Received May 12, 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 | — | — |
cardiac arrest; autonomic injuries; heart attack; cardiomyopathy/myocarditis/swelling in her legs/tachycardia; Autoimmune injuries; heavy periods; neurological injuries; Information has been received from a lawyer regarding a case in litigation and referred to a 20-year-old female patient (pt). Prior to receiving quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was happy and healthy. Her other medical history, concurrent conditions and concomitant therapies were not provided. On 22-Mar-2022 (at the age of 20 years old), the pt was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by her doctor, with her consent, for prophylaxis. Following her first vaccination, pt experienced swelling in her legs but assumed this was due to standing while nursing. On dates of 31-May-2022 and 26-Sep-2022 (at the age of 20 years old), the pt was vaccinated with the second and third doses of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact doses, route of administration, anatomical locations, lots # and expiration dates were not provided). Following her second quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, pt began having very heavy periods which had never occurred previously. The morning following her third vaccination, pt went to school and then to a restaurant for lunch. Pt collapsed in the doorway leaving the restaurant. A waitress began cardiopulmonary resuscitation (CPR) immediately, but pt never regained consciousness before being pronounced deceased. She was taken by ambulance to a local hospital and then flown to a regional hospital. During the flight, she went into extreme tachycardia, which the medical personnel could never get under control. Later that night, pt was taken for heart catheterization and pacemaker insertion. Shortly thereafter, her parents were notified that she had passed away. The doctors told the parents that they were baffled as to what caused pt's death. Based up on her medical records, pt was diagnosed with various medical conditions, including but not limited to, heavy menstrual bleeding and myocarditis before her death. The death certificate listed cause of death as cardiac arrest due to cardiomyopathy/ myocarditis. It was unknown whether the autopsy was done. Pt's parents contended that their daughter's quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating injuries, including but not limited to heavy menstrual bleeding and cardiomyopathy/myocarditis causing a heart attack and her death. It was contended that her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused pt to sustained serious and debilitating autoimmune, autonomic and neurological injuries (Autoimmune disorder; Neurological disorder NOS; Autonomic dysfunction), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are 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 quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and continued 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 his 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 quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt 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 these losses and expenses in the future. The outcome of events of Heavy periods, Autoimmune disorder, Neurological disorder NOS, Heart attack and Autonomic dysfunction was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events to be disabling / incapacitating. This is one of several reports received from same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user :, Index date : 2025-05-07 , number : , number : , number : , number : , Central date : 2025-05-05 , Classification :, Attachment description : Legal , Safety case number :; Reported Cause(s) of Death: cardiac arrest; myocarditis