Researchers Identify 14 Safety Signals of COVID-19 Vaccines for Women of Childbearing Age

Pregnancy and menstrual abnormalities are significantly more frequent following COVID-19 vaccinations when compared to influenza vaccinations leading a group of researchers to recommend banning COVID vaccines in pregnancy until randomized prospective trials show its safe for pregnant women and their offspring.

In a new preprint study released Sept. 28, researchers identified 14 safety signals for COVID-19 vaccines for women of childbearing age including menstrual abnormalities, miscarriage, stillbirth and fetal cardiac arrest.

Using data collected from Vaccine Adverse Event Reporting System (VAERS), researchers assessed the rates of adverse events associated with pregnancy and menstruation reported by women of reproductive age after receiving a COVID-19 vaccine.

VAERS is a database for reporting adverse vaccine reactions co-managed by the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA).

Researchers in the study used proportional reporting ratio (PRR) analysis to analyze rates of adverse events by time, dose and person. PRR involves comparing the rates of adverse events following one type of vaccination with the rates of adverse events following a different vaccination or all other types of vaccinations.

The researchers found COVID-19 vaccines, when compared to the Influenza vaccines are associated with a significant two-fold increase in 14 adverse events including menstrual abnormalities, 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.

According to the CDC, a twofold increase constitutes a safety signal, which identifies a possible connection between a vaccine and an adverse event.

“When normalized by time-available, doses-given, or persons-received, all COVID-19 vaccine AE [adverse events] far exceed the safety signal on all recognized thresholds,” they wrote.

The CDC said it would perform PRR analysis on VAERS reports by comparing reports following a COVID-19 vaccine to reports following all other vaccines. Yet the CDC, to date, has refused to provide the results to the public.

The agency, earlier this year, said it didn’t perform and wouldn’t perform PRR on reports, contradicting previous statements. Dr. John Su, a top CDC official, then said the agency started performing these analysis in February 2021. The CDC later reversed itself again, saying it didn’t begin using PRR until 2022.

CDC Director Dr. Rochelle Walensky said in a recent letter that the PRRs the CDC performed identified “no additional unexpected safety signals.” Yet, they only assessed four adverse events linked to COVID-19 vaccines including allergic shock, blood clotting, Guillain-Barré syndrome and heart inflammation. They also utilize narrowed definitions of these conditions, which potentially exclude thousands of reported adverse events.

The FDA said it performed another type of analysis known as empirical Bayesian data mining, which didn’t identify any safety signals, but they have refused to release the results.