Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile
Abstract
:1. Introduction
2. Methodology
2.1. Ethics Statement
2.2. Study Design and Location
2.3. Study Population
2.4. Validation and Reliability of Study Instrument
2.5. Components of Study Instrument
2.6. Data Collection
2.7. Sample Size
2.8. Statistical Analysis
3. Results
3.1. Demographic Profile
3.2. Side Effects Profile
3.3. Association of Side Effects among Types of Vaccine
3.4. Association of Individual Side Effects across Demographics
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variables | Frequency (N) | Percentage (%) |
---|---|---|
Age | ||
18–35 years | 177 | 44.5% |
36–50 years | 177 | 44.5% |
>50 years | 44 | 11.0% |
Gender | ||
Male | 235 | 59.0% |
Female | 163 | 41.0% |
Geographic location | ||
Central Region | 197 | 49.5% |
Northern Region | 122 | 30.7% |
Eastern Region | 21 | 5.3% |
Southern Region | 6 | 1.5% |
Western Region | 52 | 13.1% |
Occupation | ||
Students | 46 | 11.6% |
Private sector employees | 51 | 12.8% |
Government sector employees | 230 | 57.8% |
Retired | 27 | 6.8% |
Own Business | 44 | 11.0% |
Occupational field | ||
Medical | 157 | 39.4% |
Non-medical | 241 | 60.6% |
Average monthly income | ||
<5 thousand SAR | 108 | 27.1% |
5–15 thousand SAR | 141 | 35.4% |
15–20 thousand SAR | 71 | 17.8% |
>20 thousand SAR | 78 | 19.6% |
Marital status | ||
Married | 276 | 69.3% |
Single | 107 | 26.9% |
Divorced | 15 | 3.8% |
Nationality | ||
Saudi | 382 | 96.0% |
Non-Saudi | 16 | 4.0% |
Highest Certificate Obtained | ||
High school | 48 | 12.1% |
Bachelor’s degree | 222 | 55.8% |
Masters | 38 | 9.5% |
Ph.D. | 60 | 15.1% |
Post-secondary diploma | 30 | 7.5% |
Type of vaccine receive | ||
Pfizer | 224 | 56.3% |
AstraZeneca | 174 | 43.7% |
Second dose received | ||
Yes | 90 | 22.6% |
No | 308 | 77.4% |
Time recommended for 2nd dose | ||
3 weeks | 224 | 56.3% |
3 months | 174 | 43.7% |
Variables | N | Mean ± S.D. | p-Value |
---|---|---|---|
Age | 0.181 | ||
18–35 years | 177 | 3.59 ± 2.13 | |
36–50 years | 177 | 3.19 ± 2.21 | |
51–65 years | 44 | 3.14 ± 2.28 | |
Gender | <0.001 | ||
Male | 235 | 2.89 ± 1.95 | |
Female | 163 | 4.04 ± 2.33 | |
Geographic location | 0.390 | ||
Central | 197 | 3.15 ± 2.24, | |
Northern | 122 | 3.57 ± 2.26 | |
Eastern | 21 | 3.33 ± 1.77 | |
Southern | 6 | 3.83 ± 1.6 | |
Western | 52 | 3.63 ± 2 | |
Occupation | <0.001 | ||
Student | 46 | 3.35 ± 1.98 | |
Private sector employee | 51 | 3.92 ± 2.28 | |
Government sector employee | 230 | 3.2 ± 2.08 | |
Retired | 27 | 2.19 ± 1.88 | |
Own Business | 44 | 4.32 ± 2.57 | |
Occupational field | 0.205 | ||
Medical | 157 | 3.22 ± 2.06 | |
Non-medical | 241 | 3.46 ± 2.27 | |
Average monthly income | 0.062 | ||
<5 thousand SAR | 108 | 3.7 ± 2.31 | |
5–15 thousand SAR | 141 | 3.45 ± 2.09 | |
15–20 thousand SAR | 71 | 2.85 ± 1.93, | |
>20 thousand SAR | 78 | 3.19 ± 2.35, | |
Marital Status | 0.006 | ||
Married | 276 | 3.17 ± 2.12 | |
Single | 107 | 3.67 ± 2.21 | |
Divorced | 15 | 4.73 ± 2.71 | |
Nationality | 0.009 | ||
Saudi | 382 | 3.3 ± 2.18 | |
Non-Saudi | 16 | 4.75 ± 1.95 | |
Highest Certificate Obtained | 0.718 | ||
High school | 48 | 3.35 ± 2.06 | |
Bachelor’s degree | 222 | 3.37 ± 2.23 | |
Masters | 38 | 2.92 ± 2.12 | |
Ph.D. | 60 | 3.57 ± 2.36 | |
Post-secondary diploma | 30 | 3.43 ± 1.85 | |
Type of vaccine receive | <0.001 | ||
Pfizer | 224 | 2.74 ± 2.07 | |
AstraZeneca | 174 | 4.16 ± 2.08 |
Side Effect | Total (398) | Pfizer (N = 224) | AstraZeneca (N = 174) | p-Value | R2 |
---|---|---|---|---|---|
N (%) | N (%) | N (%) | |||
Pain at the injection site | 339 (85.2%) | 203 (90.6%) | 136 (78.20%) | 0.001 | 0.030 |
Redness at the injection site | 73(18.3%) | 34 (15.2%) | 39 (22.40%) | 0.064 | 0.009 |
Swelling at the injection site | 106 (26.7%) | 64 (28.6%) | 42 (24.10%) | 0.321 | 0.002 |
Fever | 169 (42.5%) | 51 (22.8%) | 118 (67.80%) | <0.001 | 0.204 |
Bone or joint pain | 215 (38.4%) | 86 (38.4%) | 129 (74.10%) | <0.001 | 0.127 |
Fatigue | 246 (54.0%) | 100 (44.6%) | 146 (83.90%) | <0.001 | 0.161 |
Loss of appetite | 67 (16.8%) | 25 (11.2%) | 42 (24.10%) | 0.001 | 0.030 |
Headache | 43 (10.8%) | 16 (7.1%) | 27 (15.50%) | 0.008 | 0.018 |
Sexual disturbance | 11 (2.8%) | 10 (4.5%) | 1 (0.60%) | 0.019 | 0.014 |
Drowsiness | 14 (3.5%) | 4 (1.8%) | 10 (5.70%) | 0.033 | 0.011 |
Nausea | 13 (3.3%) | 7 (3.1%) | 6 (3.40%) | 0.857 | 0.000 |
Shortness of breath | 6 (1.5%) | 3 (1.3%) | 3 (1.70%) | 0.775 | 0.000 |
Diarrhea | 4 (1.0%) | 2 (0.9%) | 2 (1.10%) | 1.000 | 0.000 |
Chills | 4 (1.0%) | 2 (0.9%) | 2 (1.10%) | 1.000 | 0.000 |
Insomnia | 3 (0.8%) | 2 (0.9%) | 1 (0.60%) | 1.000 | 0.000 |
Tightness in the hand | 5 (1.3%) | 1 (0.4%) | 4 (2.30%) | 0.173 | 0.007 |
Numbness | 4 (1.0%) | 2 (0.9%) | 2 (1.10%) | 1.000 | 0.000 |
Psychological | 3 (0.8%) | 1 (0.4%) | 2 (1.10%) | 0.583 | 0.002 |
Taste | 2 (0.5%) | 0 (0.0%) | 2 (1.10%) | 0.191 | 0.007 |
Heaviness | 2 (0.5%) | 0 (0.0%) | 2 (1.10%) | 0.191 | 0.007 |
Sleep disturbance | 3 (0.8%) | 0 (0.0%) | 3 (1.70%) | 0.083 | 0.010 |
Fainting | 1 (0.3%) | 0 (0.0%) | 1 (0.60%) | 0.437 | 0.003 |
Blurred vision | 1 (0.3%) | 0 (0.0%) | 1 (0.60%) | 0.437 | 0.003 |
Rapid heart rate | 1 (0.3%) | 1 (0.4%) | 0 (0.00%) | 1.000 | 0.002 |
Osteomalacia | 1 (0.3%) | 0 (0.0%) | 1 (0.60%) | 0.437 | 0.003 |
Thinking | 1 (0.3%) | 0 (0.0%) | 1 (0.60%) | 0.437 | 0.003 |
Inability to concentrate | 1 (0.3%) | 0 (0.0%) | 1 (0.60%) | 0.437 | 0.003 |
Variables | Pain | Fatigue | Joint Pain | Fever | Redness | Swelling | Loss of Appetite | Headache | Drowsiness | Nausea | Sexual Disturbance | Shortness of Breath |
---|---|---|---|---|---|---|---|---|---|---|---|---|
N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
Gender | ||||||||||||
Male | 191 (56.3%) | 132 (53.7%) | 114 (53%) | 87 (51.5%) | 31 (42.5%) | 49 (46.2%) | 19 (28.4%) | 16 (37.2%) | 6 (42.9%) | 6 (46.1%) | 11 (100%) | 1 (16.6%) |
Female | 148 (43.7%) | 114 (46.3%) | 101 (47%) | 82 (48.5%) | 42 (57.5%) | 57 (53.8%) | 48 (71.6%) | 27 (62.8%) | 8 (57.1%) | 7 (53.9%) | 0 (0%) | 5 (83.4%) |
p-value | 0.009 * | 0.005 * | 0.008 * | 0.008 * | 0.001 * | 0.002 * | <0.001 * | 0.002 * | 0.21 | 0.337 | 0.005 * | 0.033 * |
Geographic location | ||||||||||||
Central | 179 (52.8%) | 103 (41.9%) | 94 (43.7%) | 65 (38.5%) | 35 (47.9%) | 46 (43.4%) | 36 (53.7%) | 19 (44.2%) | 6 (42.9%) | 7 (53.9%) | 9 (81.8%) | 5 (83.3%) |
Northern | 91 (26.8%) | 84 (34.1%) | 72 (33.5%) | 65 (38.5%) | 29 (39.7%) | 40 (37.7%) | 22 (32.8%) | 11 (25.6%) | 4 (28.6%) | 4 (30.8%) | 2 (18.2%) | 0 (0%) |
Eastern | 18 (5.3%) | 17 (6.9%) | 12 (5.6%) | 10 (5.9%) | 2 (2.7%) | 4 (3.8%) | 1 (1.5%) | 2 (4.7%) | 2 (14.3%) | 0 (0%) | 0 (0%) | 0 (0%) |
Southern | 5 (1.5%) | 5 (2%) | 6 (2.8%) | 4 (2.4%) | 1 (1.4%) | 2 (1.9%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Western | 46 (13.6%) | 37 (15%) | 31 (14.4%) | 25 (14.8%) | 6 (8.2%) | 14 (13.2%) | 8 (11.9%) | 11 (25.6%) | 2 (14.3%) | 2 (15.4%) | 0 (0%) | 1 (16.7%) |
p-value | 0.003 * | 0.002 * | 0.037 * | 0.004 * | 0.272 | 0.378 | 0.42 | 0.125 | 0.624 | 0.907 | 0.267 | 0.441 |
Age | ||||||||||||
18–35 years | 155 (45.7%) | 124 (50.4%) | 104 (48.4%) | 87 (51.5%) | 36 (49.3%) | 46 (43.4%) | 35 (52.2%) | 17 (39.5%) | 7 (50%) | 4 (30.8%) | 3 (27.3%) | 2 (33.3%) |
36–50 years | 150 (44.2%) | 100 (40.7%) | 89 (41.4%) | 65 (38.5%) | 28 (38.4%) | 44 (41.5%) | 28 (41.8%) | 19 (44.2%) | 6 (42.9%) | 8 (61.6%) | 8 (72.7%) | 4 (66.7%) |
51–65 years | 34 (10%) | 22 (8.9%) | 22 (10.2%) | 17 (10.1%) | 10 (13.7%) | 16 (11.1%) | 4 (6%) | 7 (16.3%) | 1 (7.1%) | 1 (7.7%) | 1 (9.1%) | 0 (0%) |
p-value | <0.001 * | <0.001 * | 0.038 * | 0.008 * | 0.622 | 0.151 | 0.298 | 0.259 | 0.928 | 0.627 | 0.258 | 0.678 |
Occupation | ||||||||||||
Student | 39 (11.5%) | 30 (12.2%) | 25 (11.6%) | 22 (13%) | 5 (6.8%) | 9 (8.5%) | 11 (16.4%) | 6 (14%) | 2 (14.3%) | 0 (0%) | 0 (0%) | 1 (16.7%) |
Private sector employees | 43 (12.7%) | 38 (15.4%) | 37 (17.2%) | 25 (14.8%) | 11 (15.1%) | 15 (14.2%) | 10 (14.9%) | 7 (16.3%) | 2 (14.3%) | 4 (30.8%) | 0 (0%) | 1 (16.7%) |
Government sector employees | 199 (58.7%) | 135 (54.9%) | 114 (53%) | 92 (54.4%) | 39 (53.4%) | 59 (55.7%) | 31 (46.3%) | 22 (51.2%) | 6 (42.9%) | 7 (53.9%) | 11 (100%) | 4 (66.7%) |
Retired | 17 (5%) | 9 (3.7%) | 12 (5.6%) | 5 (3%) | 2 (2.7%) | 6 (5.7%) | 1 (1.5%) | 3 (7%) | 1 (7.1%) | 0 (0%) | 0 (0%) | 0 (0%) |
Own Business | 41 (12.1%) | 34 (13.8%) | 27 (12.6%) | 25 (14.8%) | 16 (21.9%) | 17 (16%) | 14 (20.9%) | 5 (11.6%) | 3 (21.4%) | 2 (15.4%) | 0 (0%) | 0 (0%) |
p-value | 0.001 * | 0.001 * | 0.028 * | 0.017 * | 0.007 * | 0.287 | 0.007 * | 0.898 | 0.719 | 0.191 | 0.082 | 0.848 |
Profession | ||||||||||||
Medical | 141 (41.6%) | 94 (38.2%) | 79 (36.7%) | 57 (33.7%) | 23 (31.5%) | 39 (36.8%) | 23 (34.3%) | 16 (37.2%) | 4 (28.6%) | 7 (53.9%) | 3 (27.3%) | 2 (33.3%) |
non-medical | 198 (58.4%) | 152 (61.8%) | 136 (63.3%) | 112 (66.3%) | 50 (68.5%) | 67 (63.2%) | 44 (65.7%) | 27 (62.8%) | 10 (71.4%) | 6 (46.2%) | 8 (72.7%) | 4 (66.7%) |
p-value | 0.036 * | 0.521 | 0.232 | 0.045 * | 0.125 | 0.514 | 0.347 | 0.751 | 0.397 | 0.28 | 0.402 | 0.758 |
Monthly income | ||||||||||||
<5000 SAR | 93 (27.4%) | 75 (30.5%) | 65 (30.2%) | 51 (30.2%) | 25 (34.2%) | 29 (27.4%) | 28 (41.8%) | 12 (27.9%) | 5 (35.7%) | 4 (30.8%) | 0 (0%) | 4 (66.7%) |
5000–15,000 SAR | 120 (35.4%) | 88 (35.8%) | 82 (38.1%) | 69 (40.8%) | 24 (32.9%) | 35 (33%) | 25 (37.3%) | 19 (44.2%) | 6 (42.9%) | 2 (15.4%) | 3 (27.3%) | 1 (16.7%) |
15,000–20,000 SAR | 57 (16.8%) | 41 (16.7%) | 36 (16.7%) | 25 (14.8%) | 10 (13.7%) | 15 (14.2%) | 6 (9%) | 6 (14%) | 1 (7.1%) | 3 (23.1%) | 0 (0%) | 0 (0%) |
>20,000 SAR | 69 (20.4%) | 42 (17.1%) | 32 (14.9%) | 24 (14.2%) | 14 (19.2%) | 27 (25.5%) | 8 (11.9%) | 6 (14%) | 2 (14.3%) | 4 (30.8%) | 8 (72.7%) | 1 (16.7%) |
p-value | 0.554 | 0.152 | 0.041 * | 0.025 * | 0.441 | 0.274 | 0.006 * | 0.523 | 0.624 | 0.449 | <0.001 * | 0.156 |
Marital status | ||||||||||||
Married | 233 (68.7%) | 159 (64.6%) | 142 (66%) | 105 (62.1%) | 45 (61.6%) | 72 (67.9%) | 36 (53.7%) | 27 (62.8%) | 9 (64.3%) | 9 (69.2%) | 11 (100%) | 4 (66.7%) |
Single | 95 (28%) | 74 (30.1%) | 62 (28.8%) | 53 (31.4%) | 24 (32.9%) | 29 (27.4%) | 26 (38.8%) | 11 (25.6%) | 5 (35.7%) | 3 (23.1%) | 0 (0%) | 2 (33.3%) |
Divorced | 11 (3.2%) | 13 (5.3%) | 11 (5.1%) | 11 (6.5%) | 4 (5.5%) | 5 (4.7%) | 5 (7.5%) | 5 (11.6%) | 0 (0%) | 1 (7.7%) | 0 (0%) | 0 (0%) |
p-value | 0.241 | 0.035 * | 0.23 | 0.012 * | 0.29 | 0.13 | 0.008 * | 0.012 * | 0.796 | 0.814 | 0.172 | 0.954 |
Nationality | ||||||||||||
Saudi | 326 (96.2%) | 231 (93.9%) | 201 (93.5%) | 156 (92.3%) | 70 (95.9%) | 102 (96.2%) | 60 (89.6%) | 40 (93%) | 12 (85.71%) | 13 (100%) | 11 (100%) | 5 (83.3%) |
non-Saudi | 13 (3.8%) | 15 (6.1%) | 14 (6.5%) | 13 (7.7%) | 3 (4.1%) | 4 (3.8%) | 7 (10.4%) | 3 (7%) | 2 (14.29%) | 0 (0%) | 0 (0%) | 1 (16.7%) |
p-value | 0.652 | 0.007 * | 0.006 * | 0.001 * | 0.966 | 0.88 | 0.003 * | 0.296 | 0.047 * | 0.453 | 0.491 | 0.112 |
Education | ||||||||||||
High school | 39 (11.5%) | 34 (13.8%) | 28 (13%) | 27 (16%) | 6 (8.2%) | 7 (6.6%) | 11 (16.4%) | 5 (11.6%) | 2 (14.3%) | 0 (0%) | 0 (0%) | 0 (0%) |
Bachelor’s degree | 191 (56.3%) | 132 (53.7%) | 118 (54.9%) | 90 (53.3%) | 43 (58.9%) | 65 (61.3%) | 42 (62.7%) | 24 (55.8%) | 7 (50.0%) | 7 (53.8%) | 1 (9.1%) | 5 (83.3%) |
Masters | 28 (8.3%) | 22 (8.9%) | 19 (8.8%) | 13 (7.7%) | 7 (9.6%) | 8 (7.5%) | 3 (4.5%) | 5 (11.6%) | 1 (7.14%) | 2 (15.4%) | 0 (0%) | 0 (0%) |
Ph.D. | 53 (15.6%) | 42 (17.1%) | 30 (14%) | 27 (16%) | 14 (19.2%) | 16 (15.1%) | 8 (11.9%) | 5 (11.6%) | 2 (14.29%) | 3 (23.1%) | 7 (63.6%) | 1 (16.7%) |
Post-secondary diploma | 28 (8.3%) | 16 (6.5%) | 20 (9.3%) | 12 (7.1%) | 3 (4.1%) | 10 (9.4%) | 3 (4.5%) | 4 (9.3%) | 2 (14.29%) | 1 (7.7%) | 3 (27.3%) | 0 (0%) |
p-value | 0.321 | 0.395 | 0.554 | 0.236 | 0.487 | 0.291 | 0.339 | 0.961 | 0.489 | 0.719 | <0.001 * | 0.727 |
Vaccine | ||||||||||||
Pfizer | 203 (59.9%) | 100 (40.7%) | 86 (40%) | 51 (30.2%) | 34 (46.6%) | 64 (60.4%) | 25 (37.3%) | 16 (37.2%) | 4 (28.57%) | 7 (53.9%) | 10 (90.9%) | 3 (50%) |
AstraZeneca | 136 (40.1%) | 146 (59.3%) | 129 (60%) | 118 (69.8%) | 39 (53.4%) | 42 (39.6%) | 42 (62.7%) | 27 (62.8%) | 10 (71.43%) | 6 (46.2%) | 1 (9.1%) | 3 (50%) |
p-value | 0.001 * | <0.001 * | <0.001 * | <0.001 * | 0.064 | 0.321 | 0.001 * | 0.008 * | 0.033 * | 0.857 | 0.019 * | 0.755 |
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Alzarea, A.I.; Khan, Y.H.; Alatawi, A.D.; Alanazi, A.S.; Alzarea, S.I.; Butt, M.H.; Almalki, Z.S.; Alahmari, A.K.; Mallhi, T.H. Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile. Vaccines 2022, 10, 924. https://doi.org/10.3390/vaccines10060924
Alzarea AI, Khan YH, Alatawi AD, Alanazi AS, Alzarea SI, Butt MH, Almalki ZS, Alahmari AK, Mallhi TH. Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile. Vaccines. 2022; 10(6):924. https://doi.org/10.3390/vaccines10060924
Chicago/Turabian StyleAlzarea, Abdulaziz Ibrahim, Yusra Habib Khan, Ahmed D. Alatawi, Abdullah Salah Alanazi, Sami I. Alzarea, Muhammad Hammad Butt, Ziyad Saeed Almalki, Abdullah K. Alahmari, and Tauqeer Hussain Mallhi. 2022. "Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile" Vaccines 10, no. 6: 924. https://doi.org/10.3390/vaccines10060924