Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Autoimmune disorder, Autonomic nervous system imbalance, Bladder disorder, Chronic fatigue syndrome
Clinical narrative: involuntary movements; abnormal weight loss; heat intolerance; bladder issues; Chronic Fatigue Syndrome (CFS)/fatigue/myalgias/muscle pain/hypermobility arthralgia; autonomic dysfunction/weak/stomach pain/muscle weakness; autoimmune disease; could not walk or move any of her limbs; abdominal pain/discomfort; Seizures/frequent tonic-clonic seizures; All she did was sleep after each episode; Information has been received from a lawyer regarding a case in litigation and referred to a 14-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. It was reported that she loved to draw and had other hobbies, had been part of an assortment of clubs including soccer, girl scouts, dance, band, volleyball, and color guard. She had always been a good student, routinely making A's and B's, and never had any issues with attendance. She also had no significant medical issues growing up. On 05-FEB-2018, during a routine visit, the pt's doctor recommended that pt receive quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. Under the pt's consent, the pt was vaccinated with a total of two separate doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (dose, route of administration, anatomical location, lot number, and expiration dates were not reported). She was 14 years old when she received the first dose (05-FEB-2018). Within a few hours of receiving her first dose, pt began experiencing abdominal and stomach pain. Because her pain never subsided, pt's mother decided to take her to the Emergency Room (ER), where she stayed for 48 hours. The doctors were concerned that her "waves/episodes" were seizures, and they ran an electroencephalography test (EEG) on her. The doctors were not able to determine the cause. She started developing more seizures and returned to the hospital in March, where she underwent a full work up. Pt's seizure episodes would last for 45 seconds to 1 minute. During those episodes, she would curl up into a ball and would only respond to her name when talked to. With each month, she began to develop more symptoms in addition to the seizures: fatigue, myalgias, and abdominal pain. Because of this, pt was unable to go to school on various occasions. In May 2018, pt returned to her doctor's office to receive the second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection. Approximately 30 minutes after she received the injection, Plaintiff started seizing on the floor. She began having those events every few minutes. Her mother called the doctor to mention that she was reacting to the vaccine, and took her to the ER. Approximately in June 2018 (reported as summer of 2018), pt's symptoms worsened; she made various trips to doctors, and ERs. All that time, she was extremely fatigued, weak, and would have frequent tonic-clonic seizures. She could not walk sometimes or move any of her limbs. Her family would have to assist her to the bathroom and carry her to bed. The seizures would take so much out of her that all she did was sleep after each episode. As the months progressed, so did her injuries, which now included: chronic fatigue syndrome (CFS), involuntary movements, muscle pain, seizures, hypermobility arthralgia, abnormal weight loss, abdominal pain/discomfort, heat intolerance, bladder issues and stomach pain. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she could not engage in the normal activities that a high schooler would typically enjoy. She could no longer be physically active, participate in the activities she used to, or attend school as often as she would like. She had to be homeschooled for 6 weeks her freshman year of high school, and used a wheelchair whenever she was out longer than 30 minutes. Pt continued having seizures, fatigue and a high heat intolerance that also triggered her seizures. She had been attending physical therapy sessions for her overall muscle weakness and had started with bladder strengthening. Pt had been diagnosed with various medical conditions, including but not limited to CFS, seizures, and autonomic dysfunction. Therefore, it was claimed, that the pt sustained autoimmune disease and other serious injuries as a result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. As a proximate result of vaccination, pt had suffered and continued to suffer severe and permanent physical injuries and associated symptomatology and had 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 as a result of her exposure to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). At the reporting time, he had not recovered from the events. The reporter considered all events to be disabling and related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events seizure, autoimmune disorder, generalized tonic-clonic seizure were determined to be medically significant.