Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Restless legs syndrome, Sympathomimetic effect, Tachycardia, Temperature intolerance, Tension headache
Clinical narrative: restless leg syndrome; autoimmune injuries; menstrual irregularities; POTS/chronic headaches/fatigue/tachycardia/dizziness/shortness of breath/nausea/constipation/bloating/neurological&autonomic injuries/exercise intolerance/chest pain/palpitation/insomnia/inability to concentrate/decreased appetite/early fullness/pain; muscle twitching; temperature intolerance; Information was received from a lawyer regarding a case in litigation and refers to an adult female patient (pt). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 01-MAY-2023, at the age of 31-years-old, the pt was vaccinated with the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported), recommended by her physician, for prophylaxis (also reported as "touted as safe and effective for preventing cervical cancer"). Prior to the second hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination, the pt was healthy and happy. She was a 33-year-old (at the reporting time) treatment coordinator, residing with her 3-year-old son and husband. Before receiving the second hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination, her life was vibrant and active. She relished activities such as hiking, weightlifting, reading, and playing with her son. Additionally, she was committed to her career and pursuing further education to become a Medical Coder. Life was full of joy, health, and aspirations. On 05-JUN-2023, the pt was vaccinated with the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Following second vaccination, she felt as her world turned upside down. She began experiencing chronic headaches, menstrual irregularities, and persistent fatigue. On 30-OCT-2023, the pt received the third dose of injection hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). After the third hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination, her symptoms worsened leading to a cascade of debilitating symptoms. Those symptoms included tachycardia, dizziness, shortness of breath, nausea, extreme and prolonged fatigue, decreased appetite, early fullness, severe constipation, bloating, widespread pain including back pain and joint pain, exercise intolerance, chronic headaches, temperature intolerance, chest pain, palpitations, muscle twitching, insomnia and inability to concentrate. On 16-NOV-2023, the pt was seen at medical center. At that time, she reported increased heart rate (HR) with exertion 90-100s (no units provided) for two weeks, relieved with rest to 80s (no units provided); tension headaches that were coming in in the afternoon and were relieved with ibuprofen; joint pain in knees and intermittent blurry vision that were coming and going. The pt specifically related her symptoms to the third hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination she had received two weeks before. It was also noted on the visit at medical center that HR seemed to start after the third hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination. On the same date (16-NOV-2023), QTc on EKG "was at goal". On 04-DEC-2023, the pt was again seen at medical center for follow up for episodes of tachycardia. She gave a history of good health (reported also as baseline) until 30-OCT-2023, when she had her hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination. The pt stated that all her symptoms started 48 hours later (conflicting information, also reported that headaches, menstrual irregularities and fatigue started after the second dose administered on 05-JUN-2023). She initially was having "adrenaline surges". These subsided in the past week and half. At that time, she was noticing more that her heart rate was 30 - 60 beats higher when standing compared to sitting. The pt was concerned about postural orthostatic tachycardia syndrome (POTS). She also had some mild nausea and GERD symptoms (also stated "no GERD symptoms", conflicting information). The pt noticed brain fog and was slightly more constipated than baseline. Her sleep was affected, she was waking up 5-10 minutes per night. Most of the time could not fall back to sleep, but sometimes could take as much as 45 minutes. She was waking up because of heart racing. She needed a Zio patch. Denied any chest pain. Status post echocardiogram. Did not feel anxiety or depression was an issue. She was taking escitalopram (LEXAPRO), seeing her therapist. Joint pain improved. The assessment and plan were for concerns of postural tachycardia, joint pain, insomnia, "all started after HPV shot". It was noted that tachycardia was postural in nature and the next step would be a tilt table test. Echo was non-concerning. Zio patch pending. An urgent referral to cardiology was made. Hydration was continued and salt intake increased. It was noted that insomnia had significant impact on her. On 06-DEC-2023, after an extensive battery of blood and cardiac tests, the pt was diagnosed with POTS. On that day, following extensive examination/evaluation of the pt, her cardiologist sent the following correspondence to the pt's other physician: "POTS: her constellation of symptoms, in particular reproductive tachycardia with changes in position, was consistent with POTS. We discussed that it was quite possible that some of her symptoms were the consequence of the vaccination leading to possible autonomic dysfunction". On 14-DEC-2023, the physicians at medical centre specifically noted the relationship of pt's POTS to hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination stating: "Diagnosed with POTS. It was felt that it was quite possible that some of the autonomic symptoms are a consequence of the vaccination". The pt was also seen in cardiology. Mainstay of treatment was symptom management, hydration, compression stockings, trial of propranolol, Zio patch results were pending. It was reported that using short acting propranolol was helpful. Sleeping was better and overall was feeling slightly better. The pt had time off of work, needed intermittent leave. On 08-JAN-2024, the pt came to medical center. It was stated that since being diagnosed with POTS in December 2023, she was noted with insomnia for which she was taking propranolol. The pt reported that she was having difficult time sleeping not because of insomnia itself, but more because she was having restless leg syndrome symptoms. She reported that she could not find a spot for herself and she was constantly feeling as if she needed to move around. Trialing her on a very low-dose of pramipexole (MIRAPEX) was discussed and the pt was very amenable so pramipexole (MIRAPEX) was prescribed. The impact of these health issues was nothing short of catastrophic for the patient. She was forced to abandon hobbies, halt her academic pursuits, and take medical leave from work. She could not complete simple tasks such as grocery shopping, cleaning, or showering without suffering from debilitating fatigue and a myriad of other symptoms. The relentless symptoms not only stripped away her ability to enjoy life but have also transformed her into a mere shadow of the mother, wife, friend, and employee she once was. This situation not only ruined her life but shattered the dreams and aspirations she held for herself and her family. The pt contended that her hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological injuries, including but not limited to POTS 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 hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or otherwise linked to her hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)-induced autoimmune disorder. As a proximate result of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the pt suffered and continued to suffer severe and permanent physical injuries and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). As a direct and proximate result of her hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of all events was considered to be not resolved.  The reporter considered all events to be related to hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  Upon internal review, autoimmune disorder was determined to be medically significant.  The reporter considered all events to be disabling.