Received Apr 9, 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 | — | — |
polycystic ovary syndrome (PCOS); Autoimmune Injuries; Information has been received from a lawyer regarding a case in litigation referring to an adult female patient (pt) of unknown age. Prior to receiving the suspect vaccine, the pt was a healthy, active, and enthusiastic teenager who loved playing club volleyball, being involved in math and science clubs, socializing with friends, and excelling academically. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, at the age of 15-year-old, the pt received three doses of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer, upon the recommendation of a physician and with the consent of her mother. On an unknown date, following the third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced irregular periods excess androgens (hirsutism), and weight gain. The pt's periods became light and abnormal, even with the help of medroxyprogesterone. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to polycystic ovary syndrome (PCOS). The pt also contended that she sustained serious autoimmune injuries (Autoimmune disorder) as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. As a proximate result the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The 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 her 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 the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and would continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered. The lawyer considered the events of PCOS and autoimmune disorder to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events of PCOS and autoimmune disorder were considered to be disabling by the lawyer.