Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia

<i>Background</i>: Individuals with underlying chronic illnesses have demonstrated considerable hesitancy towards COVID-19 vaccines. These concerns are primarily attributed to their concerns over the safety profile. Real-world data on the safety profile among COVID-19 vaccinees with como...

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Main Authors: Tauqeer Hussain Mallhi, Yusra Habib Khan, Muhammad Hammad Butt, Muhammad Salman, Nida Tanveer, Nasser Hadal Alotaibi, Abdulaziz Ibrahim Alzarea, Abdullah Salah Alanazi
Format: Article
Language:English
Published: MDPI AG 2022-12-01
Series:Medicina
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Online Access:https://www.mdpi.com/1648-9144/58/12/1799
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author Tauqeer Hussain Mallhi
Yusra Habib Khan
Muhammad Hammad Butt
Muhammad Salman
Nida Tanveer
Nasser Hadal Alotaibi
Abdulaziz Ibrahim Alzarea
Abdullah Salah Alanazi
author_facet Tauqeer Hussain Mallhi
Yusra Habib Khan
Muhammad Hammad Butt
Muhammad Salman
Nida Tanveer
Nasser Hadal Alotaibi
Abdulaziz Ibrahim Alzarea
Abdullah Salah Alanazi
author_sort Tauqeer Hussain Mallhi
collection DOAJ
description <i>Background</i>: Individuals with underlying chronic illnesses have demonstrated considerable hesitancy towards COVID-19 vaccines. These concerns are primarily attributed to their concerns over the safety profile. Real-world data on the safety profile among COVID-19 vaccinees with comorbid conditions are scarce. This study aimed to ascertain the side-effects profile after two doses of COVID-19 vaccines among chronic-disease patients. <i>Methodology</i>: A cross-sectional questionnaire-based study was conducted among faculty members with comorbid conditions at a public educational institute in Saudi Arabia. A 20-item questionnaire recorded the demographics and side effects after the two doses of COVID-19 vaccines. The frequency of side effects was recorded following each dose of vaccine, and the association of the side-effects score with the demographics was ascertained through appropriate statistics. <i>Results</i>: A total of 204 patients with at least one comorbid condition were included in this study. A total of 24 side effects were reported after the first dose and 22 after second dose of the COVID-19 vaccine. The incidence of at least one side effect was 88.7% and 95.1% after the first and second doses of the vaccine, respectively. The frequent side effects after the first dose were pain at the injection site (63.2%), fatigue (58.8%), fever (47.5%), muscle and joint pain (38.7%), and headache (36.3%). However, pain at the injection site (71.1%), muscle and joint pain (62.7%), headache (49.5%), fever (45.6%), and stress (33.3%) were frequent after the second dose. The average side-effects score was 4.41 ± 4.18 (median: 3, IQR: 1, 6) and 4.79 ± 3.54 (median 4, IQR: 2, 6) after the first and second dose, respectively. Female gender, diabetes mellitus, hypertension, hyperlipidemia, comorbidity > 2, family history of COVID-19, and the AstraZeneca vaccine were significantly associated with higher side-effect scores. Only 35.8% of study participants were satisfied with the safety of COVID-19 vaccines. <i>Conclusions</i>: Our analysis showed a high proportion of transient and short-lived side effects of Pfizer and AstraZeneca vaccines among individuals with chronic illnesses. However, the side-effects profile was comparable with the safety reports of phase 3 clinical trials of these vaccines. The frequency of side effects was found to be associated with certain demographics, necessitating the need for further investigations to establish a causal relationship. The current study’s findings will help instill confidence in the COVID-19 vaccines among people living with chronic conditions, overcome vaccine hesitancy, and increase vaccine coverage in this population.
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spelling doaj.art-223a15f0bc624a72accfde6aadb1abc92023-11-24T16:32:57ZengMDPI AGMedicina1010-660X1648-91442022-12-015812179910.3390/medicina58121799Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi ArabiaTauqeer Hussain Mallhi0Yusra Habib Khan1Muhammad Hammad Butt2Muhammad Salman3Nida Tanveer4Nasser Hadal Alotaibi5Abdulaziz Ibrahim Alzarea6Abdullah Salah Alanazi7Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Medicinal Chemistry, Faculty of Pharmacy, Uppsala University, 75123 Uppsala, SwedenInstitute of Pharmacy, Faculty of Pharmaceutical and Allied Health Sciences, Lahore College for Women University, Lahore 54000, PakistanInstitute of Molecular Cardiology, University of Louisville, Louisville, KY 40202, USADepartment of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia<i>Background</i>: Individuals with underlying chronic illnesses have demonstrated considerable hesitancy towards COVID-19 vaccines. These concerns are primarily attributed to their concerns over the safety profile. Real-world data on the safety profile among COVID-19 vaccinees with comorbid conditions are scarce. This study aimed to ascertain the side-effects profile after two doses of COVID-19 vaccines among chronic-disease patients. <i>Methodology</i>: A cross-sectional questionnaire-based study was conducted among faculty members with comorbid conditions at a public educational institute in Saudi Arabia. A 20-item questionnaire recorded the demographics and side effects after the two doses of COVID-19 vaccines. The frequency of side effects was recorded following each dose of vaccine, and the association of the side-effects score with the demographics was ascertained through appropriate statistics. <i>Results</i>: A total of 204 patients with at least one comorbid condition were included in this study. A total of 24 side effects were reported after the first dose and 22 after second dose of the COVID-19 vaccine. The incidence of at least one side effect was 88.7% and 95.1% after the first and second doses of the vaccine, respectively. The frequent side effects after the first dose were pain at the injection site (63.2%), fatigue (58.8%), fever (47.5%), muscle and joint pain (38.7%), and headache (36.3%). However, pain at the injection site (71.1%), muscle and joint pain (62.7%), headache (49.5%), fever (45.6%), and stress (33.3%) were frequent after the second dose. The average side-effects score was 4.41 ± 4.18 (median: 3, IQR: 1, 6) and 4.79 ± 3.54 (median 4, IQR: 2, 6) after the first and second dose, respectively. Female gender, diabetes mellitus, hypertension, hyperlipidemia, comorbidity > 2, family history of COVID-19, and the AstraZeneca vaccine were significantly associated with higher side-effect scores. Only 35.8% of study participants were satisfied with the safety of COVID-19 vaccines. <i>Conclusions</i>: Our analysis showed a high proportion of transient and short-lived side effects of Pfizer and AstraZeneca vaccines among individuals with chronic illnesses. However, the side-effects profile was comparable with the safety reports of phase 3 clinical trials of these vaccines. The frequency of side effects was found to be associated with certain demographics, necessitating the need for further investigations to establish a causal relationship. The current study’s findings will help instill confidence in the COVID-19 vaccines among people living with chronic conditions, overcome vaccine hesitancy, and increase vaccine coverage in this population.https://www.mdpi.com/1648-9144/58/12/1799COVID-19side effectssafetyvaccine hesitancycomorbiditieshypertension
spellingShingle Tauqeer Hussain Mallhi
Yusra Habib Khan
Muhammad Hammad Butt
Muhammad Salman
Nida Tanveer
Nasser Hadal Alotaibi
Abdulaziz Ibrahim Alzarea
Abdullah Salah Alanazi
Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia
Medicina
COVID-19
side effects
safety
vaccine hesitancy
comorbidities
hypertension
title Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia
title_full Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia
title_fullStr Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia
title_full_unstemmed Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia
title_short Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia
title_sort surveillance of side effects after two doses of covid 19 vaccines among patients with comorbid conditions a sub cohort analysis from saudi arabia
topic COVID-19
side effects
safety
vaccine hesitancy
comorbidities
hypertension
url https://www.mdpi.com/1648-9144/58/12/1799
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