Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiolipin antibody positive, Chronic fatigue syndrome, Depression, Headache, Pulmonary embolism
Clinical narrative: depression; anxiety; autonomic nervous system dysfunction/neurological injuries; pulmonary embolism/Multiple Pulmonary embolisms; inappropriate schedule of vaccine administration (first dose on 11-DEC-2018, second dose on 15-APR-2020); Chronic Fatigue Syndrome/headaches,joint pain,fatigue/rheumatological issue/neurological injuries; antiphospholipid syndrome (with positive cardiolipin antibodies)/APS/autoimmune; 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 11-DEC-2018, at the age of 16 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. By the end of October 2019, the pt began suffering autoimmune and rheumatological issues and pronounced symptom. On 15-APR-2020, the pt received second of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The pt's condition worsened and progressed after the second vaccination. Her adverse reaction to both vaccinations has lasted for more than 6 months. The pt's autoimmune issues were caused-in-fact by the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination received on 11-DEC-2018 and aggravated by her vaccinations on 15-APR-2020. She had been diagnosed with pulmonary embolism, antiphospholipid syndrome (APS) (with positive cardiolipin antibodies) and had signs and symptoms consistent with autonomic nervous system dysfunction and chronic fatigue syndrome (CFS). As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: multiple pulmonary embolisms as well as APS with positive cardiolipin antibodies, which is a disorder of the immune system that causes increased risk of blood clots. She was told that the signs and symptoms of my condition are consistent with autonomic nervous system dysfunction and CFS. 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. She missed celebrating her eighteenth birthday, her senior prom, and her high school graduation party as a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms. Her symptoms also caused her to have to miss several college courses that were covered by scholarship, causing her to have to enroll in them later and pay for the courses out-of-pocket, as they were no longer covered by the scholarship. She continued with chronic headaches, joint pain, fatigue, depression, anxiety and as of most recent, must now give herself two daily injections to prevent further embolisms. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, autonomic nervous system dysfunction and CFS and APS. 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, autonomic nervous system dysfunction and CFS and APS, 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 has 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 events of APS and pulmonary embolism were determined to be medically significant.