Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
heart palpitations; autoimmune, autonomic, and neurological injuries; autoimmune, autonomic, and neurological injuries; headache; diaphoresis; instability, dizziness,; loss of appetite; anxiety, agitations,; ocular pain; Hashimoto's Disease and Thyroiditis, depression, brain fog, memory loss, low sex drive, cold intolerance, hair loss, extreme mood swings, and severe weakness, hypothyroidism; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a 25-year-old female patient (pt). The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On an unknown date, the pt was vaccinated with the first (when she was 25 years old) and second (when she was 26 years old) doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for preventing cervical cancer. The pt experienced serious and debilitating injuries, including but not limited to autoimmune, autonomic, and neurological injuries. It was reported that on an unknown date (reported as following her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt began to experience headaches, heart palpitations, diaphoresis, instability, dizziness, loss of appetite, extreme fatigue, anxiety, agitations, depression, brain fog, memory loss, low sex drive, cold intolerance, hair loss, ocular pain, extreme mood swings, and severe weakness. The pt reached out to her primary care provider and had bloodwork performed. Her thyroid test came back abnormal, and she was urgently referred to an endocrinologist. In December 2022, the pt was diagnosed with hypothyroidism. After multiple visits with the endocrinologist and extensive thyroid testing, she was ultimately diagnosed with Hashimoto's Disease and Thyroiditis in July 2023. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: hypothyroidism, headaches, heart palpitations, diaphoresis, instability, dizziness, loss of appetite, extreme fatigue, anxiety, agitations, depression, brain fog, memory loss, low sex drive, cold intolerance, hair loss, ocular pain, extreme mood swings, and severe weakness. The pt continued to experience daily fatigue, memory loss, and depression, which were made worse during a Hashimoto flare-up. The pt was on thyroid medication and continued to see multiple providers. She had also enrolled in numerous outpatient programs. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been unable to engage in activities that a normal young person would enjoy. Following her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt experienced symptoms that negatively affected her career, ultimately leading to her discharge. Additionally, pt's symptoms had also made it challenging to keep up with her responsibilities for her child and her job at a veterinary clinic. Furthermore, the pt was unable to complete her typical weekly 5k runs or participate in the various sports she once enjoyed prior to receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune and neurological injuries, including but not limited to Hashimoto's Disease and thyroiditis, 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) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of the company's alleged wrongful acts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) manufacturing defects, pt suffered and continued to suffer severe and permanent physical injuries and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. Also, she 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 his 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 her quadrivalent human papillomavirus (types 6,11,16,18) recomb. 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 she would continue to incur those losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events Hashimoto's disease, anxiety, autonomic nervous system imbalance, decreased appetite, diaphoresis, dizziness, headache, ocular pain, palpitations and neurological disorder, were considered disabling by the reporter.
Test Name: thyroid test; Result Unstructured Data: abnormal