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Analysis of COVID-19 Vaccine Type and Adverse Effects Following 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 Citiz...

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Autores principales: Beatty, Alexis L., Peyser, Noah D., Butcher, Xochitl E., Cocohoba, Jennifer M., Lin, Feng, Olgin, Jeffrey E., Pletcher, Mark J., Marcus, Gregory M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8696570/
https://www.ncbi.nlm.nih.gov/pubmed/34935921
http://dx.doi.org/10.1001/jamanetworkopen.2021.40364
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author Beatty, Alexis L.
Peyser, Noah D.
Butcher, Xochitl E.
Cocohoba, Jennifer M.
Lin, Feng
Olgin, Jeffrey E.
Pletcher, Mark J.
Marcus, Gregory M.
author_facet Beatty, Alexis L.
Peyser, Noah D.
Butcher, Xochitl E.
Cocohoba, Jennifer M.
Lin, Feng
Olgin, Jeffrey E.
Pletcher, Mark J.
Marcus, Gregory M.
author_sort Beatty, Alexis L.
collection PubMed
description 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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spelling pubmed-86965702022-01-10 Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination Beatty, Alexis L. Peyser, Noah D. Butcher, Xochitl E. Cocohoba, Jennifer M. Lin, Feng Olgin, Jeffrey E. Pletcher, Mark J. Marcus, Gregory M. JAMA Netw Open Original Investigation 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. American Medical Association 2021-12-22 /pmc/articles/PMC8696570/ /pubmed/34935921 http://dx.doi.org/10.1001/jamanetworkopen.2021.40364 Text en Copyright 2021 Beatty AL et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Beatty, Alexis L.
Peyser, Noah D.
Butcher, Xochitl E.
Cocohoba, Jennifer M.
Lin, Feng
Olgin, Jeffrey E.
Pletcher, Mark J.
Marcus, Gregory M.
Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination
title Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination
title_full Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination
title_fullStr Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination
title_full_unstemmed Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination
title_short Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination
title_sort analysis of covid-19 vaccine type and adverse effects following vaccination
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8696570/
https://www.ncbi.nlm.nih.gov/pubmed/34935921
http://dx.doi.org/10.1001/jamanetworkopen.2021.40364
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