Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral swelling, Pharyngeal mass, Swollen tongue, Systemic lupus erythematosus, Thrombectomy
Clinical narrative: patient continued to experience swelling as the weeks went by. Her entire body was hurting due to swelling, especially in her hands, fingers, and ankles. Physician prescribed steroids, but she continued to experience pain for months; histoplasmosis; feeding tube placed; full hysterectomy; endometriosis/Abdominal pain; clots removed from her legs; lumps removed from her throat; had lost significant weight; difficulty swallowing; patient's palms began to swell. Within 12 hours, patient's tongue was enlarged and she could no longer swallow. Her husband took her to the emergency room for an allergic reaction to the vaccine; Patient was 35 years old when she received her first dosage of Gardasil; This initial spontaneous report was received from a lawyer on 24-JAN-2025 regarding a case in litigation and refers to a female patient (pt) of 35 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On 15-DEC-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular Injection route of administration, lot number and expiration date were not reported) for preventing cervical cancer (Product administered to patient of inappropriate age). The second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular Injection route of administration, lot number and expiration date were not reported) for preventing cervical cancer was administered on 28-JAN-2021.  It was reported that on 28-JAN-2021 within two hours of receiving the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine, pt.'s palms began to swell. Within 12 hours, pt.'s tongue was enlarged and she could no longer swallow. Her husband took her to the emergency room for an allergic reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine (Allergy to vaccine). Pt. was given intravenous medication to reduce the swelling and was eventually discharged with an emergency EpiPen.  Pt. continued to experience swelling as the weeks went by. Her entire body was hurting due to swelling, especially in her hands, fingers, and ankles. Physician prescribed steroids, but she continued to experience pain for months.  Pt. was eventually diagnosed with autoimmune Lupus (Systemic lupus erythematosus). She had also been diagnosed with histoplasmosis, endometriosis, and had had a full hysterectomy. She continued to experience severe daily pain and fatigue. She has had clots removed from her legs several times (Thrombectomy), as well as lumps removed from her throat (Mass excision). She experienced abdominal pain and difficulty swallowing (Dysphagia) and had lost significant weight (Weight decreased). She had had a feeding tube placed (Gastrointestinal tube insertion) and must use it to take her daily medications.  Before Vaccination, pt. was very active outdoors. She jogged every morning and was always at their children's school functions. She would go swimming and work out at her local GYM. She enjoyed having fun with her family. They would take trips to theme parks. Since the Gardasil vaccine, Pt's life had changed from a normal, healthy, active person to barely being able to get out of bed to go to the bathroom. She had a long-term goal of starting her own restaurant, but that has changed due to her health.  She could no longer participate in her children's school functions, go on trips, or do fun things with her family.  As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced injuries, patient had suffered and continues 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 reported as not recovered.  Causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was related.  Upon internal review the events of Systemic lupus erythematosus, Histoplasmosis, Gastrointestinal tube insertion, hysterectomy, allergy to vaccine treated with given intravenous medication to reduce the swelling and was eventually discharged with an emergency EpiPen were considered medically significant.  The events were considered disabling by the reporter.