Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Food allergy, Headache, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Sjögren's syndrome/Sicca diagnosis/autoimmune disease/autonomic disorder/drymouth,swollenandpainfullymphnodes, fatigue and lethargy, moderate hair loss, headaches, dry and itchy skin and redness, light sensitivity,occasional rashes,depression,anxie; food allergies; acne; palpitations; cold extremities; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female patient (pt) of an unknown age. Prior to receiving the suspect vaccine, she had no autoimmune diseases, and no autonomic issues, and she was in her normal state of health. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 18-MAY-2017, at the age of 24 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On 10-JAN-2018, she received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On 09-MAY-2018, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unspecified date in June 2018, (reported as over the summer), the symptoms first started, and by November 2018, the pt was experiencing full blown autoimmune disease. Her symptoms persisted for longer than six months. She was seen by multiple physicians and specialists for her complaints. On an unknown date in June 2018, the pt experienced severe dry mouth, swollen and painful lymph nodes, and was followed by fatigue and lethargy, moderate hair loss, headaches, severe acne, cold extremities, dry and itchy skin and redness, palpitations, food allergies, light sensitivity, occasional rashes, severe depression, and severe anxiety. 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. On unknown dates, 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, Sjogren's syndrome/Sicca diagnosis and autoimmune diseases. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, 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 suffered and at the time of report continued to suffer severe and permanent physical injuries, and associated symptomatology 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 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 at the time of report 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 of Sjogren's syndrome, acne, palpitations, cool extremities and food allergies was considered to be not recovered. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of Sjogren's syndrome was determined to be medically significant. All events were considered to be disabling.