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. 2021 Dec 1;4(12):e2140364.
doi: 10.1001/jamanetworkopen.2021.40364.

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

Alexis L Beatty  1   2 , Noah D Peyser  2 , Xochitl E Butcher  2 , Jennifer M Cocohoba  3 , Feng Lin  1 , Jeffrey E Olgin  2 , Mark J Pletcher  1 , Gregory M Marcus  2
Affiliations

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

Alexis L Beatty et al. JAMA Netw Open. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Beatty reported being formerly employed by and holding stock in Apple, Inc, outside the submitted work. Dr Olgin reported receiving personal fees from Vivalnk and grants from Samsung outside the submitted work. Dr Pletcher reported receiving grants from the Patient-Centered Outcomes Research Institute, the National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Adverse Effects by Participant Characteristics
Participants could report more than 1 adverse effect. Denominators include all participants who provided an answer to the question.
Figure 2.
Figure 2.. Adverse Effects by Vaccine Brand
Participants could report more than 1 adverse effect. Denominators include all participants who provided an answer to the question.
See this image and copyright information in PMC

References

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