Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
blood clots in her lungs; declining kidney function; sepsis; nerve complications; pleurisy; multifocal avascular necrosis; her body sent out thousands of clots; This is a literature report from License Party for the following literature source(s). A 31-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Nov2020 (unspecified if ongoing); "hypertrophic cardiomyopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "her body sent out thousands of clots"; OSTEONECROSIS (medically significant) with onset Jul2021, outcome "not recovered", described as "multifocal avascular necrosis"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "blood clots in her lungs"; RENAL IMPAIRMENT (medically significant), outcome "unknown", described as "declining kidney function"; SEPSIS (medically significant), outcome "unknown"; NERVE INJURY (medically significant), outcome "unknown", described as "nerve complications"; PLEURISY (medically significant), outcome "unknown". Clinical course: the patient was used to caring for others as the director of a nursing home until she developed a condition that caused her bones to rot after taking the Covid shot. The patient (at the time of the article was 34 years old), was working at a nursing home in her native state when the Covid pandemic hit in 2020. She watched patients die alone and missed her son's birthday out of fear of becoming infected and bringing the virus home with her. In January 2021, Covid vaccines became available and, feeling a sense of duty to protect her patients, she took the Pfizer vaccine. She experienced no immediate side effects, but in Jul2021, the patient developed 'unbearable' pain in both of her hips. She was told she had arthritis at 31 years old and had to use a wheelchair when the pain made it too hard to walk. Believing her pain was something else, another doctor ordered an magnetic resonance imaging (MRI), which revealed the patient's hip bones were literally rotting, and she underwent her first hip replacement in Dec2021. The second followed a few months later in 2022. However, her hips were just the beginning. Over the next nearly four years - and still ongoing today the patient would undergo surgeries on both shoulders and knees, three surgeries on her elbow, one on her left foot and she was scheduled to have another procedure on her right foot. About a year after her ordeal began, one of her doctors attributed her complications to her bout of Covid in late Nov2020 and subsequent vaccines. The patient told the social media: 'The pain is so debilitating. I have never felt so helpless in my entire life. I've always been trying to be the best provider I could be caring for other people.' However, due to the patient's condition, she had to quit her job as a nurse and director in an elder care home and go on disability. She continued: 'Now I can't even drive my kids to school in the morning anymore... it's devastating. I have really had to mourn the life that I thought I was going to have because I will no longer be able to be the same person I've always wanted to be because of a virus and a vaccine. It's absolutely destroyed my life, and so I've had to just totally sit back and reevaluate everything.' The patient attributed her ailments to the shot. The patient she has experienced nerve complications - the researchers said vaccine injuries can manifest differently from patient to patient. Prior to her vaccine, the patient had been living with hypertrophic cardiomyopathy - thickening of the heart muscle - but her condition was well managed under the care of a cardiologist. Since her new symptoms began, she has seen doctors across multiple specialties, including orthopedics and a geneticist. She told this website her geneticist attributes her complications to a combination of her Covid infection and the vaccines. The doctor told her when she received the vaccine it prompted an immune response and her body sent out thousands of clots that cut off the blood supply to her bones and joints, which causes them to collapse and die. The patient's other doctors believe she has the autoimmune diseases either lupus or rheumatoid arthritis, but diagnostic tests have come back negative or inconclusive. She has been diagnosed with multifocal avascular necrosis (AVN), also called multifocal osteonecrosis (MFON). AVN is a condition in which bones throughout the body lose their blood supply, causing them to die. It can be caused by trauma to the body, like broken or fractured bones. A 2023 study investigated the relationship of avascular necrosis (AVN) and Covid infection in 17 patients. Researchers found 82 percent of patients complained of pain in both hips, leading nearly 18 percent to undergo total hip replacements and they concluded 'there is a risk of developing AVN after Covid-19.' There is no published research on the connection between AVN and Covid vaccines. Functional neurologist at the Neuro Center Dr (redacted), who is not involved in the patient's care, told social media AVN can be triggered by inflammation and blood clotting abnormalities. These, Dr (redacted) said, have been documented both in severe Covid cases and post-vaccination adverse reactions. He explained: 'Given that Covid-19 is known to affect the vascular system and trigger inflammatory responses, it is plausible that a vaccine administered soon after an infection could further exacerbate these effects, particularly in individuals with underlying predispositions.' Since her hip replacements, the patient has also undergone a partial left shoulder replacement in Sep2022 and had three surgeries on her elbow to remove dead bone and repair a nerve in Jan2023, Aug2024 and November 2024. She underwent a right knee replacement in Aug2023, a partial right shoulder replacement in May2023, a left knee replacement in Feb2023 and in Jul2023 her left heel broke and had to be surgically repaired. The patient would then undergo surgery in the next few weeks to repair another fracture in her right foot. She told this website: 'Even though I have had all of these replacements and surgeries I am still in constant deep bone pain every day. 'It isn't as bad as bone death pain but some days are still unbearable. The pain is so bad some days it takes everything I have to get out of bed and move, let alone be a mother and wife. 'Doctors think I will likely suffer with bone pain for the rest of my life.' Not only has she had to cope with AVN, her doctors said the infection and vaccine triggered a 'domino effect' in her body, leading to blood clots in her lungs, declining kidney function, sepsis and pleurisy - inflammation of the lining in the lungs and chest cavity. The patient believes in vaccines, when she first started speaking out about her experience with the Covid shot, she said she was met with people questioning whether she was an anti-vaxxer. The patient, however, has always been pro-vaccine and she and her children received all the recommended shots. Now, however, she is extremely wary of new ones. She told this website she will never get or give her children another Covid vaccine but has no problem getting them routine vaccinations of shots that have been around and researched for decades. The patient said: 'I did everything that I needed to do, vaccinating my children. I was vaccinated, but I will never get another flu shot or COVID vaccine, and I won't give my kids either as well. They will get... the other ones that have been well studied and researched, and there's lots of information on over the years. I just think that newer vaccines, before mandated, need to be researched because these are people's lives that it's destroying.' Therapeutic measures were taken as a result of osteonecrosis. BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Medical History/Concurrent Conditions: COVID-19; Hypertrophic cardiomyopathy
Test Name: diagnostic tests; Result Unstructured Data: Test Result:come back negative or inconclusive; Comments: autoimmune diseases either lupus or rheumatoid arthritis; Test Name: MRI; Result Unstructured Data: Test Result:hip bones were literally rotting; Test Name: x-ray; Result Unstructured Data: Test Result:Unknown results; Comments: double hip repllacement