Table 3.
Seriousness and outcome of AEFI related to maternal exposure during pregnancy to COVID-19 vaccines reported in EudraVigilance from 1 January 2021 to 31 December 2021.
| Variable | Level | 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) | ||||
| Seriousness | Caused/Prolonged Hospitalization (%) | 554 (8.62) | 758 (18.20) | 354 (13.15) | 42 (16.60) | 26 (21.49) | 1,734 (12.69) |
| Other Medically Important Condition (%) | 3,043 (47.33) | 1,310 (31.45) | 1,050 (39.02) | 68 (26.88) | 50 (41.32) | 5,521 (40.42) | |
| Life Threatening (%) | 184 (2.86) | 152 (3.65) | 98 (3.64) | 108 (42.69) | 6 (4.96) | 548 (4.01) | |
| Results in Death (%) | 203 (3.16) | 10 (0.24) | 68 (2.53) | – | 2 (1.65) | 283 (2.07) | |
| Disabling (%) | 177 (2.75) | 98 (2.35) | 176 (6.54) | – | – | 451 (3.30) | |
| Congenital Anomaly (%) | 170 (2.64) | 247 (5.93) | 215 (7.99) | 3 (1.19) | 13 (10.74) | 648 (4.74) | |
| Not Serious (%) | 2,098 (32.63) | 1,590 (38.18) | 730 (27.13) | 32 (12.65) | 24 (19.83) | 4,474 (32.75) | |
| Outcome | Recovered/Resolved (%) | 1,392 (21.65) | 1,931 (46.36) | 706 (26.24) | 79 (31.23) | 2 (9.92) | 4,120 (30.16) |
| Recovering/Resolving (%) | 749 (11.65) | 257 (6.17) | 285 (10.59) | 9 (3.56) | 14 (11.57) | 1,314 (9.62) | |
| Not Recovered/Not Resolved (%) | 1,038 (16.15) | 898 (21.56) | 394 (14.64) | 70 (27.67) | 19 (15.70) | 2,419 (17.71) | |
| Fatal (%) | 203 (3.16) | 10 (0.24) | 68 (2.53) | – | 2 (1.65) | 283 (2.07) | |
| Recovered/Resolved with Sequelae (%) | 94 (1.46) | 19 (0.46) | 61 (2.27) | – | 8 (6.61) | 182 (1.33) | |
| Unknown (%) | 2,953 (45.93) | 1,050 (25.21) | 1,177 (43.74) | 95 (37.55) | 66 (54.55) | 5,341 (39.10) | |
*Mix vaccination was represented by the following combinations: Oxford-AstraZeneca/Pfizer-BioNTech, Moderna/Pfizer-BioNTech, and Moderna/Oxford-AstraZeneca.
§ Total number of unique ICSR-PT combinations (superior to the number of ICSRs because an ICSR may be assigned one or more MedDRA PTs).
Data are expressed as n (%).
AEFI, adverse event following immunization; mRNA, messenger RNA.