Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Erythromelalgia, Fatigue, Fibromyalgia, Gastrointestinal disorder
Clinical narrative: POTS/ rapid heart rate/ dizziness/ lightheadedness/ shortness of breath/ brain fog/vision issues/ gastrointestinal issues such as vomiting and nausea//sleep difficulties/autonomic/ neurological; Fibromyalgia/ sleep difficulties/ migraines; Erythromelalgia/beet red color/stabbing pain/ burning pain/ tingling in her extremities/ could not control her body temperature; idiopathic small fiber peripheral neuropathy/ numbness/autonomic/ neurological; idiopathic small fiber peripheral neuropathy/ numbness/autonomic/ neurological; chronic fatigue/sleep difficulties/depression; menstrual problems; autoimmune, autonomic, and neurological, injuries; Inappropriate schedule of vaccine administered; Information has been received from a lawyer regarding a case in litigation and referring to a female patient (pt) of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 08-AUG-2019 (when pt was 12 years old), the pt was vaccinated with the 1st dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, as recommended by a physician, with her mother's consent, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). Soon after receiving the 1st vaccination, pt's extremities would turn a beet red color, she would get stabbing pain, a burning pain, numbness, and tingling in her extremities. She also could not control her body temperature. On 15-MAY-2020 (when pt was 13 years old), the pt was vaccinated with the 2nd dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, as recommended by a physician, with her mother's consent, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). Following the 2nd vaccination, pt's symptoms worsened. She was seen by multiple physicians and specialists for her complaints which now included: a rapid heart rate, dizziness, lightheadedness, shortness of breath, brain fog, chronic fatigue, vision issues, sleep difficulties, menstrual problems, gastrointestinal issues such as vomiting and nausea, and depression. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been unable to engage in activities that a normal young person would enjoy. Pt no longer attended school in person and must attend virtually because of her symptoms. She was homebound most of the time. She had few friends due to her medical conditions. Pt rarely went out due to her constant pain and fatigue. She needed assistance with most things including showering, brushing her teeth, and washing her face. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to Postural Orthostatic Tachycardia Syndrome (POTS), fibromyalgia, erythromelalgia, idiopathic small fiber peripheral neuropathy, chronic fatigue and migraines, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's wrongful acts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)'s manufacturing defects, pt had suffered and continued to suffer severe and permanent physical injuries and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. The outcome of all the events was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered all the events to be disabling. Upon internal review, autoimmune disorder and autonomic neuropathy were determined to be medically significant.