How to cite: Thorp, J.A.; Rogers, C.; Deskevich, M.P.; Tankersley, S.; Benavides, A.; Redshaw, M.D.; McCullough, P.A. COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function. Preprints 2022, 2022090430 (doi: 10.20944/preprints202209.0430.v1). Thorp, J.A.; Rogers, C.; Deskevich, M.P.; Tankersley, S.; Benavides, A.; Redshaw, M.D.; McCullough, P.A. COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function. Preprints 2022, 2022090430 (doi: 10.20944/preprints202209.0430.v1).Copy
Objectives: Assess rates of adverse events (AE) after COVID-19 vaccines experienced by women of reproductive age, focusing on pregnancy and menstruation, using data collected by the US Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS) database. Design: Population based retrospective cohort study. Setting: US and global entries in US Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS). Participants CDC VAERS entries from January 1, 1998 to June 30, 2022. Interventions: None. Main Outcome and Measures: A proportional reporting ratio analysis is performed using data in the VAERS system comparing adverse events (AE) reported post COVID-19 vaccines with that of post-Influenza vaccines. Results: COVID-19 vaccines, when compared to the Influenza vaccines are associated with a significant increase in AE with all proportional reporting ratios of > 2.0: menstrual abnormality, miscarriage, fetal chromosomal abnormalities, fetal malformation, fetal cystic hygroma, fetal cardiac disorders, fetal arrhythmia, fetal cardiac arrest, fetal vascular mal-perfusion, fetal growth abnormalities, fetal abnormal surveillance, fetal placental thrombosis, low amniotic fluid, and fetal death/stillbirth (all p values were much smaller than 0.05). When normalized by time-available, doses-given, or persons-received, all COVID-19 vaccine AE far exceed the safety signal on all recognized thresholds. Conclusions: Pregnancy and menstrual abnormalities are significantly more frequent following COVID-19 vaccinations than that of Influenza vaccinations. A worldwide moratorium on the use of COVID-19 vaccines in pregnancy is advised until randomized prospective trials document safety in pregnancy and long-term follow-up in offspring.