Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Sudden onset of sleep
Clinical narrative: Autoimmune Type I Narcolepsywith cataplexy; neurological dysfunctions:Autoimmune Type I Narcolepsywith cataplexy/chronically falling asleep during the day; was 14 years old when she received her fist dosage of Gardasil and 16 when she received her second dose; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date (when she was 14-years old), the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection as prevention of cervical cancer (dose, route of administration, anatomical location, lot number, and expiration date were not provided). Also, on an unspecified date (when she was 16) she received the second dose of the vaccine (inappropriate schedule of product administration). On an unknown date following vaccination, the patient inexplicably began to chronically fall asleep during the day, including during school, on the school bus, and at home. Based on the mentioned symptoms she was diagnosed with various medical conditions, included but not limited to severe autoimmune type 1 narcolepsy with cataplexy. She stated that the first time she discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2020. As a result of her post-vaccine symptoms, the pt has been unable to engage in activities that a young person her age would normally enjoy. She must take medication to function and work and could no longer do things like drive a car at night or swim in water any deeper than three feet without wearing a life jacket due to her symptoms. Moreover, as a result of company's alleged wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the pt has suffered and would continue to suffer severe and permanent physical injuries, and associated symptomology and has 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 now being at an increased risk of cancer, and future symptoms and harms associated with her injuries caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Additionally, as a direct and proximate result of her vaccine-induced injuries the pt has suffered and would continue to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and would continue to incur. The patient had not recovered from the adverse event, and it was considered the event was related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  The reporter considered autoimmune type 1 narcolepsy with cataplexy to be a disabling event.   Upon internal review the event autoimmune type 1 narcolepsy with cataplexy was considered to be medically significant.