Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | OT |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | OT |
fear that one day she will lose her independence because of the seizures; autoimmune and neurological injuries; Diagnosed with various medical conditions; Epilepsy/seizure/focal seizure/fatigue; This initial spontaneous report was received from a Lawyer and patient regarding a case in litigation and refers to a 15-year-old female patient (Pt). The Pt's concurrent conditions, medical history, concomitant medication, drug reactions or allergies were not reported. On an unspecified date (when she was 14 and 15 years old), the Pt was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL); and on an unspecified date in 2021, she received the second dose of the vaccine (lot #, expiration date, strength, route of administration, anatomical location not provided for any dose), for Preventing cervical cancer, after recommendation of Pt's health care provider and agreement with her father. On approximately 17-Feb-2021, less than a month after her second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the Pt had her first seizure and 911 was called. The following week, Pt was seen by a neurologist at the hospital where she was ultimately diagnosed with epilepsy. Her parents reported to the neurologist about recent vaccination and wondered if that caused her the seizure/epilepsy. The Pt had two more seizures in the following months, and as the months progressed, so did her symptoms. Pt was seen by multiple physicians/specialist for seizures and fatigue. The type of seizures was recently identified as focal seizures. As a result of her post-Gardasil symptoms, Pt had been unable to engage in activities that a normal young person would enjoy. Pt was required to take seizure medication to maintain the seizures and experienced daily fatigue. Pt lived with fear that one day she would lose her independence because of the seizures. Based upon her chronic and severe post-Gardasil symptoms, Pt had been diagnosed with various medical conditions/constellation of adverse symptoms/adverse events/complications/injuries, including but not limited to, epilepsy. Pt contended that Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune and neurological injuries. As a proximate result of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, Pt had suffered and continue to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. 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 their autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). At the reporting time, the outcome of all the events was considered as not recovered. The reporter considered all the events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). The reporter considered all the events to be disabling.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-15 , MNSC number : , CLIC number : , ESTAR number : LEGCOL , IRMS number : 68935 , Central date : 2025-07-14 , Classification : DMC, Attachment description : Legal , Safety case number :