Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
Gastroparesis / nausea; POTS/brain fog,nausea,HA,dizziness,fatigue,blood pooling in legs,palpitation,chest pain,tachycardia,tremors,temp dysregulation,cognitive issue,insomnia,vision blackout upon standing,cold hand&feet,blue fingers,temp intolerance,light sensitivity,pain; Mitral valve prolapse; small intestinal bacterial overgrowth (SIBO) / nausea; low ferritin / nausea, severe fatigue, dizziness, extreme cold hands and feet, severe chronic headaches; autoimmune injuries/autoimmune disorders; loss of hearing in her left ear; fructose malabsorption / nausea, severe fatigue; Hippus pupils; difficulty swallowing; pins and needles in her feet up to her knees; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age (adult at the time of report). The pt's concurrent conditions included Ehlers-Danlos syndrome (reported as an adverse event, conflicting information), medical history and concomitant therapies were not provided. On an unknown date, at the age of 14 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot# and expiration date were not reported), for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), as recommended by the pt's physician (referred to as a doctor and also as a health care provider) and consented by the pt's mother. On unspecified dates following vaccination, the pt suffered severe chronic headaches, dizziness, vision blackout upon standing, loss of hearing in her left ear, palpitations, chest pain, tachycardia, difficulty swallowing, tremors, nausea, back and neck pain, pins and needles in her feet up to her knees, temperature intolerance, extreme cold hands and feet, blue fingers, temperature dysregulation, severe fatigue, severe leg pain, blood pooling in legs, light sensitivity, hippus pupils, gastroparesis, brain fog, cognitive issues and insomnia. The pt's deteriorating health following the human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination occurred in the beginning of her freshman year of high school. She could not get out of bed to go to school. The more she sat upright, the worse the symptoms became. She saw numerous specialists, including cardiologists, gastroenterologists, hematologists, neurologists, physical therapists, and urologists. At one point, she was taking 18 pills a day and only growing more ill with each passing day. The pt was diagnosed with gastroparesis, fructose malabsorption, Hippus Pupil, and postural orthostatic tachycardia syndrome (POTS). Due to her post- human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to participate in activities that a typical young person would enjoy. She has always loved the outdoors, animals, and playing sports. Growing up, she had a variety of pets, including dogs, cats, birds, fish, a snake, a hamster, and a hedgehog. She began playing soccer around the age of five and started softball at age six. She excelled in every sport she participated in and was a standout in physical education classes at school. She was even invited to play on a softball team with kids two years older than her, where she often played first base, third base, or shortstop. She was also a starter on her basketball team, ran track, and played volleyball. A tough and determined kid, she did not let anything hold her back-even playing through broken fingers, broken toes, and tom muscles. She rarely complained and always pushed herself. Growing up, she had many friends. She was a quiet and caring person who was easygoing and low-maintenance, and always ready to help those in need. Unfortunately, her symptoms significantly impacted her ability to live a normal life. Based upon her chronic and severe post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to POTS, mitral valve prolapse, gastroparesis, small intestinal bacterial overgrowth (SIBO), fructose malabsorption and low ferritin. The pt contended her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries and a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to their human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorders. As a proximate result of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to being at that time at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and they would continue to incur these losses and expenses in the future. The outcome of the events was considered as not recovered. The reporter considered all the events to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered all events to be disabling.
Ehlers-Danlos syndrome