Multiple Pregnancies in a Pfizer Trial Ended in Miscarriages. Pfizer Misleadingly Reclassified Them
A Pfizer adverse events document released by the Food and Drug Administration (FDA) on July 1, 2022, reveals chilling data showing 44 percent* of pregnant women participating in Pfizer’s mRNA COVID vaccine trial suffered miscarriages. [125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.pdf, https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/070122/125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.zip] A section of the document, on page 3643, called Listing of Subjects Reporting Pregnancy After Dose 1, shows that 50 women became pregnant during the trial. However, one must dig through the rest of the large document to learn that 22* of the 50* women suffered “Abortion Spontaneous,” “Abortion Spontaneous Complete,” “Abortion Spontaneous Incomplete,” or “Miscarriage.” [pp. 219, 561, 708, 1071, 1146, 1179, 1349, 1749, 1758, 1806, 1809, 3519, 3526, 3560, 3536, 3537, 3538, 3536, 3547, and 3551.] The adverse events report cut-off date was March 13, 2021, and the FDA received the report from Pfizer on April 1, 2021. Thus, the FDA was aware of the horrifying rate of fetal death by the start of April 2021.
The women listed in Listing of Subjects Reporting Pregnancy After Dose 1 received between one and four injections each. 42 of the women received the trial drug right away. Eight received the placebo and were then unblinded and given the vaccine. So, by March 31, 2021, all the pregnant women in the trial had received Pfizer’s BNT162b2 version of the vaccine.
Pfizer notes the miscarriages as serious adverse events (SAEs) with ‘moderate’ (2) or ‘severe’ (3) toxicity ratings. However, all the miscarriages were reported as being unrelated to the trial vaccine – i.e., having ‘Other’ causes – and marked as ‘Recovered/resolved’ adverse effects. To reiterate, not only does Pfizer deny any vaccine-related causality and assert the losses of life had other causes, but it also categorizes losing a baby as a ‘resolved adverse effect’ – like a headache that went away.
Here are some questions the public should be asking:
- How did Pfizer determine their experimental vaccine product did not cause the miscarriages?
- What ‘Other’ causes did Pfizer identify, and how did it identify them?
- Did the FDA and Centers for Disease Control and Prevention (CDC) simply accept the miscarriages as unrelated to the product, or did they demand information on those ‘Other’ causes?
- And, crucially, what happened to the pregnancies which were ongoing at the report cut-off date of March 13, 2021? Were healthy babies born? Were damaged babies born? Were there more miscarriages?
The FDA had access to this data by April 1, 2021. The agency knew that a significant percentage of pregnancies ended in ‘Abortion Spontaneous,’ yet it seems to have failed in its duty to study the data and investigate what basis Pfizer had for marking the fetal deaths as unrelated to the vaccine and having ‘Other’ causes. And, certainly, the FDA failed to inform the public of this very serious adverse event. Without that information, women were not able to give informed consent for receiving Pfizer’s mRNA COVID vaccine.
**[Correction: 44% figure is incorrect. Two analysts have reviewed this Pfizer document and reached different totals and percentages than did the author of this report. The Naked Emperor finds, “If we remove all the withdrawn participants and pregnancies connected with participants’ partners (instead of the participants themselves) we are left with 66 pregnancies and 12 miscarriages/abortions, giving a total of 18%.” Phil Kerpen finds, “So really all we can say is that at the timepoint when the file was generated there had been 11 miscarriages after Pfizer vaccine.” Please reference Pfizer document: 125742_S1_M5_5351_
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A couple of questions come to mind after reading this. What is the population studied by Pfizer representative of the population at large? If not, then all of the results from any aspect of the study are completely invalid. If the population studied by Pfizer was representative of the population at large, the next question is whether it is normal for 50% of pregnant women to miscarry.
I think the miscarriage rate is only about 6% if I’ve done my calculation correctly.
There are 50 “subjects reporting pregnancy after dose 1.” See pg. 3643. If I understand it correctly, this means the patients took the vaccine before pregnancy . These are the patient IDs:
C4591001 1006 10061040
C4591001 1006 10061094
C4591001 1008 10081337
C4591001 1015 10151071
C4591001 1015 10151101
C4591001 1016 10161103
C4591001 1016 10161265
C4591001 1019 10191002
C4591001 1037 10371214
C4591001 1042 10421129
C4591001 1042 10421217
C4591001 1046 10461118
C4591001 1048 10481088
C4591001 1055 10551084
C4591001 1055 10551092
C4591001 1083 10831162
C4591001 1087 10871557
C4591001 1089 10891181
C4591001 1089 10891273
C4591001 1092 10921208
C4591001 1110 11101164
C4591001 1116 11161059
C4591001 1122 11221051
C4591001 1123 11231204
C4591001 1136 11361082
C4591001 1150 11501069
C4591001 1152 11521053
C4591001 1152 11521450
C4591001 1162 11621128
C4591001 1177 11771222
C4591001 1178 11781061
C4591001 1220 12201020
C4591001 1226 12261210
C4591001 1230 12301045
C4591001 1231 12311635
C4591001 1231 12312205
C4591001 1231 12312378
C4591001 1231 12314395
C4591001 1231 12315677
C4591001 1232 12321159
C4591001 1232 12321293
C4591001 1241 12411208
C4591001 1241 12411343
C4591001 1241 12411514
C4591001 1241 12411766
C4591001 1241 12411915
C4591001 1241 12412411
C4591001 1251 12511060
C4591001 1254 12541142
C4591001 1037 10371141
There were 11 uique miscarriages documented on [pp. 219, 561, 708, 1071, 1146, 1179, 1349, 1749, 1758, 1806, 1809, 3519, 3526, 3560, 3536, 3537, 3538, 3536, 3547, and 3551.] These are the IDs:
C4591001 1013 10131255
C4591001 1083 10831162
C4591001 1101 11011115
C4591001 1146 11461133
C4591001 1150 11501084
C4591001 1156 11561007
C4591001 1177 11771222
C4591001 1231 12311812
C4591001 1231 12312205
C4591001 1231 12313998
C4591001 1231 12314134
Only 3 IDs exist in both lists. Namely C4591001 1083 10831162, C4591001 1177 11771222 and C4591001 1231 12312205.
This means out of 50 people who took the vaccine before pregnancy, 3 people had miscarriages. This translates to a 6% of miscarriage rate. From Mayo’s site:
“Miscarriage is the spontaneous loss of a pregnancy before the 20th week. About 10 to 20 percent of known pregnancies end in miscarriage.”
It looks like it’s aligning with the baseline. Am I making a mistake here?
You are making a mistake, but so is the article. The article used the correct numerator (22), but took the wrong denominator (50) as you point out. The real rate should be 22/(A + B), where A is the amount of women who became pregnant after at least one shot (50), and B is the amount of women who were pregnant before accepting a shot (unknown).
You’ve pointed out an issue with the denominator, but have taken the wrong numerator: You’re only considering women who became pregnant after accepting a shot, but the shot could potentially impact fetal development if administered during pregnancy as well.
What’s really needed, here, is B (the amount of women pregnant prior to the shot). It’s not apparent to me what that number actually is. At a minimum, B would be 22-3 = 19 (excluding the women who became pregnant after their first shot), so the worst the miscarriage rate could be, from this data, is 22/(50+19) = 31.9%.
To follow up, I only now noticed that you said that there were only 11 *unique* miscarriage reports. If that’s accurate, that would change the 22 (that I just took from the article) to 11 (assuming that some of the 22 events reported in the article were duplicate entries). In that case, the worst the miscarriage rate could be is 11/(50+8) = 19%.
I also parsed the data as listed and found the same as Data Guy. The 22 subjects are actually the same 11 in duplicate. It appears the first set of 11 are from the list of all adverse events, and the second set are from the list of serious adverse events (which are all on the first list).
Hi Montgomery. Thanks a lot. That answers my question of why we have that many duplicates on those pages.
Hi Nohbody. Thanks a lot for the comment. Allow me to respond to this.
> The real rate should be 22/(A + B), where A is the amount of women who became pregnant after at least one shot (50), and B is the amount of women who were pregnant before accepting a shot (unknown).
After some thinking, I mostly agree with your definition on set A. However I would point out that these women also **reported** their pregnancies to the survey. Hence the title of the form shows “Subjects Reporting Pregnancy After Dose 1.”
I just realized that your definition of set B might be incomplete and needs further inspections (not a criticism to you, since I made the same assumption too.)
This “reported” status is important because I can split all pregnant women who participated in the survey into these groups:
A: Reported pregnancy & took vaccine before pregnancy
B: Reported pregnancy & took vaccine after pregnancy
C: Didn’t report pregnancy & took vaccine before pregnancy
D: Didn’t report pregnancy & took vaccine after pregnancy
To calculate the probability of miscarriage of the entire pregnant women group, we should do:
11 unique cases / (A + B + C + D)
As you pointed out, we don’t have information on B, C & D. Therefore the best we can guess is using below probability to proxy the miscarriage rate:
P(Miscarriage | Reported pregnancy & took vaccine before pregnancy)
IMO this certainly is a biased proxy. However this might be the closest we can get using the available data.
I agree with your assessment in the worst case scenario:
> In that case, the worst the miscarriage rate could be is 11/(50+8) = 19%.
However I think it’s much lower than that because we don’t know the B group in your previous thread (or the B, C & D groups in my response to your thread.)
This is what I found on the Mayo’s site (https://www.mayoclinic.org/diseases-conditions/pregnancy-loss-miscarriage/symptoms-causes/syc-20354298#:~:text=About%2010%20to%2020%20percent,even%20know%20about%20a%20pregnancy.)
> About 10 to 20 percent of known pregnancies end in miscarriage. But the actual number is likely higher because many miscarriages occur very early in pregnancy — before you might even know about a pregnancy.
Your worst case, 19 percent, is still within the normal range according to Mayo.
The 6%-19% miscarriage range passes my smell test, because 44% miscarriage rate would be a catastraphic human extinction event… Maybe it’s my selection bias, but I don’t see that many women who have lost their babies in my life yet.
No women were pregnant before getting the shot. All pregnant women were rejected from the trial
Hi MDT. Very interesting point. Where did you find the information about “no women were pregnant before getting the shot?” I would love to look closer if you can provide the page number in the doc. Thanks.
” Where did you find the information about “no women were pregnant before getting the shot?””
See section 8.2.5 in the study Protocol. I cannot seem to copy the text, but a negative pregnancy test immediately before dosing is required for women of childbearing potential. If it is not negative they will not be dosed (vaccine or placebo).
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_file/nejmoa2034577_protocol.pdf
“…and B is the amount of women who were pregnant before accepting a shot (unknown).”
The number of women who were pregnant before getting a shot would be zero. A pregnancy test is required for women of childbearing potential just before a shot would be administered, and that test must have a negative result. This is pretty standard for clinical trials where pregnancy is an exclusion criterion or subject of interest.
B here is the number of subjects in the placebo arm who got pregnant. These subjects would never get a dose of the actual vaccine, and they do not appear in the listing where the original author pulled the number of 50 pregnancies.
In case people wonder about the other 8 subjects in the 11 miscarriages, I think they are subjects who took the vaccine after pregnancy. Hence these 8 subjects were not on the list of 50.
This is my speculation though. I don’t know for sure why these 8 people didn’t show up in the list of 50.
“I don’t know for sure why these 8 people didn’t show up in the list of 50.”
The populations for the Adverse Events listings were all subjects, but the pregnancy list was just subjects who had one dose of the vaccine. But then there is the group who never got a dose of the vaccine…this would be the subjects which started in the placebo group who for whatever reason never made it to the point where they could get the actual vaccine.
Now, we have no idea how many pregnancies there were in the placebo-only group, but I would bet it is not negligible, and these 8 subjects probably belong to that group. What we need is a listing of pregnant subjects who never got a dose of the vaccine, but that is not included.
Data Guy – very interesting analysis. Question: have you checked for “abortion” as well as “miscarriage”? Another question: how are you defining a “unique miscarriage”?
Hi Vincent. I simply parsed through the pages mentioned in the article to find patient IDs with “Abortion Spontaneous,” “Abortion Spontaneous Complete,” “Abortion Spontaneous Incomplete,” or “Miscarriage.”
See pages [pp. 219, 561, 708, 1071, 1146, 1179, 1349, 1749, 1758, 1806, 1809, 3519, 3526, 3560, 3536, 3537, 3538, 3536, 3547, and 3551.]
In total, I found 18 of them:
C4591001 1013 10131255
C4591001 1013 10131255
C4591001 1083 10831162
C4591001 1083 10831162
C4591001 1101 11011115
C4591001 1146 11461133
C4591001 1146 11461133
C4591001 1150 11501084
C4591001 1150 11501084
C4591001 1156 11561007
C4591001 1177 11771222
C4591001 1177 11771222
C4591001 1231 12311812
C4591001 1231 12312205
C4591001 1231 12312205
C4591001 1231 12313998
C4591001 1231 12313998
C4591001 1231 12314134
Many of them are duplicated. The unique ones are:
C4591001 1013 10131255
C4591001 1083 10831162
C4591001 1101 11011115
C4591001 1146 11461133
C4591001 1150 11501084
C4591001 1156 11561007
C4591001 1177 11771222
C4591001 1231 12311812
C4591001 1231 12312205
C4591001 1231 12313998
C4591001 1231 12314134
Therefore the miscarriages given that they are on the 50 list are 3.
P(Miscarriage | Reporting Pregnancy after Dose 1) = 6%
I might be wrong, but I think the team made a mistake that might be misleading.
Happy to learn where I did wrong though.
Thanks! I hope Berberine will respond with their methods. If this statistic is correct, it’s damning, but because of that it demands transparency. I appreciate your analysis–I was about ready to share this report but I figured I’d check for helpful comments and found yours. Now I’m going to continue to monitor to see if the author will respond.
Data Guy:
You said: “Many of them are duplicated. The unique ones are…”
Just wondering if we know whether the dups could have been additional pregnancies after miscarriage?
Great question sycomputing. I’ll refer to Montgomery’s earlier comment:
> It appears the first set of 11 are from the list of all adverse events, and the second set are from the list of serious adverse events (which are all on the first list).
These 11 seem appeared twice on two lists — all adverse events and serious adverse events.
Therefore I think they are less likely to be additional pregnancies.
“These 11 seem appeared twice on two lists — all adverse events and serious adverse events.”
Ah, so the set of all serious adverse events is a subset of adverse events it seems.
Thanks!
Fwiw, my daughters lifelong best friend had a miscarriage 4 days after becoming seriously ill with the first Pfizer vax. She’s a nurse in a children’s hospital and it was either vax or loose her job. This was more than 18 months ago. She had a healthy check up just days before she took the jab. She’s been unable to get pregnant again and her doc says she’s done and might consider adoption. Severe damage was caused by her first miscarriage
“Just wondering if we know whether the dups could have been additional pregnancies after miscarriage?”
They are not. They are true repeats…same dates and such.
@Berberine: could you respond to Data Guy and Nohbody? I think we really need to see how you arrived at your numbers to resolve this. Thank you.
Thanks Vincent. I’m very curious too. I also reached out to @Berberine and @DrNaomiRWolf on Gettr. There haven’t been any responses so far as of 8/17/2022.
If the 44% is a genuine mistake, I’m worried this might be used by an unfriendly group to damage DailyClout’s reputation.
Data Guy, it looks like Berberine has edited the article referencing an analysis that brought the rate down to 18%. The article is behind a paywall unfortunately, but I think this means Berberine is admitting their mistake.
Great thoughtful comments here. So many I didn’t read them all. One thing….the potential effects on fertility could take place before a woman is pregnant. People like Michael Eden have been raising the red flag on this for a long time. Also there is probably a dose dependent response which would be pretty damning. So I think the numerator should include anyone with a shot at anytime not just during pregnancy. So it’s probably a matter of comparing a few groups. Unvaccinated vs various dose levels.
Regarding the correction, “if we remove…pregnancies connected with the participants partners..” In these cases, did the father receive a dose, then a pregnancy occurred that ended in miscarriage. If so, perhaps those should not be removed (or could be studied separately).
Why have you asterisked the 44% number in the main article, with the correction at the bottom?
Why aren’t you changing the totally false number in the text, with the correction note at the bottom indicating what changes were made – as any self-respecting writer would do.
Is it because that number shows up in thumbnails making people more likely to still share it?
Is it also because the false number is the entire foundation for the article, without which there is nothing of interest?
Are you interested in reality, or misleading and inflammatory headlines and subtexts to pull in clicks?
You’ve also failed to acknowledge that this document alone doesn’t provide sufficient context for establishing accurate denominators for treatment or control groups, so extrapolating any of these numbers is complete folly.
This isn’t the first time you’ve done this, and we both know it won’t be the last.
Also, I’m sure you’re intelligent enough to understand terms like ‘resolved adverse effect’ are standard clinical data classifications – but I suppose the pearl clutching pads the article out a bit. Maybe you’d prefer they more emotive language in a clinical trial document, although you’d probably claim it was unprofessional.
Anyway, good luck with the grift. Maybe consider engaging in something productive and useful, rather than profiteering from paranoia. You might look back one day and think ‘why did I waste my life being such a spineless parasite?’
I checked this quickly and got the 44% that the author mentions. However, there are more in this study than the 50 who reported pregnancy after a shot. The total number in the study is not mentioned. So, of the 50 who reported pregnancy after a shot only 3 had spontaneous abortion/miscarriage. This is 6%. The 44% is just wrong. Please check and double check your reporting as mistakes like this severely damage your credibility. I can no longer read a report of listed to Naomi and accept the report.
Pregnancy was listed by Pfizer as an exclusion item in its Phase 1 trial requirements.
How many participants would possibly not have disclosed any pregnancy or subsequent pregnancy, if that meant they would have been removed from the trial? How certain can anyone be of a failure of any such pregnancy?
A failed pregnancy where the male partner was vaccinated should also be considered relevant.
My greatest concern is that a failed pregnancy is classified as a “resolved” outcome. It was not so for the unborn child who clearly does not participate in the data.
It is considered “resolved” because there is no follow-up required on the physicians. They cannot reverse a failed pregnancy.
“How many participants would possibly not have disclosed any pregnancy or subsequent pregnancy, ”
Pregnancy tests were conducted for women of childbearing potential at dosing visits before the vaccine was administered. So, this would not be an issue.
https://pgibertie.com/2022/08/19/les-pieges-de-lessai-pfizer/
THIS ARTICLE COUNTED DUPLICATE AND FORGOTTEN TO REMOVE THE SPELL OF LOST TO SIGHT PREGNANT WOMEN, it’s not 22 out of 50 miscarriages but 11 out of 37
50 women ended up pregnant in a trial they were banned from
17 were officially withdrawn from the study, including 13 for which no information on pregnancy monitoring is given
We know that for 37 women followed for a few months, 11 lost their babies during this period covering the 1st and the days following the 2nd dose.
It is necessary to hunt for duplicates and triplets but in order not to help subject codes fluctuate, it is impossible to find the same codes by comparing the list of 50 vaccinated pregnant women and the list of women for whom we have an abortion (except 3)
All the women who have lost their babies are in the list of 50
Would someone please look at “Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons” New England Journal of Medicine, April 21, 2021. They had to retract the miscarriage (spontaneous abortion) statistic from this paper because they had calculated it incorrectly. It could not be calculated correctly until all tie pregnancies in the study had come to term, and that had not happened when the paper was published. Obviously, the data should be available now. The data came from a CDC data set, so it should be available to the public.
I expect Dr. Wolf to issue a correction and spread it far and wide. Many are now stating the incorrect 44% stat, including Paul Alexander, Steve Kirsch, and Ryan Cole, who have all repeated this incorrect stat. Furthermore, there needs to be a review process for these conclusions before they are disseminated. This renders all prior claims suspect.