Report 69: BOMBSHELL – Pfizer and FDA Knew in Early 2021 That Pfizer mRNA COVID “Vaccine” Caused Dire Fetal and Infant Risks, Including Death. They Began an Aggressive Campaign to Vaccinate Pregnant Women Anyway.
The batch of Pfizer clinical trial documents released in April 2023 by the Food and Drug Administration (FDA) under court order contains a shocking, eight-page document titled, “Pregnancy and Lactation Cumulative Review.” The data in the Cumulative Review span “…from the time of drug product development to 28-FEB-2021.” A Pfizer employee, Robert T. Maroko, approved the Review on April 20, 2021. (p. 8)
This document is among the most horrifying yet to emerge into public view. It reveals that both Pfizer and the FDA knew by early 2021 that Pfizer’s mRNA COVID vaccine, BNT162b2, resulted in horrible damage to fetuses and babies. (Though I arrived at the conclusions in this article on my own from reviewing the document linked here, Sonia Elijah previously covered some of this same material on April 22nd on TrialSiteNews and on April 26th on Substack and Redacted.) Pfizer tabulated:
- Adverse events in over 54% of cases of “maternal exposure” to vaccine (248 out of 458). “Maternal exposure” is defined on pp. 1-2 as: “PTs Maternal exposure timing unspecified, Maternal exposure during pregnancy, Maternal exposure before pregnancy, Exposure during pregnancy.” These definitions imply that Pfizer may have been looking at damage to women and babies that could result from intercourse, inhalation, and skin contact prior to pregnancy, as Pfizer defines “exposure” including all three in its protocol (Protocol Amendment 14, https://www.phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf, pp. 213, 246, 398, 431, 575, 607, 751, 783, 918, 948, 1073, 1103, 1226, 1255, 1378, 1406, 1522, 1549, 1663, 1688, 1813, 1836, 1949, 1969, 2081, 2100, 2211, 2228, and 2337.)
- Pfizer’s tally of damages to fetuses and babies includes:
- “53 reports [or 21% – 53/248] of spontaneous abortion (51)/ abortion (1)/ abortion missed (1) following BNT162b2 vaccination.” (p. 4). A “missed abortion” is “an empty gestational sac, blighted ovum, or a fetus or fetal pole without a heartbeat prior to completion of 20 weeks 0 days gestation.” (https://www.acog.org/practice-management/coding/coding-library/billing-for-interruption-of-early-pregnancy-loss)
- Fetal tachycardia (irregular heart rate faster than 180 beats per minute) that required early delivery and hospitalization of the affected newborn for five days. “The clinical outcome of fetal tachycardia was unknown.” (p. 2)
- Six premature labor and delivery cases (p. 3) resulting in:
- Two newborn deaths. Cause of death for one baby “was cited as extreme prematurity with severe respiratory distress and pneumothorax.” Pfizer stated the other death was due to “premature baby less than 26 weeks and severe respiratory distress and pneumothorax.” Note that newborn pneumothorax is a condition where air leaks out of the lung and collects between the lung and the chest wall.
- Newborn severe respiratory distress. (Note: California midwife, Ellen Jasmer, has described exactly this phenomena happening in her practice in a recent DailyClout interview.)
It is not just fetuses and newborn babies that Pfizer calmly noted were being damaged in the company’s internal records. Pfizer also recorded multiple harms to babies through the milk of vaccinated mothers. According to Pfizer in the Cumulative Review, 19% (41/215) of babies in Pfizer’s records exposed to the company’s COVID mRNA vaccine via their mothers’ breast milk were recorded as suffering from 48 different categories of adverse events* (pp. 6-7). These included:
| Preferred Term | Explanation | # of Events |
| Pyrexia | Fever | 9 |
| Off label use | 8 | |
| Product use issue | 7 | |
| Infant irritability | 5 | |
| Headache | 5 | |
| Rash | 5 | |
| Diarrhoea | 3 | |
| Illness | 3 | |
| Insomnia | 3 | |
| Suppressed lactation | 3 | |
| Breast milk discolouration | 2 | |
| Infantile vomiting | 2 | |
| Lethargy | 2 | |
| Pain | 2 | |
| Peripheral coldness | 2 | |
| Urticaria | Hives | 2 |
| Vomiting | 2 | |
| Abdominal discomfort | 1 | |
| Agitation | 1 | |
| Allergy to vaccine | 1 | |
| Angioedema | An area of swelling of the lower layer of skin and tissue just under the skin or mucous membranes. The swelling may occur in the face, tongue, larynx, abdomen, or arms and legs. Often it is associated with hives, which are swelling within the upper skin. | 1 |
| Anxiety | 1 | |
| Axillary pain | 1 | |
| Breast pain | 1 | |
| Breast swelling | 1 | |
| Chills | 1 | |
| Cough | 1 | |
| Crying | 1 | |
| Dysgeusia | Also known as parageusia. A distortion of the sense of taste. | 1 |
| Dysphonia | Hoarseness, most frequently caused by a problem with a person’s vocal cords or larynx. | 1 |
| Eructation | Belching. | 1 |
| Epistaxis | Nosebleeds. | 1 |
| Eyelid ptosis | Droopy eyelid. | 1 |
| Facial paralysis | 1 | |
| Fatigue | 1 | |
| Increased appetite | 1 | |
| Lymphadenopathy | Swollen lymph nodes. | 1 |
| Myalgia | 1 | |
| Nausea | 1 | |
| Paresis | 1 | |
| Poor feeding infant | 1 | |
| Poor quality sleep | 1 | |
|
Pruritis |
Itchy skin. | 1 |
| Restlessness | 1 | |
| Rhinorrhoea | Runny nose. | 1 |
| Roseola | An infection that can cause a high fever followed by a rash. | 1 |
| Skin exfoliation | 1 | |
| Vision blurred | 1 |
*From Table 2 - Number of Adverse Events Reported in Infants with ‘Exposure via Lactation’ (pp. 6-7)
Some of the babies’ suffering was serious: there were ten “Serious Adverse Events” (SAEs) from “Exposure via Lactation.” The Review outlines six of them (p. 7):
-
“A 15-month old infant with medical history of vomiting experienced skin exfoliation and infant irritability while being breastfed (latency <7 days). The outcome of the event ‘skin exfoliation’ was not recovered and outcome of event ‘infant irritability’ was unknown. No causality was reported by the physician.”
- “A 9-month old infant with a medical history of meningococcal vaccine and no history of allergies, asthma, eczema or anaphylaxis experienced rash and urticaria a day after exposure via lactation. The outcome of the events was ‘resolved’ and event did not happen after the second day. No causality assessment was provided.”
-
“A day after the mother received vaccination, a baby developed a rash after breastfeeding. At the time of the report, the event was ‘not recovered. [Sic] A causality assessment was not provided.”
- “An 8-month old infant experienced angioedema [an area of swelling of the lower layer of skin and tissue just under the skin or mucous membranes] one day after his mother received vaccination. The event was considered non-serious by health authority and the outcome at the time of the report was unknown. No causality was provided.”
- “There were 2 cases reporting ‘illness’ after exposure via breast milk’. In the first case, a 6-month old infant developed an unspecified sickness 2 days post mother’s vaccination. The outcome of the event sickness was recovered, and no causality assessment was provided. The second case, a 3-month old infant developed an unspecified illness and required hospitalization for 6 days post exposure via breast milk (>7 days latency). The event outcome was reported as ‘recovering’ and no causality assessment was provided.”
Pfizer’s Summary and Conclusion section of the Cumulative Review states, “The cases reviewed above are indicative of what is in the Pfizer safety database as of 28 February 2021. The sponsor (Pfizer/BioNTech) will continue to monitor and report on all pregnancy exposure and lactation cases. It is important to note that the spontaneous safety database is intended for hypothesis generation and not hypothesis testing.” (p. 7)
Despite Pfizer and the FDA knowing by April 20, 2021, the extent of damage to fetuses and babies, including the fact that fetuses and newborns had died, on April 23, 2021, inexplicably Dr. Rochelle Walensky held a White House press briefing where she recommended pregnant women get vaccinated. (https://www.verywellhealth.com/pregnant-women-covid-vaccine-5092509)
Please read this damning “Pregnancy and Lactation Cumulative Review” below.
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