Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Headache, Impaired work ability, Inappropriate schedule of product administration, Infertility female
Clinical narrative: POTS like symptom, chronic fatigue syndrome (CFS), dizziness, passing out and falling, insomnia, brain fog, difficulty walking long distances; chronic fatigue syndrome (CFS); fibromyalgia; lymphadenopathy; intersticial cystitis; infertility; constellation of adverse symptoms, complications, injuries, and other adverse events; premenstrual dysphoric disorder (PMDD); autoimmune, and neurological injuries; autoimmune, and neurological injuries; second vaccine on 19-jan-2009, third vaccine on 14-aug-2015; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a 22-year-old female patient (pt). The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On an unknown date in 2009, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for preventing cervical cancer, on 19-JAN-2009, she received the second dose and on 14-AUG-2015, the third dose (inappropriate schedule of product administration), as per healthcare providers' recommendation. It has been reported that the pt sustained serious autoimmune, autonomic, and neurological Injuries as a result. It was reported that on an unknown date, following her GARDASIL injections, the pt began to experience extreme fatigue, dizziness, passing out and falling, insomnia, brain fog, difficulty walking long distances, difficulty concentrating and remembering, severe chronic headaches, constantly feeling ill which was debilitating, and she was practically bed ridden ending her career as a chef, she was ultimately diagnosed with chronic fatigue syndrome (CFS), autonomic dysfunction, and postural orthostatic tachycardia syndrome (POTS)-like symptoms. As the months progressed, so did pt's injuries, she was seen by multiple physicians and specialists for her complaints, she did not know and had no reason to know that her symptoms were caused by the 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 the GARDASIL was the cause of her symptoms and injuries. As a result of her post-GARDASIL symptoms, pt had been unable to engage in activities that a normal young person would enjoy, she enjoyed being outdoors and traveling, she had to give up her promising career as a chef for a more sedentary career, she had also given up the dream of having children, she could no longer enjoy her life and being as active as she had been before the GARDASIL vaccines. Based upon her chronic and severe post-GARDASIL symptoms, pt has been diagnosed with various medical conditions, including but not limited to CFS, autonomic dysfunction, and POTS-like symptoms, she contended that her GARDASIL injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological injuries, including but not limited to CFS, autonomic dysfunction, fibromyalgia, lymphadenopathy, interstitial cystitis, infertility, and premenstrual dysphoric disorder (PMDD) 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 GARDASIL or otherwise linked to her GARDASIL -induced autoimmune disorder. As a proximate result of company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of GARDASIL, pt had suffered and continued 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 GARDASIL. As a direct and proximate result of her GARDASIL-induced injuries, she had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to GARDASIL.  Upon internal review, the event autoimmune disorder were considered medically significant.  The events were considered disabling by the reporter.