Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Fear-related avoidance of activities, Headache, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: arthritis; Postural Tachycardia syndrome/headache/dizziness/ blurry vision in both eyes feeling dizzy immediately after changing physical positions/ "heart rate would increase, and he would become lightheaded lasting for 10-15 seconds; migraine headaches/recurrent headaches; chronic fatigue of an undetermined origin/tiredness,; left and right knee pain; Vitamin D deficiency; the third dose on 20-JAN-2016; second dose of Gardasil on 18-NOV-2014; This initial spontaneous report was received from a lawyer and patient's mother   regarding a case in litigation and refers to a 10-year-old male patient. Current condition include hypoglycemia and asthma and the conditions were being monitored and the pt. received unspecified medical treatment.  On 03-DEC-2013, patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prevention of cervical cancer (lot#, expiration date, dose, and route not specified). On 18-NOV-2014, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Inappropriate schedule of product administration) and on 20-JAN-2016, the pt. received the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prevention of cervical cancer (lot#s, expiration dates, doses, and routes not specified (Inappropriate schedule of product administration).  On 27- JAN- 2016, the pt. was seen at the clinic with complaints of constant fatigue, tiredness, and bilateral knee pain. The nurse practitioner, performed a physical evaluation of patient and diagnosed him as suffering from chronic fatigue of an undetermined origin, left and right knee pain (Arthralgia), and Vitamin D deficiency.  Following the visit, pt.'s fatigue, headaches and dizziness worsened. He returned to clinic on 31-MAR-2016, with complaints of severe headaches that were now occurring twice a week with dizziness spells, and intermittent bilateral knee pain.  He was evaluated by nurse practitioner, and she diagnosed him as suffering from migraine headaches and pain in both knees. Since she was unable to determine the etiology of pt.'s fatigue, headaches, and lightheadedness, she referred him to the children's specialist for further evaluation. On 14-JUN-2016, pt. was seen in pediatric neurology with complaints of headaches and dizziness of an unclear etiology. During the initial consultation, pt. also complained of blurry vision in both eyes occurring during headaches and a history of feeling dizzy immediately after changing physical positions. Progress notes from the visit indicated that patient's "heart rate would increase, and he would become lightheaded lasting for 10-15 seconds."Ultimately, pt.  was diagnosed with Postural Tachycardia Syndrome (POTS) and recurrent headaches.  As a result of his post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, patient has been unable to engage in normal activities that a normal young person would enjoy. Pt.  feared playing outside with others because he did not want to collapse and injure himself. Plaintiff also missed numerous days from school which drastically affected his social life.  Based upon his chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, pt. had been diagnosed with various medical conditions, including but not limited to, Postural Tachycardia Syndrome, recurrent headaches and arthritis.  As a proximate result of company's 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. has suffered and continues to suffer severe and permanent physical injuries, and associated symptomatology and has suffered severe and permanent emotional injuries, including pain and suffering. Pt. also has 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, pt had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he will continue to incur these losses and expenses in the future.  The following events: fatigue, dizziness, arthritis, migraine, postural orthostatic tachycardia syndrome, vitamin d deficiency and arthralgia were considered disabling by the reporter and the outcoem was not recovered.  Fatigue, dizziness, arthritis, migraine, postural orthostatic tachycardia syndrome, vitamin d deficiency and arthralgia to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).