Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Educational problem, Flushing, Heart rate increased, Housebound, Loss of consciousness
Clinical narrative: feeling flushed; Non-Epileptic Seizures/multiple seizures/ pins and needles sensations in both her legs; Vasovagal Syncope/passing out/lightheadedness; being wheelchair bound multiple times for inability to put weight on her legs or feet; her lower extremities turn purple and blue at times; autoimmmune disorder/autoimmune disease/autoimmune injuries; autonomic injuries/autonomic dysfunctions/autonomic diseases; Ovarian Cysts/multiple cysts removed; 1st dose 22-APR-2019 and 2nd on 15-JUL-2020; Supraventricular tachycardia/high heart rate; severe depression/loss of concentration; Information has been received from a lawyer regarding a case in litigation and refers to a female adult patient (pt). The pt's concurrent conditions, medical history and concomitant therapies were not provided. Before receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was an honor student and enjoyed cheerleading, sports, and many social activities. On 22-APR-2019, when the patient was 16 years old, she was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), as recommended by the pt's physician. On an unknown date, she experienced symptoms, including but not limited to feeling flushed and light-headed. On 15-JUL-2020, the pt was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, lot #, expiration date, route of administration and anatomical location were not provided). On an unknown date in 2020, as a result, the pt began suffering further conditions by September 2020, including but not limited to supraventricular Tachycardia, passing out, high heart rate, and severe depression. The suspect vaccine-induced diagnoses included but were not limited to supraventricular tachycardi, vasovagal syncope, and non- epileptic seizures. Her adverse reactions to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations lasted for more than six months. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints, which then included multiple seizures, vasovagal syncope, multiple cysts removed, and being wheelchair bound multiple times for inability to put weight on her legs or feet. She also experienced pins and needles sensations in both her legs and feet, and her lower extremities turned purple and blue at times. 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 activities that a normal young person would enjoy. As her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) -induced medical diagnoses and seizures continued, the pt experienced a loss of concentration, which led to a decline in her academic performance, as she struggled to pass her classes. Due to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) -induced symptoms, she had to live a more homebound lifestyle and had withdrawn from her friends and social settings. 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, supraventricular tachycardia, ovarian cysts, vasovagal syncope and non- epileptic seizures. 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 supraventricular tachycardia, ovarian cysts, vasovagal syncope and non-epileptic seizures, 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. As a proximate result 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. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to then 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 recovered/not resolved. The reporter considered all the events to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events of non-eplipetic seizures, syncope vasovagal, autoimmune disorder and autonomic disease were determined to be medically significant. The reporter considered all events to be disabling.