Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Product administered to patient of inappropriate age, Tachycardia, Vision blurred, Visual impairment
Clinical narrative: pain at the injection site; vaccinated at 42 years of age; Postural Orthostatic Tachycardia Syndrome (POTS)/ dizzy/ light-headed/ headache/ vision becoming blurry/ pain behind her eyes/ joint pain/ increased heart rate/ palpitations/ pain/ suffering/ autonomic dysfunction/ dysautonomia; autonomic, neurological, heterogenous autoimmune disease/ Gardasil-induced autoimmune disorder/ achy all over her body; Information has been received from a lawyer regarding a case in litigation, concerning adult female patient (pt) of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) the pt led a physically active lifestyle as nurse, mother and volunteer. She had no autoimmune diseases, and no autonomic issues. She had a successful career and was always very active in her life, including walking frequently. On 24-APR-2020, at the age of 42-years-old the pt was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) to prevent cervical cancer (dose, route of administration, anatomical location, lot # and expiration date were not provided) (product administered to patient of inappropriate age). On 17-JUL-2020, she received second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) to prevent cervical cancer (dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date in 2020, after receiving the second dose, the pt felt dizzy, light-headed and achy all over her body. Those symptoms persisted for at least two weeks following the second dose. The symptoms from the pt's reaction to second dose improved, and the final dose was scheduled. On 24-NOV-2020, the pt received third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) to prevent cervical cancer (dose, route of administration, anatomical location, lot # and expiration date were not provided). After final dose, the pt began to feel dizzy and began to experience headache. The pt noticed that her vision was becoming blurry and she was developing pain behind her eyes. Dizziness continued to such a severe extent that she was forced to hold herself up inside a store to prevent a fall. The pt regularly communicated with her medical providers and expressed concern that her symptoms were being caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On 24-NOV-2020, she sought medical care and treatment from an eye doctor to address her sudden onset of blurred vision and eye pain. The eye doctor concluded that pt was experiencing an acute reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On 25-NOV-2020, vision and eye pain symptoms persisted. On or about 25-NOV-2020, the pt also experienced severe joint pain throughout her body, continuous light-headed sensation and increased heart rate causing noticeable palpitations. After receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was in pain and was suffering. As the months progressed thereafter, the pt's injuries, pain and suffering also progressed. After vaccinations, the pt was seen by multiple physicians and specialist for her complaints which included, but were not limited to, vision degradation, tachycardic heart rates with palpitations, severe dizziness, extreme fatigue and pain at the injection site. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities that a normal 43-year-old person would enjoy, suffered emotional distress, was unable to work the schedule she worked prior to receiving the vaccination and she had to reduce her shifts at the hospital, was unable to pursue the recreational activities she enjoyed prior to receiving the vaccination because her fatigue renders her unable to participate in even light physical activity after approximately 3 p.m. each day. Based on her chronic and severe post-vaccination symptoms, the pt was diagnosed with various medical conditions, including but not limited to, adverse effect from the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, chronic pain, autonomic dysfunction and postural orthostatic tachycardia syndrome (POTS). As a result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, pt's day-to-day life dramatically changed. The pt sustained autoimmune disease, autonomic dysfunction and other serious injuries, as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and its ingredients caused the pt's autoimmune disease and other related injuries and resulted in her suffering from severe, debilitating, disabling and painful chronic injuries. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations caused her do develop serious and debilitating injuries, including but not limited to, autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events all of which were caused by or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of wrongful acts and omissions and negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and 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 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 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 resolved. The reporter determined the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of autonomic, neurological, heterogenous autoimmune disease was considered to be medically significant. The events were considered to be disabling by a reporter.