Safety of and Adverse Reactions to the COVID-19 Vaccine Among Pregnant and Breastfeeding Women
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Data Collection Method
2.3. Statistical Analysis
3. Results
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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Characteristics | N | % | |
---|---|---|---|
Age | 18–25 | 139 | 11.5 |
26–30 | 539 | 44.8 | |
31–35 | 379 | 31.5 | |
36–40 | 124 | 10.3 | |
>40 | 23 | 1.9 | |
Mean ± SD (Min–Max) | 30.25 ± 4.36 (19–44) | ||
Education | Elementary school or less | 30 | 2.5 |
Junior high school | 90 | 7.5 | |
High school | 262 | 21.8 | |
University/post-graduate | 822 | 68.3 | |
Job | Freelancers/housework | 89 | 7.4 |
Farmer | 795 | 66.0 | |
Worker | 36 | 3.0 | |
Business | 260 | 21.6 | |
Officer | 13 | 1.1 | |
Unemployment | 11 | 0.9 | |
Residence | Rural | 1061 | 88.1 |
Urban | 143 | 11.9 | |
History of allergies | No | 1090 | 90.5 |
Yes | 114 | 9.5 | |
Number of children | 0 | 254 | 21.1 |
1 | 552 | 45.8 | |
2 | 314 | 26.1 | |
3 | 78 | 6.5 | |
4 | 6 | 0.5 | |
Number of injections | 1 | 85 | 7.1 |
2 | 1119 | 92.9 |
Group | Symptoms | Pregnant Women (n = 991) | Breastfeeding Women (n = 213) | Total (n = 1204) |
---|---|---|---|---|
n (%) | n (%) | n (%) | ||
Mouth | Numbness around the lips/tongue | 9 (0.9%) | 17 (1.4%) | 8 (3.8%) |
Skin | Rash | 2 (0.2%) | 3 (0.2%) | 1 (0.5%) |
Redness, purple rash | 7 (0.7%) | 8 (0.7%) | 1 (0.5%) | |
Bleeding | 16 (1.6%) | 23 (1.9%) | 7 (3.3%) | |
Throat | Itchy throat | 1 (0.1%) | 4 (0.3%) | 3 (1.4%) |
Tight throat | 1 (0.1%) | 1 (0.1%) | 0 (0.0%) | |
Choking, difficulty speaking | 21 (2.1%) | 26 (2.2%) | 5 (2.3%) | |
Nervous system | Prolonged, severe, lethargic headache | 60 (6.1%) | 75 (6.2%) | 15 (7.0%) |
Drowsiness, confusion | 1 (0.1%) | 3 (0.2%) | 2 (0.9%) | |
Coma | 1 (0.1%) | 1 (0.1%) | 0 (0.0%) | |
Heart | Chest pain | 44 (4.4%) | 51 (4.2%) | 7 (3.3%) |
Nervous palpitations | 3 (0.3%) | 6 (0.5%) | 3 (1.4%) | |
Fainting | 1 (0.1%) | 1 (0.1%) | 0 (0.0%) | |
Digestion | Vomiting, diarrhea | 45 (4.5%) | 54 (4.5%) | 9 (4.2%) |
Respiratory | Shortness of breath | 35 (3.5%) | 38 (3.2%) | 3 (1.4%) |
Wheezing | 4 (0.4%) | 4 (0.3%) | 0 (0.0%) | |
Vestibular disorders | Dizziness, lightheadedness, unusual fatigue | 105 (10.6%) | 146 (12.1%) | 41 (19.2%) |
Painful | Pain, soreness, swelling, or itching at the injection site or the entire body | 258 (26.0%) | 316 (26.2%) | 58 (27.2%) |
Fever | High fever (≥39 °C) | 0 (0.0%) | 3 (0.2%) | 3 (1.4%) |
Fever (<39 °C) | 128 (12.9%) | 190 (15.8%) | 62 (29.1%) | |
Other | Epistaxis | 1 (0.1%) | 1 (0.1%) | 0 (0.0%) |
Abdominal pain and bleeding | 1 (0.1%) | 1 (0.1%) | 0 (0.0%) | |
Premature birth | 0 (0.0%) | 1 (0.1%) | 1 (0.5%) | |
Slow fetal development | 1 (0.1%) | 1 (0.1%) | 0 (0.0%) | |
Loss of breast milk | 0 (0.0%) | 1 (0.1%) | 1 (0.1%) | |
Axillary/neck lymph nodes | 3 (0.3%) | 3 (0.3%) | 0 (0.0%) | |
Flu-like symptoms (runny nose, sneezing) | 8 (0.8%) | 12 (1.0%) | 4 (2.0%) |
Factor | Adverse Reaction, n (%) | cOR | p (95%CI) | aOR | CI 95% | ||
---|---|---|---|---|---|---|---|
No | Yes | ||||||
Age | 18–25 | 79 (56.8) | 60 (43.2) | reference | reference | ||
26–30 | 271 (50.3) | 268 (49.7) | 1.30 | 0.168 (0.89–1.90) | 1.32 | 0.85–2.06 | |
31–35 | 169 (44.6) | 210 (55.4) | 1.64 | 0.014 (1.11–2.42) | 1.56 | 0.96–2.52 | |
36–40 | 46 (37.1) | 78 (62.9) | 2.23 | 0.001 (1.36–3.66) | 2.04 * | 1.10–3.78 | |
>40 | 13 (56.5) | 10 (62.9) | 1.01 | 0.978 (0.41–2.47) | 0.81 | 0.27–2.42 | |
Education | Elementary school or less | 16 (53.3) | 14 (46.7) | reference | reference | ||
Junior high school | 50 (55.6) | 40 (44.4) | 0.91 | 0.832 (0.40–2.10) | 1.03 | 0.39–2.69 | |
High school | 141 (53.8) | 121 (46.2) | 0.98 | 0.960 (0.46–2.09) | 1.25 | 0.51–3.12 | |
University/post-graduate | 371 (45.1) | 451 (54.9) | 1.39 | 0.378 (0.67–2.88) | 1.48 | 0.59–3.65 | |
Job | Freelancers/housework | 32 (36.0) | 57 (64.0) | reference | reference | ||
Farmer | 372 (46.8) | 423 (53.2) | 0.64 | 0.053 (0.41–1.01) | 0.56 * | 0.34–0.95 | |
Worker | 21 (58.3) | 15 (41.7) | 0.40 | 0.024 (0.18–0.89) | 0.45 | 0.18–1.10 | |
Business | 143 (55.0) | 117 (45.0) | 0.46 | 0.002 (0.28–0.76) | 0.52 * | 0.30–0.91 | |
Officer | 5 (38.5) | 8 (61.5) | 0.90 | 0.861 (0.27–2.98) | 1.12 | 0.30–4.14 | |
Unemployment | 5 (45.5) | 6 (54.5) | 0.67 | 0.540 (0.19–2.38) | 0.69 | 0.14–3.54 | |
Residence | Rural | 493 (46.5) | 568 (53.5) | reference | reference | ||
Urban | 85 (59.4) | 58 (40.6) | 0.59 | 0.004 (0.42–0.85) | 0.64 * | 0.43–0.97 | |
History of allergies | No | 534 (49.0) | 556 (51.0) | reference | reference | ||
Yes | 44 (38.6) | 70 (61.4) | 1.53 | 0.036 (1.03–2.27) | 1.59 * | 1.02–2.51 | |
Number of children | 0 | 132 (52.0) | 122 (48.0) | reference | reference | ||
1 | 288 (52.2) | 264 (47.8) | 0.99 | 0.957 (0.74–1.34) | 0.88 | 0.64–1.22 | |
2 | 127 (40.4) | 187 (59.6) | 1.59 | 0.006 (1.14–2.22) | 1.21 | 0.80–1.82 | |
3 | 29 (37.2) | 49 (62.8) | 1.83 | 0.023 (1.09–3.08) | 1.57 | 0.74–3.32 | |
4 | 2 (33.3) | 4 (66.7) | 2.16 | 0.378 (0.39–12.03) | 1.73 | 0.14–21.33 | |
Gestational age | 2nd-trimester pregnancy | 157 (48.3) | 168 (51.7) | reference | reference | ||
3rd-trimester pregnancy | 342 (51.4) | 324 (48.6) | 0.89 | 0.368 (0.68–1.15) | 0.91 | 0.69–1.19 |
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Thanh, N.T.M.; Hang, L.T.; Hung, M.T.; Phuong, T.H.; Lan, N.T.P.; Tuan, M.D.; Bach, N.X.; Anh, N.D. Safety of and Adverse Reactions to the COVID-19 Vaccine Among Pregnant and Breastfeeding Women. Med. Sci. 2025, 13, 38. https://doi.org/10.3390/medsci13020038
Thanh NTM, Hang LT, Hung MT, Phuong TH, Lan NTP, Tuan MD, Bach NX, Anh ND. Safety of and Adverse Reactions to the COVID-19 Vaccine Among Pregnant and Breastfeeding Women. Medical Sciences. 2025; 13(2):38. https://doi.org/10.3390/medsci13020038
Chicago/Turabian StyleThanh, Nguyen Thi Minh, Le Thi Hang, Mai Trong Hung, Tran Hoa Phuong, Nguyen Thi Phuong Lan, Mac Dang Tuan, Nguyen Xuan Bach, and Nguyen Duy Anh. 2025. "Safety of and Adverse Reactions to the COVID-19 Vaccine Among Pregnant and Breastfeeding Women" Medical Sciences 13, no. 2: 38. https://doi.org/10.3390/medsci13020038
APA StyleThanh, N. T. M., Hang, L. T., Hung, M. T., Phuong, T. H., Lan, N. T. P., Tuan, M. D., Bach, N. X., & Anh, N. D. (2025). Safety of and Adverse Reactions to the COVID-19 Vaccine Among Pregnant and Breastfeeding Women. Medical Sciences, 13(2), 38. https://doi.org/10.3390/medsci13020038