Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Muscle disorder, Orthostatic hypotension, Pain
Clinical narrative: abdominal pain; bowel inflammation; low-grade fevers; psoriatic arthritis, joint pain,loss of range of motion/lack of control of some muscles and fingers; second dose 22-APR-2022; fibromyalgia, severe chronic pain,weakness/joint pain; POTS-like symptoms/tachycardia/postural hypotesion/elevated antinuclear antibodies/dizziness; 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 23-APR-2021 (when she was 30-years old), the pt was inoculated with the first dose of 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). Subsequently on 22-APR-2022, she received the second dose of the vaccine (Inappropriate schedule of product administration), both vaccines were administered under her physician's recommendation. On approximately 30-APR-2021 (reported as "within approximately a week from receiving the first Gardasil injection"), the pt began experiencing unusual joint pain. The pain began at the knees and progressed to the pt's shoulder joints and smaller joints. In addition, she began experiencing daily POTS-like (postural orthostatic tachycardia syndrome) symptoms, including tachycardia, dizziness, postural hypotension, and abdominal pain. Due to the abdominal pain, she made reoccurring visits to the hospital. As well as relied on medications such as hydroxychloroquine (PLAQUENIL) and various over-the-counter pain relief items like heat wraps, lidocaine patches, NSAID creams, and more. Unfortunately, none of these remedied the pain. Moreover, on an unknown date, the pt was diagnosed with elevated antinuclear antibodies, low-grade fevers, severe chronic pain, loss of range of motion, weakness, and lack of control of some muscles and fingers, and bowel inflammation. Post vaccination, the pt visited numerous specialists to evaluate her symptoms, such as an orthopedist, gastroenterologist, rheumatologist, and the emergency room. Thus, she was diagnosed with psoriatic arthritis and fibromyalgia. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: joint pain, tachycardia dizziness, POTS-like symptoms, postural hypotension, abdominal pain, low-grade fevers, chronic pain, loss of range of motion, weakness, muscle function loss, bowel inflammation, and elevated antinuclear antibodies levels. 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. As the sole caregiver and a healthcare professional, her career has been significantly impacted by the physical limitations caused by these symptoms. She was no longer able to complete a full shift without experiencing considerable pain and now depended on lidocaine patches for relief. Additionally, the medications that help her manage these symptoms have severely restricted her ability to pursue her personal aspirations, such as traveling, making such goals nearly impossible to achieve. Furthermore, the medication prescribed to manage her symptoms carries the risk of causing blindness, instilling a profound fear for the long-term quality of her life and future. Based upon her chronic and severe symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, psoriatic arthritis, fibromyalgia, and POTS-like symptoms. In addition, 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 and autonomic injuries, including but not limited to psoriatic arthritis, fibromyalgia, and POTS-like symptoms, as well as a constellation of adverse events 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 and autonomic disorder. Moreover, the pt sustained that The Company's negligence was the proximate cause of the injuries, harm, and economic losses that she suffered, and will continue to suffer, as described herein. Additionally, as a direct and proximate result of her vaccine-induced injuries the pt has suffered considerable non-economic and economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and will continue to incur. The patient had not recovered from the adverse events, and it was considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review the event psoriatic arthropathy was considered to be medically significant.   Lot numbers are being requested and will be submitted if received.