Age: 21.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse event, Asthenia, Autoimmune disorder, Autonomic nervous system imbalance, Chest discomfort
Clinical narrative: postural orthostatic tachycardia (POTS) / dysautonomia / orthostatic intolerance; autoimmune disease / Gardasil-induced autoimmune disorder; Product origin unknown; Information has been received from a lawyer, regarding a case in litigation and concerning a n approximately 21-year-old female patient (pt). Prior to receiving the suspect vaccine, she had no autoimmune diseases, and no autonomic issues. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided.  On 17-DEC-2018, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints. On an unknown date, within a month after receiving the vaccination, the pt began to experience daily headaches and occasional dizziness. Although she attempted to treat these issues with over-the-counter pain medication (unspecified), the symptoms progressed over time. Although she was dealing with these medical issues and dealing with her spring semester, the pt returned to her home and made an appointment with her primary care physician (PCP) on 30-MAY-2019. She told the doctor of her almost daily migraine headaches along with some vision problems she had been experiencing. She was prescribed medication (unspecified) to control her headaches and told to return in 4-5 weeks for re-evaluation. On 29-JUN-2019, the pt experienced a near syncope episode, vomiting, numbness in the right arm and collapse and she was taken to a local emergency room (ER). Laboratory (lab) tests and an electrocardiogram (EKG) were performed (results not provided) and she was given intravenous (IV) fluids and discharged. On 01-JUL-2019, the pt met with her PCP. She advised her doctor that she was still having some vomiting. After addressing the nausea issue, the pt was told to return if symptoms persisted. On 08-JUL-2019, she returned to her PCP, and continued to complain about nausea, as well as shooting pain and cramps in her arms and legs. On 07-AUG-2019, the pt received her second HPV vaccination (unspecified; manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported) (product origin unknown), and she advised the doctor that she continued to experience tingling and heaviness in her extremities. Her condition worsened after "this second vaccination". On unspecified dates in October 2019, she had over 18 "icepick" headaches and over 28 on unspecified dates in November 2019. Along with these headaches, the pt began to experience muscle weakness, orthostatic intolerance, pre-syncope, extreme dizziness, coughing, shortness of breath, and a racing heart upon standing. She sought help at a university's student wellness facility but received no relief or answers as to what was happening. In 2020, the pt had multiple visits with a neurologist, who treated her for chronic migraines. She began to experience worsening symptoms, including dizziness during her second semester, causing her to go to a local ER on 05-FEB-2021 and again on 10-MAR-2021. On 07-APR-2021, the pt had her initial visit at a "heart and vascular" facility. Believing that her symptoms were consistent with autonomic dysfunction and postural orthostatic tachycardia syndrome (POTS), the doctor ordered a tilt table test to be performed. On 29-APR-2021, an autonomic function test (tilt table test) was performed. Upright tilt testing demonstrated evidence of postural orthostatic tachycardia with multiple symptoms including "dizziness, headache, chest pressure, palpitations, sweating, nausea, redness in feet". Baseline heart rate was 61 beats per minute; peak heart rate was 120 beats per minute. Findings were consistent with postural orthostatic tachycardia and orthostatic intolerance. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities. She contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) (also reported as quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and its ingredients) caused her to develop serious and debilitating injuries (also reported as disabling and painful chronic injuries), including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia (also reported as autonomic dysfunction), 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 her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. She had suffered and at the time of report continued to suffer severe and permanent physical injuries, and associated symptomatology 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 her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt had suffered and at the time of report 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. The outcome of the events of POTS and autoimmune disorder was considered to be not recovered/not resolved. The lawyer considered the event s of POTS and autoimmune disorder to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and unspecified HPV vaccination (manufacturer unknown).  Upon internal review, the event of autoimmune disorder was determined to be medically significant. The events of POTS and autoimmune disorder was considered to be disabling.