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. 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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