COVID-19 Vaccine Safety Analysis Finds Signals for Miscarriage, Menstrual Irregularities

A healthcare worker prepares a COVID-19 vaccine in Southfield, Mich., in an Aug. 24, 2021, file image. (Emily Elconin/Getty Images)

Researchers have identified 14 safety signals for the COVID-19 vaccines for women of childbearing age, including menstrual abnormality, miscarriage, and fetal cardiac arrest, according to a study released on Sept. 28.

Dr. James Thorp, a maternal fetal medicine specialist in Florida, and other researchers performed a type of analysis called proportional reporting ratio (PRR) on reports submitted to the Vaccine Adverse Event Reporting System (VAERS). The system accepts reports of adverse events following vaccination.

Comparing the rates of events following COVID-19 vaccination to those reported following influenza vaccination for women who can bear children, the researchers found a significant increase in 14 conditions, including fetal malformation, fetal cardiac arrest, and stillbirth.

“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,” researchers said in the study, which was published online ahead of peer review.

“There’s enough of a safety signal in our research in looking at VAERS that really we should take a pause from the vaccines until they are studied more in depth,” Claire Rogers, with the Truth for Health Foundation and one of the authors, told The Epoch Times.

The Centers for Disease Control and Prevention (CDC) recommends COVID-19 vaccines for virtually all people aged 6 and older, including pregnant women. Other governments have offered mixed signals; the British government says that “sufficient reassurance of safe use of” the Pfizer vaccine in pregnant women “cannot be provided at the present time,” although the UK Medicines and Healthcare Products Regulatory Agency says that pregnant women should be offered COVID-19 vaccines, including the Pfizer one.

Some groups and doctors support widespread vaccination, while others have called for a pause on some or all of the vaccines due in part to safety concerns.

The pause on administering the vaccines to pregnant women would allow randomized prospective trials to be run to analyze vaccine safety, researchers said in the new study.

PRR Analysis

Proportional reporting ratio analysis involves comparing the rates of adverse events following one type of vaccination with the rates of adverse events following a different type or all other types of vaccination. The researchers in the new study analyzed the relative rates by time, by dose, and per person.

Adverse events that were identified as having an increase with COVID-19 vaccination of twofold or more, compared to flu vaccination include 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, stillbirth, and low amniotic fluid.

An increase of twofold or more constitutes a safety signal, according to the CDC. A safety signal is an identification of a possible connection between a vaccine or vaccines and an adverse event.

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

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

CDC Director Dr. Rochelle Walensky said in a recent letter that the PRRs the CDC did perform identified “no additional unexpected safety signals.” The expected signals were four adverse events that have been linked to COVID-19 vaccines, a CDC spokesperson told The Epoch Times via email. They are severe allergic shock, blood clotting, Guillain-Barré syndrome, and heart inflammation.

Another type of analysis on VAERS data, empirical Bayesian data mining, was done by Food and Drug Administration researchers. They have said they didn’t identify any signals for the vaccines authorized in the United States, but they also have refused to release the results.