Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Heart rate increased, Impaired driving ability, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: autonomic dysfunctions; Neurological Injuries; back pain; extremely painful menstruation; anxiety; autoimmune disease; Postural orthostatic tachycardia syndrome; Information has been received regarding a case in litigation from a lawyer and referred to a 16-year-old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. Prior to receiving her Quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections, the patient was very healthy, extremely active and had a lot of energy, she danced competitively starting at age 10. She was strong and she could easily get through a long day of practice. Plaintiff was an excellent student and enjoyed an active life. On 02-MAR-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported) to prevent HPV and cervical cancer. On 01-APR-2018, the patient was attending church and she began to feel weak and faint. She started to walk to the back of the church and fainted in the aisle. Her father caught her as she fell, and eventually regained consciousness. On 09-MAY-2018 and on 09-OCT-2018, the patient received the second and third doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported), respectively. It was claimed, that the patient sustained autoimmune disease and other serious injuries, including but not limited to, postural orthostatic tachycardia syndrome ("POTS") and autonomic dysfuntion as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. Quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and its ingredients caused plaintiff's autoimmune disease and other related neurological injuries and has resulted in her suffering from severe, debilitating, disabling and painful chronic injuries. The patient was involved in competitive dancing during her senior year of high school. After Gardasil, Plaintiff began to experience intermittent nausea and weakness while dancing. Patient would feel weak and hot and almost faint multiple times a day. She was no longer able to get through a long day of practice like she used to be able to easily do. As the months progressed, so did patient's injuries. She was seen by multiple physicians and specialists for various complaints and symptoms including but not limited to: weakness, dizziness, fainting, extreme fatigue, rapid heartbeat, nausea, back pain, extremely painful menstruation, brain fog, and anxiety. The patient was referred to a cardiologist for testing and was ultimately diagnosed with POTS in May 2020. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, patient had been unable to continue with the active lifestyle that she used to enjoy. She frequently feels faint, which sometimes prohibits her from driving or leaving her house. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms and adverse events as outlined above, the patient has been diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome ("POTS"). The outcome of the events was unknown. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   The reporter considered Autoimmune disorder, Postural orthostatic tachycardia syndrome, Nervous system disorder and Autonomic nervous system imbalance as disabling events.   Upon internal review the event Autoimmune disorder was determined to be medically significant.