Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Fear, Fibrocystic breast disease, Headache
Clinical narrative: fibrocystic disease of the breast; daily fear and anxiety over her health. Her life is consumed by fear of each new ailment; shakiness; heart palpitations; autoimmune disease/ heterogenous autoimmune injuries/ Gardasil-induced autoimmune disorder; autonomic dysfunction; intractable migraine with aura without status migrainosus, complicated migraine, vertigo/muscle weakness/frequent headaches/dizziness, fatigue, mental confusion, numbness and tingling/arm weakness; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female patient (pt) of an unknown age. Prior to receiving the suspect vaccine, she was in her usual state of health. The pt had no autoimmune diseases, and no autonomic issues. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 25-OCT-2018, at the age of 23 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On 08-JAN-2019, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported). Within days, (considered as unspecified date in January 2019), the pt developed migraines, numbness, and arm weakness. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: frequent headaches and migraines, dizziness, fatigue, shakiness, heart palpitations, mental confusion, numbness and tingling, muscle weakness, vertigo and anxiety. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt now experienced daily fear and anxiety over her health. Her life was consumed by fear of each new ailment, muscle weakness, and headaches. On unknown dates, based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to, intractable migraine with aura without status migrainosus, complicated migraine, vertigo, fibrocystic disease of the breast and autonomic dysfunction. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries (also reported as disabling and painful chronic injuries), including but not limited to autonomic, neurological, heterogenous autoimmune disease, autonomic dysfunction, 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. The pt had suffered and at the time of report continued to suffer severe and permanent physical injuries, and associated symptomatology and had 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 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 pt suffered and at the time of report 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).  The events were considered to be disabling.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.