Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 3 | — | — |
Postural Orthostatic Tachycardia Syndrome (POTS), increased heart rate, intense fatigue, dizziness, and lightheadedness, abnormally long hours of sleep, vasovagal syncope, decrease in appetite; debilitating autoimmune, autonomic, and neurological, injuries; debilitating autoimmune, autonomic, and neurological, injuries; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a 16-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, the pt was vaccinated with the first, second and third doses 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 preventing cervical cancer. It was reported that on an unknown date (reported as within a few weeks of receiving the second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt began to experience increased heart rate, intense fatigue, dizziness, and lightheadedness. On an unknown day (reported as following the third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt's fatigue increased and she experienced abnormally long hours of sleep. Furthermore, pt often felt like she was going to faint, she sought an expert opinion and evaluation after experiencing these abnormalities, such as a cardiologist and electrophysiologist. She was diagnosed with a vasovagal syncope. After undergoing a tilt table test, the pt was diagnosed with dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS). Since those diagnoses, the pt had been prescribed propranolol to help control her heart rate. However, she continued to experience daily fatigue, dizziness, an increased heart rate, and a decrease in appetite. As the months progressed, so did pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: lightheadedness, chronic fatigue, dizziness, increased heart rate, and a decrease in appetite. As a result of his post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she had been unable to engage in activities that a normal young person would enjoy. She was obligated to make lifestyle accommodation for the rest of her life that were opposite to the active lifestyle she had before receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccines. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been diagnosed with various medical conditions, including but not limited to, dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS). 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 dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS), 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 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 the company's alleged wrongful acts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) manufacturing defects, 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. Also, she 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 her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, she suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur those 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.
Test Name: tilt table test; Result Unstructured Data: was diagnosed with dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS).