Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
fibromyalgia symptoms singificantly aggravated / numbness / body aches / fatigue / muscle tension / pain; autoimmune injuries / GARDASIL-induced autoimmune disorder; autonomic injuries; neurological injuries; endometriosis / pelvic pain / abdominal cramping / enlarged uterus; polycystic ovary syndrome (PCOS) / ovarian cysts / enlarged uterus; Information has been received from a lawyer, regarding a case in litigation, and refers to an adult female patient (pt). The pt's medical history was not reported. Her current conditions included fibromyalgia. Concomitant therapies were not reported. On 25-May-2021, at the age of 29 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis (reported as recommended by the pt's physician for preventing cervical cancer). On an unknown date, the pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) injection. On an unknown date, reported as within months of her injection, the pt started to experience severe numbness and body aches. It was reported to have gotten so bad that at some point, the pt went to an emergency room (ER) because of her symptoms. On an unknown date in 2022, reported as sometime in early 2022, the pt began experiencing severe debilitating pelvic and abdominal cramping, with episodes lasting up to three weeks. She described the pain as if two knives were embedded within her abdomen. In an attempt to find relief, the pt sought the expertise of a gynecologist. Following a series of diagnostic tests (unspecified, no results provided), the gynecologist diagnosed her with ovarian cysts and an enlarged uterus. The pt was later diagnosed with polycystic ovary syndrome (PCOS) and endometriosis. At some point, the pt also received a fibromyalgia diagnosis. Her fibromyalgia symptoms were significantly aggravated by her exposure to the suspect vaccine. Until the time of report, reported as "to this day", the pt experienced daily severe fatigue, muscle tension, and pain. As a result of her post-quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) symptoms, she had been unable to engage in activities that a normal young person would enjoy. Due to her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL)-induced injuries, her social life had deteriorated. She could not even walk for more than 10 minutes at a time. Her dream of one day opening a restaurant was no longer possible. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to PCOS and endometriosis. The pt contended that her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to PCOS and endometriosis, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which alleged herein and all of which caused by the suspect vaccine or otherwise linked to her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL)-induced autoimmune disorder. It was stated that as a proximate result of the Company's wrongful acts and quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) manufacturing defects, the pt 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. She 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 the suspect vaccine. As a direct and proximate result of her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL)-induced injuries, the pt 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 of all events was not recovered/not resolved/ongoing. All events were related to the suspect vaccine. Upon internal review, the events of PCOS, autoimmune disorder, and autonomic neuropathy were determined to be medically significant. All events were considered to be disabling/incapacitating.
Fibromyalgia