Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Complex regional pain syndrome, Connective tissue disorder, Deafness, Depression, Diplopia
Clinical narrative: weakened connective tissue / mixed connective tissue disease; hearing loss; vision loss; neurogenic bladder; intractable vertigo; double vision; visual floaters; unsteady when she stood / balance difficulties; anxiety; panic attacks; sleep apnea; depression; atypical response to antidepressants; numbness and tingling in her lower extremities; cognitive difficulties; numbness and tingling in her lower extremities; involuntary movements; tics; hypoxia; vaginismus; endometriosis; sinus tachycardia; chronic joint pain / sleep disturbances / chronic fatigue syndrome (CFS); complex regional pain syndrome (CRPS) / pain in nerves / burning nerve pain of the CRPS; sinus tachycardia; pediatric acute-onset neuropsychiatric syndrome (PANS); pelvic floor dysfunction; daily seizures / convulsions; Autoimmune Disease; Trouble walking the halls; pain in her bones, nerves; mother did not consent to daughter receiving a third shot of Gardasil; dizziness and shakiness, headache, and nausea/ increased heartbeat and felt faint and unsteady when she stood/ Postural Orthostatic Tachycardia Syndrome (POTS)/ dysautonomia; This initial spontaneous report was received from a lawyer and patient's mother regarding a case in litigation and refers to a 15-year-old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 02-OCT-2013, the patient received her first shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported). On 03-DEC-2013, the patient received her second shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported). It was claimed that as a result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the patient sustained autoimmune disease, including postural orthostatic tachycardia syndrome (POTS), dysautonomia and other serious injuries. It was reported that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and its ingredients caused patient's autoimmune disease and other related injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injections, patient was doing well and maintaining overall good health. She had no autoimmune diseases, and no autonomic issues and no orthostasis.   Within one week following her second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection, patient began experiencing dizziness and shakiness, headache, and nausea. She also noticed an increased heartbeat and felt faint and unsteady when she stood. Considering these post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) symptoms, and her rapidly declining health, patient's mother did not consent to patient receiving a third shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  As the months progressed, so did patient's injuries. She was seen by multiple physicians and specialists for her complaints which included: daily seizures; intractable vertigo and nausea exacerbated by double vision; visual floaters; balance difficulties; fatigue; anxiety and panic attacks; convulsions; sleep apnea and sleep disturbances; depression and atypical response to antidepressants; cognitive difficulties; numbness and tingling in her lower extremities; involuntary movements and tics; weakened connective tissue and chronic joint pain; vision and hearing loss; vaginismus and endometriosis.  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 teenager would enjoy. She no longer could participate in school and choir events in the same manner she used to prior to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injections, her physical activities declined, she was constantly tired, dizzy, fatigued or in pain. Patient's vision and cognitive abilities declined, she was taken out of school had to complete the majority of her high school classes via homebound and one-on-one tutoring. Patient could no longer physically attend school in a normal fashion due to her deteriorated medical condition.  Studies, including serum samples from June 2018, demonstrated that patient tested positive for the anti-alpha-1 adrenergic antibodies, anti-beta-2 adrenergic antibodies, anti-muscarinic cholinergic receptor 1 antibodies, anti-muscarinic cholinergic receptor 3 antibodies, and anti-muscarinic cholinergic receptor 4 antibodies. Patient is at risk for anti-AT1R antibodies and anti-ETAR antibodies.  Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) symptoms and adverse events as outlined above and the tests performed by her medical providers, patient had been diagnosed with various medical conditions, including but not limited to, POTS, sinus tachycardia, chronic fatigue syndrome (CFS), mixed connective tissue disease, complex regional pain syndrome (CRPS), pediatric acute-onset neuropsychiatric syndrome (PANS), pelvic floor dysfunction, endometriosis, vaginismus, neurogenic bladder, worsened hearing loss, progressive vision loss in both central acuity and peripheral vision, seizures and sleep apnea.  Patient contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injections caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, 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.  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), patient had suffered and continues to suffer severe and permanent physical injuries and associated symptomology and has 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 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, patient had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future.  The outcome of all events was not recovered/not resolved. The reporter considered all events to be disabling and related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Information regarding this patient was also received via 02-APR-2021. Additional information was reported: as a result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the patient also experienced hypoxia, trouble walking and pain in bones, nerves, and joints. Her physical activities were drastically limited. It was reported that before Covid-19 pandemic, patient was able to alleviate some of her pain with ketamine infusions, which gave her relief from the burning nerve pain of the CRPS. She was not able to receive the treatment in nearly a year due to the pandemic, and the pain in her bones, nerves, and joints was constant.  The outcome of the events was resported as not recovered/not resolved. The events were considered to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, the events of POTS, mixed connective tissue disease, hearing loss, vision loss, neurogenic bladder, seziures/convulsions, hypoxia and autoimmune disease were considered to be medically significant.