Article Text

Download PDFPDF

Safety of Tdap vaccine in pregnant women: an observational study
  1. Helen Petousis-Harris1,
  2. Tony Walls2,
  3. Donna Watson1,
  4. Janine Paynter1,
  5. Patricia Graham3,
  6. Nikki Turner1
  1. 1Department of General Practice and Primary Health Care, Immunisation Advisory Centre, The University of Auckland, Auckland, New Zealand
  2. 2Department of Paediatrics, University of Otago, Christchurch, New Zealand
  3. 3Canterbury District Health Board, Christchurch, New Zealand
  1. Correspondence to Helen Petousis-Harris; h.petousis-harris{at}


Objectives Actively recruit and intensively follow pregnant women receiving a dose of acellular pertussis vaccine for 4 weeks after vaccination.

Design and settings A prospective observational study conducted in 2 New Zealand regions.

Participants Women in their 28th–38th week of pregnancy, recruited from primary care and antenatal clinics at the time of Tdap administration. Telephone interviews were conducted at 48 h and 4 weeks postvaccination.

Main outcomes measures Outcomes were injection site reactions, systemic symptoms and serious adverse events (SAEs). Where available, data have been classified and reported according to Brighton Collaboration definitions.

Results 793 women participated with 27.9% receiving trivalent inactivated influenza vaccine concomitantly. 79% of participants reported mild or moderate pain and 2.6% severe pain. Any swelling was reported by 7.6%, induration by 12.0% (collected from 1 site only, n=326), and erythema by 5.8% of participants. Fever was reported by 17 (2.1%) participants, 14 of these occurred within 24 h. Headache, dizziness, nausea, myalgia or arthralgia was reported by <4% of participants, respectively, and fatigue by 8.4%. During the study period, there were 115 adverse events in 113 participants, most of which were minor. At the end of the reporting period, 31 events were classified as serious (eg, obstetric bleeding, hypertension, infection, tachycardia, preterm labour, exacerbation of pre-existing condition and pre-eclampsia). All had variable onset time from vaccination. There were two perinatal deaths. Clinician assessment of all SAEs found none likely to be vaccine related.

Conclusions Vaccination with Tdap in pregnant women was well tolerated with no SAE likely to be caused by the vaccine.

Trial registration number ACTRN12613001045707.

  • whooping cough
  • acellular pertussis vaccine
  • safety
  • vaccination
  • pregnancy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:

View Full Text

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.