Qualitative Assessment of Early Adverse Effects of Pfizer–BioNTech and Sinopharm COVID-19 Vaccines by Telephone Interviews
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Data Collection
2.3. Ethical Approval
2.4. Statistical Analysis
3. Results
3.1. Characteristics of the Sample
3.2. Frequency of Adverse Reactions Based on the Vaccine
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | Categories | Total | Pfizer | Sinopharm | p-Value |
---|---|---|---|---|---|
Total | 1004 (100) | 491 (48.9) | 513 (51.1) | ||
Gender | 0.7 | ||||
Male | 673 (67) | 332 (49.3) | 341 (50.7) | ||
Female | 331 (33) | 159 (48) | 172 (52) | ||
Age | <0.01 | ||||
18–30 | 13 (1.3) | 5 (38.5) | 8 (61.5) | ||
31–40 | 36 (3.6) | 22 (61.1) | 14 (38.9) | ||
41–50 | 262 (26.1) | 160 (61) | 102 (39) | ||
51–60 | 118 (11.7) | 30 (25.4) | 88 (74.6) | ||
61–70 | 50 (5) | 31 (62) | 19 (38) | ||
above 70 | 525 (52.3) | 243 (46.3) | 282 (53.7) | ||
BMI | 0.08 | ||||
Underweight | 10 (1) | 8 (80) | 2 (20) | ||
Normal | 259 (25.8) | 116 (44.8) | 143 (55.2) | ||
Overweight | 488 (48.7) | 249 (51) | 239 (49) | ||
Obese | 246 (24.5) | 117 (47.6) | 129 (52.4) | ||
Chronic diseases | |||||
Hypertension | 428 (42.6) | 186 (43.5) | 242 (56.5) | <0.01 | |
Coronary artery disease | 76 (7.6) | 26 (34.2) | 50 (65.8) | <0.01 | |
Diabetes | 301 (30) | 149 (49.5) | 152 (50.5) | 0.8 | |
Thyroid disorders | 36 (3.6) | 16 (44.4) | 20 (55.6) | 0.6 | |
Dyslipidemia | 113 (11.3) | 49 (43.4) | 64 (56.6) | 0.2 | |
Respiratory disorder | 21 (2) | 9 (42.9) | 12 (57.1) | 0.6 | |
Currently smoking | 332 (33.1) | 176 (53) | 156 (47) | 0.07 | |
History of COVID-19 infection | 41 (4) | 17 (41.5) | 24 (58.5) | 0.3 |
First Dose of the Vaccine | Second Dose of the Vaccine | ||||||||
---|---|---|---|---|---|---|---|---|---|
Adverse Reaction | Total | Pfizer | Sinopharm | p-Value | Adverse Reaction | Total | Pfizer | Sinopharm | p-Value |
Having an adverse reaction | 465 (46.3) | 307 (62.5) | 158 (30.8) | <0.01 | Having an adverse reaction | 488 (48.6) | 320 (65.2) | 168 (32.8) | <0.01 |
Local side effects | 338 (33.7) | 247 (50.3) | 91 (17.7) | <0.01 | Local side effects | 293 (30) | 217 (44.2) | 76 (14.8) | <0.01 |
Systemic side effects | 238 (23.7) | 148 (30.2) | 90 (17.5) | <0.01 | Systemic side effects | 313 (31.2) | 200 (40.7) | 113 (22) | <0.01 |
Frequency | Onset of Symptoms (Hours) | Duration of Symptoms (Hours) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Reaction | Total | Pfizer | Sinopharm | p-Value | Total | Pfizer | Sinopharm | p-Value | Total | Pfizer | Sinopharm | p-Value |
Local adverse reactions | ||||||||||||
Pain at the site of the injection | 333 (33.2) | 245 (49.9) | 88 (17.2) | <0.01 | 8.9 ± 10.4 | 9.4 ± 9.9 | 7.8 ± 11.4 | 0.2 | 39.4 ± 34.5 | 40.4 ± 35.3 | 36.5 ± 32.1 | 0.4 |
Swelling at site of injection | 28 (2.8) | 23 (4.7) | 5 (1) | <0.01 | 20.5 ± 20.4 | 18.5 ± 18 | 29 ± 29.8 | 0.3 | 51.4 ± 37.7 | 47.9 ± 30.8 | 67.2 ± 62.1 | 0.3 |
Systemic adverse reaction | ||||||||||||
General weakness | 124 (12.4) | 81 (16.5) | 43 (8.4) | <0.01 | 18.3 ± 21 | 17.4 ± 17 | 20.1 ± 21 | 0.4 | 58 ± 84 | 43.3 ± 43.9 | 83.9 ± 124.6 | 0.01 |
Headache | 80 (8) | 51 (10.4) | 29 (5.7) | <0.01 | 20 ± 34.3 | 11.4 ± 11 | 35.4 ± 52.5 | <0.01 | 38.1 ± 34.3 | 34.4 ± 28.7 | 45.5 ± 43.1 | 0.2 |
Muscle pain | 58 (5.8) | 47 (9.6) | 11 (2.1) | <0.01 | 23.2 ± 32.8 | 21.3 ± 27.9 | 30.5 ± 48.6 | 0.4 | 55 ± 81 | 45.4 ± 52.4 | 91.9 ± 144 | 0.09 |
Rigors | 42 (4.2) | 33 (6.7) | 9 (1.8) | <0.01 | 22.3 ± 30.7 | 20.4 ± 31.5 | 28.9 ± 28.3 | 0.5 | 42.3 ± 81.8 | 48.5 ± 91 | 21.2 ± 21.3 | 0.4 |
Arthralgia | 48 (4.8) | 38 (7.7) | 10 (2) | <0.01 | 36.3 ± 70 | 33.4 ± 21.3 | 46.1 ± 70 | 0.4 | 44.7 ± 83.6 | 27 ± 28 | 103 ± 157.6 | 0.01 |
Fever | 47 (4.7) | 31 (6.3) | 16 (3.1) | 0.02 | 19.8 ± 26 | 17.8 ± 26.6 | 23.3 ± 25.4 | 0.5 | 34.5 ± 37.1 | 32 ± 32.8 | 30.3 ± 45.3 | 0.5 |
Abdominal pain/diarrhea | 14 (1.4) | 7 (1.4) | 7 (1.4) | 0.9 | 40.7 ± 45.5 | 28.3 ± 24.7 | 28.8 ± 64.4 | 0.3 | 31.9 ± 30.9 | 40.8 ± 28.9 | 25.5 ± 32.8 | 0.4 |
Nausea/vomiting | 24 (2.4) | 13 (2.7) | 11 (2.2) | 0.6 | 35.2 ± 54.4 | 27.3 ± 42.7 | 43.1 ± 65.1 | 0.5 | 34.4 ± 28.5 | 31.9 ± 19.8 | 37.2 ± 36.8 | 0.7 |
Skin rash | 4 (0.4) | 2 (0.4) | 2 (0.4) | 0.9 | 92.3 ± 162.8 | 180 ± 220.6 | 4.5 ± 2.1 | 0.4 | 13 ± 15.6 | 13 ± 15.6 | 13 ± 15.6 | 1 |
Allergic reaction | 8 (0.8) | 4 (0.8) | 4 (0.8) | 1 | 7 ± 16.6 | 40 ± 13.9 | 16 ± 9.8 | 0.04 | 145.5 ± 158 | 75 ± 62.3 | 216 ± 203.7 | 0.2 |
Flu-like symptoms | 30 (3) | 18 (3.7) | 12 (2.3) | 0.2 | 53.3 ± 75.2 | 55.6 ± 82.9 | 40.1 ± 62.4 | 0.8 | 92.8 ± 102.1 | 72.6 ± 109 | 127.7 ± 82 | 0.2 |
Frequency | Onset of Symptoms (Hours) | Duration of Symptoms (Hours) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Reaction | Total | Pfizer | Sinopharm | Adverse Reaction | Total | Pfizer | Sinopharm | Adverse Reaction | Total | Pfizer | Sinopharm | Adverse Reaction |
Local Adverse reactions | ||||||||||||
Pain at the site of the injection | 292 (29) | 216 (44) | 76 (14.8) | <0.01 | 9.9 ± 14.8 | 10.3 ± 12.1 | 8.7 ± 20.3 | 0.4 | 46.5 ± 60.8 | 44 ± 46 | 46.5 ± 60.8 | 0.7 |
Swelling at site of injection | 24 (2.4) | 20 (4) | 4 (0.8) | <0.01 | 11.4 ± 12.2 | 10.7 ± 12.5 | 14.1 ± 11.8 | 0.6 | 50.5 ± 30.6 | 49.2 ± 31.3 | 57 ± 9 | 0.7 |
Systemic Adverse reactions | ||||||||||||
General weakness | 171 (17) | 120 (24.4) | 51 (10) | <0.01 | 19.5 ± 26.5 | 17.1 ± 15.6 | 25.5 ± 42.3 | 0.06 | 54.1 ± 61.8 | 45.5 ± 36.4 | 75.1 ± 97.2 | <0.01 |
Headache | 91 (9.1) | 57 (11.6) | 34 (6.6) | <0.01 | 21.2 ± 21.1 | 18.5 ± 29.3 | 25.6 ± 21.9 | 0.1 | 51.3 ± 46.1 | 45.7 ± 40.2 | 61 ± 54 | 0.1 |
Muscle pain | 86 (8.6) | 67 (13.7) | 19 (3.7) | <0.01 | 24.8 ± 25 | 20.7 ± 21.1 | 39 ± 32.3 | <0.01 | 58 ± 60.8 | 45 ± 32.1 | 103.6 ± 103.6 | <0.01 |
Rigors | 67 (6.7) | 53 (10.8) | 14 (2.8) | <0.01 | 27.1 ± 41.8 | 22.7 ± 30.5 | 43.4 ± 68.7 | 0.1 | 43.2 ± 52.6 | 38.9 ± 35.7 | 59.1 ± 92 | 0.2 |
Arthralgia | 84 (8.4) | 62 (12.6) | 22 (4.3) | <0.01 | 64.5 ± 110.5 | 38.4 ± 32.4 | 136.3 ± 192.9 | <0.01 | 52.4 ± 87.8 | 45.9 ± 82.7 | 69.7 ± 100 | 0.3 |
Fever | 73 (7.3) | 59 (12) | 14 (2.8) | <0.01 | 18 ± 17.5 | 16.9 ± 14.8 | 22.4 ± 26.2 | 0.3 | 50.7 ± 61 | 44.8 ± 38.8 | 75.3 ± 113.6 | 0.09 |
Abdominal pain/diarrhea | 15 (1.5) | 12 (2.4) | 3 (0.6) | 0.02 | 35.9 ± 38.5 | 28.9 ± 27.3 | 64 ± 69.3 | 0.2 | 42.7 ± 41.7 | 42.4 ± 45.8 | 44 ± 25 | 0.96 |
Nausea/vomiting | 29 (2.9) | 23 (4.7) | 6 (1.2) | <0.01 | 29.9 ± 45 | 30.9 ± 45.5 | 26 ± 46.8 | 0.8 | 29 ± 42.4 | 46 ± 44.1 | 18.1 ± 27.9 | 0.15 |
Skin rash | 7 (0.7) | 6 (1.2) | 1 (0.2) | 0.05 | 17.6 ± 15.1 | 21.3 ± 20.2 | 3 | N/A | 34.5 ± 68.9 | 2 | 63 ± 62 | N/A |
Allergic reaction | 10 (1) | 3 (0.6) | 7 (1.4) | 0.2 | 32.6 ± 20 | 34.7 ± 33.3 | 18 ± 9.3 | 0.3 | 109.3 ± 93.8 | 56 ± 13.8 | 136 ± 107 | 0.3 |
Flu-like symptoms | 61 (6.1) | 34 (6.9) | 27 (5.3) | 0.3 | 50.9 ± 59.6 | 30.1 ± 43.3 | 77 ± 67.3 | <0.01 | 79.3 ± 70.6 | 12 ± 70.3 | 80.8 ± 72.2 | 0.9 |
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Abu-Halaweh, S.; Alqassieh, R.; Suleiman, A.; Al-Sabbagh, M.Q.; AbuHalaweh, M.; AlKhader, D.; Abu-Nejem, R.; Nabulsi, R.; Al-Tamimi, M.; Alwreikat, M.; et al. Qualitative Assessment of Early Adverse Effects of Pfizer–BioNTech and Sinopharm COVID-19 Vaccines by Telephone Interviews. Vaccines 2021, 9, 950. https://doi.org/10.3390/vaccines9090950
Abu-Halaweh S, Alqassieh R, Suleiman A, Al-Sabbagh MQ, AbuHalaweh M, AlKhader D, Abu-Nejem R, Nabulsi R, Al-Tamimi M, Alwreikat M, et al. Qualitative Assessment of Early Adverse Effects of Pfizer–BioNTech and Sinopharm COVID-19 Vaccines by Telephone Interviews. Vaccines. 2021; 9(9):950. https://doi.org/10.3390/vaccines9090950
Chicago/Turabian StyleAbu-Halaweh, Sami, Rami Alqassieh, Aiman Suleiman, Mohammed Qussay Al-Sabbagh, Maram AbuHalaweh, Duaa AlKhader, Rozan Abu-Nejem, Roa’a Nabulsi, Mohammad Al-Tamimi, Mallak Alwreikat, and et al. 2021. "Qualitative Assessment of Early Adverse Effects of Pfizer–BioNTech and Sinopharm COVID-19 Vaccines by Telephone Interviews" Vaccines 9, no. 9: 950. https://doi.org/10.3390/vaccines9090950
APA StyleAbu-Halaweh, S., Alqassieh, R., Suleiman, A., Al-Sabbagh, M. Q., AbuHalaweh, M., AlKhader, D., Abu-Nejem, R., Nabulsi, R., Al-Tamimi, M., Alwreikat, M., Alnouti, M., Suleiman, B., Yousef, M., Jarbeh, M. E., Al-Shudifat, A.-E., Alqassieh, A., & Bsisu, I. (2021). Qualitative Assessment of Early Adverse Effects of Pfizer–BioNTech and Sinopharm COVID-19 Vaccines by Telephone Interviews. Vaccines, 9(9), 950. https://doi.org/10.3390/vaccines9090950