Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Impaired work ability, Insomnia, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: postural orthostatic tachycardia syndrome (POTS)/ dysautonomia/ chronic fatigue/ dizziness/ dyspnea with exertions/ chest pains/ blurry vision/ nasal congestion/ headaches/ memory loss/ insomnia/ nausea/ abdominal distention/ decreased appetite; Fibromyalgia/sleep paralysis/syncope; mast cell activation syndrome (MCAS)/ generalized anxiety/ major depressive disorder/ skin flushing/ cognitive impairment/ brain fog/ frequent allergies/ hives; hit hear head on the window or windowsill; Hashimoto's thyroiditis/autoimmune disease; ulcerative colitis/ abdominal pain and nausea/ constipation; Information has been received from a lawyer regarding a case in litigation, concerning adolescent female patient (pt). Medical history, concurrent conditions and concomitant medications were not provided. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections pt was a happy, physically active teenager in her usual state of health. The pt was an excellent student, and she was involved in competitive soccer and ice skating. On 29-DEC-2015, at age of 13 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided). The pt returned to physician's office on 29-FEB-2016 to receive second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 12-JUL-2016, she received the third dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided). All doses were administered for prophylaxis. Immediately following her third vaccination with the suspect vaccine (considered to be on the same date), the pt fainted and hit her head on the window or windowsill in the examination room at physician's office. Two days later on 14-JUL-2016, the pt was seen by her allergist and reported that she became severely short of breath after five minutes of a soccer game and had to stop playing. The pt was referred to a cardiologist based on her symptoms. On an unknown date in August 2016, the pt went to a cardiologist for evaluation of her symptoms, which included dizziness, dyspnea with exertions, chest pains, blurry vision, nasal congestion, headaches, memory loss and insomnia. She was also experiencing gastrointestinal (GI) symptoms including nausea, abdominal distention and decreased appetite. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for complaints, which included, among others: severe fatigue, weakness, body pains, sleep paralysis, abdominal pain and nausea, decreased appetite and early satiety, constipation, cold intolerance, frequent headaches, insomnia, cognitive impairment, brain fog, palpitations, syncope, chest pains, lightheadedness, skin flushing, hives and frequent allergies, panic attacks, photophobia, phonophobia, anxiety and depression. On 16-OCT-2017, the pt was evaluated by physician, who conducted testing (unspecified) and diagnosed the pt with postural orthostatic tachycardia syndrome (POTS). Physician continued to treat the pt, and on 24-SEP-2018, he conducted further orthostatic testing which confirmed the pt's POTS diagnosis. As a result of her post quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been unable to engage in the normal activities that a teenager and young adult would enjoy. The pt had to drop out of high school to complete her schooling at home. Due to her fatigue and other debilitating symptoms, the pt had to give up her dreams of a career in the medical field. She was not able to work a normal job and relied on her parents for financial support. The pt sustained autoimmune disease and other serious injuries, including but not limited to POTS, fibromyalgia, mast cell activation syndrome (MCAS) and dysautonomia 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 pt's autoimmune disease and other related injuries and has resulted in her suffering from severe, debilitating, disabling and painful chronic injuries. Based on her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)s ymptoms and adverse events as outlined above and the tests performed by a number of medical providers, the pt has been diagnosed with various medical conditions, including but not limited to POTS, MCAS, Hashimoto's thyroiditis, ulcerative colitis, chronic fatigue, generalized anxiety, and major depressive 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 had 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 recovered/ not resolved. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events of MCAS, Hashimoto's thyroiditis and colitis ulcerative were determined to be medically significant. All events were considered to be disabling by the reporter.