Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data

Inclusion Criteria

Inclusion Criteria: * For pregnant individuals: * Continuous enrollment, with no more than a 1-month administrative gap from 90 days prior to their last menstrual period (LMP) * Continuous enrollment for the duration of their pregnancy through delivery or termination of pregnancy (or 6 weeks postpartum for preeclampsia/eclampsia and 28 days for PPH) unless censored at death in order to capture study outcomes * At least 1 prenatal visit prior to 27 weeks of gestation during pregnancy * For offspring: * Infants delivered by pregnant individuals who meet all the inclusion criteria above * With gestational age as calculated based on date of birth recorded in the EMR Exclusion Criteria: * For pregnant individuals: * Loss of pregnancy or with delivery before 27 weeks of gestation * Vaccinated with Boostrix® (Tdap vaccine, GSK), or with an unknown brand of Tdap vaccine, or Td (tetanus, diphtheria) vaccine during pregnancy * Vaccinated with any Tdap vaccine prior to the ACIP recommended optimal timeframe of ≥ 27 0/7 weeks of gestation * Received more than one Tdap vaccine during pregnancy * Vaccinated with one or more live vaccines during pregnancy * Pregnant individuals with multiple gestation pregnancies (eg, twins, triplets) * For offspring: * Infants delivered by pregnant individuals who meet any of the exclusion criteria above