Table 2.
AEFI related to maternal exposure during pregnancy to COVID-19 vaccines distributed by Event Groups and Preferred Terms§.
| Event Groups | mRNA vaccines | Viral vector-based vaccines | Mix vaccination*(n=121) | Total(n=13,659) | ||
|---|---|---|---|---|---|---|
| Pfizer(n=6,429) | Moderna(n=4,165) | AstraZeneca(n=2,691) | Janssen(n=253) | |||
|
Maternal other AEFI
Headache Pyrexia Fatigue Myalgia Pain in extremity |
3,389 (52.71)
211 (3.28) 126 (1.96) 173 (2.69) 98 (1.52) 110 (1.71) |
2,287 (54.91)
122 (2.93) 133 (3.19) 136 (3.27) 71 (1.70) 93 (2.23) |
1,660 (61.69)
139 (5.17) 145 (5.39) 79 (2.94) 91 (3.38) 31 (1.15) |
139 (54.94)
4 (1.58) 8 (3.16) 6 (2.37) 2 (0.79) 2 (0.79) |
59 (48.86)
4 (3.31) 2 (1.65) 8 (6.61) 2 (1.65) 6 (4.96) |
7,534 (55.16)
480 (3.51) 414 (3.03) 402 (2.94) 264 (1.93) 242 (1.77) |
|
Termination of pregnancy and risk of abortion
Abortion spontaneous Fetal death Abortion missed Stillbirth Abortion |
490 (7.62)
381 (5.93) 41 (0.64) 35 (0.54) 8 (0.12) 5 (0.08) |
428 (10.28)
326 (7.83) 45 (1.08) 14 (0.34) 15 (0.36) 5 (0.12) |
270 (10.03)
222 (8.25) 2 (0.07) 5 (0.19) 4 (0.15) 17 (0.63) |
20 (7.91)
19 (7.51) - - 1 (0.40) - |
6 (4.96)
4 (3.31) 1 (0.83) 1 (0.83) - - |
1,214 (8.89)
952 (6.97) 89 (0.65) 55 (0.40) 28 (0.20) 27 (0.20) |
|
Pregnancy, labor, and delivery complications and risk factors (excluding abortions and stillbirth)
Hemorrhage in pregnancy Uterine contractions during pregnancy Premature labor Premature delivery Preeclampsia |
255 (3.97)
35 (0.54) 44 (0.68) 24 (0.37) 11 (0.17) 6 (0.09) |
249 (5.98)
31 (0.74) 13 (0.31) 26 (0.62) 23 (0.55) 16 (0.38) |
52 (1.93)
2 (0.07) 1 (0.04) 5 (0.19) 3 (0.11) 5 (0.19) |
12 (4.74)
- - 1 (0.40) 2 (0.79) 1 (0.40) |
7 (5.79)
1 (0.83) - - 2 (1.65) - |
575 (4.21)
69 (0.51) 58 (0.42) 56 (0.41) 41 (0.30) 28 (0.20) |
|
Fetal disorders
Fetal growth restriction Fetal hypokinesia Fetal heart rate abnormal Tachycardia fetal Amniorrhea |
166 (2.58)
40 (0.62) 32 (0.50) 16 (0.25) 9 (0.14) 4 (0.06) |
99 (2.38)
12 (0.29) 16 (0.38) 14 (0.34) 2 (0.05) 6 (0.14) |
14 (0.52)
- - 1 (0.04) 4 (0.15) 1 (0.04) |
7 (2.77)
- 3 (1.19) 1 (0.40) - - |
2 (1.65)
- 1 (0.83) 1 (0.83) - - |
288 (2.11)
52 (0.38) 52 (0.38) 33 (0.24) 15 (0.11) 11 (0.08) |
|
Congenital, familial, and genetic disorders
Congenital anomaly Multiple congenital abnormalities Ventricular septal defect Heart disease congenital Atrial septal defect |
103 (1.60)
12 (0.19) 3 (0.05) 3 (0.05) 6 (0.09) 4 (0.06) |
36 (0.86)
- 2 (0.05) 2 (0.05) - 2 (0.05) |
14 (0.52)
1 (0.04) 1 (0.04) 1 (0.04) - - |
1 (0.40)
- - - - - |
2 (1.65)
- - - - - |
156 (1.14)
13 (0.10) 6 (0.04) 6 (0.04) 6 (0.04) 6 (0.04) |
|
Neonatal disorders
Premature baby Low birth weight baby Death neonatal Jaundice neonatal Hypoglycemia neonatal |
97 (1.51)
56 (0.87) 2 (0.03) 4 (0.06) 4 (0.06) 3 (0.05) |
32 (0.77)
12 (0.29) 3 (0.07) 2 (0.05) 1 (0.02) 1 (0.02) |
11 (0.41)
5 (0.19) 2 (0.07) 1 (0.04) - - |
- - - - - - |
- - - - - - |
140 (1.02)
73 (0.53) 7 (0.05) 7 (0.05) 5 (0.04) 4 (0.03) |
|
Neonatal other AEFI
Cerebrovascular accident Pyrexia Cerebral infarction Death Anal fistula |
43 (0.67)
- 2 (0.03) 2 (0.03) 2 (0.03) 1 (0.02) |
8 (0.19)
- - - - - |
3 (0.11)
2 (0.07) - - - - |
2 (0.79)
1 (0.40) - - - - |
6 (4.96)
- - - - - |
62 (0.45)
3 (0.02) 2 (0.01) 2 (0.01) 2 (0.01) 1 (0.01) |
|
Fetal other AEFI
Cerebral ventricle dilatation Ureteric dilatation Myocarditis Pericarditis Brain hypoxia |
13 (0.20)
2 (0.03) 2 (0.03) 1 (0.02) 1 (0.02) 1 (0.02) |
- - - - - - |
- - - - - - |
- - - - - - |
- - - - - - |
13 (0.10)
2 (0.01) 2 (0.01) 1 (0.01) 1 (0.01) 1 (0.01) |
|
PTs not indicating AEFI
Maternal exposure during pregnancy Exposure during pregnancy Maternal exposure timing unspecified Fetal exposure during pregnancy Inappropriate schedule of product administration |
1,873 (29.13)
1170 (18.20) 239 (3.72) 105 (1.63) 45 (0.70) 83 (1.29) |
1,026 (24.63)
547 (13.13) 364 (8.74) 2 (0.05) 13 (0.31) 8 (0.19) |
667 (24.79)
379 (14.08) 158 (5.87) 2 (0.07) 40 (1.49) 2 (0.07) |
72 (28.46)
9 (3.56) 35 (13.83) - 2 (0.79) 1 (0.40) |
39 (32.23)
13 (10.74) 4 (3.31) - 3 (2.48) 1 (0.83) |
3,677 (26.92)
2118 (15.51) 800 (5.86) 109 (0.80) 103 (0.75) 95 (0.70) |
§ The first 5 mostly reported Preferred Terms were listed; the other Preferred Terms are reported in electronic Supplementary Table S1 .
* Mix vaccination was represented by the following combinations: Oxford-AstraZeneca/Pfizer-BioNTech, Moderna/Pfizer-BioNTech, and Moderna/Oxford-AstraZeneca.
Data are expressed as n (%).
AEFI, adverse event following immunization; mRNA, messenger RNA; PTs, preferred terms.Bold values stand for the total number of each single groups.