Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Neuropathy peripheral, Oral pain, Pain, Pain in extremity, Pruritus
Clinical narrative: struggled physically/stiff person syndrome; Hashimoto's thyroiditis; chronic eye edema/drooping skin around eyes/blepharochalasis; overall joint pain/painful hands/join pain/hand pain/dry eyes and dry mouth/Sjorgen's syndrome/face pain/chronic mouth sores/chronic mouth pain/extreme priritus on her legs; general malaise/extreme fatigue/debilitating fatigue/struggled physically/fell asleep from small amount of exertion/heart rate symptoms/GI issues/IVIG treatments/back pain lasts for hours/autonomic dysfunction/symptoms of POTS; extreme foot pain/painful hands/neuropathy/foot and ankle pain/hand pain/general body pain/small fiber neuropathy ("SFN")/face pain; extreme foot pain/painful hands/foot and ankle pain/back pain/neck pain/hand pain/joint hypermobility spectrum disorder; within few days of first injection, her right eye was covered in a red rash and swollen / ophthalmologist who deemed it "contact dermititis"; Information has been received on 18-JAN-2023 from a lawyer, regarding a case in litigation and concerning a 42-year-old female patient (pt). Concerning current conditions, it was reported that the pt led a very active, energetic, and fulfilling life, very active social life, she was an avid competitive runner and played tennis, ski, kayak (exercise regular). No information about the pt's medical history and concomitant medications was provided. On 03-DEC-2018, the pt received first dosage of quadrivalent human papillomavirus (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 an unknown date in 2019 (reported as within a few days of first papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), her right eye was covered in a red rash and swollen. When it did not resolve in a few days, she visited an ophthalmologist who deemed it "contact dermatitis" and prescribed steroid cream to use for a few days. The rash did not easily resolve, and the pt continued to use the cream for several weeks. On 07-FEB-2019, the pt received second dosage of quadrivalent human papillomavirus (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 February 2019 (reported as that night), the pt was awakened in the middle of the night with extreme pruritus on her legs, causing her to scratch them raw, and the only thing that calmed down the itching was antihistamines. After a few days, the pruritus had not resolved, so the pt sought medical help. The pt also began to experience unrelenting general malaise and extreme fatigue. On 10-JUL-2019, the pt received her third dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot #, and expiration date were not reported). On an unknown date in 2019 (reported as within days), she was experiencing overall joint pain, extreme foot pain, and continuing debilitating fatigue. The pt did not connect her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections to her symptoms. She went to see a rheumatologist for her complaints and otherwise tried to continue with her life as usual. In March 2020, the pt was relieved the world "shut down" due to COVID and she was able to work from home because she did not believe she would have been able to stay employed otherwise. At her worst, she struggled physically to get out of bed and walk down the hall to the couch. She needed help unloading the dishwasher because the dishes were too heavy for her painful hands. The pt fell asleep changing the sheets on her bed from that small amount of exertion. As the months progressed, so did the pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: joint pain, neuropathy, foot and ankle pain, back pain, face and neck pain, hand pain, general body pain, extreme fatigue, chronic mouth sores and pain, dry eyes and dry mouth, chronic eye edema, drooping skin around eyes, heart rate symptoms, and gastrointestinal (GI) issues. None of the doctors could figure out what was wrong. 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 her normal activities. She was consumed with doctor visits, researching her rare medical conditions and treatments, and managing her care, which included intravenous immune globulin (IVIG) treatments. She experienced pain and severe fatigue constantly throughout the day. She could not participate in long distance running and no longer has many social engagements due to pain and fatigue. Standing to teach, or even for a short duration of time could leave her with back pain that lasted for hours. 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, small fiber neuropathy (SFN), stiff person syndrome, autonomic dysfunction, Sjogren's syndrome, joint hypermobility spectrum disorder, blepharochalasis, and Hashimoto's thyroiditis. 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 SFN, stiff person syndrome, autonomic dysfunction, Sjogren's syndrome, joint hypermobility spectrum disorder, blepharochalasis, and Hashimoto's thyroiditis, symptoms of postural orthostatic tachycardia syndrome (POTS), all resulting in joint pain, neuropathy, foot and ankle pain, back pain, face and neck pain, hand pain, general body pain, extreme fatigue, chronic mouth sores and pain, chronic eye edema, drooping skin around eyes, heart rate symptoms, and GI issues, 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. As a proximate result of manufacturing defects of suspect vaccine, the pt suffered and continued to suffer severe and permanent physical injuries and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. The 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 autoimmune disease and other injuries caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The outcome of all events was considered not recovered/not resolved.   The reporter considered the events to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  All events were considered to be disabling. Upon internal review, the events of stiff person syndrome, Sjogren's syndrome, autoimmune thyroiditis were determined to be medically significant. The event of postural orthostatic tachycardia syndrome was considered to be medically significant as the pt received IVIG (immunoglobulin therapy) treatment for it, which upon internal review was determined to be a medically significant procedure.