Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
Sustained Autoimmune Disease and Other Serious Autoimmune Autonomic and Neurological injuries; Sustained Autoimmune Disease and Other Serious Autoimmune Autonomic and Neurological injuries; POTS, weight loss and loss of appetite, headaches, rapid heart rate, and dizziness; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a 19-year-old male 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, the pt was vaccinated with the first and only dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for prophylaxis. It was reported that on an unknown date (reported as following receipt of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt began to experience headaches, rapid heart rate and dizziness, causing him to visit his primary care doctor. Prior to receiving his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt was a happy, healthy, physically active young person. He enjoyed playing sports, exercising, and hanging out with friends. The months following his first and only dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt experienced weight loss and loss of appetite, in addition to the headaches, rapid heart rate, and dizziness. The pt was ultimately diagnosed with Postural Tachycardia Syndrome (POTS) and was told his condition was something that would not go away and that he would have to deal with it for the rest of his life. In approximately September 2022, the pt was informed by his doctor that the HPV vaccination might be the cause of his POTS. Prior to this date, the pt had no reason to suspect that his illness was caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a result of his post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, he had been unable to engage in activities that a teenager and young adult his age would normally enjoy. As a result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)- induced injuries, he was unable to continue his participation in the varsity football team and recreational basketball. ln addition, the pt was no longer able to exercise or play sports without feeling extremely dizzy and fatigued. He was forced to make small and calculated physical movements to avoid the symptoms. Furthermore. Pt's plans to travel after high school, attend an out of state. university, and live an active life were necessarily altered due to his illness. While attending his first year of college, the pt experienced daily fatigue, dizziness, headaches and loss of appetite due to his POTS symptoms. Due to the severity of the symptoms, pt's academic performance was adversely affected and he was forced to move back home to continue his education online. Based on his chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms and adverse events as outlined above and the tests performed by a number of me.die.al providers, pt had been diagnosed with POTS, the pt contended that his injection of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused him to develop serious and debilitating injuries, including bm not limited, POTS as well as a constellation of adverse symptoms, complications and injuries, 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 his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's wrongful acts and omission 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 his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of his 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 he would 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 quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events POTS, autoimmune disorder and neurological disorder, were considered disabling by the reporter.