I was wrong: the miscarriage rate after mRNA shots was not 82%, it was increased by 430%!
Revisiting the infamous Shimabukuro et al pregnancy study with adjustment for the background rates of miscarriage.
Dear Readers,
I have provided the information in this article to Senator Ron Johnson as an input to his open investigation into Tom Shimabukuro and other CDC/NIH officials hiding and destroying safety signals of the covid shots, and he has acknowledged the receipt.
Let me address the recent news which you have likely heard by now - the indictment of Dr. Morens, a Fauci underling for “managing” Fauci’s emails into a black hole. It is of course good news, but I am not going to spin this into “justice is finally here” headline, at least not yet. That’s because justice is not here - as of now, we still have the PREP Act declaration for the fake covid pandemic, and until it’s revoked by Kennedy or his successor, anything advertised as “justice” is a political theater in an election year. Here is a very good take from Celia Farber. I share her bitterness and anger at the same tactics being used by the power cabal and swallowed by zombified public for decades:
I have previously published a high level assessment of the infamous study[1], by numerous prominent co-authors with Tom Shimabukuro as the lead author, that claimed there were “no obvious safety signals” associated with COVID-19 vaccines in pregnancy:
The reason for the use of the modifier “obvious” by the authors will become obvious to you shortly.
Edit: for historical reference, this is the first version of the Shimabukuro et al article as originally published on NEJM.
After publishing the above article, pointing at the math fraud pulled by Shimabukuro et al, I was subjected to a campaign of online attacks and smears from the anonymous mouse agents, and their numerous hangers-on. You may know these characters - Sam Saidi, aka Jikky, aka Arkmedic and his associates and a few affiliated named individuals. Anonymous trolls claiming to be fighters for health freedom tend to do this type of stuff quite a lot. I didn’t have time to do an in-depth reanalysis of Shimabukuro data at the time, and I was hoping that the full dataset will eventually be released and the truth will become self evident.
The complete v-safe dataset for pregnancy has not been released to date. Currently, the covid injection labels state that there is no information for the use in pregnancy. This is despite “post marketing commitment” that the manufacturers were supposed to conduct these studies by 2023 or so. In addition, I was recently motivated by a colleague to actually look into the missing “background/normal” rate of miscarriage and perform this reanalysis.
The work of Shimabukuro et al., which is repeatedly cited as a reference for the good tolerability of the COVID-19 vaccine, used numerous methods to lie professionally, with statistics, including using middle school-level math fraud to conceal elevated pregnancy losses among 3,958 women who signed up to participate in the v-safe registry (a mobile app by CDC). As reported in the “preliminary” paper published in NEJM, the total dataset included 1224 covid vaccinated women enrolling in registry at the first trimester of pregnancy (<14 weeks), starting on Dec 14, 2020. Most of the women were healthcare workers.
The study protocol[2] defined the primary outcome measures of “pregnancy loss” after COVID-19 vaccination as “miscarriage” (<20 weeks) and “stillbirth” (20+ weeks) of gestation. The “preliminary” analysis of outcomes was restricted to “completed pregnancies only” in a subset of 827 women, who both, received the vaccination and already reported the pregnancy outcome to v-safe between December 14, 2020 and February 28, 2021. Of these, 700 women received vaccination in the 3rd and 127 - in 1st-2nd trimester. In 104 women, the child was lost before the 20th week of gestation (a “miscarriage” per protocol definition), and 11 lost pregnancies after the 20th week (a “stillbirth” per protocol definition).
The authors’ conclusion declared that there was “no obvious safety signal” for increased pregnancy losses with COVID-19 vaccination. This statement is recklessly negligent and deceptive. In a footnote of Table 4 the authors stated that the protocol-required miscarriage rate could not be computed: “No denominator was available to calculate a risk estimate for spontaneous abortions, because at the time of this report, follow-up through 20 weeks was not yet available for 905 of the 1224 participants vaccinated within 30 days before the first day of the last menstrual period or in the first trimester”. This is deceptive, because according to the clinical research standards[3],[4], it is not scientifically acceptable to disregard the prespecified primary outcome measure and simply declare a result preferred by the authors or study sponsors.
Due to the data restriction to the narrow 6-week window for capturing pregnancy outcomes, only pregnancy losses could be captured for the 127 women which were vaccinated in early pregnancy. All 127 suffered a pregnancy loss, of whom 104 suffered a miscarriage before the 20th week. However, despite stating that calculation of the miscarriage rate in this dataset could not be done, Shimabukuro et al, nonetheless, reported the miscarriage rate as 12.6% elsewhere - not in Table 4 but in the text of the paper. They arrived at this false figure by including all subjects in the denominator, the vast majority of whom (700) could not have had a protocol-defined miscarriage, having been vaccinated and enrolled in the 3rd trimester of pregnancy (i.e. after 20 weeks). Therefore, the reported 12.6% is fraudulent mathematics.
Further, Shimabukuro et al simultaneously claimed that there was no applicable statistic for “background” or normally expected rate for miscarriages. This is false. The background rate is available in scientific literature, including risk estimates by week at early weeks of gestation. Specifically, one highly cited prospectively designed cohort study, S. Tong et al[5] in a cohort of 696 pregnancies observed from around week 6 to term demonstrated that for clinically recognized pregnancies, “The risk of miscarriage among the entire cohort was 11 of 696 (1.6%). The risk fell rapidly with advancing gestation; 9.4% at 6 (completed) weeks of gestation, 4.2% at 7 weeks, 1.5% at 8 weeks, 0.5% at 9 weeks and 0.7% at 10 weeks (chi(2); test for trend P=.001)…Conclusion: For women without symptoms, the risk of miscarriage after attending a first antenatal visit between 6 and 11 weeks is low (1.6% or less)”.
Additionally, background rate of stillbirths reported by CDC in the US is ~6/1000 live births[6], corresponding very well to what was found by Tong et al, i.e. at week 11 the risk is 0.7% and therefore, after 11 weeks and to term it is a steady ~0.6%.
At this point, some of you may pause and say - wait… what about the 10%, 15% or even 20% miscarriage rates frequently cited everywhere? How come, when observed prospectively to term, we see only 1.6% rate for pregnancy loss? The below chart should explain the fallacy about 10%-20% miscarriage rates that the establishment medical system, including CDC and FDA want you to believe, IMO, because they need to cover up the devastating impact of vaccines and drugs pushed on pregnant women as “safe in pregnancy”. The establishment quotes the highest rates they can find, obtained in cross-sectional analyses of miscarriage before 6 weeks of gestation. They then project this risk (falsely!) on the entire first 20 weeks, which is arbitrarily declared a “miscarriage” period.
The above chart shows how most of the public and professionals misinterpret the risk, falsely ascribing a MUCH higher rate for an inappropriately long period of time.
The true risk calculation is demonstrated below. The very high risk of 20%+ exists only very briefly at the very first weeks of pregnancy. The risk falls to ~10% by week 6, and then rapidly drops to 1% or less by week 11! Six weeks of gestation represent only 15% of the duration of pregnancy, the next 5-6 weeks (another 15% of the gestation time) show an average of 5%, and subsequent 28 weeks have a risk rate of 0.6%-0.7%. Using these estimates, we arrive at the total risk of pregnancy loss, when estimated for each individual woman on a cohort basis, i.e. longitudinally, at around 1%-2%!
Therefore, the risk estimates from cross-sectional population studies are population statistics, not individual risk estimates, and the vast majority of pregnancies (at least for now) are carried to term, i.e. they pass the week 6 and beyond uneventfully.
Applying the background miscarriage risk to the Shimabukuro et al v-safe pregnancy dataset:
Given these established background rates, it is straightforward to calculate that in the entire cohort of 1224 women, who enrolled in the v-safe pregnancy registry during the 1st trimester, the total expected pregnancy losses should have been ~20 (1224x1.6%). Yet, in the first 6 weeks of the registry Shimabukuro et al dataset already captured 104 pregnancy losses for the entire 1st trimester cohort! This represents ~431% increase from the expected! Even considering that 92 of the pregnancies were enrolled earlier than 6 weeks and applying a reported higher risk rate of 15% or even 30% (which is higher than reported in literature) to that group, the resulting increase in miscarriages in the 1st trimester cohort is ~188%-280%. This is a gigantic safety signal, which Shimabukuro et all declared “not obvious” by obfuscation and fraudulent math.
Of additional concern was the remainder of pregnancy losses in Shimabukuro et al study, specifically 10 cases which were lost after 20 weeks of gestation. Only 1 was reported by the authors as a stillbirth, others – as “induced abortion”. Per definitions of the protocol outcome measures, they should have been counted as “stillbirths”. Therefore, in a set of 712 live births, approximately 4 still births should have been expected (0.6%). Thus, an increase in stillbirths of around 140% is observed in this study, which is a separate and very alarming safety signal.
Miscarriage safety signals were TRUE:
Of course, we all know that the safety signals observed very early in v-safe registry have been validated by the observed severe harms to pregnancies. The safety signal from v-safe registry was loud, clear and also TRUE, and was ignored and covered up by the US Government, academia and healthcare establishment.
To preempt the usual “debunking” and “fact checking” and arguments from the “health freedom” side that wants to paint me as a radical - if you search for “miscarriage” and “spontaneous abortion” in the VAERS symptom field, you will find approximately the following statistics:
ALL vaccines excluding covid-19 shots, for ALL time (30+ years) will return approximately 750 reports.
Searching for COVID-19 vaccines only will produce ~1500 reports!
I am not a radical on this topic at all. I am an experienced drug development professional. Given the magnitude of the problem, I am willing to bet large amounts of money that there is no possible statistical adjustment out there to make this signal go away.
It is not a surprise, that while calling the study “preliminary” and promising to perform a complete data analysis, Shimabukuro et al seemed to have lost interest in this important dataset and never published a follow up. The full v-safe pregnancy registry remains unaccounted for and has not been publicly released to date. These poisoners knew that it will be impossible to “disappear” the increases in miscarriage rates of around 400% by any statistical adjustment tricks, and thus, they are not interested in making this dataset public. The dataset should be FOIAed and fully analyzed. I am not optimistic about this ever happening, and it is possible that Tom Shimabukuro already destroyed it.
Shimabukuro was (still is?) subject to a Congressional investigation for data fraud, hiding safety signals and destruction of safety data, yet no development has happened in this investigation since April 2025.
“Dr. Shimabukuro’s potential mishandling of his official records is highly concerning. His actions, if true, would have directly obstructed my multi-year oversight efforts of the COVID-19 vaccines and would be in clear violation of my November 19, 2024 demand to HHS, CDC, and the Food and Drug Administration to ‘preserve all records referring or relating to the development, safety, and efficacy of the COVID-19 vaccines.’ Furthermore, given Dr. Shimabukuro’s role at CDC, which includes monitoring adverse events relating to the COVID-19 vaccines, his communications are directly responsive to my January 28, 2025, subpoena to HHS for records relating to the development and safety of the COVID-19 vaccines. Any attempt to obstruct or interfere with my investigatory efforts would be grounds for contempt of Congress,” Chairman Johnson wrote.
Chairman Johnson has called on these agencies to initiate an investigation to determine:
The extent to which officials with HHS and its sub-agencies, including Dr. Tom Shimabukuro, deleted or destroyed official agency records; and
The extent to which officials with HHS and its sub-agencies, including Dr. Tom Shimabukuro, deleted or destroyed official agency records to avoid or subvert Congressional oversight or the Freedom of Information Act.
Read more about the letter in the New York Post.
Full text of the letter can be found here.
It is not clear whether any progress on this investigation has been made. In the meantime, the system for real-time tracking, surveillance and targeting of the pregnant women with poison shots is being quietly installed:
[1] https://www.nejm.org/doi/full/10.1056/NEJMoa2104983
[2] https://www.nejm.org/doi/suppl/10.1056/NEJMoa2104983/suppl_file/nejmoa2104983_appendix.pdf
[3] https://clinicaltrials.gov/policy/results-definitions#outcomeMeasures
[4] https://www.consort-spirit.org/item14-outcomes
[5] https://pubmed.ncbi.nlm.nih.gov/18310375/
[6] https://pubmed.ncbi.nlm.nih.gov/26222771/
Art for today: Poppies in a blue vase, oil on panel, 9x12 in. Available art here.
Thank you for this research. I have a friend who was working in a big obstgyn clinic in Montreal. She has been there for 18 years. During the rollout (not the covid period prior), they have seen it all: miscarriages, still borns, menstrual problems, bleeding in menopausal women (even women in their 80s), dormant feminine cancers resurging. The doctors were baffled but kept pushing really hard for all their patients to be jabbed. the receptionnists were quite discouraged to answer another catastrophic call. That bad. My friend had never seen this situation at the clinic before. She noticed a clear pattern: most of their patients's miscarriages happened exactly 2 weeks after the jab. It was a very dark period for her. Because of severe allergies to medication she refused to be jabbed, was fired by a doctor who insisted she be vaccinated (it could mean a death sentence for her). She proposed working remotely, they accepted but still insisted on my friend being jabbed! - as if this makes sense-. She refused and found another opportunity. The zealous doctor died a year later from a very strange, quick spreading blood cancer. I consider this clinic guilty of murders. All obsgyn medical facilities fully participated in this genocide by refusing to sound the alarm.
In my small circle of close relatives, all vaxxed: one baby died in utero at 8 mos gestation from a fetal brain bleed; three mothers-to-be miscarried, one with unexplained infertility starting IVF. And that’s just what I know. All forced to vax or lose jobs. They are young and felt pressured and couldn’t imagine the gov would cause them harm. They naively trusted their obgyn. So very sad. It is horrific.