An Analysis of SARS-CoV-2 Vaccine Reactogenicity: Variation by Type, Dose, and History, Severity, and Recency of Prior SARS-CoV-2 Infection

Ann I Scher; Catherine M Berjohn; Celia Byrne; Rhonda E Colombo; Christopher J Colombo; Margaret Sanchez Edwards; Evan C Ewers; Anuradha Ganesan; Milissa Jones; Derek T Larson; Daniel Libraty; David A Lindholm; Cristian S Madar; Carlos J Maldonado; Ryan C Maves; Katrin Mende; Stephanie A Richard; Julia S Rozman; Jennifer Rusiecki; Alfred Smith; Mark Simons; David Tribble; Brian Agan; Timothy H Burgess; Simon D Pollett; EPICC COVID-19 Cohort Study Group

doi:10.1093/ofid/ofac314

An Analysis of SARS-CoV-2 Vaccine Reactogenicity: Variation by Type, Dose, and History, Severity, and Recency of Prior SARS-CoV-2 Infection

Open Forum Infect Dis. 2022 Jun 28;9(7):ofac314. doi: 10.1093/ofid/ofac314. eCollection 2022 Jul.

Authors

Ann I Scher¹, Catherine M Berjohn^{2

3}, Celia Byrne¹, Rhonda E Colombo^{3

4

5

6}, Christopher J Colombo^{3

6}, Margaret Sanchez Edwards^{4

5}, Evan C Ewers⁷, Anuradha Ganesan^{4

5

8}, Milissa Jones⁹, Derek T Larson^{2

3

7}, Daniel Libraty^{2

4

5}, David A Lindholm^{3

10}, Cristian S Madar⁸, Carlos J Maldonado¹¹, Ryan C Maves^{2

3}, Katrin Mende^{4

5

10}, Stephanie A Richard^{4

5}, Julia S Rozman^{4

5}, Jennifer Rusiecki¹, Alfred Smith¹², Mark Simons⁴, David Tribble⁴, Brian Agan^{4

5}, Timothy H Burgess⁴, Simon D Pollett^{4

5}; EPICC COVID-19 Cohort Study Group

Collaborators

EPICC COVID-19 Cohort Study Group:
S Merritt, T Merritt, Joint Base Lewis McChord, S Chambers, Col P Faestel, Col C Mount, M Stein, C Uyehara, C Broder, Col Ret K Chung, N Epsi, Col P Hickey, Ltc J Livezey, E Parmelee, E Samuels, M Wayman, TSgt T Chao, K Lanter, J Meyer, K Reynolds, C Starr, Capt J Iskander, Cdr I Kamara, Ltc D Hostler, Maj N Huprikar

Affiliations

¹ Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
² Naval Medical Center San Diego, San Diego, California, USA.
³ Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
⁴ Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
⁵ Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA.
⁶ Madigan Army Medical Center, Joint Base Lewis McChord, Washington, USA.
⁷ Fort Belvoir Community Hospital, Fort Belvoir, Virginia, USA.
⁸ Walter Reed National Military Medical Center, Bethesda, Maryland, USA.
⁹ Tripler Army Medical Center, Honolulu, Hawaii, USA.
¹⁰ Brooke Army Medical Center, JBSA Ft Sam Houston, Texas, USA.
¹¹ Womack Army Medical Center, Fort Bragg, North Carolina, USA.
¹² Naval Medical Center Portsmouth, Portsmouth, Virginia, USA.

Abstract

Background: There is limited information on the functional consequences of coronavirus disease 2019 (COVID-19) vaccine side effects. To support patient counseling and public health messaging, we describe the risk and correlates of COVID-19 vaccine side effects sufficient to prevent work or usual activities and/or lead to medical care ("severe" side effects).

Methods: The EPICC study is a longitudinal cohort study of Military Healthcare System beneficiaries including active duty service members, dependents, and retirees. We studied 2789 adults who were vaccinated between December 2020 and December 2021.

Results: Severe side effects were most common with the Ad26.COV2.S (Janssen/Johnson and Johnson) vaccine, followed by mRNA-1273 (Moderna) then BNT162b2 (Pfizer/BioNTech). Severe side effects were more common after the second than first dose (11% vs 4%; P < .001). First (but not second) dose side effects were more common in those with vs without prior severe acute respiratory syndrome coronavirus 2 infection (9% vs 2%; adjusted odds ratio [aOR], 5.84; 95% CI, 3.8-9.1), particularly if the prior illness was severe or critical (13% vs 2%; aOR, 10.57; 95% CI, 5.5-20.1) or resulted in inpatient care (17% vs 2%; aOR, 19.3; 95% CI, 5.1-72.5). Side effects were more common in women than men but not otherwise related to demographic factors.

Conclusions: Vaccine side effects sufficient to prevent usual activities were more common after the second than first dose and varied by vaccine type. First dose side effects were more likely in those with a history of COVID-19-particularly if that prior illness was severe or associated with inpatient care. These findings may assist clinicians and patients by providing a real-world evaluation of the likelihood of experiencing impactful postvaccine symptoms.

Keywords: COVID-19; SARS-CoV-2; reactogenicity; side effects; vaccination.

Published by Oxford University Press on behalf of Infectious Diseases Society of America 2022.This work is written by (a) US Government employee(s) and is in the public domain in the US.

Grants and funding

Y01 AI005072/AI/NIAID NIH HHS/United States