Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Ill-defined disorder, Inappropriate schedule of product administration, Laboratory test, Loss of personal independence in daily activities, Nervous system disorder
Clinical narrative: racing heart/purple limbs/dizziness/blood pressure changes/shooting pain in his groin and abdomen/diagnosed with POTS/severe fatigue/brain fog/fainting; numbness in his limbs; autoimmune (...) injuries; autonomic, autoimmune, and neurological injuries and resulting sequalae/various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome (POTS); first dosage of GARDASIL on 10-SEP-2019/on 25-JAN-2021, the patient returned to his provider/doctor recommended that he recive a second Gardasil shot, to which he consented; Information has been received from a lawyer regarding a case in litigation concerning an adult at the reporting time, male patient (pt). The pt's medical history, concurrent conditions and concomitant medications were not provided. On 10-SEP-2019, the pt was 16 years old and received his first dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) at healthcare provider's office. On 10-JAN-2021, the pt returned to his provider for a yearly physical and to get his sports form signed off for future lacrosse season. During this appointment, the pt's doctor recommended that he receive a second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact doses, formulations, lot #, expiration dates, sites and routes of administration were not provided for any dose; all received for prophylaxis) (inappropriate schedule of product administration), to which he consented. On the following day, the pt began experiencing racing heart, numbness in his limbs, purple limbs, and dizziness. He also experienced blood pressure changes and shooting pain in his groin and abdomen. The pt went to hospital and was admitted for four days. He had to use a walker to get around. After undergoing multiple tests, no definitive answers were found. The doctors speculated the pt might have a form of Lyme's disease, and recommended he follow up with an infectious disease specialist. On 06-FEB-2021, the pt went to another hospital where he was diagnosed with postural orthostatic tachycardia syndrome (POTS). As a result of his post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been unable to engage in activities that a normal young person would enjoy. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was an active, athletic teenager. He played hockey and varsity lacrosse, he was a volunteer firefighter, and owned his own landscaping business. Now, the pt was struggling to get through the day and keep up with normal activities despite his symptoms. There were days when he was unable to get out of bed. Based upon his chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions (Ill-defined disorder), including but not limited to, POTS. The pt contended that his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused him to develop serious and debilitating autoimmune (Auto-immune disorder), autonomic and neurological injuries, including but not limited to POTS (reported also as serious and debilitating injuries, including but not limited to autonomic, autoimmune, and neurological injuries and resulting sequalae that the pt sustained as a result of receiving the vaccine), resulting in the pt experiencing severe fatigue and brain fog, numbness in limbs, dizziness, racing heart, and fainting, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the 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. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his 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 had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment (unspecified), and diminished income capacity, and he would continue to incur these losses and expenses in the future. The outcome of 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).  The reporter considered all events to be disabling. Upon internal review, the event of autoimmune disorder was determined to be medically significant.