Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Menstruation irregular, Muscle spasms
Clinical narrative: POTs: dysautonomia,autonomic dysfunc,headaches,chest tight and pain,heart palp,rapid heartrate, feeling faint,dizziness(standing and stumbling),lightheaded nausea, sensitivity light & sunlight, fatigue, joint pain, muscle spasms, exhaustion, stomach; Gardasil-induced autoimmune, autonomic, and neurological diseases; Gardasil-induced autoimmune, autonomic, and neurological diseases; increased chronic backpain; leg jerks; increased irregular menstrual cycle; weight loss; she received her first dosage of Gardasil on 01-DEC-2016 and the second dosate on 02-OCT-2019; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning an adult (age not specified) female patient (pt). Pt's current conditions, medical history and concomitant therapy was not reported. On 01-DEC-2016 (at 14 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) intramuscular injection and on 02-OCT-2019, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) intramuscular injection (strengths, doses, lot numbers, expiration dates, route of administration and anatomical locations were not provided), both doses administered for prevention cervical cancer (inappropriate schedule of product administration). On an unknown date, following her second vaccination, pt experienced severe headaches, chest tightness and pain, heart palpitations, rapid heartrate, feeling faint, dizziness upon standing and stumbling, lightheaded, nausea, sensitivity to light and sunlight, fatigue, increased chronic backpain, joint pain, leg jerks (dyskinesia), muscle spasms, severe exhaustion, stomach pain, brain fog, weight loss, and increased irregular menstrual cycle. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints. As a result of her post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, pt has been unable to engage in activities that a normal young person would enjoy. Pt athletic performance and social life has been negatively affected and has been challenging. Pt loved being outdoors actively playing sports. She was unable to participate in any sports or physical activity as her level of strength and endurance diminished. She no longer had the energy to run track due to chest pains, rapid heartrate, constant fatigue, increased shortness of breath, and exhaustion from heat. Pt's symptoms affected her ability to handle tasks at work, which caused her to take a leave of absence because it was unsafe for her to continue working due to dizziness and risk of falling. Pt quality of life decreased, and activities of daily living have been impaired. Based upon her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, Pt has been diagnosed with various medical conditions, including but not limited to, Postural Orthostatic Tachycardia (POTS) and dysautonomia. Pt sustained serious autoimmune (autoimmune disorder), autonomic, and neurological injuries (nervous system disorder) as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections. As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) -induced injuries, Pt suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. At the reporting time, the Pt had not recovered from the events. Pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to postural orthostatic tachycardia (POTS) and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) -induced autoimmune disorder (related).   All the events were considered as disabling by reporter.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.