Table 6.

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

Participant	Event	SAE definition	Onset post-Tdap (days)	Gestation at time of event (weeks)
1	PV bleeding	Required hospitalisation	11	30
2	Hypertension in pregnancy	Required hospitalisation	27	40+
3	Pelvic pain, bacterial vaginitis	Required hospitalisation	9	34
4	Cellulitis	Required hospitalisation	6	38
5	Hypertension in pregnancy	Required hospitalisation	11	34
6	Threatened labour and group A strep infection	Required hospitalisation	20	31
7	Bleeding	Required hospitalisation	24	36
8	Maternal tachycardia	Required hospitalisation	16	34
9	Gestational diabetes and antenatal partum haemorrhage	Required hospitalisation	29	34
10	Preterm labour	Required hospitalisation	1	36
11	Preterm labour	Required hospitalisation	24	36
12	Preterm labour	Required hospitalisation	7	33
13	Exacerbation of pre-existing condition	Required hospitalisation	17	36
14	Exacerbation of pre-existing condition	Required hospitalisation	7	19
15	Pre-eclampsia	Required hospitalisation	8	36
16	Preterm labour	Required hospitalisation	16	36
17	Preterm labour	Required hospitalisation	19	36
18	Preterm labour	Required hospitalisation	11	33
19	Preterm labour	Required hospitalisation	19	36
20	Vaginal bleeding	Required hospitalisation	21	34
21	Preterm labour	Required hospitalisation	9	34
22	Preterm labour	Required hospitalisation	∼15*	36
23	Infection (coronavirus)	Required hospitalisation	1	34

*No delivery date was recorded for this participant.

SAE, serious adverse event.