Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
POTS: orthostatic hypotension,fainting spells,falling,headaches,migraines,brain fog,fatigue,lack of attention,difficulty concentrating,dizziness,difficulty breathing,brain fog,abdpain,constipation, anxiety,depression,mental anguish; autoimmune injuries; emotional distress; Small fiber neuropathy (SFN): odd numbness in her legs, tingling; Complex regional pain syndrome (CRPS): unexplained musculoskeletal pain, tremors, excessive pain; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning an adult female patient. Patient's current conditions, medical history and concomitant therapy was not reported. On an unknown date and on 28-AUG-2020, (at 14 (the first) and 15 (the second) years old), the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prevention cervical cancer. On an unknown date, following her vaccination, pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her injection; following her vaccination, she deteriorated drastically. She experienced multiple orthostatic hypotension incidents during her classes, which included fainting spells and falling. She also started complaining of persistent daily headaches and migraines, brain fog, fatigue, lack of attention, difficulty concentrating, digestive issues, odd numbness in her legs, and unexplained musculoskeletal pain. She was seen by a neurologist and prescribed various medications, amitriptyline and nortriptyline antidepressants to try to prevent the headaches. None of the medications worked. As the months progressed, so did her symptoms. She was seen by multiple physicians and specialists for her complaints which now include migraines, dizziness, fainting, difficulty breathing, brain fog, numbness, tingling, tremors, abdominal pain, constipation, excessive pain, anxiety, depression, emotional distress and mental anguish. As a result of her post-vaccination symptoms, she has been unable to engage in activities that a normal young person would enjoy. She contends 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 Postural orthostatic tachycardia syndrome (POTS), Complex regional pain syndrome (CRPS), and Small fiber neuropathy (SFN), 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 Merck's misleading statements and omissions concerning the safety and efficacy of the vaccine, the pt have suffered and continue to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also have 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 their 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 their quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced injuries, Pt have suffered and continue to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and they will continue to incur these losses and expenses in the future. 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). All the events were considered as disabling by reporter. This is 1 of 6 cases received from the same reporter.