Symptomology following mRNA vaccination against SARS-CoV-2

Joseph E Ebinger¹, Roy Lan², Nancy Sun¹, Min Wu¹, Sandy Joung¹, Gregory J Botwin³, Patrick Botting¹, Daniah Al-Amili⁴, Harriet Aronow⁵, James Beekley⁶, Bernice Coleman⁵, Sandra Contreras⁶, Wendy Cozen⁷, Jennifer Davis³, Philip Debbas³, Jacqueline Diaz¹, Matthew Driver¹, Justyna Fert-Bober⁸, Quanquan Gu⁹, Mallory Heath¹, Ergueen Herrera⁶, Amy Hoang¹, Shehnaz K Hussain⁶, Carissa Huynh¹⁰, Linda Kim⁵, Michelle Kittleson¹, Yunxian Liu¹, John Lloyd¹, Eric Luong¹, Bhavya Malladi¹, Akil Merchant¹¹, Noah Merin¹², Angela Mujukian³, Nathalie Nguyen⁶, Trevor-Trung Nguyen¹, Valeriya Pozdnyakova³, Mohamad Rashid¹, Koen Raedschelders¹³, Karen L Reckamp⁶, Kylie Rhoades¹, Sarah Sternbach¹, Rocío Vallejo¹, Shane White³, Rose Tompkins¹, Melissa Wong¹⁴, Moshe Arditi¹⁵, Jane C Figueiredo⁶, Jennifer E Van Eyk⁸, Peggy B Miles¹⁶, Cynthia Chavira¹¹, Rita Shane¹⁷, Kimia Sobhani¹⁸, Gil Y Melmed³, Dermot P B McGovern³, Jonathan G Braun¹⁹, Susan Cheng²⁰, Margo B Minissian²¹

Affiliations

¹ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
² College of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
³ F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars Sinai, USA.
⁴ Biomedical Imaging Research Institute, Cedars-Sinai Medical Centre, Los Angeles, CA, USA.
⁵ Brawerman Nursing Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁶ Department of Medicine, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁷ Division of Hematology/Oncology, Department of Medicine, School of Medicine at UCI, Irvine, CA, USA; Department of Pathology, School of Medicine at UCI, Irvine, CA, USA; Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA.
⁸ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Advanced Clinical Biosystems Institute, Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁹ Department of Computer Science, University of California, Los Angeles, CA, USA.
¹⁰ Biobank & Translational Research Core Laboratory, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹¹ Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹² Department of Internal Medicine, Division of Hematology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹³ Advanced Clinical Biosystems Institute, Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁴ Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁵ Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Departments of Pediatrics, Division of Infectious Diseases and Immunology, and Infectious, Immunologic Diseases Research Center (IIDRC), Los Angeles, CA, USA; Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁶ Employee Health Services, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁷ Department of Pharmacy, Cedar-Sinai Medical Center, Los Angeles, CA, USA.
¹⁸ Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁹ F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars Sinai, USA; Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.. Electronic address: jonathan.braun2@cshs.org.
²⁰ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: biodatacore@cshs.org.
²¹ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Brawerman Nursing Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: minissianm@cshs.org.

PMID: 34687733
PMCID: PMC8527734
DOI: 10.1016/j.ypmed.2021.106860

Observational Study

Symptomology following mRNA vaccination against SARS-CoV-2

Joseph E Ebinger et al. Prev Med. 2021 Dec.

. 2021 Dec:153:106860.

doi: 10.1016/j.ypmed.2021.106860. Epub 2021 Oct 20.

Authors

Affiliations

¹ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
² College of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
³ F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars Sinai, USA.
⁴ Biomedical Imaging Research Institute, Cedars-Sinai Medical Centre, Los Angeles, CA, USA.
⁵ Brawerman Nursing Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁶ Department of Medicine, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁷ Division of Hematology/Oncology, Department of Medicine, School of Medicine at UCI, Irvine, CA, USA; Department of Pathology, School of Medicine at UCI, Irvine, CA, USA; Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA.
⁸ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Advanced Clinical Biosystems Institute, Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁹ Department of Computer Science, University of California, Los Angeles, CA, USA.
¹⁰ Biobank & Translational Research Core Laboratory, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹¹ Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹² Department of Internal Medicine, Division of Hematology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹³ Advanced Clinical Biosystems Institute, Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁴ Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁵ Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Departments of Pediatrics, Division of Infectious Diseases and Immunology, and Infectious, Immunologic Diseases Research Center (IIDRC), Los Angeles, CA, USA; Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁶ Employee Health Services, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁷ Department of Pharmacy, Cedar-Sinai Medical Center, Los Angeles, CA, USA.
¹⁸ Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁹ F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars Sinai, USA; Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.. Electronic address: jonathan.braun2@cshs.org.
²⁰ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: biodatacore@cshs.org.
²¹ Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Brawerman Nursing Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: minissianm@cshs.org.

PMID: 34687733
PMCID: PMC8527734
DOI: 10.1016/j.ypmed.2021.106860

Abstract

Despite demonstrated efficacy of vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causative agent of coronavirus disease-2019 (COVID-19), widespread hesitancy to vaccination persists. Improved knowledge regarding frequency, severity, and duration of vaccine-associated symptoms may help reduce hesitancy. In this prospective observational study, we studied 1032 healthcare workers who received both doses of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine and completed post-vaccine symptom surveys both after dose 1 and after dose 2. We defined appreciable post-vaccine symptoms as those of at least moderate severity and lasting at least 2 days. We found that symptoms were more frequent following the second vaccine dose than the first (74% vs. 60%, P < 0.001), with >80% of all symptoms resolving within 2 days. The most common symptom was injection site pain, followed by fatigue and malaise. Overall, 20% of participants experienced appreciable symptoms after dose 1 and 30% after dose 2. In multivariable analyses, female sex was associated with greater odds of appreciable symptoms after both dose 1 (OR, 95% CI 1.73, 1.19-2.51) and dose 2 (1.76, 1.28-2.42). Prior COVID-19 was also associated with appreciable symptoms following dose 1, while younger age and history of hypertension were associated with appreciable symptoms after dose 2. We conclude that most post-vaccine symptoms are reportedly mild and last <2 days. Appreciable post-vaccine symptoms are associated with female sex, prior COVID-19, younger age, and hypertension. This information can aid clinicians in advising patients on the safety and expected symptomatology associated with vaccination.

Keywords: SARS-CoV-2; Vaccination; Vaccine-associated symptoms.

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Figures

**Fig. 1**
Post-vaccine symptoms frequency, type, severity, and duration by age, sex and prior COVID-19 infection status.

**Fig. 2**
Multivariable-adjusted correlates of appreciable post-vaccine symptoms following dose 1 (Panel A) and dose 2 (Panel B) of an mRNA SARS-CoV-2 vaccine. Appreciable symptoms are defined as any self-reported symptoms of at least moderate severity and lasting at least 2 days in duration. Multivariable-adjusted models included all covariates with P < 0.10 in the age- and sex-adjusted models.

See this image and copyright information in PMC

References

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Symptomology following mRNA vaccination against SARS-CoV-2

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Symptomology following mRNA vaccination against SARS-CoV-2

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