14 CCS is hosted on the Eureka Research Platform (University of California, San Francisco), a digital platform for clinical research studies including a mobile application (app) and web-based software. The COVID-19 Citizen Science (CCS) study is an online cohort study that began enrolling participants on March 26, 2020. These results may help the public gain a greater understanding of the real-world experience of adverse effects after COVID-19 vaccination. In addition, the study sought to identify factors associated with more severe adverse effects. The objectives of this study were to describe adverse effects and identify factors associated with adverse effects after COVID-19 vaccination in participants in an online cohort study. 5, 6, 8 Although data have begun to emerge on adverse effects reported through government-sponsored reporting systems, 9 - 13 there is little real-world, patient-reported data on adverse effects after receiving COVID-19 vaccination and in whom adverse effects may be more common. 5 - 8 Most adverse effects were mild, but studies reported approximately 50% to 90% of participants experiencing some adverse effects. In randomized clinical trials of COVID-19 vaccines, reported adverse effects included injection site events (eg, pain, redness, swelling) and systemic effects (eg, fatigue, headache, muscle or joint pain), with rare serious adverse events. 3 However, some individuals have concerns about receiving COVID-19 vaccination related to vaccine safety and adverse effects. 1, 2 Billions of doses of vaccine have been administered worldwide. In December 2020, the first COVID-19 vaccines received emergency use authorization in the United States.
Large digital cohort studies may provide a mechanism for independent postmarket surveillance of drugs and devices.
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The strongest factors associated with adverse effects were vaccine dose (2 doses of BNT162b2 or mRNA-1273 or 1 dose of JNJ-78436735 vs 1 dose of BNT162b2 or mRNA-1273 odds ratio, 3.10 95% CI, 2.89-3.34 P < .001), vaccine brand (mRNA-1273 vs BNT162b2, OR, 2.00 95% CI, 1.86-2.15 P < .001 JNJ-78436735 vs BNT162b2: OR, 0.64 95% CI, 0.52-0.79 P < .001), age (per 10 years: OR, 0.74 95% CI, 0.72-0.76 P < .001), female sex (OR, 1.65 95% CI, 1.53-1.78 P < .001), and having had COVID-19 before vaccination (OR, 2.17 95% CI, 1.77-2.66 P < .001).Ĭonclusions and Relevance In this real-world cohort, serious COVID-19 vaccine adverse effects were rare and comparisons across brands could be made, revealing that full vaccination dose, vaccine brand, younger age, female sex, and having had COVID-19 before vaccination were associated with greater odds of adverse effects. Allergic reaction or anaphylaxis was reported in 26 of 8680 participants (0.3%) after 1 dose of the BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna) vaccine, 27 of 11 141 (0.2%) after 2 doses of the BNT162b2 or mRNA-1273 vaccine or 1 dose of the JNJ-78436735 (Johnson & Johnson) vaccine. Results The 19 586 participants had a median (IQR) age of 54 (38-66) years, and 13 420 (68.8%) were women. Candidate factors in multivariable logistic regression models included age, sex, race, ethnicity, subjective social status, prior COVID-19 infection, medical conditions, substance use, vaccine dose, and vaccine brand. Main Outcomes and Measures Participant-reported adverse effects and adverse effect severity. This analysis includes participants who provided consent between March 26, 2020, and May 19, 2021, and received at least 1 COVID-19 vaccine dose.Įxposures Participant-reported COVID-19 vaccination. Participants complete daily, weekly, and monthly surveys on health and COVID-19–related events.
Objective To evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination.ĭesign, Setting, and Participants The COVID-19 Citizen Science Study, an online cohort study, includes adults aged 18 years and older with a smartphone or internet access.
Importance Little is known about the factors associated with COVID-19 vaccine adverse effects in a real-world population.
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