Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
type 1 diabetes (blood sugar level was 534 and she was admitted to hospital, excessive weight loss and thirst, fatique); adrenal insufficiency (weight loss, spasms throughout her body; Hashimoto's thyroiditis/autoimmune injury (fatique, confusion); non-classical congenital adrenal hyperplasia (abnormal bloodwork for 17-hydroxyprogesterone); amenorrhea (headache); legally blind in one eye/blindness; fluttering feeling in brain; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female 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 12 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On an unknown date, at the age of 14, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. Vaccination date was reported as 12-DEC-2017, but it was unknown if that was the first or second dose. On an unspecified date, following second vaccination with quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt experienced excessive weight loss in a short timeframe, extreme thirst, and headaches. Her blood sugar level was 534 and she was admitted to the hospital. Pt was diagnosed with type-1 diabetes, adrenal insufficiency, nonclassical congenital adrenal hyperplasia, Hashimoto's thyroiditis, amenorrhea, and has been declared legally blind in one eye. She also experienced headaches, a fluttering feeling in her brain, confusion, fatigue, spasms throughout her body, and abnormal bloodwork for 17-hydroxyprogesterone. The pt must have taken insulin injections several times per day and currently has an insulin pump. She has been taking hydrocortisone steroids three times per day and thyroid medication daily. She also took hormones to regulate menstruation. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities. On unknown dates, based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to type-1 diabetes, adrenal insufficiency, non-classical congenital adrenal hyperplasia, Hashimoto's thyroiditis, amenorrhea, and blindness. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to type-1 diabetes, adrenal insufficiency, non-classical congenital adrenal hyperplasia, Hashimoto's thyroiditis, amenorrhea, and blindness, 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. 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. She 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 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 quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt 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 she 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. This is one of several reports received from the same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : (redacted)@merck.com , Index date : 2025-05-07 , MNSC number : , CLIC number : , ESTAR number : LEGCLAPOL , IRMS number : 68710, 68707 , Central date : 2025-05-05 , Classification : DMC, Attachment description : Legal , Safety case number :
Test Name: Bloodwork (17-hydroxyprogesterone); Result Unstructured Data: abnormal; Test Name: blood sugar level; Result Unstructured Data: was 534 (units not provided)