Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Insomnia, Irritability, Juvenile myoclonic epilepsy, Loss of consciousness
Clinical narrative: non-intractable juvenile myoclonic epilepsy without status epilepticus/neurological injuries/fatigue/sensitivity to light and sunlight/head twitching/headaches/hypersomnia/insomnia/irritability/grand mal seizures/lost consciousness; menstrual issues/menstrual irregularity; tongue producing blood/tongue trauma; laceration over the left eye; permanent scar; autonomic injuries; autoimmune disorder; first dose of Gardasil on 27-OCT-2017, second dose on 29-MAR-2019; Information has been received from a lawyer regarding a case in litigation and referred to a 16-year-old female patient (pt). The pt's medical histories, concurrent conditions and concomitant therapies were not reported. The pt was a healthy, bright, sociable teenager who enjoyed singing and performing in musicals at school and the local children's community center before vaccination. On 27-OCT-2017, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, strength, lot #, expiry date, and route of administration were not provided) for preventing cervical cancer, upon pt's doctor's recommendations and with mother's consent. On 29-MAR-2019, the pt was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). On unknown dates following the second vaccination, the pt experienced sensitivity to light and sunlight, grand mal seizures, head twitching, headaches, tongue trauma, fatigue, irritability, insomnia, hypersomnia, and menstrual irregularity. The pt's seizure episodes were so severe that she blacked out, bit her tongue producing blood, lost consciousness and hit her head on a countertop, which caused a laceration over the left eye. The patient's eye laceration required sutures, and she had a permanent scar. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints. She was prescribed antiepileptics and rescue medications to treat the seizures. At one point, her symptoms were so severe that she was taken to the emergency room and admitted to the hospital. The pt had been unable to engage in activities that a normal young person would enjoy, her social life had been negatively impacted. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to non-intractable juvenile myoclonic epilepsy without status epilepticus, menstrual issues, and fatigue. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating neurological injuries, including but not limited to non-intractable juvenile myoclonic epilepsy without status epilepticus, 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 neurological, autonomic and autoimmune disorders. As a proximate result of The Company's 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 had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The 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 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 pt had 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. Outcome of the events juvenile myoclonic epilepsy, menstruation irregular, tongue haemorrhage, eye injury, scar, autonomic neuropathy, autoimmune disorder was not recovered. Causal relationship between the events mentioned ahead and vaccine was related.   The lawyer considered the events mentioned ahead to be disabling.   Upon internal view, the events juvenile myoclonic epilepsy, autonomic neuropathy and autoimmune disorder were determined to be medically significant.