Table 7.

SAEs during labour in and among infants of 793 pregnant women vaccinated with Tdap

Participant	Event	SAE definition	Onset post-Tdap (days)	Gestation at time of event (weeks)
24	Cyanotic episodes in infant	Prolongation of existing hospitalisation	31	39
25	Fetal death (trisomy 11q)	Resulted in death	10	36
26	Non-reassuring fetal status	Intervention to prevent permanent damage or death	11	38
27	Non-reassuring fetal status	Hospitalisation	23	39
28	Non-reassuring fetal status	Intervention to prevent permanent damage or death	37	41
29	Non-reassuring fetal status	Intervention to prevent permanent damage or death	18	39
30	Non-reassuring fetal status	Admission to the NICU and continuous positive airway pressure	28	37
31	Perinatal death (stillbirth)	Resulted in death	53	40

Clinician review and assessment of each of these cases found that none were likely to be vaccine related.

NICU, neonatal intensive care unit; SAE, serious adverse event.