Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Asthenia, Autoimmune disorder, Fatigue, Headache
Clinical narrative: Pseudotumor Cerbri (intracranial hypertension)/debilitating headaches, severe fatigue, neck pain, vision disturbance, ringing in her ears, and optic nerve swelling; hyperthyroidism/ debilitating headaches, severe fatigue, neck pain, vision disturbance, ringing in her ears, and optic nerve swelling; Gardasil induced autoimmune disorder; positive antinuclear antibody (ANA) blood test (meaning her immune system had launched a misdirected attack on her own issues/ debilitating headaches, severe fatigue, neck pain, vision disturbance, ringing in her ears, and optic nerve swelling; autoimmune and neurological injuries; adverse symptoms, complications, injuries, and other adverse events; This initial spontaneous report was received from a lawyer and the consumer regarding a case in litigation and refers to a 22 years-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 24-OCT-2019, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for for preventing cervical cancer (strength, lot #, expiry date, and route of administration were not provided). It was confirmed that the health care professional through and informed to the patient that the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine was safe and effective.  On an unknown date, following her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, the patient developed debilitating headaches, severe fatigue, neck pain, vision disturbance, ringing in her ears, and optic nerve swelling. After multiple doctor and emergency room visits, including undergoing a spinal tap, she was diagnosed with Pseudotumor Cerebri (intracranial hypertension), hyperthyroidism, and had a positive antinuclear antibody (ANA) blood test (meaning her immune system had launched a misdirected attack on her own tissues). As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient has been unable to engage in activities that a normal young person would enjoy.  Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she has been diagnosed with various medical conditions. Patient contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune and neurological injuries, 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.  The patient has suffered and continued to suffer severe and permanent physical injuries, and associated symptomatology and has suffered severe and permanent emotional injuries, including pain and suffering.  The outcome of all the events was reported as not recovered.  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and all the aforementioned events was reported as related and were also considered as disability events.   Upon internal review, autoimmune disorder, hyperthyroidism and the Pseudotumor Cerebri were determined to be medically significant events.