Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 3 | — | — |
alopecia/bald spot/autoimmune injury/hair loss; extreme and unusual pain in her arm; swollen face and neck; swollen face and neck; eyes receded into her face; voice changed; felt as if something is crawling in her hair/itchiness on her scalp; he texture of her hair completely changed; inflammation; occasional pain in her scalp; Information has been received from a lawyer referring to a 45-year-old female patient regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, at 45 years old, the patient received 3 doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, route, lot#, and expiration date were not reported). The patient agreed to receive the vaccine after being convinced that the vaccine was very safe, that the vaccine prevented cancer. The patient relied upon the company's ubiquitous representations concerning the safety and efficacy of the vaccine, in consenting to her vaccination. The patient's health care provider recommended that she receive the Gardasil vaccine, which was touted as a safe and effective vaccine for preventing cervical cancer. Upon information and belief, the patient's doctor read and relied upon information from the company, through its labeling and/or marketing, that the vaccine was safe and effective. In light of the patient's doctor's recommendations, as well as the company's relentless marketing and advertising messages, to which the patient had been exposed concerning the safety and efficacy of the vaccine, the patient consented to being injected with the vaccine. After receiving the second Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine, the patient experienced extreme and unusual pain in her arm and called the office immediately. The nurse that administered the vaccine said that this Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine was a "rough shot" and advised she would experience pain for three weeks. The following day, the patient woke up to a swollen face and neck. The patient's eyes receded into her face and her voice changed from swelling in her neck. In between the second and third Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine, the patient went to the emergency room three times for facial swelling. The doctors could not diagnose her, but she was prescribed water pills and blood pressure medication to decrease her swelling. The patient visited her primary care provider once a month for the swelling and still received no answers or diagnosis to these symptoms. The patient became ill within two days after receiving the last Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) shot. She developed a bald spot, and the texture of her hair completely changed. Thereafter, the patient visited a specialist and was diagnosed with alopecia. The patient had to cut off all her hair, purchased costly hair products, and over the counter supplements to counteract her hair loss and inflammation. She still suffered from occasional pain in her scalp and felt as if something is crawling in her hair. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: facial and neck swelling, hair loss, and pain and itchiness on her scalp. Following her vaccinations, the patient's confidence has been deeply shaken because of the physical changes she had experienced following her vaccinations. Based upon her chronic and severe post-Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, the patient has been diagnosed with various medical conditions, including but not limited to, alopecia. The patient contended that her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to, alopecia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's wrongful acts and the vaccine's manufacturing defects, the patient has suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The patient 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 autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). As a direct and proximate result of her vaccine-induced injuries, the patient had suffered and continued 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. The outcome of the events was not recovered. The causality between the events and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was considered to be related. The lawyer considered the events to be disability.