Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Lung disorder
Clinical narrative: The patient was diagnosed with fibromyalgia/She has pain throughout her body/Her muscles are painful/fatigue/Stomach issues/chronic headaches/insommnia/She has difficulty; The patient was diagnosed with chronic fatigue; The patient was diagnosed with postural orthostatic tachycardia syndrome (POTS)/dizziness when she stands up or lays down/rapid heartbeat, palpitations, fatigue/She has difficulty sleeping; depression/She has difficulty sleeping/Insomnia; anxiety/Stomach issues/insommnia/She has difficulty sleeping; panic attacks; mood disorders; hormonal problems; Lung issues; Her joints are painful all the time; Autoimmune disease; Autonomic and Neurological injuries; The patient was diagnosed with polycystic ovary syndrome (PCOS)/Her monthly cycle became very irregular/gynecological issues and her menstrual cycle is irregular/gynecological issues; This initial spontaneous report was received from a lawyer via legal memo regarding a case in litigation regarding an adult female patient who was 22 years old at the time of vaccination. No information about the patients medical history, concurrent conditions or concomitant medications was provided.   On 26-OCT-2011, 21-DEC-2011, and on 20-APR-2012, the patient was vaccinated with the first, second, and t3hird doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) intramuscular injection, as prophylaxis (strengths, doses, lot numbers, expiration dates, anatomical locations, and rotes of administration where not reported).   Following vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), on an unknown date, she sustained serious autoimmune, autonomic and neurological injuries (Autonomic nervous system imbalance) as a result of the suspect vaccine, she also developed chronic fatigue, stomach issues, lung issues and hormonal problems. Her monthly cycle became very irregular. She was prescribed birth control pills, but they did not help. On 02-FEB-2016, she  was diagnosed with polycystic ovary syndrome (PCOS). She had also been told that she had fibromyalgia (onset date was not reported). She continued to have gynecological issues and her menstrual cycle was irregular. Her stomach issues continued. She had dizziness when she stood up or laid down. She had pain throughout her body. Her joints were painful all the time. Her muscles were painful. She had chronic headaches. She had difficulty sleeping She was seen by multiple physicians and specialists for her complaints which now included: pain in joints (Arthralgia), body-aches, rapid heartbeat, palpitations, fatigue, chronic headaches, and insomnia. In addition to her physical injuries, the patient now had depression, anxiety, panic attacks and mood disorders (Affective disorder). In addition to her current diagnosis, it had been suggested that she had developed chronic fatigue and postural orthostatic tachycardia syndrome (POTS). 350. As a result of her 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 quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccination, she was a happy and healthy young woman who had energy. She would participate in social and recreational activities with her many friends. As a result of her post-suspect vaccine symptoms, she had been unable to engage in normal activities that a normal young person would enjoy. She had lost friends and is no longer able to work. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, she had been diagnosed with various medical conditions, including but not limited to PCOS, chronic fatigue, chronic pain, depression, anxiety, panic attacks, POTS, and possible fibromyalgia. 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), she 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. Patient 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, she had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. At the time of this report, the patient had not recovered from POTS, PCOS, fibromyalgia, fatigue, depression, anxiety, and panic attack; the outcome of the remaining events was not known.   All the events were considered related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  The events of PCOS, POTS, fibromyalgia, fatigue, depression, anxiety, and panic attack were considered to have caused disability.  Upon internal review, the events of autoimmune disorder and PCOS were considered to be medically significant.