Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Magnetic resonance imaging, Migraine, Seizure
Clinical narrative: Likely Related to Autoimmune Dysregulation; Autonomic Nervous System disregulation; have unsteady hands; Non-Epileptic Seizures; chronic fatigue syndrome; brain fog; depression; anxiety; Neurocardiogenic Syncope; Chronic Migraine Headaches and Dizziness; Chronic Migraine Headaches and Dizziness; Information has been received from a lawyer regarding a case in litigation and refers to a 18-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 20-OCT-2014, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot#, expiration date, dose, dose# and route not specified) for prevention of cervical cancer.   On 22-OCT-2022, the patient experienced extreme dizziness while at school and went to a nurse's office. While there, the patient fainted and her mother took her to an emergency center, where she was diagnosed with syncope of an unknown origin at that time. It was further reported that the patient experienced syncope of unknown origin along with extreme headaches and dizziness within the following months. On 06-NOV-2014, due to the patient's unexplained and suddenly arising condition, she assisted to a cardiology center, where she was fitted with a Holter monitor following a computerized tomogram (CT) (results not reported). Then, she was scheduled to underwent a magnetic resonance imaging (MRI) and, at that time, the patient's syncope was believed to be Neurocardiogenic in origin. On unspecified dates between November and December 2014, the patient's family video-recorded her fainting spells and, along with the data from the Holter monitor, her cardiologist diagnosed her with complex seizure disorder. It was also reported that, along with seizures, syncope of an unknown origin and dizziness, the patient experienced migraines and other debilitating symptoms.  On 23-APR-2015, the patient was vaccinated with a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot#, expiration date, dose, dose# and route not specified) for prevention of cervical cancer. Immediately after, the patient experienced non-epileptic seizures. It was also mentioned that the patient experienced seizures on 25-APR-2015, 05-MAY-2015, 16-MAY-2015, 18-MAY-2015, 20-MAY-2015 and 29-JUN-2015. Besides, it was mentioned that the patient's condition deteriorated into the following year and her academic performance was notably deteriorated (both school and college). It was mentioned that, approximately in September 2016 (reported as "fall") the patient was unable to handle chemicals during class because her medical condition caused her to have unsteady hands. The patient refused to receive a third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) due to the events.  At the reporting time, the outcome of seizure, anxiety, depression, cerebral disorder, chronic fatigue syndrome, dizziness, migraine, autonomic nervous system imbalance, syncope and autoimmune disorder was reported as not recovered. The outcome of Tremor was not reported.  The reporter considered that the events non-epileptic seizures, autoimmune dysregulation, neurocardiogenic syncope, dysregulation of the autonomic nervous system, chronic fatigue syndrome, chronic migraines, headaches, and dizziness, depression, anxiety, and brain fog, were severe an related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events autoimmune disorder, seizure and syncope were determined to be medically significant events. The events seizure, dizziness, migraine, autonomic nervous system imbalance, syncope, chronic fatigue syndrome and autoimmune disorder were considered serious due to disability.