Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
Raynaud's Syndrome; menstrual cycle also changed from light and sporadic to heavy with constant bleeding and with only a few days of relief in between; sporadic bloating of her stomach; Autoimmune Injuries; Neurologic Injuries; chronic joint pain; sun allergies; Information has been received from a lawyer referring to a female patient of unknown age (currently as an adult) regarding a case in litigation. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unknown dates, at the age of 14-year-old, the patient was vaccinated with the first dosage and the second dosage of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) Injection, both 1 dosage form total administered for preventing cervical cancer, upon recommendation of her health care provider and consent of her mother (strength, exact dose, route of administration, anatomical site, lot # and expiration date were not reported). On an unknown date, within weeks of receiving the second Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, the patient experienced a series of symptoms in her hands such as, coldness, pain, and swelling. The patient often experienced low body temperature and had trouble regulating her body temperature. During warm weather, her feet were painful, swollen, and red. During cold weather, her feet became painful and turned white and/or purple color. Eventually, the patient was diagnosed with Raynaud's Syndrome. Following the second Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine, the patient developed chronic joint pain causing difficulty with daily tasks. She also developed sun allergies, such as developing painful blisters and bumps on her hands and feet during sun exposure. The patient's menstrual cycle also changed from light and sporadic to heavy with constant bleeding and with only a few days of relief in between (Menometrorrhagia). Additionally, the patient developed sporadic bloating of her stomach (Abdominal distension) to the point she sometimes appeared seven months pregnant. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints which now included trouble regulating body temperature, coldness, pain, and swelling in hands and feet, purple and/or white hues in feet, chronic joint pain, sensitivity to sun, blisters and bumps on skin during skin exposure, abnormal menstrual periods, and heavy bloating of the abdomen. Based upon her chronic and severe post-Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, the patient has been diagnosed with various medical conditions, including but not limited to, Raynaud's Syndrome, sun allergy, chronic joint pain, and abnormal menstrual cycles. 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, neurologic, and menstrual injuries, including but not limited to Raynaud's Syndrome, sun allergy, chronic joint pain, and abnormal menstrual cycles, 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) 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 the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the patient has suffered and continues to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The patient also has 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 her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, the patient has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. At the reporting time, the patient had not recovered from all aforementioned events. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not applicable. The reporter considered all aforementioned events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). The lawyer considered all aforementioned the events to be disabling/incapacitating.