Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
autonomic/neuro/POTS/SOB,lightheadedness,nausea,pounding headache,body temperature elevated,felt hot,blood pressure dropped,blacked out;was unconscious for 20min;dizziness, chronic fatigue,hotflashes,syncope,palpitations,chest pain,weakness,brain fog; anxiety; tinnitus; autoimmune injuries; Information has been received from a lawyer regarding a case in litigation and refers to an adult female patient (pt) (exact age was not provided). The patient's medical history, concurrent conditions and concomitant therapies were not provided. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, she was happy, extremely active, bright, and healthy. On 26-MAR-2021, at the age of 17 years, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided), as recommended by her health care provider. After receiving the second vaccination, while at the doctor's office, the patient experienced shortness of breath, lightheadedness, nausea, and a pounding headache. Her body temperature elevated, she felt hot, her blood pressure dropped, she blacked out and was unconscious for 20 minutes. It took an hour for the patient to gain strength to sit up. She had ringing in her ears, felt fatigued, shaky, and the pounding headache persisted with hot flashes. As the months progressed, so did the patient's injuries. She was seen by multiple physicians and specialists for her complaints which now include dizziness, chronic fatigue, hot flashes, syncope, palpitations, chest pain, shortness of breath, weakness, brain fog, increased nausea, bloating, tingling in the upper and lower extremities, sweating abnormality, visual disturbance, tinnitus, cold extremities, anxiety, bilateral leg tremors, and increased hand tremors. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient has been unable to engage in activities that a normal young person would enjoy. She enjoyed dancing, swimming, and running. She was actively engaged in cross country 5k races and swimming long distances at swim meets. These activities made her happy and were things she looked forward to every day. Unfortunately, she was not physically capable of maintaining her competitive sports lifestyle. The patient's ability to attend school has been affected due to physical exertion, fatigue, headaches, and chronic body pain, despite these challenges, she was able to graduate from High School. Now, as a college student, she required disability accommodations due to her ongoing symptoms. 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, postural orthostatic tachycardia (POTS). The patient contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to postural orthostatic tachycardia (POTS) 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. The patient had suffered and continues to suffer severe and permanent physical injuries and associated symptomology and had suffered severe 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, she had 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 not recovered. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered all events to be disabling. Upon internal review, the event of autoimmune disorder was determined to be medically significant.