Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram abnormal, Fatigue, Gait inability, Gastrointestinal disorder, Gastrooesophageal reflux disease
Clinical narrative: Serious Autoimmune, Autonomic, and Neurological Injuries; Serious Autoimmune, Autonomic, and Neurological Injuries; hypothyroidism/menorrhagia/menstrual irregularities/weakness/loss of muscle strength/chronic fatigue/joint pains/body temperatures irregularities dysregulation; neuropathy(pins-and-needles/tingling and numbness/burning sensations); gastrointestinal problems/ GERD/heartburn,chest pain; atypical somatic symptom disorder; sleep apnea,; tinnitus; insomnia,; light sensitivity; vision problems; memory loss; skin infections; abnormal blood pressure and EKG results; abnormal blood pressure and EKG results; headaches.; pressure on her chest; oral problems (dry mouth and bleeding gums),; difficulty breathing; oral problems (dry mouth and bleeding gums),; weight-loss,; mobility problems, had to be in a wheelchair because she was unable to stand, walk or sit; Toe nails developed black dots and lines; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a an adult (age not specified) female patient. Patient's current conditions, medical history and  concomitant therapy was not reported. On 29-JAN-2021 (at the age of 40 years-old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, then on 10-JUN-2021, the pt received the second dose (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) both doses administered for prevention of cervical cancer. On an unknown date, following her vaccination, pt began experiencing extreme chronic fatigue, weakness, joint pains, burning sensations, tinnitus, insomnia, shock sensations in her chest and left arm, pressure on her chest, difficulty breathing, pins-and-needles, tingling and numbness, vision problems, light sensitivity, heartburn, body temperature dysregulation, menorrhagia, and severe headaches. Pt spent numerous days in and out of the Emergency Room, pt had to be in a wheelchair because she was unable to stand, walk, or sit. As the months progressed, so did pts injuries; she was seen by multiple physicians and specialists for her complaints which now included: weight-loss, sleep apnea, insomnia, memory loss, skin infections, body shocks, difficulty breathing, paresthesia, abnormal blood pressure and EKG results, gastrointestinal problems, GERD, headaches, vision problems, light-sensitivity, weakness, loss of muscle strength, tinnitus, heartburn, oral problems (dry mouth and bleeding gums), body temperature irregularities, toenails developed black dots and lines, menstrual irregularities and mobility problems. 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 person her age would normally enjoy. Based upon her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been diagnosed with various medical conditions, including but not limited to, hypothyroidism, neuropathy, GERD, chest pain, atypical somatic symptom disorder, menstrual irregularities, and sleep apnea disorder, chest pain, atypical somatic symptom disorder, 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 the company's alleged fraudulent, false, and misleading statements, omissions, and conduct concerning the safety and efficacy of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). As a direct and proximate result, the pt suffered and continued 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.At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the events Autoimmune disorder, hypothyroidism, neuropathy peripheral were determined to be medically significant.