Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | OT |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | OT |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 3 | — | OT |
POTS-like symptoms, rapid heart beat, chronic&daily fatigue, abnormal perspiration without exercise&excessive sweating,dizziness,abdominal bloating,autonomic&neurological injuries,excessive daytime sleepiness,daily pain,muscle fatigue; inhaler which she used five to ten times a day, but with little to no relief; extreme thirst; joint stiffness; extreme allergies, acute allergies (which can develop after changes in the immune system); Autoimmune injuries; abnormal menstruation, menstrual injuries; weight gain; daily coughing; wheezing; epithelial cell abnormality, atypical squamous cell of undetermined significance (abnormal cells in the tissue that lines the outer part of the cervix); Information was received from a lawyer regarding a case in litigation and refers to an adult female patient (pt). The pt's concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, at the age 23 years old, the pt was vaccinated with the first and the second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported). On an unspecified date, at the age of 24 years old, the patient received the third dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot number and expiration date were not reported). All doses were administered for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), with the pt's consent and the pt's physician (referred to as a doctor and also as a health care provider) recommendation. On an unknown date, following third human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced an onset of extreme allergies, rapid heart rate, fatigue, abnormal perspiration without exercise, constant sweating, extreme thirst, joint stiffness, abnormal menstruation, muscle fatigue, weight gain, dizziness, and daily coughing and wheezing. She was prescribed an inhaler (name was not provided) which she used five to ten times a day, but with little to no relief. Her daily fatigue caused excessive sleeping during the day. After multiple tests and appointments, the pt was diagnosed with chronic fatigue and acute allergies (which could develop after changes in the immune system). The pt was later diagnosed with epithelial cell abnormality, atypical squamous cell of undetermined significance (abnormal cells in the tissue that lines the outer part of the cervix). She was experiencing daily pain, fatigue, joint stiffness, and abdominal bloating. As a result of her post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in activities that a normal young person would enjoy. The pt's symptoms were ongoing and would require treatment for the foreseeable future and possibly the rest of her life. Based upon her chronic and severe post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to, chronic fatigue, acute allergies, epithelial cell abnormality, atypical squamous cell of undetermined significance, and postural orthostatic tachycardia syndrome (POTS)-like symptoms. The pt contended that her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, menstrual, and neurological injuries, including but not limited to chronic fatigue, acute allergies, and POTS-like symptoms, 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 human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and suffered severe 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 her injuries caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her 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 the events was considered to be not recovered/not resolved. The causality assessment between therapeutic product effect incomplete and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided. The reporter considered the other events to be related to the suspect vaccine. The reporter considered all events to be disabling.