Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Mouth ulceration, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Crohn's Disease; incoherent; unable to walk; migraines; candida; systemic complications; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; chronic fatigue; Plaintiff was 29 years old when she received her first dosage of Gardasil; Information has been received from a lawyer regarding a case in litigation and referred to a female adult patient (pt) (exact age not provided). Her other medical history, concurrent conditions and concomitant therapies were not provided. On 28-JAN-2019 (at the age of 29 years old), the pt was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by her health care provider, with pt's consent, for prophylaxis (reported as for preventing cervical cancer) (Product administered to patient of inappropriate age). On 08-APR-2019, the pt was vaccinated with the second dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On 15-AUG-2019, the pt was vaccinated with the third dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On unknown dates following her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, pt began experiencing terrible digestive problems, including bloating, gas, diarrhea, and internal bleeding/bloody stool. In addition, her hair started to fall out at an alarming rate, and she developed ulcerative sores in her mouth. After doing bloodwork, her doctor detected elevated white blood cells. She saw a gastroenterologist specialist to perform a colonoscopy for her digestive problems and was diagnosed with Crohn's Disease. Evidence of ulceration in her digestive tract was detected during this procedure. Doctors prescribed different medications, courses of steroids, and biologic infusions to suppress her immune system, however, her condition continued to deteriorate, and her doctors sent her to the emergency room. Eventually, pt became incoherent and was unable to walk (Gait inability). She was then hospitalized and in extreme pain. During this hospitalization, pt required a blood transfusion. She had also lost 50 pounds, leaving her at just over 100 pounds. After her hospitalization, pt required the assistance of a wheelchair and a walker to move around and relied on her parents for care. Pt tried new medications that would help with her symptoms and continued her round of steroids. She also developed migraines and had recurrent fevers of 103 degrees. The severe mouth sores persisted, and she continued to lose weight. She developed candida and suffered systemic complications (Candida infection; Disease complication). During this time, pt required the assistance of her mother to feed, bathe, and dress her. Post-quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections, pt has visited the emergency room many times and was on her fourth treatment plan for her Crohn's Disease, which required an injection every eight weeks.  As a result of her post-quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been unable to engage in activities that a normal young person would enjoy, and her ability to function had been severely impacted. Her ill health had negatively impacted her career, ability to travel, and her social life. Pt had been seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post-quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt has been diagnosed with various medical conditions, including but not limited to Crohn's disease, chronic fatigue, and migraines. Pt did not know and had no reason to know that her symptoms were caused by the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, as no information to the contrary was given to her by her medical providers. It was not until early 2023 that pt began to suspect that quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) could be the cause of her symptoms and injuries. Pt contended that her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to Crohn's disease, chronic fatigue, and migraines, 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 (Adverse event; Ill-defined disorder). As a proximate result of company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), 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. 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 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, pt 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 all claimed events was not recovered. The lawyer considered all claimed events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL).  The lawyer considered all claimed events to be disabling.  Upon internal review, the event Crohn's disease was determined as medically significant.