Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
autoimmune disease; resulting in head injuries; fainting episodes; abnormal sensations in his arms and legs; insomnia; Vomiting; severe migraines that hindered his ability to read and caused difficulty with word recall and communication/ neurological injuries; joint and limb pain; a persistently cold body temperature; joint and limb pain; lightheadedness/ lightheadedness when rising from a seated or lying position; Nausea; Information has been received from a lawyer regarding a case in litigation concerning to a 13-year-old male patient (pt). The pt's concurrent conditions, his medical history and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with his first and only dose of quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route and anatomical location of administration, lot number and expiration date were not provided) administered for prevent cervical cancer. The pt's mother, agreed to her son receiving the vaccine after being exposed to Company's marketing that the vaccine was very safe, prevents cancer, and that teenagers must get the vaccine. Pt's health care provider recommended that pt receive the quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine (GARDASIL), which was touted as a safe and effective vaccine for preventing cervical cancer. Prior receiving the vaccination, the pt was happy, bright, athletic, and healthy. Immediately after receiving the vaccination, pt experienced lightheadedness, and nausea, he waited 20 minutes before he was able to leave. On an unspecified date, the pt sustained serious autoimmune (autoimmune disorder), autonomic, and neurological injuries as a result of his vaccine. As the months progressed, so did pt's symptoms. He was seen by multiple physicians and specialists for his ongoing symptoms, which included increased nausea and vomiting, fainting episodes (syncope) resulting in head injuries, lightheadedness when rising from a seated or lying position (dizziness postural), joint and limb pain particularly in his legs (arthralgia/ pain in extremity), abnormal sensations in his arms and legs (sensory disturbance), a persistently cold body temperature (body temperature decreased), insomnia, and severe migraines that hindered his ability to read and caused difficulty with word recall and communication (migraine with aura). As a result of his post-vaccine symptoms, pt was unable to engage in activities that a normal young person would enjoy. Pt was highly athletic and full of energy, playing soccer, basketball, t-ball, and flag football. He also enjoyed karate, bike riding, skateboarding, and even playing on a pogo stick. Academically, pt excelled, attending a school for gifted and talented students. However, his ongoing exhaustion significantly impacted his ability to focus on schoolwork and complete assignments, while also preventing him from maintaining an active, competitive sports lifestyle due to the physical toll. He suffered and continues to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt 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 his autoimmune disease and other injuries caused by the vaccine. As a direct and proximate result of his vaccine-induced injuries, pt had suffered and continues 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. At the reporting time, the pt had not recovered from all the events. The reporter considered all the events to be related to quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine (GARDASIL) vaccine. All the events were considered to be disabling by the reporter.