Table 6

SAEs reported among pregnant women following immunisation in 793 pregnant women vaccinated with Tdap

ParticipantEventSAE definitionOnset post-Tdap (days)Gestation at time of event (weeks)
1PV bleedingRequired hospitalisation1130
2Hypertension in pregnancyRequired hospitalisation2740+
3Pelvic pain, bacterial vaginitisRequired hospitalisation934
4CellulitisRequired hospitalisation638
5Hypertension in pregnancyRequired hospitalisation1134
6Threatened labour and group A strep infectionRequired hospitalisation2031
7BleedingRequired hospitalisation2436
8Maternal tachycardiaRequired hospitalisation1634
9Gestational diabetes and antenatal partum haemorrhageRequired hospitalisation2934
10Preterm labourRequired hospitalisation136
11Preterm labourRequired hospitalisation2436
12Preterm labourRequired hospitalisation733
13Exacerbation of pre-existing conditionRequired hospitalisation1736
14Exacerbation of pre-existing conditionRequired hospitalisation719
15Pre-eclampsiaRequired hospitalisation836
16Preterm labourRequired hospitalisation1636
17Preterm labourRequired hospitalisation1936
18Preterm labourRequired hospitalisation1133
19Preterm labourRequired hospitalisation1936
20Vaginal bleedingRequired hospitalisation2134
21Preterm labourRequired hospitalisation934
22Preterm labourRequired hospitalisation∼15*36
23Infection (coronavirus)Required hospitalisation134
  • *No delivery date was recorded for this participant.

  • SAE, serious adverse event.