Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Hypersomnia, Investigation, Lethargy, Loss of personal independence in daily activities
Clinical narrative: idiopathic hypersomnolence/trouble waking up in the mornings, staying awake during the day, slept more than the average hours, sleeping twelve hours or more per day, long lasting headaches that persisted for days/fatigue/lethargy/difficulty waking up; autonomic, autoimmune, and neurological injuries; autonomic, autoimmune, and neurological injuries; nausea; Information has been received from a lawyer regarding a case in litigation and refers to an adolescent (reported as adult, discrepant information) male patient (exact age not provided). His medical history, concurrent conditions and concomitant therapies were not provided. On 23-NOV-2015, at the age of 15 years old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) as recommended by physician, with his mother's consent, for prophylaxis. On unknown dates, the patient experienced serious autoimmune, autonomic and neurological injuries as a result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). On unspecified dates, reported as soon after the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), he began to experience nausea, lethargy, and fatigue. Between the first and the second administration of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (date of administration not provided, exact dose, route of administration, anatomical location, lot # and expiration date were not reported), the patient was taken to multiple physicians to evaluate his symptoms and underwent many screenings (results not provided). Following the second vaccination, the patient's symptoms worsened. He had trouble waking up in the mornings, staying awake during the day, and slept more than the average hours. Eventually, he began sleeping twelve hours or more per day and was missing school. The patient also experienced long lasting headaches that persisted for days. On an unspecified date in April 2016, based upon his chronic and severe post- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient was diagnosed with idiopathic hypersomnolence. As the months progressed, so did the patient's symptoms. He was seen by multiple physicians and specialists for his complaints which included: nausea, lethargy, fatigue, and difficulty waking from a long sleep. As a result of his 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. Prior to receiving quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections, he was healthy and active. He challenged himself academically by enrolling in honors chemistry and engineering courses, while simultaneously maintaining a social life. Post quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the patient's schoolwork suffered, and he had to obtain academic accommodations. The patient contended that his vaccination caused him to develop the serious and debilitating autoimmune and neurological injury called idiopathic hypersomnolence, 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 his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injury. 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. He 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 his injuries caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the patient and his mother suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he 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 event of autoimmune disorder was determined to be medically significant.  The reporter considered all events to be disabling.