Healthcare workers across the nation are gevaccine. Pool/Getty ImagesTo date, safety data on the vaccine has been collected from 37,586 participants enrolled in an ongoing phase 3 clinical trial.The most commonly reported side effect from the vaccine is injection site reaction.Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain.
Earlier this month, the Food and Drug AdministrationTrusted Source issued its first emergency use authorization (EUA) for a vaccine against COVID-19 in people aged 16 years and older.Under this EUA, Pfizer-BioNTech’s new COVID-19 vaccine can now be distributed in the United States.The FDA issued this authorization after reviewing the available efficacy and safety data on the new vaccine. Based on evidence from ongoing clinical trials, the FDA found that the known and potential benefits of the vaccine outweigh the known and potential risks.The available data suggests that after two doses, the vaccine is 95 percent effective at preventing COVID-19. So far, research has also found that the vaccine has a good safety profile.“Based on the large number of folks that have been closely monitored during the study, the patient safety profile is excellent in terms of side effects,” Dr. Matthew Heinz, a hospitalist based in Tucson, Arizona, told Healthline.“Of course, we have to continue to monitor going forward. We need to continue to collect data to make sure it stays that way,” he said.
Pain around the injection siteThe Pfizer-BioNTech COVID-19 vaccine is administered in two doses, 3 weeks apart.To date, safety data on the vaccine has been collected from 37,586 participants enrolled in an ongoing phase 3 clinical trial.Among those participants, 18,801 have received the vaccine and 18,785 have received a placebo. They have been followed for a median of 2 months following vaccination.The most commonly reported side effect from the vaccine is injection site reaction. Such reactions can cause some pain and other symptoms around the area where the vaccine is injected.“You sometimes get some redness, some warmth, a little bit of mild swelling or firmness around the site of the injection. That’s very typical,” Heinz told Healthline.“It can be a little tender, it can hurt to move the arm a little bit,” he continued.Injection site reactions were reported by 84 percentTrusted Source of participants who received the vaccine.
