Received Jul 23, 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 | — | — |
Sjogren's disease; sinus tachycardia; dysautonomia; small fiber neuropathy; Vitamin D and B12 deficiency; Vitamin B12 deficiency; tachycardia; Information has been received from a lawyer regarding a case in litigation referring to an adult female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Prior to the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, the patient had no health issues such as sinus tachycardia, dysautonomia, small fiber neuropathy, Sjogren's disease, and vitamin D deficiency. She was an active athlete in high school and college, she enjoyed playing volleyball, socializing and working out. On an unknown date, the patient was vaccinated with first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), (dose, lot # and expiration date were not reported) for preventing cervical cancer. The patient was 24 years old when she received three doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). On an unknown date, following the first Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine, the patient experienced an increase in heart rate. Activities she was able to do in the past became difficult. She started to experience shortness of breath with simple everyday tasks like walking her dog, walking to class, or going up the stairs at her apartment. The patient sought treatment from multiple physicians, and she underwent extensive testing. The patient was ultimately diagnosed with sinus tachycardia by physician A; tachycardia by physician B; dysautonomia, small fiber neuropathy, and Sjogren's disease by physician C; and Vitamin D and B12 deficiency by physician D. To manage her illnesses, each morning began with a regimen of medicines: Lidocaine-prilocaine Cream (applied twice daily), Ergocalciferol 1,250mcg, Fluconazole 150mg (taken once per week), Lidocaine 5% cream, Alprazolam 02.5mg, Ketorolac 10mg, Conjugated Estrogens 0.625mg (taken three times weekly), Methylprednisolone (taper pack), Propranolol 60mg, Duloxetine 30mg, Hydroxychloroquine 200mg, and Pilocarpine 5mg) taken three times daily). The patient regularly visited multiple doctors and underwent routine blood work. As the months progressed, so did the patient's symptoms. She could no longer function in the same capacity as before. Her school experience and career had suffered. She was now a lawyer, but she had to request an extension and accommodation to take the bar exam later because of her health condition. Exercise was no longer enjoyable because of her increased heart rate and tiredness. What might be a common cold for others could escalate into a severe infection for her, necessitating intensive treatment. Her immunologist recommended jobs with minimal contact with others, presenting a significant challenge as a lawyer, affecting both her daily life and income. Simple outings required meticulous planning and precautions, from carrying hand sanitizer everywhere to avoid peak flu seasons and wearing masks in airports. Fatigue was her constant battle. It was a silent struggle, invisible to those who do not understand the daily battles she faced. The patient always dreamed of having a large family, but now she was concerned about having children. Fetal lupus or congenital heart block were potential risks for babies born to mothers with Sjogren's disease. The patient's life changed from a normal, healthy, active young woman to living with a serious immune deficiency. The patient was navigating a constant battle between health and illness. Simple tasks that others took for granted, like going to crowded places or shaking hands, became calculated risks. Her injuries from the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations were ongoing and she would require constant treatment and medication for the rest of her life, as there was no cure for her health conditions. The patient was seen by multiple physicians and specialists for her complaints of neuropathy, brain fog, fainting, fatigue, heart palpitations, chest pain, tachycardia, dry eyes, mouth and vaginal dryness, anxiety, shortness of breath while exercising, headaches and migraines, trouble sleeping, weakness, and she cannot produce sweat. Based upon her chronic and severe post-Gardasil symptoms, the patient had been diagnosed with various medical conditions, including but not limited to, sinus tachycardia, dysautonomia, small fiber neuropathy, Sjogren's disease, and vitamin deficiency. The patient contended that her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to, sinus tachycardia, dysautonomia, small fiber neuropathy, Sjogren's disease, and vitamin deficiency, brain fog, fainting, fatigue, heart palpitations, chest pain, tachycardia, dry eyes, mouth and vaginal dryness, anxiety, shortness of breath while exercising, headaches and migraines, insomnia, weakness, and she could not produce sweat, 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) Recombinant Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's fraudulent, false, and misleading statements, omissions, and conduct concerning the safety and efficacy of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the patient 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. The patient 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 Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). As a direct and proximate result of their Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, the patient had 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 these losses and expenses in the future. The outcome was considered as not recovered. The lawyer considered all the events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). The lawyer considered all the events to be disabling.