Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Autonomic nervous system imbalance, Impaired work ability, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS/autonomic injuries/neurological injuries; autoimmune injuries/Gardasil-induces autoimmune disorder; Information has been received from a lawyer regarding a case in litigation and refers to an adult female patient (pt) (exact age was not provided). The pt's medical history, concurrent conditions and concomitant therapies were not provided. On 15-NOV-2006, at the age of 18 years, the pt received her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided), as recommended by her healthcare provider (HCP). On an unknown dates, the pt received two additional doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she has been diagnosed with various medical conditions, including but not limited to postural orthostatic tachycardia syndrome (POTS). The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological injuries, including but not limited to POTS, 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 continued to suffer severe and permanent physical injuries, and associated symptomology 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 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. The outcome of the events was considered not recovered.   The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered all events to be disabling.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.