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DailyClout Pfizer Documents Analysis Pfizer Reports

Report 38: Women Have Two and a Half Times Higher Risk of Adverse Events Than Men. Risk to Female Reproductive Functions Is Higher Still.

August 20, 2022 • by Dr. Robert W. Chandler, MD, MBA

The Pfizer documents demonstrate a strong signal that women have far more adverse events than males, particularly when considering reproductive organs and function. Primary source material from Pfizer shows a strong, sex-linked Adverse Event (AE) difference. Two major data collections, Reissue of Pfizer’s “5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021” and “APPENDIX 2.1 Cumulative Number of Case Reports (Serious and Non-Serious, Medically Confirmed and Non Medically-Confirmed) from Post-Marketing Data Sources, Overall, by Sex, Country, Age Groups and in Special Populations and Summary Tabulation by Preferred Term and MedDRA System Organ Class,” show substantially greater numbers of Adverse Events in women contrasted with men. This signal is particularly strong for the reproductive organs and their functions. Women have approximately three times the risk of Adverse Events than do males, and the specific risk to the reproductive organs and their functions is even stronger.

 

Two large data sets in the Pfizer confidential document collection, released pursuant to a court order, report consistent sex differences in the absolute number and percentage of Adverse Events (AEs) and Adverse Events of Special Interest (AESI). This report will examine primary source documents that collect Adverse Events at two points in time – February 28, 2021, the end of first two and a half months following widespread inoculation with Pfizer’s COVID-19 vaccine, and then at a second time ending on March 15, 2022.

 

Most AEs appear to have been spontaneously reported through a mechanism the public is still waiting to learn about, which means they were not part of a well-regulated and proactive surveillance program and may underestimate the actual frequency of such events. 

 

Many people having a complication related to Pfizer’s Lipid Nanoparticle Messenger Ribonucleic Acid (LNP/mRNA) prodrug, BNT162b2 (the Pfizer COVID-19 vaccine), are not aware of how to report or are unable to report in cases of a severe complication. Alternatively, reporting may be being actively suppressed. 

 

As a review of the entries in Appendix 2.1, the 170-page registry of 4,563,770 Adverse Events logged in by April 15, 2022, shows that over-reporting and, in some cases, questionable relevance of the reporting in some disease categories is a possibility.

 

Sex Differences Example 1:

Reissue of Pfizer’s 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021

 

The FDA reissued Pfizer’s 5.3.6 Adverse Events document on April 1, 2022, and it offers a summary of Adverse Events and Adverse Events of Special Interest after injection of BNT162b2, Pfizer’s LNP/mRNA vaccine. 

 

This data set comprises 42,086 subjects from the first two and a half months following the Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020.

 

Table 1 below shows a tally of Adverse Events and Adverse Events of Special Interest by organ system from the 5.3.6 Reissue document, although it must be pointed out that some cases were reassigned to organ categories by the author.

 

For instance, myopericarditis was moved from Pfizer’s Autoimmunity assignment to Cardiac based on the organ involved rather than the assumed disease process.

 

Table 1: AEs and ASEIs up to 2/28/2021

In every category, females substantially outnumber males. Charts 1 and 2 are graphical representations of this data. 

Study Females % Males % F M N = Unk p
Table 1 from 5.3.6 77% 23% 29914 9182 42086 2990 p < 0.001
Table 7 from 5.3.6
    Autoimmune 81% 19% 682 156 838 N/A p < 0.001
    Cardiac 77% 21% 1076 291 1403 36 p < 0.04
    Covid-19 66% 34% 1650 844 3067 573 p < 0.001
    Dermatologic 94% 6% 17 1 19 1 See note

below

Chart 1

    Hematologic 75% 25% 676 222 898 0 p = 0.385
    Hepatic 61% 37% 43 26 70 0 p =0.019
    Musculoskeletal 80% 20% 2760 711 3471 0 p < 0.001
    Neurologic 69% 31% 623 283 927 21 p < 0.001
    Other (Pyrexia and Herpes) 76% 24% 5969 1860 7829 0 p = 0.527
    Renal 67% 33% 46 23 69 0 p = 0.085
    Respiratory 55% 45% 72 58 130 0 p < 0.001
    Stroke 67% 33% 182 91 273 0 p = 0.001
    Thromboembolic event 62% 38% 89 55 144 0 p < 0.001
    Vasculitis 81% 19% 26 6 32 0 p = 0.549
Total excl. Unknown 75% 25% 13911 4627 18538

Chart 1 illustrates this finding with 29,914 females with AEs compared with only 9,182 for males. (i.e., p < 0.001).

 

It should be noted that “p,” as shown in p < 0.001 above, indicates the level of significance. Commonly, p < 0.05 is the minimal level of acceptance, meaning there is a 95% chance that the number is the true number with a certain confidence interval. Therefore, p < 0.001 indicates a 99.999% probability that the number did not occur by chance. “p” values this low are rarely seen in clinical medical studies.

 

Chart 1: Female/Male Ratio in 39,096 Subjects

 

This trend follows through Table 7 (AESI), from 5.3.6 Reissue. Chart 2 shows the female-to-male ratio as percentages for each organ system as reported. Note that females substantially outnumber males in all categories and by more than a factor of three overall. 

 

There is no category in which the number of cases for males outnumber females. Statistical significance exists at p < 0.05 in comparison of the rates of particular types of AEs in females versus males. Hematologic, Dermatologic, Other (Pyrexia and Herpes), Renal and Vasculitis all appear as exceptions with p values > 0.05. Note: Dermatologic was evaluated using Fisher exact test due to small sample size, p = 0.093.

 

Chart 2: Organ System Detail

 

Sex Differences Example 2: Appendix 2.1

 

A second large series of Adverse Events associated with Pfizer’s BNT162b2 vaccine document trove, Appendix 2.1, recently surfaced following a FOIA request from the Australian Therapeutic Goods Administration (TGA) and consists of a 170-page document that tallies Adverse Events by diagnosis in 1,348,079 subjects (i.e., patients). The sex was known in 1,282,113 cases – 923,194 women (72% of those with known sex and 68% of total series including unknown sex) and 358,919 men. Data capture ended on April 15, 2022. 

 

The total number of Adverse Events reported in this document is 4,563,770 for an average of 3.4 AEs per case. The disproportionate representation of AEs in females presents again strongly here, as it did in Pfizer’s 5.3.6 Reissue document. 

 

Table 2: Female:Male Difference in 1,282,113 Cases of Adverse Events

Study Females % Males % Females Males N =
                  Appendix 2.1

                   16-April-2022

72% 28% 923194 358919 1282113

 

 

Chart 3: Female:Male Comparison in AEs Subjects

 

Adverse Events occur two and a half times more in women than men as shown in Chart 3 above. This is the same pattern seen in the earlier reporting of a smaller series from Document 5.3.6, p < 0.001.

 

Chart 4 illustrates this same disparity in the specific data referable to female and male reproductive organ and organ function disorders with much higher absolute numbers for women as well as in terms of percent of adverse events. 

 

A striking difference is shown here with 148,874 women reporting Reproductive System AEs contrasted with only 1,745 males, p < 0.001.

 

Chart 4: Reproductive Organ and Function Sex Differences

 

As seen in Chart 5, below left, females appear to have fewer diagnostic categories than males but only because there are so many for women that a charting of them is too busy if all are plotted. 

 

For comparison of the sexes see Appendix 2 (females) and Appendix 3 (males) that list the reported reproductive organ and organ function disorders by sex following injection of Pfizer’s BNT162b2. This tally lists diagnoses with reporting frequency of ten or more.

 

Chart 5 shows the numbers of the just the top ten menstrual dysfunctions contrasted with the much smaller number of reproductive issues in men.

 

Chart 5:  Menstrual Disorders compared with Male Reproductive Disorders 

 

Why do Women Have So Many More Adverse Events than Males?

 

No immediate answer to this question exists. However, the signal is strong.

 

Is there some distortion in the reporting mechanism that might explain such a wide difference? Perhaps. Is there some kind of systematic reporting bias? We can only speculate at present.

 

Alternatively, are there true sex differences in reaction to Pfizer’s LNP/mRNA injections? Are women more prone to having complications after receiving Pfizer’s BNT162b2 vaccine? Perhaps. Is there something about the LNP/mRNA concentration in ovaries that leads to production of more mRNA transcribed Spike or Spike-related proteins that have been shown to be toxic in multiple studies.

 

We have seen from the preclinical animal studies, Chart 6 following, that ovaries are one of the top four organs as far as concentration of LNP/mRNA is concerned. But, unfortunately, this study in Wistar Han Rats only ran for two days and no longer-term studies were performed. Furthermore, the ovaries – like liver, spleen and adrenal glands – had LNP/mRNA concentrations that were steeply rising at the time of animal sacrifice. 

 

Had autopsies had been performed in a systematic manner following widespread human inoculation in individuals dying in the weeks following injection of Pfizer’s BNT162b2, we may have had the answer by now and would certainly know more about gross and microscopic changes occurring in organs following the injection. Spike and related protein levels in the various organ systems would be of great interest.

 

Chart 6 illustrates deposition of LNP/mRNA at the injection site, left chart, followed by rapid dissemination throughout the body with concentration in four organs, liver, spleen, adrenal glands and ovaries, right chart.

 

Chart 6: Distribution of LNP/mRNA in Wistar Han Rats

 

LNP/mRNA concentrates in ovaries as shown in Chart 6 illustrating data from preclinical studies performed in Wistar Han Rats. Note: The X-axis is nonlinear in Charts 6 and 7. Interpret the data accordingly.

 

Caution is needed here as animal studies may be misleading. There is such a thing as species-specific reactions, and humans may have different findings. 

 

Chart 7 illustrates the disparity between ovaries and testes with respect to LNP/BNT162b2 uptake showing more than 38 times more concentration in ovaries than testes, as shown in these animal studies.

 

Chart 7: Tissue Concentration of LNP/mRNA Ovaries vs. Testes

 

Why do ovaries concentrate lipid nanoparticles and mRNA contained therein so much more effectively than testes? 

 

And does this account for the large disparity in the incidence of Adverse Events and Adverse Events of Special Interest following injection of BNT162b2 in women as opposed to men? 

 

Or are these differences in AEs overall and with respect to the dysfunction in the Reproductive Systems specifically a result of some methodological quirk? 

 

We cannot definitively answer that question at present. For now, we must interpret these data as showing women are at increased risk for Adverse Events from Pfizer’s LNP/mRNA product than are men, both in terms of many or all organ systems but especially with respect to reproductive organ systems and their functions. 

 

Assuming this differential is caused by the disproportionate impact of BNT162b2 on women and their reproductive systems and organs, the implications could be profound.

 

Appendix 1: Female Reproductive AEs Following Inoculation with BNT162b2

 

148,874 reproductive organ AEs occurred in women which represents ~16% of the total number of Adverse Events in women. The list below gives the diagnoses reported 10 or more times.

Total AEs N = 923194
Heavy menstrual bleeding 27685
Menstrual disorder 22145
Menstruation irregular 15083
Menstruation delayed 13989
Dysmenorrhea 13904
Intermenstrual bleeding 12424
Amenorrhea 11363
Polymenorrhea 9546
Breast pain 4800
Vaginal hemorrhage 4699
Oligomenorrhea 3437
Hypomenorrhea 2643
Postmenopausal hemorrhage 2456
Abortion spontaneous 1809
Breast swelling 1339
Menstrual discomfort 1199
Premenstrual syndrome 998
Breast tenderness 792
Menometrorrhagia 632
Adnexa uteri pain 609
Premenstrual pain 585
Breast enlargement 483
Vaginal discharge 480
Breast discomfort 443
Mastitis 392
Ovulation pain 347
Endometriosis 337
Menstrual cycle management 308
Anovulatory cycle 273
Uterine pain 270
Abnormal withdrawal bleeding 265
Uterine hemorrhage 231
Vulvovaginal pain 191
Ovulation delayed 181
Premature baby 181
Vulvovaginal mycotic infection 173
Breast cancer 147
Fetal death 147
Fetal growth restriction 124
Vulvovaginal candidiasis 122
Breast cyst 115
Genital hemorrhage 115
Breast edema 113
Abnormal uterine bleeding 100
Pelvic venous thrombosis 98
Labor pain 95
Uterine leiomyoma 91
Polycystic ovaries 82
Breast discharge 71
Vulvovaginal pruritus 71
Breast disorder 68
Uterine contracture during pregnancy 68
Ectopic pregnancy 67
Premature labor 64
Morning sickness 62
Vaginal infection 60
Vulvovaginal discomfort 59
Abortion 58
Premature menopause 58
Vulval ulceration 56
Stillbirth 56
Vulvovaginal dryness 54
Coital bleeding 46
Ovarian cyst rupture 44
Premature delivery 44
Endometrial thickening 42
Genital burning syndrome 42
Adenomyosis 41
Breast abscess 41
Fetal heart rate abnormal 41
Menarche 40
Premenstrual headache 40
Uterine contractions abnormal 40
Breast induration 39
Premature rupture of membranes 37
Uterine polyp 37
Vulvovaginal swelling 37
Abortion induced 36
Uterine inflammation 36
Vulval hemorrhage 34
Pelvic inflammatory disease 33
Pregnancy 32
Pelvic discomfort 30
Premature menarche 27
Premature ovulation 27
Breast hematoma 26
Infertility female 26
Postpartum hemorrhage 26
Uterine disorder 26
Pelvic hemorrhage 25
Noninfective oophoritis 23
Vaginal ulceration 23
Dyspareunia 22
Ovarian disorder 22
Unintended pregnancy 22
Vaginal order 22
Vulvovaginal inflammation 21
Breast cancer 20
Breast disorder female 20
Hemorrhagic ovarian cyst 20
Placental disorder 20
Gestational diabetes 19
Abortion early 19
Endometrial disorder 18
Nipple inflammation 18
Endometrial hyperplasia 18
Ovarian hemorrhage 17
Ovarian failure 16
Vulvovaginal erythema 16
Ovarian vein thrombosis 15
Polymenorrhagia 15
Threatened labor 14
Fibrocystic breast disease 13
Ovarian enlargement 13
Uterine enlargement 13
Cervix hemorrhage uterine 12
Breast atrophy 11
Breast hemorrhage 11
Breast neoplasm 11
Cesarean section 11
Cervical dysplasia 11
Pelvic girdle pain 11
Vaginal disorder 11
Vulval disorder 11
Bartholin’s cyst 10
Decidual cyst 10
Fetal cardiac disorder 10
Fetal growth abnormality 10
Fetal vascular malperfusion 10
Vaginal cyst 10
Small for dates baby 10
Vaginal cyst 10

Appendix 2: Male Reproductive Disorders Following Inoculation with BNT162b2

 

1,745 reproductive organ AEs were reported in men which represents 0.49% of the total number of Adverse Events in men. AEs list occurred 10 or more times.

 

Males
Total AEs = 358919
Testicular pain 362
Prostatitis 99
Testicular disorder 90
Epididymitis 73
Orchitis 52
Hematospermia 43
Scrotal pain 40
Penile pain 31
Penis disorder 31
Benign prostatic hypertrophy 26
Penile swelling 25
Scrotal swelling 24
Erection increased 23
Testicular disorder 22
Orchitis noninfective 20
Ejaculation disorder 18
Ejaculation failure 18
Prostatomegaly 18
Priapism 17
Testes discomfort 16
Spontaneous penile erection 15
Penile edema 13
Prostatic disorder 13
Penile hemorrhage 11
Penile erythema 10
Penile vein thrombosis 10
Scrotal erythema 10

 

Author: Robert W. Chandler, MD, MBA, Team 5

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