How anyone can trust the FDA after seeing what happened to this vibrantly healthy 12-year-old is a mystery at best. Wanting to help out - and collect payment of $119 per visit - Maddie enrolled in Pfizer’s COVID vaccine trial for 12- to 15-year-olds. Never did she dream this would end up being her story.
[embed]https://www.bitchute.com/video/g20wreb8XMwK/[/embed]STORY AT-A-GLANCE
- Maddie de Garay signed up for Pfizer’s COVID-19 shot trial when she was 12; previously a healthy preteen, her life has been forever changed due to health problems caused by the shots
- Maddie suffered a severe systemic adverse reaction to her second dose of the shot and struggled through 11 ER visits and four hospital admissions in the year and a half that followed
- Injuries from the shot have left her unable to walk or eat — she receives her nutrition via a feeding tube — and suffering from constant pain, vision problems, tinnitus, allergic reactions and lack of neck control
- Maddie and her family were continually dismissed by the medical professionals put in place to help, ignored by the U.S. Food and Drug Administration and denied the care needed to help Maddie
- The medical professionals went so far as to label Maddie’s health problems as psychological in nature, and they still haven’t been contacted by anyone from Pfizer or the FDA — even after her true diagnosis was revealed and found to be related to the shots
When Stephanie de Garay allowed her three children to sign up for Pfizer’s COVID-19 shot trial, she assumed the worst that could happen was anaphylactic shock — and in that case, they’d be treated with an EpiPen and be fine. From her daughter’s perspective, the trial was a way to keep up with a close friend who had already signed up for the trial.
As though the physical trauma weren’t enough, Maddie and her family were continually dismissed by the medical professionals put in place to help, ignored by the U.S. Food and Drug Administration and denied the care needed to help Maddie.
Participants were given access to the TrialMax app to record side effects, like a swollen arm, but de Garay was surprised at the format it used. There wasn’t space for open-ended comments, only direct questions with “yes” or “no” options for answers, or check boxes to signify a set of predetermined potential effects.
With the first shot, Maddie had a fever and her arm swelled. She received the second dose January 20, 2021, which the children said hurt more than the first shot. At that point, de Garay started writing notes to make sure she was documenting what happened to the children; she thought it would be valuable for the trial.
The next day, she barely made it through the day at school, and when she walked in the door from the bus, she wasn’t in good shape. De Garay’s husband sent her a text at work saying Maddie was having a reaction to the shot. In the background, de Garay could hear her daughter screaming that her heart felt like it was going to be ripped out through her neck; she was in that much pain.
A trip to the ER was useless — they checked her out for appendicitis, ruled it out and sent her home, saying it was most likely an adverse reaction to the COVID-19 shot and would get better in time.
“After reporting everything to the Pfizer clinical trial Principal Investigator [Dr. Robert Frenck] and being brushed aside, we started documenting every detail of Maddie’s injury. Cincinnati Children’s first tried to treat Maddie as “a mental patient,” telling us it was anxiety and it was all in Maddie’s head.
Pfizer listed her traumatic systemic adverse reaction as “functional abdominal pain” when reporting to the FDA. A day before Pfizer submitted their request for emergency approval for the covid vaccine for 12-15-year-olds and before necessary testing was done, they put Functional Neurological Disorder (FND) as a diagnosis in her chart.”Maddie’s symptoms continued into February, with old symptoms getting worse and new symptoms, including extreme bloating after eating, starting. Maddie was dizzy, nauseous and in pain. She felt like her heart was on fire and soon began throwing up when she ate, until she couldn’t eat at all. Her ability to shower on her own became a thing of the past.7
It was Dr. Amal Assa’ad at Cincinnati Children’s Hospital who, after spending just 15 minutes with Maddie, determined that her physical symptoms weren’t the result of the shots but were due to a functional neurological disorder.
“My assessment is that Madeline has a functional impairment that is not organic in nature … I also discourage further work up since this is usually detrimental in functional disorders because it drives the patient to thinking that there must be something wrong that is indicating all this work up. It also delays the necessary psychologic intervention that is needed to help resolve the functional disorder.”
‘It’s Like We’re Stuck in a Nightmare’
Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital, was principal investigator of the Pfizer COVID-19 trial, put there to act as an advocate for the people in the trial and making sure that they were safe, as well as determine if any reactions they experienced were due to the vaccine. He offered little help to the de Garays, even as Maddie’s symptoms persisted and worsened.February 19, 2021, de Garay wrote that Maddie fainted and, when she came to, couldn’t remember her birthday or her friend’s names. In response, the hospital gave her a different tape for her IV and said she may have a rubber allergy.
During her second hospital stay, Maddie woke up from an MRI of her brain and upper GI, fell to the ground and hasn’t been able to walk since. Her father said, “It’s like we’re stuck in a nightmare,” and they feel they’ve been abandoned.
- March 24, blackout that lasted 20 minutes, pulse went up to 150
- March 28, 10 convulsions and seizures, can’t walk, gets around by scooting on her butt
After she didn’t make any physical progress, the hospital transferred Maddie to a mental institution — but after seeing the harsh conditions used at the facility, the de Garays took Maddie home instead, with no support offered for her care.
Pfizer Reported Maddie’s Severe Reaction as Abdominal Pain
If you’re wondering how Pfizer got away with this, in Pfizer’s April 2021 disclosure of Maddie’s case to the FDA, it’s stated:12“One participant experienced an SAE [serious adverse event] reported as generalized neuralgia, and also reported 3 concurrent non-serious AEs (abdominal pain, abscess, gastritis) and 1 concurrent SAE (constipation) within the same week. The participant was eventually diagnosed with functional abdominal pain. The event was reported as ongoing at the time of the cutoff date.”Bigtree stated, “That looks like fraud to me.” Even as the de Garays tried to transfer Maddie’s care to a different local hospital, they were met with bias and red tape; the health care providers who received all the digital records had already made their minds up about the diagnosis before Maddie was seen.
“The findings were consistent with severe distal chronic acquired demyelinating polyradiculoneuropathy, small fiber sensory neuropathy and orthostatic intolerance in the setting of COVID vaccination.”
Pfizer Classifies Severe Reactions as ‘Not Related’ to Shots
The FDA and Pfizer attempted to hide the COVID-19 shot clinical trial data for 75 years, but the FDA was ordered by the U.S. District Court for the Northern District of Texas to release redacted versions of trial documents on a much faster schedule. As part of the court order, 80,000 pages of documents related to the FDA’s approval of Pfizer’s COVID-19 shots were released June 1, 2022.15“The many serious adverse events — and several deaths — recorded during the Phase 3 trials are also apparent in a separate, massive document exceeding 2,500 pages, cataloging such adverse events. This document lists a wide range of adverse events suffered by trial participants classified as toxicity level 4 — the highest and most serious such level.
However, not one of the level 4 (most severe) adverse events listed in this particular document is classified as being related to the vaccination … Similarly, only a small number of toxicity level 3 adverse events were indicated as having been “related” to vaccination.”Even the instances that were attributed to the shots were downplayed, such as the report of “one younger participant with no past medical history [who] had a life-threatening SAE of myocardial infarction 71 days after Dose 2 that was assessed by the investigator as related to study intervention.” The report then goes on to state that the SAE “lasted one day and resolved the same day.”20
The FDA Ignored Maddie’s Case
Just as it ignored the many red flags in Pfizer’s clinical trial data, the FDA also ignored Maddie’s case, even when attorneys got involved. In August 2021, the de Garays reached out to ICAN’s legal team; ICAN’s Aaron Siri is now representing them. According to Siri:21“What happened to Maddie is not only the story of an injury to a child, which is heartbreaking in and of itself. But Maddie was in a clinical trial that only had 1,000 children in the age bracket of 12 to 15 years old that got the COVID-19 vaccine.
When she suffered that reaction, there should have been every medical expert at Cincinnati and at the FDA that should have descended to study what happened to Maddie, because if that could happen to one in 1,000 children, the repercussions could be really devastating, especially for an infection that doesn’t harm children anywhere near that rate.”After ICAN’s team got Maddie’s medical records and reviewed them, they believe the causal connection to Pfizer’s COVID-19 shot is extraordinarily strong. In October 2021, they sent a letter to the FDA, including all of Maddie’s medical records and highlighting how Pfizer downplayed the condition in their disclosure, describing Pfizer’s move as “at best dishonest. To regulators, it should be criminal.”22
“The hope is that we make sure that we always have the choice to say no. As long as we can say no, that is the safeguard. That is the stopgap to all of this bad conduct. It’s not going to protect those who don’t know better to say no in certain situations, but it will protect those who do … There should be a lot of hope out there because COVID vaccine mandates have receded all across this country …
Freedom of speech, the ability to have individual liberties. That is what will save us … The ability to become educated, to have access to information and to make informed decisions … the ability to say no about something, or a medical procedure, that we don’t want to have on our bodies or our children’s bodies.”Originally published September 10, 2022 on Mercola.com
Sources and References
- 1 The Highwire, Rigged: Maddie’s Story August 13, 2022, 5:56
- 2, 6, 13 Life Funder, Help Maddie de Garay get essential medical care
- 3 The Highwire, Rigged: Maddie’s Story August 13, 2022
- 4 The Highwire, Rigged: Maddie’s Story August 13, 2022, 7:13
- 5 The Highwire, Rigged: Maddie’s Story August 13, 2022, 10:40
- 7 The Highwire, Rigged: Maddie’s Story August 13, 2022, 12:23
- 8 The Highwire, Rigged: Maddie’s Story August 13, 2022, 14:00
- 9 The Highwire, Rigged: Maddie’s Story August 13, 2022, 21:03
- 10 The Highwire, Rigged: Maddie’s Story August 13, 2022, 26:07
- 11 The Highwire, Rigged: Maddie’s Story August 13, 2022, 59:00
- 12 The Highwire, Rigged: Maddie’s Story August 13, 2022, 1:04
- 14 The Highwire, Rigged: Maddie’s Story August 13, 2022, 1:08
- 15 Children’s Health Defense, The Defender, February 7, 2022
- 16, 17, 18, 19, 20 Children’s Health Defense, The Defender, June 21, 2022
- 21 The Highwire, Rigged: Maddie’s Story August 13, 2022, 1:18
- 22 The Highwire, Rigged: Maddie’s Story August 13, 2022, 1:22
- 23 The Highwire, Rigged: Maddie’s Story August 13, 2022, 1:31
- 24 The Highwire, Rigged: Maddie’s Story August 13, 2022, 1:34