Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tinnitus, Urticaria, Vertigo, Vestibular migraine
Clinical narrative: Fibromyalgia; lump in her breast (fibroadenoma); Dermographism; vertigo; hives; postural orthostatic tachycardia syndrome (POTS)/headaches / ear pains/ dizziness/ body aches/ muscle weakness/ migraines/ gastrointestinal issues/ diarrhea/ Orthostatic intolerance / dysautonomia; flu-like symptoms; ear pressure; tinnitus; This initial spontaneous report was obtained from social media, and was received from a lawyer, via vendor, regarding a case in litigation concerning a 13-year-old female patient (pt). Information on medical history, concurrent conditions and concomitant medications was not provided. Pt alleged that she suffered and continued to suffer severe and permanent physical injuries such as an autoimmune disease known as postural orthostatic tachycardia syndrome (POTS) after receiving multiple injections of an unidentified Merck hpv vaccine (reported both as HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)). Within hours of receiving the first dose, pt experienced flu-like symptoms, including achiness, headache, nausea, and low-grade fever. The symptoms lasted for approximately 24 to 48 hours. In the weeks that followed, pt experienced ear pressure, tinnitus, and headaches. Her symptoms were atypical and over-the-counter medication did not bring her any relief. A few months later, pt experienced more frequent and severe ear pain and tinnitus. Her mother took her to her doctor who prescribed pt steroids. She received her second dose of an unidentified Merck hpv vaccine during this visit and proceeded to experience the same flu-like symptoms as before. As months passed, pt began to experience headaches of varying seriousness and continued to deal with ear pain and tinnitus. She also complained of fatigue and body aches. Her symptoms were severe enough to increasingly keep her from attending school. Pt and her mother visited multiple specialists to understand why she was experiencing these "spells" that caused severe dizziness, headaches, ear pressure, and tinnitus. No one could give them a satisfactory answer or relief, and her symptoms continued unabated. When pt was due for her third unidentified Merck hpv vaccine injection, her mother started to believe that the unidentified Merck hpv vaccine may have been the cause of pt's symptoms. The family doctor agreed that the timeline following each of the shots and the symptoms pt experienced was suspicious but could not say for certain that the unidentified Merck hpv vaccine was the cause. Outcome and causality of flu-like symptoms, ear pressure and tinnitus were not reported.  Follow up information was received from a lawyer and the 13-year old pt on 25-AUG-2020. Before the vaccination, pt had no autoimmune diseases, no autonomic issues and no orthostatis. Pt received the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) on 04-AUG-2014. Immediately after vaccination, in August 2014, pt began experiencing flu-like symptoms, including achiness, headache, nausea, and fever. Shortly thereafter she began experiencing ear pressure, tinnitus, and headaches. Pt received the second dose on 16-OCT-2014. On unspecified dates, after her second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) in, pt again had the same transitory flu-like symptoms but continued to have more frequent (almost daily) chronic headaches, ear pains and also started experiencing dizziness. She also started to tire easily and experienced body aches and muscle weakness. Soon thereafter she began experiencing migraines, postural dizziness, and vertigo. Pt was seen by multiple physicians and specialist for her complaints which now included: pressure in her ears as if something was moving inside her ear; lack of balance; tinnitus; vestibular migraines; dizziness; headaches; presyncope, vasovagal syncope, nausea; vision issues; muscle weakness; joint pain; extreme fatigue; sleep disturbance; gastrointestinal issues; diarrhea; lump in her breast (fibroadenoma); dermatographism and hives. As result of her symptoms, pt was unable to engage in normal activities. Serum samples from November 2016, demonstrated that pt had tested positive for the anti-alpha-1 adrenergic antibodies, anti-beta-2 adrenergic antibodies and the anti-muscarinic cholinergic receptor 4 antibodies. Pt was diagnosed with various medical conditions, including but not limited to, fibromyalgia, orthostatic intolerance ("OI") and/or postural orthostatic tachycardia syndrome (POTS). Pt contended that her two injections of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), individually or in combination, caused her to develop serious and debilitating autoimmune disease, including but not limited to POTS, OI, as well as a constellation of adverse symptoms, complications, injuries such as fibromyalgia, and other adverse events, many of which were alleged in this case 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.