Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Extrasystoles, Fluid retention, Gait disturbance, Headache, Heart rate increased
Clinical narrative: The patient was diagnosed with worsened seizure disorder; The patient was diagnosed with high blood pressure; The patient was diagnosed with neurological dysfunction; Serious autoimmune and neurological disorders; Epilepsy worsened; Fell upon her head creating a significant swollen area on her head indicating potential impact; irregular menstrual cycles with long periods without or continous menstruation; Rapid and skipping heart rate; fluid retention; Facial rash; issues with sleep; Has gained 100 pounds since her third injection; Suspected premature ovarian failure (POF); 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 included epilepsy (since age of 9). Her medical history, concomitant medications, drug reactions or allergies were not reported. On 12-APR-2021, the Pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL); on 24-MAY-2021, with the second dose of the vaccine; and on 25-OCT-2021, with the third dose of 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 suffered a seizure episode during which she lost consciousness, and she was taken to the emergency room by her husband. There was some uncertainty whether she fell upon her head creating a significant swollen area on her head indicating potential impact. For next 3 weeks, Pt could barely walk, suffered from swelling, soreness and achy muscle joints which had not subside to this day. As months progressed, so the Pt's symptoms. Pt also experienced serious autoimmune injuries, and irregular menstrual cycles with long periods without and long periods of continuous menstruation, with rapid and skipping heart rate, fluid retention and facial rash. Suffered from headaches, issues with sleep, had gained 100 pounds since third injection dose. It was suspected that she had premature ovarian failure (POF). In March 2023, she underwent a hysteroscopy, and the physician attempt to regulate her periods using progesterone which proved ineffective. Pt was also diagnosed with high blood pressure and her epilepsy had worsened. Pt had been prescribed zonisamide for headaches and seizure activities, trazadone for sleeping issues, atenolol for blood pressure, tretinoin for facial rash and furosemide for fluid retention. Before quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), Pt was able to accomplish her daily to do list, but since vaccines, Pt no longer felt in control of her days or body, had difficulty maintaining her to do list because of fatigue, muscle and joint pain, racing heart, lightheadedness and swelling. She was no longer able to walk for over 15 minutes without needing a break. Pt struggles to make a fist, lift objects, experiences joint pain, and the swelling in her legs had become so severe that she must use an electronic convenience vehicle in order to walk longer distances and longer periods of time. Based upon her chronic and severe post-Gardasil symptoms, Pt was diagnosed with various medical conditions, including but not limited to high blood pressure, worsened seizure disorder and neurological dysfunction. 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 considereable 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 seizure, autoimmune disorder and epilepsy were determined to be medically significant.