Table 2.
Cumulative incidence of pregnancy-related adverse events and neonatal AEs of interest in current pregnancy in the exposed and unexposed cohorts (total-enrolled cohort).
| Exposed cohort N = 1199 |
Unexposed cohort N= 1259 |
|||
|---|---|---|---|---|
| Adverse event or birth outcome | n | Incidence proportion per 1000 (99% CI) |
n | Incidence proportion per 1000 (99% CI) |
| Gestational diabetes | 10 | 8.34 (3.10; 17.85) | 22 | 17.47 (9.37; 29.56) |
| Pregnancy-related hypertensiona | 11 | 9.17 (3.60; 19.00) | 31 | 24.62 (14.72; 38.47) |
| Pre-Eclampsia | 10 | 8.34 (3.10; 17.85) | 30 | 23.83 (14.11; 37.50) |
| Eclampsia | 2 | 1.67 (0.09; 7.73) | 0 | 0.00 (0.00; 4.21) |
| HELLP Syndrome | 0 | 0.00 (0.00; 4.42) | 1 | 0.79 (0.00; 5.90) |
| Vaginal hemorrhage | 4 | 3.34 (0.56; 10.50) | 19 | 15.09 (7.66; 26.52) |
| Preterm birth | 64 | 53.38 (37.76; 73.09) | 121 | 96.11 (75.10; 120.99) |
| Small for gestational age | 69 | 57.55 (41.27; 77.92) | 62 | 49.25 (34.63; 67.77) |
Abbreviations: CI, confidence interval; N, number of participants at risk (unexposed cohort) and with vaccination date (exposed cohort); n, number of participants where at least one event that occurred (1) between index date and date of delivery for pregnancy-related adverse events and (2) after index date for birth outcome events (preterm birth and small for gestational age). Vaginal hemorrhage includes ante-partum, intra-partum, and post-partum hemorrhage.
Note: aIn the total cohort, 146 pregnant women (93 in the exposed cohort and 53 in the unexposed cohort) experienced gestational or pregnancy-related hypertension independently of pre-eclampsia or eclampsia recorded in the free text variable of the electronic case report form.