Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
Catatonic Schizophrenia, unresposive, paranoia, hallucinations, loss of motor skills, behavioral changes, cognitive decline, laugh randomly, scrunch his face, tics that caused his arms to move in unusual ways; autoimmune injuries; genital pain; Eye pain; eye pain with light sensitivity; Information has been received from a lawyer, regarding a case in litigation and concerning a minor male patient (pt) of an unknown age. No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, at the age of 13 years old, the pt received his first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On an unspecified dates, following his Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, the pt sustained serious autoimmune injuries and began experiencing genital pain and eye pain with light sensitivity. He began to experience tics that caused his arms to move in unusual ways, laugh randomly at nothing and, sometimes, at inappropriate times, and scrunch his face almost as if he was wincing in pain. He began suffering from paranoia and was unresponsive during school. He began experiencing hallucinations. As the months progressed, so did pt's symptoms. He was seen by multiple physicians and specialists for his complaints which included loss of motor skills, tics, behavioral changes, cognitive decline, light sensitivity, genital pain, and hallucinations. On unknown dates, based upon his chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to catatonic schizophrenia. The pt suffered and at the time of report continued to suffer severe and permanent physical injuries, 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 his 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 his Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, the pt have suffered and at the time of report continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he would continue to incur these losses and expenses in the future. The outcome of the events was considered not recovered. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All events were considered disabling.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-03-31 , MNSC number : , CLIC number : , ESTAR number : LEGCLAPOL , IRMS number : 68514 , Central date : 2025-03-27 , Classification : DMC, Attachment description : Legal , Safety case number :