Key Points Question What factors are associated with adverse effects after COVID-19 vaccination? Findings In an online cohort study including 19 586 adults who received a COVID-19 vaccination, the factors most strongly associated with adverse effects were full vaccination dose, brand of vaccine, younger age, female sex, and having had COVID-19 before vaccination. Allergic reaction or anaphylaxis was reported in 0.3% of participants after partial vaccination and 0.2% of participants after full vaccination. Meaning These findings suggest that some individuals experience more adverse effects after COVID-19 vaccination, but serious adverse effects are rare. This cohort study evaluates factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. Importance Little is known about the factors associated with COVID-19 vaccine adverse effects in a real-world population. Objective To evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. Design, 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. Participants complete daily, weekly, and monthly surveys on health and COVID-19–related events. This analysis includes participants who provided consent between March 26, 2020, and May 19, 2021, and received at least 1 COVID-19 vaccine dose. Exposures Participant-reported COVID-19 vaccination. Main Outcomes and Measures Participant-reported adverse effects and adverse effect severity. 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. Results The 19 586 participants had a median (IQR) age of 54 (38-66) years, and 13 420 (68.8%) were women. 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. 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 [OR], 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). Conclusions 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. Large digital cohort studies may provide a mechanism for independent postmarket surveillance of drugs and devices.
【초록키워드】 COVID-19, Vaccine, COVID-19 vaccine, vaccination, mRNA-1273, severity, Sex, Substance use, drug, cohort study, vaccine dose, BNT162b2, adverse effects, Cohort, Health, COVID-19 vaccination, Surveillance, COVID-19 infection, comparison, female, age, women, mechanism, Moderna, Pfizer/BioNTech, anaphylaxis, Analysis, dose, exposure, Odds ratio, Medical conditions, allergic reaction, Science, adverse effect, mRNA-1273 vaccine, Older, Factor, 95% CI, individual, multivariable logistic regression, measure, candidate, participant, serious COVID-19, finding, Johnson & Johnson, JNJ-78436735, Complete, objective, setting, independent, Result, greater, evaluate, include, reported, events, provided, median, Importance, IQR, of BNT162b2, Point, Relevance, with COVID-19, 【제목키워드】 COVID-19, Adverse, Effect, Type,