Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
fibromyalgia, joint pain, hip pain, dizzy; autoimmune injury; chronic fatigue syndrome, brain fog, short term memory problem; hypothyroidism; chronic pain; adrenal gland dysfunction; gluten intolerance, stomach pain, trouble eating; corn intolerance, stomach pain, trouble eating; fever; red arm; 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, current conditions and concomitant therapies were not reported. On 15-OCT-2020, at the age of 14 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 health care provider for preventing cervical cancer). On unspecified date (reported as shortly after receiving the first GARDASIL injection), the pt experienced fever, a red arm, joint pain, hip pain, and began feeling dizzy. After practicing on the ice rink, the pt began to experience extreme pain to the point of not being able to complete her session. On 23-APR-2021, the pt received second dose of GARDASIL (no more details provided). On unspecified date (reported as after receiving the second GARDASIL injection), the pt experienced horrible pain, and her pain progressed. While at school, the pt would frequently call her parents weeping because she had difficulty walking due to the pain. Despite not dancing or skating as was her normal routine, The pt's hip and joint pain became worse. The pt had trouble walking from class to class at school. She was taken to see an orthopedic surgeon at university to examine her hip where she underwent multiple exams, including blood work. The orthopedic surgeon suspected that the pt's suffering was due to an autoimmune disorder. By this time, the pt had already received two cortisone shots in her hip that, unfortunately, did not relieve her symptoms entirely. The pt's primary care physician diagnosed her with fibromyalgia. A rheumatologist subsequently confirmed that diagnosis. The pt was later diagnosed with chronic fatigue syndrome (CFS). She would sleep 18 hours straight and not feel rested. In addition to these symptoms, she developed brain fog, short term memory problems, vision and hearing problems, stomach pain and trouble eating. 281. Thereafter, the pt was diagnosed with hypothyroidism. As the months progressed, so did the pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: fibromyalgia, CFS, chronic pain, hypothyroidism, adrenal gland dysfunction, gluten and corn intolerance, extreme brain fog, short term memory problems, vision and hearing problems, stomach pain and trouble eating. As a result of her post-GARDASIL symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. Post-GARDASIL injections, her academic performance plummeted from once having a 4.0 GPA to a 3.3 GPA. Her dreams of going to college and becoming a doctor now feel impossible. The pt was still unable to participate in the daily activities she previously did before she received the GARDASIL injections. Based upon her chronic and severe post-GARDASIL symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, fibromyalgia, CFS, chronic pain, hypothyroidism, adrenal gland dysfunction, and gluten and corn intolerance. The pt contended her GARDASIL injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to fibromyalgia, CFS, chronic pain, hypothyroidism, adrenal gland dysfunction, and gluten and corn intolerance, 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 GARDASIL or otherwise linked to her GARDASIL-induced autoimmune disorder. It was stated that as a proximate result of the Company's misleading statements and omissions concerning the safety and efficacy of GARDASIL, the pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The pt also have 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 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. All events were considered to be disabling/incapacitating by the reporter.