Odds

Environmental health

Population

Family medicine

Infectious disease (medical specialty)

Adverse effect

Disease

Coronavirus disease 2019 (COVID-19)

Vaccination

Logistic regression

Odds ratio

Cohort

Internal medicine

Immunology

Medicine

JAMA Network Open

<h3>Importance</h3> Little is known about the factors associated with COVID-19 vaccine adverse effects in a real-world population. <h3>Objective</h3> To evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. <h3>Design, Setting, and Participants</h3> 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. <h3>Exposures</h3> Participant-reported COVID-19 vaccination. <h3>Main Outcomes and Measures</h3> 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. <h3>Results</h3> 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 &amp; 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;<i>P</i> &lt; .001), vaccine brand (mRNA-1273 vs BNT162b2, OR, 2.00; 95% CI, 1.86-2.15;<i>P</i> &lt; .001; JNJ-78436735 vs BNT162b2: OR, 0.64; 95% CI, 0.52-0.79;<i>P</i> &lt; .001), age (per 10 years: OR, 0.74; 95% CI, 0.72-0.76;<i>P</i> &lt; .001), female sex (OR, 1.65; 95% CI, 1.53-1.78;<i>P</i> &lt; .001), and having had COVID-19 before vaccination (OR, 2.17; 95% CI, 1.77-2.66;<i>P</i> &lt; .001). <h3>Conclusions and Relevance</h3> 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.

Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination