Safety of Tdap vaccine in pregnant women: an observational study.
OBJECTIVE
Actively recruit and intensively follow pregnant women receiving a dose of acellular pertussis vaccine for 4 weeks after vaccination.


METHODS
A prospective observational study conducted in 2 New Zealand regions.


METHODS
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.


METHODS
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.


BACKGROUND
ACTRN12613001045707.
Department of General Practice and Primary Health Care, Immunisation Advisory Centre, The University of Auckland, Auckland, New Zealand.
Helen
H
Petousis-Harris
Department of Paediatrics, University of Otago, Christchurch, New Zealand.
Tony
T
Walls
Department of General Practice and Primary Health Care, Immunisation Advisory Centre, The University of Auckland, Auckland, New Zealand.
Donna
D
Watson
Department of General Practice and Primary Health Care, Immunisation Advisory Centre, The University of Auckland, Auckland, New Zealand.
Janine
J
Paynter
Canterbury District Health Board, Christchurch, New Zealand.
Patricia
P
Graham
Department of General Practice and Primary Health Care, Immunisation Advisory Centre, The University of Auckland, Auckland, New Zealand.
Nikki
N
Turner
D000293:Adolescent; D000328:Adult; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects; D005260:Female; D006801:Humans; D007252:Influenza Vaccines; D009520:New Zealand / Q000453:epidemiology; D010567:Pertussis Vaccine / Q000009:adverse effects*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology; D037841:Pregnant People; D015995:Prevalence; D011446:Prospective Studies; D012449:Safety; D014611:Vaccination / Q000009:adverse effects*; D014917:Whooping Cough / Q000517:prevention & control; D055815:Young Adult
D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D007252:Influenza Vaccines; D010567:Pertussis Vaccine
acellular pertussis vaccine; pregnancy; safety; vaccination; whooping cough