Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Ill-defined disorder, Impaired driving ability, Impaired work ability, Injection site pain
Clinical narrative: fatigue, chronic fatigue syndrome; anxiety,Nausea, diarrhea, sleepless; Gardasil-induced autoimmune disorder; depression; injection site very pain; POTS/brain fog/fatigue/nausea/dizziness/chest tightness and pain/migraines/vomiting/abdominal bloating/sleepless/lightheadness/; dysautonomia/postural lightheadedness/heart racing/nausea/constipation/diarrhea/abdominal bloating/GI disorder/photophobia/phonophobia/exercise intolerance/brain fog/chest pain&tightness/dizziness/sleepless/spinning/migraine/digestive attacks; some pre-exisiting symptoms that were previously well-managed were exacerbated.; Inappropriate age at vaccine administration; exacerbation of pain with routine physical activity, chronic pain syndrome; panic attacks; osmophobia; Information has been received from a lawyer regarding a case in litigation and referred to a 40-year-old female patient. The patient had experienced migraines in the past, she had not had one for many months and in the past her migraines occurred during her menstrual cycle. The patient had well managed pre-exisiting symptoms. The patient concomitant drug was not reported. On 04-MAR-2020 and 04-MAY-2020, the patient was vaccinated with the first and second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (lot#, expiration date, dose, dose# and route not specified) to prevent cancer.  On unknown dates in May 2020 (reported as soon after receiving second dose) (Product administered to patient of inappropriate age ), the patient began to experience new gastrointestinal issues and diarreha and some pre-exisiting symptoms were exacerbated. On 20-SEP-2020, the patient received the third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). The injection site was very painful. The next day (21-SEP-2020), the patient had a migraine. Over the following couple of weeks in 2020, the patient's life began to fall apart, as panic attacks, migraines, digestive attacks and sleepless nights plagued her. The patient could not walk across the room without the room spinning and having extreme tachycardia. The patient could not drive. After months progressed, the patient had seen by multiple physicians and specialists for her complaint included: diarrhea and worsening of her other symptoms including exercise intolerance, brain fog, fatigue, nausea, dizziness, chest tightness and pain, migraines, vomiting, photophobia, phonophobia, osmophobia, exacerbation of pain with routine physical activity and symptoms of dysautonomia including lightheadedness, postural lightheadedness, heart racing, nausea, constipation, diarrhea, and abdominal bloating. The patient had been diagnosis including but not limited to, POTS, dysautonomia, chronic fatigue syndrome, chronic pain syndrome, depression, and anxiety. The patient was unable to return to work or live alone. The outcome of all events were not recovered. The patient contended all above events were caused by quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) otherwise linked to her Gardasil-induced autoimmune disorder. All events were determined to be disability. Upon internal review, the event autoimmune disorder was considered as medically significant.