pcb Deinard 1981.

Methods	Prospective cohort study assessing the safety of monovalent A/NJ/8/76 vaccine administration during pregnancy
Participants	Pregnant women enrolled at several obstetric clinics (Minneapolis) on the occasion of a prenatal visit (n = 706)
Interventions	Flu vaccine containing A/NewJersey/8/76 (split‐ or whole‐virus formulation) administered during the first, second, or third pregnancy trimester. Vaccine was administered to 189 women, whereas 517 acted as unvaccinated controls.
Outcomes	Local and systemic reactions observed and reported after vaccine administration (only the vaccinated assessed by questionnaire). Pregnancy outcomes: maternal mortality, elective abortion, spontaneous abortion, stillbirth, premature live birth. Infant outcomes: deaths, major or minor congenital anomalies, abnormalities during the first 8 days of life.
Notes	This study should have been performed without external/private/industry funding. Government funded
Risk of bias
Bias	Authors' judgement	Support for judgement
PCS/RCS ‐ selection exposed cohort All outcomes	High risk
PCS/RCS ‐ selection non‐exposed cohort All outcomes	High risk
PCS/RCS ‐ comparability All outcomes	High risk
PCS/RCS ‐ assessment of outcome All outcomes	High risk
Summary assessment	High risk