Age: 51.0
Sex: M
Vaccine: HPV4
Symptoms: Nervous system injury, Neuralgia, Pain, Palpitations, Peyronie's disease
Clinical narrative: Postural Orthostatic Tachycardia Syndrome (POTS); neurological/autonomic injuries; autonomic nervous system dysfunction; fast, pounding heart rate; constant fatigue; excruciating, severe headaches; weakness in upper body and arms; arthritis; Sciatica pain / Radiating nerve pain from his waist and buttocks, down to his legs; Constant nerve pain in his left hand/ Chronic pain; Trips going up stairs; Peyronie's disease; Autoimmune injuries; Plaintiff was 51 years old when he received his first and second dosage of Gardasil; Information was received from a lawyer regarding a case in litigation and refers to an adult male patient (pt) (exact age not provided). His medical history, concurrent conditions and concomitant therapies were not provided. The pt was 51 years old when he received his first and second dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) on 31-MAR-2020, and 04-MAY-2020 respectively (exact dose, route of administration, anatomical location, lot# and expiry date were not provided for both) (Product administered to patient of inappropriate age). On 15-OCT-2020, he received a third dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot# and expiry date were not provided). All doses were administered for prophylaxis (also reported as "were touted as a safe and effective vaccines for preventing certain HPV-related cancers"), with the pt's physician recommendation and the pt's consent. Prior to receiving the third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt was healthy, active and sociable. Following the third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, he experienced a fast, pounding heart rate, constant fatigue, excruciating headaches, and weakness in his upper body and arms. The pt was additionally experiencing sciatica pain and constant nerve pain in his left hand which was still present at that time. He was often tripping going up stairs. As a result of receiving quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the pt experienced serious autonomic, autoimmune and neurologic injuries. As a result of his post- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, he was unable to engage in his active health-conscious lifestyle, such as standing in line at a grocery store without feeling radiating nerve pain from his waist and buttocks, down to his legs. He was no longer socializing with friends his own age because he could not keep up with them. Before the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccines, the pt worked out at the gym daily, did yoga and pilates, group fitness bootcamp classes, rode his bike for miles at a time, walked frequently, went to social events, and volunteered for various charitable causes. As the months progressed, so did the pt's injuries. Based upon his chronic and severe post- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, he was diagnosed with severe headaches, fatigue, chronic pain, arthritis, Peyronie's disease, autonomic nervous system dysfunction, and postural orthostatic tachycardia syndrome (POTS). As a proximate result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the 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. He also had a substantial fear of suffering additional and ongoing harms, including but not limited to being at an increased risk of cancer at that time, and future symptoms and harms associated with his autoimmune, autonomic, neurologic, and other injuries caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he would continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered.   The reporter considered the events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of autoimmune injuries was determined to be medically significant.  The reporter considered all events to be disabling.