Received Feb 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
autonomic dysfunction SOB coughing headache migraine fatigue sleep disturbance dizziness faint memory impairment concentration brain frog cognition inability to multitask difficulty speech spelling no focus impaired recall heart palpitation anxiety; autonomic, autoimmune, and neurological injuries; autonomic, autoimmune, and neurological injuries; Plaintiff received her first and second dosage of Gardasil on December 9, 2019 and January 5, 2021.; HPV Vaccination Syndrome; migratory joint pain; stiffness in the joints in her hands and in the neck; has a positive ANA factor; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning an adult female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 09-DEC-2019, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) intramuscular injection and on 05-JAN-2021 with the second dose (dose, frequency, vaccination scheme, anatomical location, route of administration, lot number and expiration date were not reported for both doses) administered for preventing cancer. It has been reported that the pt sustained serious autoimmune, autonomic, and neurological Injuries as a result. It was reported that on an unknown date, after her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, the pt began experiencing chronic shortness of breath and coughing. She began experiencing chronic headaches and chronic migraines, sometimes lasting for days and months with no relief from medications. The pt also began experiencing prolonged general fatigue and sleep disturbances. She sometimes experiences dizziness and the sensation that she would faint. Subsequent to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)vaccinations, the pt began experiencing significant memory impairment, difficulties in concentration, brain fog, difficulties with cognition, inability to multitask, difficulties with speech and spelling, inability to focus, and impaired recall, all which had impacted her both in school and on the job. Following pt's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, she developed migratory joint pain, including stiffness in the joints in her hands and in her neck. She had been seen by a rheumatologist and was tested and has a positive antinuclear antibodies (ANA) factor. She had decreased fine motor movements which made it difficult for her to use her hands, as her fingers did not bend easily. Following the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, the pt had developed chronic heart palpitations with her heart racing. She also developed anxiety because of her worsening medical condition and her inability to function. She was prescribed alprazolam (XANAX) to treat her anxiety. She also was prescribed dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate (ADDERALL) to help with her brain fog and inability to concentrate. Before pt's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, she was healthy and loved to study. As a result of her post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, it had been hard for her to function at her job and complete her post-graduate education. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, pt's collection of symptoms were consistent with human papilloma virus (HPV) Vaccination Syndrome. The underlying, unifying diagnosis would be autonomic dysfunction. As a proximate result of company's fraudulent, false, and misleading statements, omissions, and conduct concerning the safety and efficacy of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had 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 Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). As a direct and proximate result of her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, pt had 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 those losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). All the events were considered as disabling by reporter. Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Test Name: ANA; Test Result: Positive