Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Amenorrhoea, Arthralgia, Cystitis, Endocrine disorder
Clinical narrative: Sustained serious autoimmune, autonomic and neurological injuries; Sustained serious autoimmune, autonomic and neurological injuries; Sustained serious autoimmune, autonomic and neurological injuries/autonomic dysfunction/headaches, fatigue, insomnia, hypersomnia, poor sleep; polycystic ovary syndrome/missing periods, hormonal changes, amenorrhea; possibly chronic fatigue syndrome; Pain throughout her muscles and joints; Pain throughout her muscles and joints; as well as other constellation of adverse symptoms, complication, injuries and other adverse events; Began having frequent urinary tract and bladder infections; Began having frequent urinary tract and bladder infections; Worsening irritable bowel syndrome/gastric upset and pain, intense intestinal pain; Numbness in hands and feet; muscle cramping and high blood pressure; muscle cramping and high blood pressure; she received her first dosage of Gardasil on 30-MAY-2018 and second dose on 19-JAN-2019; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a 23 year old female patient (Pt). The Pt concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 30-MAY-2018, Pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL); on 19-JAN-2021, she received the second dose of the vaccine; and on 20-DEC-2021, Pt received the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, lot #, expiration date, route of administration, anatomical location not provided for any dose) for preventing cervical cancer (inappropriate schedule of product administration). On an unspecified date following her vaccinations, Pt began having gastric upset and pain which became almost unbearable at times, also developed chronic headaches, chronic fatigue, numbness in hands and feet, pain throughout her muscles and joints, insomnia, hypersomnia, amenorrhea, developed muscle cramping and high blood pressure. Also, began having frequent urinary tract and bladder infections, poor sleep, worsening of irritable bowel syndrome, intense intestinal pain, missing periods and hormonal changes. Pt did not know and had no reason to know that the symptoms she was experiencing were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine. It was not until late 2022, that Pt began to suspect that the vaccine was the cause of her symptoms and injuries. Based upon he chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, plaintiff had suffered various medical conditions, including but not limited to serious and debilitating autoimmune, neurological injuries, autonomic dysfunction, polycystic ovary syndrome (PCOS) and possibly chronic fatigue syndrome, as well as a constellation of adverse symptoms, complications, injuries and other adverse events, many of which were 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 vaccine induced autoimmune disorder. At the reporting time, the outcome of all the events was unknown. The reporters considered all the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  The reporters considered autoimmune, neurological injuries, autonomic dysfunction, PCOS, possibly chronic fatigue syndrome and the other constellation of adverse symptoms to be serious events (medically significant).