Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Heavy menstrual bleeding, Hyperacusis, Intrauterine contraception, Loss of personal independence in daily activities
Clinical narrative: heavy menstrual pain; heavy menstrual bleeding; constantly worried; migraines; autoimmune disorder; pain in legs; Mast Cell Activation Syndrome (MCAS) / intensive hives / skin rashes/ tachycardia / palpitations / headaches / chronic fatigue / dizziness / feeling faint; chronic fatigue/tachycardia/palpitation/headache/light&sound sensitivity/dizziness/unable to stand/difficulty regaining normal consciousness/near syncope consistent w dysautonomia,neurally-mediated syncope(POTStype)/dilated eyes/neurological disorder; fell in the hallway the first episode; fell to the bathroom floor in the second; widespread joint pain / metabolic origin joint pain; Information has been received from a lawyer regarding a case in litigation and refers to an adolescent (reported as minor) female patient (exact age not provided). Her medical history, concurrent conditions and concomitant therapies were not provided. On 14-NOV-2019, at the age of 14 years old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (reported also as "cervical cancer vaccine") (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) during a routine health visit, as recommended by her gynecologist, with her and her mother's consent, for prophylaxis. The patient experienced serious and debilitating injuries, including but not limited to autonomic, autoimmune, and neurological injuries and resulting sequalae that the patient sustained as a result of receiving the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. By late February 2020, the patient first started to develop symptoms of her heart racing for no reason, and an episode where she nearly fainted, was dizzy and unable to stand, and had difficulty regaining normal consciousness. The patient had also headaches and leg pains. On unknown dates in 2020, reported as shortly thereafter, the patient began to experience widespread joint pain and more frequent racing heartbeat for no reason and not associated with increased activity. She reported her symptoms to her physician. On unspecified dates between March 2020 and June 2020, the patient had two separate episodes where she nearly fainted: fell in the hallway the first episode and fell to the bathroom floor in the second, had very dilated eyes, was dizzy and unable to stand. Her blood glucose was normal, yet she had difficulty regaining normal consciousness. The patient continued to complain of headaches and leg pains. She returned to her pediatrician's office on 18-MAY-2020, and was vaccinated with the recommended second quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). Within weeks following the second quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) shot, the patient began having more diverse and more severe symptoms. As the months progressed, so the patient's injuries. She was seen by specialists in cardiology, orthopedics, gynecology and allergy. Her complaints included: heavy menstrual pain and bleeding, intensive hives and skin rashes, tachycardia, chronic fatigue, feeling faint, dizziness, migraines, light and sound sensitivity and joint and leg pains. Eventually, the patient was seen by a pediatric cardiologist 3 times, an orthopedist 1-2 times, two different gynecologists and an allergist 2-3 times. She began taking chewable fast acting loratadine (CLARITIN) on a daily basis and began new blood tests after first seeing the allergist on an unknown date in August 2021. The patient was treated for palpitations and near-syncope consistent with dysautonomia by the cardiologist, obtained an intrauterine device (IUD) to address heavy and painful periods, was recommended supplements for metabolic origin joint pains, and was continuing to obtain 24-hour urine studies at the correct time related to a diagnosis for mast cell activation syndrome (MCAS). Following the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccinations, the patient was diagnosed with various medical conditions including near-syncope consistent with dysautonomia / neurally-mediated pre-syncope (a type of postural orthostatic tachycardia syndrome (POTS) and tachycardia) and continued to test related to MCAS. As a result of her post-quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient had struggled to engage consistently in normal activities that a young adult (conflicting information) would enjoy. She was constantly worried, and she did not spend the night out with friends due to the unpredictability of her symptoms. She struggled in her academics and had to incur excessive absences. As a result of her post- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient was unable to engage in activities that a normal young person would enjoy. The patient contended that her vaccinations caused her to develop serious and debilitating autoimmune, autonomic and neurological injuries, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were 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 quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the patient suffered and continued to suffer severe and permanent physical injuries and associated symptomology and suffered severe 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 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, the patient suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events of mast cell activation syndrome and autoimmune disorder were determined to be medically significant.  The reporter considered all events to be disabling.