Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Asthenia, Autoimmune disorder, Autonomic nervous system imbalance, Depression
Clinical narrative: Postural Orthostatic Tachycardia Syndrome (POTS); Orthostatic intolerance; Autonomic Dysfunction; Vasovagal allergy; She lost at least 25 pounds and became underweight; She became severely depressed; Anxiety; This initial spontaneous report was received from a lawyer and a 19 years old female Patient regarding a case in litigation. The Patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 26-JUN-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, dose, route of administration, anatomical location not provided) for preventing cervical cancer. In the weeks following this first dose, she experienced periodic lightheadedness and dizziness. On 17-AUG-2018, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, dose, route of administration, anatomical location not provided), and after that, the patient's lightheadedness worsened, and she began to feel weak and fatigued. On 20-DEC-2018, the patient received the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, dose, route of administration, anatomical location not provided). On 03-MAR-2019, after a few minutes of eating, the patient suddenly felt very sick, she was shaking, unable to swallow, her heart was pounding in her chest and her arms and legs went weak, she felt like she was freezing even though she was sweating. Patient was taken to the emergency room and told she most likely had a food allergy attack for which she was prescribed epinephrine (EpiPen). Patient had another attack on or around 18-MAR-2019, when she went out to eat with her family and had the same reaction. She got sick in the bathroom and took her medication and the reaction eventually passed. On approximately 01-APR-2019 (reported as about two weeks later), the patient was eating and began to have another severe reaction, she was having trouble breathing and after using two epinephrine (EpiPen), her symptoms were not getting better. She was taken to the emergency room and when she arrived, she was barely able to move or walk because her body was so stiff, and she was shaking badly. Her heart was being over 200 beats per minute, and she could not get comfortable. Eventually, she was released from hospital. Pt was terrified to eat anything that would cause her to have another attack; in consequence, due to her diet with restriction, she lost at least 25 pounds and became underweight (onset, outcome and causality unknown). She was having trouble driving, she was dizzy often and became severely depressed as she felt sick every day. Her allergist eventually diagnosed her with a vasovagal allergy to peppers. As the months progressed, so did the patient's injuries. She was seen by physicians and specialists for her complaints that included dizziness, chronic pain, brain fog, breathing difficulties, severe fatigue, diarrhea, motor dysfunction, muscle weakness, tingling in arms and legs, severe weight loss, tachycardia, blue toenails upon standing, anxiety and depression (onset, outcome and causality unknown for both). On 08-JAN-2020, a Tilt table test was performed which demonstrated orthostatic intolerance and she was diagnosed with postural orthostatic tachycardia syndrome (POTS). As a result of her post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, patient was unable to engage in normal activities that a young adult would enjoy. Based upon her chronic and severe symptoms and adverse events as outlined above, and the tests performed, the patient had been diagnosed with various medical conditions, including but not limited to POTS, orthostatic intolerance (OI), dysautonomia and vasovagal allergy. quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), the patient 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 increased risk of cancer and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). At the reporting time, the outcome of all the events alleged was considered as not recovered. The reporters considered all the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  The reporters considered all the events alleged to be disabling. Upon internal review the event of vasovagal allergy was determined to be medically significant.