TableĀ 7

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

ParticipantEventSAE definitionOnset post-Tdap (days)Gestation at time of event (weeks)
24Cyanotic episodes in infantProlongation of existing hospitalisation3139
25Fetal death (trisomy 11q)Resulted in death1036
26Non-reassuring fetal statusIntervention to prevent permanent damage or death1138
27Non-reassuring fetal statusHospitalisation2339
28Non-reassuring fetal statusIntervention to prevent permanent damage or death3741
29Non-reassuring fetal statusIntervention to prevent permanent damage or death1839
30Non-reassuring fetal statusAdmission to the NICU and continuous positive airway pressure2837
31Perinatal death (stillbirth)Resulted in death5340
  • 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.