Received Jul 18, 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 | — | — |
headaches; abdominal pain/ gastrointestinal issues; loss of appetite/ gastrointestinal issues; vomiting/ gastrointestinal issues; pelvic discomfort; prolonged menstrual cycles; tested positive for elevated testosterone level; tested positive for elevated inflammatory markers; neurological injuries; Hashmioto's disease/ autoimmune injury/ dry skin and scalp/ increased sensitivity to cold (particularly in her hands and feet)/ fatigue/ weight gain/ persistent cold sensation traveling up to shaft of her leg; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female adult patient of unknown exact age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, at the age of 24 years old, the patient received the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prevention of cervical cancer, as recommended by nurse practitioner. The patient contended her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries and a constellation of adverse symptoms, complications, injuries, and other adverse events 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 disorders. The patient sustained serious autoimmune injuries as a result of her vaccination. On an unknown date, a few days following the administration of her first Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection, the patient began to experience a range of symptoms, including headaches, dry skin and scalp, increased sensitivity to cold (particularly in her hands and feet), fatigue, and abdominal pain. After receiving the second Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection on an unknown date, these symptoms intensified. Additionally, she began to experience a loss of appetite, vomiting, pelvic discomfort, prolonged menstrual cycles, weight gain, and tested positive for elevated testosterone levels and inflammatory markers. She had no reason to believe her symptoms were caused by the vaccine, so she received her third dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) on an unknown date. After third Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection, her symptoms continued to persist and worsen, with new developments including gastrointestinal issues and a persistent cold sensation traveling up the shaft of her leg. On an unknown date in September 2022, the patient was diagnosed with Hashimoto's disease. She had since sought treatment from a variety of medical specialists, including a hematologist, dermatologist, and gastroenterologist, to manage her condition. At the time of the report, the patient was required to take medication to control her systems associated with Hashimoto's disease. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, she was diagnosed with various medical conditions, including but not limited to Hashimoto's disease. 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 injuries, including but not limited to Hashimoto's disease, resulting in experiencing headaches, dry skin and scalp, increased sensitivity to cold (particularly in her hands and feet), fatigue, and abdominal pain, 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 Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the patient suffered and continued to suffer severe and permanent physical injuries 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 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 her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant 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 they will continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered. Upon internal review, the event of Hashmioto's disease was determined to be medically significant. The reporter considered the events of Hashmioto's disease, headaches abdominal pain, loss of appetite, neurological injuries, vomiting, pelvic discomfort, prolonged menstrual cycles, tested positive for elevated testosterone level and tested positive for elevated inflammatory markers to be disabling.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-15 , MNSC number : , CLIC number : , ESTAR number : LEGCLACHN , IRMS number : 68941 , Central date : 2025-07-14 , Classification : DMC, Attachment description : Legal , Safety case number :