Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Pericarditis, Product administered to patient of inappropriate age, Skin ulcer, Staphylococcal infection
Clinical narrative: Debilitating Fatigue, headaches, skin and mouth sores, joint pain in knees and legs, sores all over the body, pericarditis, arthritis, gastrointestinal problems/Behcet's disease-Gardasil-induced autoimmune disorder; miscarriage; Methicillin-resistant Staphylococcus aureus (MRSA); adverse symptoms, complications, injuries, and other adverse events; Dizzines; Nausea; Vaccine exposure during pregnancy; was 35 years old when she received her first dose of Gardasil; Information has been received from a lawyer regarding a case in litigation, concerning an adult female patient (pt) of unknown age. The pt's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date (when she was 35-years old) (product administered to patient of inappropriate age), the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection as prevention of cervical cancer (dose, route of administration, anatomical location, lot number, and expiration date were not provided). On an unknown date following vaccination, the patient began to experience debilitating fatigue, headaches, dizziness, nausea, and skin and mouth sores. The pt also began experiencing joint pain in her knees and legs, sores all over her body, gastrointestinal problems, arthritis, pericarditis, and methicillin-resistant Staphylococcus aureus (MRSA). She was ultimately diagnosed with Behcet's disease (also known as Silk Road disease, a chronic inflammatory condition caused by an autoimmune vasculitis damaging both arteries and veins). She was seen by multiple physicians and specialists for her complaints, including going to emergency room (ER). On an unknown date, the pt received a second dose of the vaccine. Also on an unknown date, reported as after the second injection, the pt suffered a miscarriage. The first time she discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in March 2021, it was then that the pt encountered an article, which led her to a website discussing Gardasil's risks. As a result of her post-vaccine symptoms, the pt has been unable to engage in activities that a young person her age would normally enjoy. She can no longer go camping, hiking, biking, or play tennis as she had previously enjoyed prior to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). She has suffered chronic and debilitating fatigue, has been consigned to a wheelchair at times, she had to resign from her job as a social worker, she has been unable to work, and lost her health insurance. Her ability to care for her child has been severely impacted because of her symptoms. Based upon her chronic and severe post-Gardasil symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, miscarriage, and Bechet's disease. 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 injuries, including but not limited to chronic fatigue, miscarriage, and Bechet's disease, 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 Gardasil-induced autoimmune disorder. Moreover, as a result of company's alleged 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), the pt has suffered and would continue to suffer severe and permanent physical injuries, and associated symptomology and has 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). Additionally, as a direct and proximate result of her vaccine-induced injuries the pt has suffered and would continue to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and would continue to incur. The patient had not recovered from the adverse events, and it was considered the events were related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  The reporter considered all the events to be disabling.   Upon internal review the events Bechet's syndrome, and abortion spontaneous were considered to be medically significant.