Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants
2.3. Instrument
2.4. Ethical Considerations
2.5. Statistical Analysis
3. Results
3.1. Demographic Characteristics
3.2. Medical Anamneses
3.3. COVID-19-Related Anamneses
3.4. Local and Systemic Side Effects
3.5. Oral and Skin-Related Side Effects
3.6. Risk Factors of AstraZeneca COVID-19 Vaccine Side Effects
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Frequency | Percentage | Cumulative Percentage | ||
---|---|---|---|---|---|
Gender | Female | 71 | 77.2% | 77.2 | |
Male | 21 | 22.8% | 100% | ||
Age | <35 years-old | 51 | 55.4% | 55.4% | |
35–49 years-old | 23 | 25% | 80.4% | ||
>49 years-old | 18 | 19.6% | 100% | ||
Profession | Physician | 12 | 13% | 13% | |
Dentist | 10 | 10.9% | 23.9% | ||
Nurse | 26 | 28.3% | 52.2% | ||
Other allied Health Professional | 44 | 47.8% | 100% | ||
Experience | 1–5 years | 42 | 45.7% | 45.7% | |
6–10 years | 12 | 13% | 58.7% | ||
11–20 years | 13 | 14.1% | 72.8% | ||
>20 years | 25 | 27.2% | 100% | ||
Region | Germany | Schleswig-Holstein | 50 | 54.3% | 54.3% |
Bayern | 19 | 20.7% | 75% | ||
Nordrhein-Westfalen | 3 | 3.3% | 78.3% | ||
Hessen | 1 | 1.1% | 79.3% | ||
Czech Republic | Praha | 1 | 1.1% | 80.4% | |
Vysočina | 11 | 12% | 92.4% | ||
Hradec Kralove | 3 | 3.3% | 95.7% | ||
Moravian-Silesian | 2 | 2.2% | 97.8% | ||
Central Bohemian | 1 | 1.1% | 98.9% | ||
Usti nad Labem | 1 | 1.1% | 100% |
Variable | <35 Years-Old | 35–49 Years-Old | >49 Years-Old | Total | Sig. 1 | ||
---|---|---|---|---|---|---|---|
Chronic Illness | Asthma | 3 (5.9%) | 0 (0%) | 1 (5.6%) | 4 (4.3%) | 0.640 | |
Allergy | 0 (0%) | 0 (0%) | 1 (5.6%) | 1 (1.1%) | 0.196 | ||
Bone Disease | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1.1%) | 1.000 | ||
Chronic Hypertension | 0 (0%) | 0 (0%) | 1 (5.6%) | 1 (1.1%) | 0.196 | ||
Neurologic Disease | 0 (0%) | 1 (4.3%) | 2 (11.1%) | 3 (3.3%) | 0.049 | ||
Psychologic Distress | 0 (0%) | 1 (4.3%) | 1 (5.6%) | 2 (2.2%) | 0.196 | ||
Rheumatoid Arthritis | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1.1%) | 1.000 | ||
Thyroid Disease | 3 (5.9%) | 2 (8.7%) | 0 (0%) | 5 (5.4%) | 0.590 | ||
Total | 6 (11.8%) | 4 (17.4%) | 4 (22.2%) | 14 (15.2%) | 0.462 | ||
Medical Treatment | Antidepressants | 3 (5.9%) | 2 (8.7%) | 3 (16.7%) | 8 (8.7%) | 0.367 | |
Antiepileptics | 0 (0%) | 1 (4.3%) | 0 (0%) | 1 (1.1%) | 0.446 | ||
Antihypertensive | 0 (0%) | 1 (4.3%) | 0 (0%) | 1 (1.1%) | 0.446 | ||
Contraceptives | 3 (5.9%) | 0 (0%) | 1 (5.6%) | 4 (4.3%) | 0.640 | ||
Immunosuppressive | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1.1%) | 1.000 | ||
Pain killers | 0 (0%) | 0 (0%) | 1 (5.6%) | 1 (1.1%) | 0.196 | ||
Thyroid Hormone | 3 (5.9%) | 3 (13%) | 0 (0%) | 6 (6.5%) | 0.216 | ||
Total | 10 (19.6%) | 7 (30.4%) | 4 (22.2%) | 21 (22.8%) | 0.626 | ||
COVID-19 anamneses | Previous Infection | 4 (7.8%) | 3 (13%) | 1 (5.6%) | 8 (8.7%) | 0.692 | |
Exposure | 19 (37.3%) | 11 (47.8%) | 5 (27.8%) | 35 (38%) | 0.416 | ||
Vaccine Dosage | One Dose | 51 (56%) | 22 (24.2%) | 18 (19.8%) | 91 (98.9%) | 0.446 | |
Two Doses | 0 (0%) | 1 (100%) | 0 (0%) | 1 (1.1%) |
Variable | Outcome | <35 Years-Old | 35–49 Years-Old | >49 Years-Old | Total | Sig. 1 |
---|---|---|---|---|---|---|
Local SEs | Injection Site Pain | 42 (82.4%) | 16 (69.6%) | 9 (50%) | 67 (72.8%) | 0.028 |
Injection Site Swelling | 8 (15.7%) | 1 (4.3%) | 1 (5.6%) | 10 (10.9%) | 0.343 | |
Injection Site Redness | 5 (9.7%) | 4 (17.4%) | 1 (5.6%) | 10 (10.9%) | 0.539 | |
Total | 42 (82.4%) | 17 (73.9%) | 9 (50%) | 68 (73.9%) | 0.035 | |
Systemic SEs | Fatigue | 46 (90.2%) | 13 (56.5%) | 9 (50%) | 68 (73.9%) | <0.001 |
Headache | 18 (35.3%) | 8 (34.8%) | 1 (5.6%) | 27 (29.3%) | 0.040 | |
Nausea | 28 (54.9%) | 8 (34.8%) | 6 (33.3%) | 42 (45.7%) | 0.138 | |
Feeling Unwell | 26 (51%) | 10 (43.5%) | 7 (38.9%) | 43 (46.7%) | 0.634 | |
Muscle Pain | 33 (64.7%) | 12 (52.2%) | 6 (33.3%) | 51 (55.4%) | 0.066 | |
Joint Pain | 24 (47.1%) | 8 (34.8%) | 6 (33.3%) | 38 (41.3%) | 0.456 | |
Fever | 8 (15.7%) | 5 (21.7%) | 1 (5.6%) | 14 (15.2%) | 0.353 | |
Chills | 31 (60.8%) | 9 (39.1%) | 5 (27.8%) | 45 (48.9%) | 0.031 | |
Lymphadenopathy | 4 (7.8%) | 1 (4.3%) | 0 (0%) | 5 (5.4%) | 0.707 | |
Total | 49 (96.1%) | 17 (73.9%) | 13 (72.2%) | 79 (85.9%) | 0.003 | |
SEs Duration | 1 day | 27 (54%) | 10 (47.6%) | 12 (75%) | 49 (56.3%) | 0.136 |
3 days | 20 (40%) | 7 (33.3%) | 4 (25%) | 31 (35.6%) | ||
5 days | 2 (4%) | 2 (9.5%) | 0 (0%) | 4 (4.6%) | ||
1 week | 1 (2%) | 2 (9.5%) | 0 (0%) | 3 (3.4%) | ||
Total | 50 (98%) | 21 (91.3%) | 16 (88.9%) | 87 (94.6%) | 0.141 | |
Total SEs | (0–12) | 5.35 ± 2.40 | 4.13 ± 2.94 | 2.89 ± 2.45 | 4.57 ± 2.71 | 0.001 |
Variable | Outcome | <35 Years-Old | 35–49 Years-Old | >49 Years-Old | Total | Sig. 1 |
---|---|---|---|---|---|---|
Solicited Oral SE | Ulcers/Blisters/Vesicles | 4 (7.8%) | 3 (13%) | 0 (0%) | 7 (7.6%) | 0.423 |
White/Red Plaque | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1.1%) | 1.000 | |
Halitosis | 1 (2%) | 0 (0%) | 2 (11.1%) | 3 (3.3%) | 0.147 | |
Bleeding Gingiva | 2 (3.9%) | 1 (4.3%) | 0 (0%) | 3 (3.3%) | 1.000 | |
Swollen Lips | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1.1%) | 1.000 | |
Unsolicited Oral SE | Taste alterations | 3 (5.9%) | 1 (4.3%) | 1 (5.6%) | 5 (5.4%) | 1.000 |
Onset | 1–3 days | 12 (100%) | 3 (42.9%) | 4 (100%) | 19 (82.6%) | 0.005 |
Within 1st week | 0 (0%) | 3 (42.9%) | 0 (0%) | 3 (13%) | ||
Within 4th week | 0 (0%) | 1 (14.3%) | 0 (0%) | 1 (4.3%) | ||
Total | 9 (17.6%) | 5 (21.7%) | 2 (11.1%) | 16 (17.4%) | 0.654 | |
Oral SE Location | Lips | 0 (0%) | 1 (4.3%) | 0 (0%) | 1 (1.1%) | 0.446 |
Labial/Buccal Mucosa | 2 (3.9%) | 2 (8.7%) | 0 (0%) | 4 (4.3%) | 0.506 | |
Tongue | 2 (3.9%) | 0 (0%) | 0 (0%) | 2 (2.2%) | 1.000 | |
Total Oral SE | (0–5) | 0.24 ± 0.55 | 0.22 ± 0.42 | 0.17 ± 0.51 | 0.22 ± 0.51 | 0.739 |
Skin-related SE | Skin Rash | 2 (3.9%) | 1 (4.3%) | 1 (5.6%) | 4 (4.3%) | 1.000 |
Variable | Outcome | Local SE (n) | Systemic SE (n) | Total | Sig. 1 |
---|---|---|---|---|---|
Gender | Female | 0.97 ± 0.77 | 3.72 ± 2.34 | 4.69 ± 2.74 | 0.539 |
Male | 0.86 ± 0.73 | 3.29 ± 2.22 | 4.14 ± 2.61 | ||
Age Group | ≤50 years-old | 1.03 ± 0.73 | 3.91 ± 2.30 | 4.93 ± 2.63 | 0.003 |
>50 years-old | 0.56 ± 0.81 | 2.25 ± 1.88 | 2.81 ± 2.43 | ||
Infection | No | 0.90 ± 0.74 | 3.55 ± 2.33 | 4.45 ± 2.70 | 0.149 |
Yes | 1.38 ± 0.92 | 4.38 ± 2.13 | 5.75 ± 2.61 | ||
Chronic Illness | No | 0.95 ± 0.75 | 3.73 ± 2.27 | 4.68 ± 2.61 | 0.230 |
Yes | 0.93 ± 0.83 | 3.00 ± 2.54 | 3.93 ± 3.22 | ||
Medical Treatment | No | 0.96 ± 0.71 | 3.73 ± 2.20 | 4.69 ± 2.53 | 0.294 |
Yes | 0.90 ± 0.94 | 3.24 ± 2.66 | 4.14 ± 3.28 |
Predictor | Local SE | Systemic SE | Total SE | ||||
---|---|---|---|---|---|---|---|
Odds Ratio | Sig. | Odds Ratio | Sig. | Odds Ratio | Sig. | ||
Gender | Female (vs. Male) | 1.588 (0.551–4.577) | 0.392 | 2.461 (0.709–8.545) | 0.156 | 5.750 (0.893–37.043) | 0.066 |
Age Group | ≤50 years (vs. >50 years) | 5.229 (1.676–16.313) | 0.004 | 2.481 (0.657–9.368) | 0.180 | 3.476 (0.531–22.744) | 0.194 |
Infection | Yes (vs. No) | 2.639 (0.308–22.646) | 0.376 | 1.167 (0.132–10.347) | 0.400 | ||
Chronic Illness | Yes (vs. No) | 0.862 (0.243–3.058) | 0.818 | 0.539 (0.128–2.273) | 0.890 | 0.703 (0.073–6.796) | 0.761 |
Medical Treatment | Yes (vs. No) | 0.473 (0.167–1.340) | 0.159 | 0.406 (0.117–1.411) | 0.156 | 0.174 (0.027–1.120) | 0.066 |
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Riad, A.; Pokorná, A.; Mekhemar, M.; Conrad, J.; Klugarová, J.; Koščík, M.; Klugar, M.; Attia, S. Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States. Vaccines 2021, 9, 673. https://doi.org/10.3390/vaccines9060673
Riad A, Pokorná A, Mekhemar M, Conrad J, Klugarová J, Koščík M, Klugar M, Attia S. Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States. Vaccines. 2021; 9(6):673. https://doi.org/10.3390/vaccines9060673
Chicago/Turabian StyleRiad, Abanoub, Andrea Pokorná, Mohamed Mekhemar, Jonas Conrad, Jitka Klugarová, Michal Koščík, Miloslav Klugar, and Sameh Attia. 2021. "Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States" Vaccines 9, no. 6: 673. https://doi.org/10.3390/vaccines9060673
APA StyleRiad, A., Pokorná, A., Mekhemar, M., Conrad, J., Klugarová, J., Koščík, M., Klugar, M., & Attia, S. (2021). Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States. Vaccines, 9(6), 673. https://doi.org/10.3390/vaccines9060673