after a UK participant was diagnosed with a neurological condition that appeared to be transverse myelitis.
Both trials resumed after regulators found no evidence that the vaccine had made volunteers sick.
“There are very high standards for safety and adverse events,” Swift said, and if adverse events were reported during the trial, Moderna and Pfizer may not have been able to submit the vaccine for FDA approval. I added that it was expensive.
CDC adds an additional layer of safety monitoring for the COVID-19 vaccine
The US Centers for Disease Control and Prevention has a number of national surveillance systems for tracking reportable adverse events from vaccines. However, authorities have added another layer of safety monitoring for the COVID-19 vaccine: V-SAFE.
This is a new smartphone-based post-vaccination health checker for mandatory workers vaccinated with COVID-19 vaccine. For registrants, the program uses text messages and web surveys to check in people about post-vaccination health issues.
CDC said We plan to enroll up to 20 million people in the first few months of the program. Text messages and emails will be sent daily for the first week after vaccination and weekly for the next 6 weeks.
Authorities will not only ask about side effects and possible adverse events, but also about COVID-19 infection to better understand efficacy and how long vaccine protection will last.
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY was partially made possible by grants from the Masimo Foundation for Ethics, Innovation and Competition for Healthcare. The Masimo Foundation does not provide editorial input.
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