Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
anxiety; vertigo; depression; ovarian cyst ruptures; bilateral ankle synovitis; vasovagal syncope; non-epileptic seizures; Information has been received regarding a case in litigation from a Lawyer and refers to a(n) 12-year-old female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-Nov-2022, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), dose number 1, 1 dosage form as prophylaxis (route of administration, lot # and expiration date were not reported). As the months progressed, so did Plaintiff's injuries, as she began seeing multiple physicians and specialists for a variety of complaints.. In December of 2022, she started seeing a Pediatric Nurse Practitioner(PNP), for nonepileptic seizures. In February 2023, she started seeing a health care professional for anxiety and depression. Around the same time, Plaintiff started experiencing dizziness and began passing out. Plaintiff was taken to physician on 13-Feb-2023 and complained that she had experienced dizziness and lightheadness 3 times in the prior week. Physician referred her to Cardiology. On 16-Feb-2023, she was rushed to the Medical Center after passing out at school. On 17-Feb-2023 at Medical Center, Plaintiff was given a cardiovascular exam, electrocardiogram (EKG), echocardiogram and stress test by physician and was diagnosed with vasovagal syncope. In December 30, 2023, she was treated at the hospital for ovarian cyst ruptures. Since February 2024, she has suffered from bilateral ankle synovitis for which she must wear boots. As a result of her post-Gardasil symptoms, Plaintiff had been unable to engage in activities that a normal young person would enjoy. Prior to Plaintiff's Gardasil vaccination, she was an active child who played soccer, participated in recreational cheer, took ballet lessons, and excelled at competitive gymnastics. Plaintiff was in the middle of her cheer season when she received the Gardasil vaccination. After passing out while extended in the air, and developing dizziness, lightheadedness and vertigo, she was forced to quit cheerleading and gymnastics. She was now medically homebound due to her continuing seizures Based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including but not limited to, vasovagal syncope, non-epileptic seizures, anxiety, depression, ovarian cyst ruptures and bilateral ankle synovitis. As a proximate result of the company wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of Gardasil, Plaintiff has suffered and continues to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Plaintiff also has 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 injuries caused by Gardasil. As a direct and proximate result of her Gardasil-induced injuries, Plaintiff has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. At the reporting time, the patient had not recovered from anxiety, bilateral ankle synovitis, vertigo, non-epileptic seizures, depression, vasovagal syncope and ovarian cyst ruptures. The reporter considered the events to be related to of ovarian cyst ruptures to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine(GARDASIL). The reporter considered the event(s) of anxiety bilateral ankle synovitis, vertigo, non-epileptic seizures, depression, vasovagal syncope and ovarian cyst ruptures to be disabling/incapacitating.
Test Date: 20230227; Test Name: EKG; Result Unstructured Data: vasovagal syncope; Test Date: 20230227; Test Name: echocardiogram; Result Unstructured Data: vasovagal syncope; Test Date: 20230227; Test Name: stress test; Result Unstructured Data: vasovagal syncope