Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Loss of personal independence in daily activities, Migraine, Musculoskeletal stiffness, Nausea
Clinical narrative: The patient ended up getting a type of HPV; Although patient received three doses of the Gardasil vaccine, she ended up getting a type of HPV that Gardasil is supposed to prevent; polycystic ovary syndrome with hirsutism; amenorrhea; gastroparesis; Patient experienced severe migraines, dizziness, blurry vision, fainting, severe abdominal pain, abnormal uterine bleeding, pelvic pain, stiffness, shortness of breath, insomnia, increased depression and anxiety, fatigue, and indigestion; polycystic ovary syndrome with hirsutism; fibromyalgia; Serious autoimmune injuries; Shortness of breath; Patient has precancerous cells; This spontaneous report was received from a lawyer and a female patient (Pt) of unknown age, regarding a case in litigation on 17-DEC-2024. The Pt's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 13-SEP-2019, the Pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL); on 13-NOV-2019, with the second dose of the vaccine; and on 13-MAR-2020, with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, lot #, expiration date, route of administration, anatomical location not provided for any dose) as prophylaxis. On an unspecified date, following the third dose of the vaccine, the Pt experienced severe migraines, dizziness, blurry vision, fainting, severe abdominal pain, abnormal uterine bleeding, pelvic pain, stiffness, shortness of breath, insomnia, increased depression and anxiety, fatigue, and indigestion including but not limited to nausea, vomiting, belching, bloating and heartburn. As months progressed, so the Pt's symptoms. Pt also experienced serious autoimmune injuries. On 09-MAY-2023, Pt underwent a Papanicolaou (pap) smear with abnormal results revealing human papillomavirus (HPV) mRNA E6/E7. On 08-JUL-2024, further testing (unspecified) showed that the Pt had precancerous cells and HPV 16, 18/45 detected. Although the Pt received the 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), she ended up getting a type of HPV that the vaccine was supposed to prevent (vaccination failure). Before vaccination, the Pt was healthy and active, actively involved in different activities, taking walks and being socially active. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, Pt had been unable to engage activities that a normal young person would enjoy, her ability to sustain gainful employment and attend school was affected due to physical exertion and chronic body pain caused by her debilitating medical conditions. Pt suffered from severe anxiety and increased depression, ongoing symptoms that had affected her daily life. Pt was diagnosed with various medical conditions, including but not limited to polycystic ovary syndrome with hirsutism, amenorrhea, gastroparesis and fybromyalgia. As a result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccination, 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. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at increased risk of cancer, and future symptoms and harms associated with her injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). As a direct and proximate result of her vaccination-induced injuries, Pt had suffered and continued to  suffer economic losses, including considerable financial expenses for medical care and treatment, diminished income capacity and she would continue to incur these losses and expenses in the future. At the reporting time, the outcome of all the events was considered as not recovered. The reporters considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  The reporters considered all the event to be disabling. Upon internal review, the events of polycystic ovarian syndrome, impaired gastric emptying, syncope and autoimmune disorder were determined to be medically significant.