Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Temperature intolerance
Clinical narrative: POTS(rapid heartbeat,chest pain,excessive sweating,dizziness,shortness of breath,exhaustion,brain fog,insomnia,extreme sensitivity to temperature)/autonomic disorder/neurological injuries/inflammatory disorder; chronic fatigue syndromes/neurological disorder; autoimmune disorder; off her fourth medication to control her heart condition because all of the medications had been ineffective; 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. She was healthy and had no autoimmune diseases or autonomic issue prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. On 25-FEB-2019, at the age of 33 years, the pt was vaccinated with the 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 health care provider. On an unknown dates, the pt received second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On an unknown date, reported as almost immediately following her third and final quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt sustained injuries. She was seen by multiple physicians and specialists for her complaints which included: rapid heartbeat, chest pain, excessive sweating, extreme sensitivity to temperatures, exhaustion, shortness of breath, dizziness, brain fog, and insomnia. 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 person would enjoy. She was initially admitted for emergency medical treatments over the span of multiple days due to her highly elevated heartbeat of over 200 BPM. Follow up treatments with the cardiologist and/or the neurologist were unsuccessful in determining the cause of the pt's life-threatening symptoms. She was currently off her fourth medication to control her heart condition because all of the medications had been ineffective. Also, the pt was no longer able to exercise and does considerably fewer daily activities, negatively affecting all of her relationships. Mostly, she had difficulties maintaining attendance and focusing on her responsibilities at work/employment. 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 inflammatory disorders, chronic fatigue syndromes (CFS), POTS, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are 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 continues 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 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, she 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. The reporter considered POTS to be life threatening and hospitalization event.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.