Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Heavy menstrual bleeding, Immune thrombocytopenia, Mouth haemorrhage, Platelet count decreased
Clinical narrative: Immune Thrombocytopenic Purpura (ITP); High blood pressure; Swelling in her feet; Weight gain; Joint pain; Lupus; Pregnancy was terminated on 15-OCT-2022; When was diagnosed with ITP, she was six weeks pregnant; This retrospective pregnancy report has been received regarding a case in litigation from a lawyer concerning a 33-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-JAN-2022, after healthcare provider recommendation, the patient was vaccinated with her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, strength, route of administration, anatomical location and lot number were not reported).  On approximately 03-FEB-2022, also reported as about two weeks after first vaccination, the patient woke up and took her retainer out of her mouth and noticed there was a large amount of blood in it. On 21-MAR-2022, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, strength, route of administration, anatomical location and lot number were not reported). Following this second vaccination, on approximately 2022, the patient began her menstrual period and it was extremely heavy and lasted at least 12 days. On 06-JUL-2022, the patient became pregnant with an estimated last menstrual period (LMP) on 22-JUN-2022 (also reported as when diagnosed with ITP, she was six weeks pregnant).   On 02-AUG-2022, the patient was vaccinated with third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, strength, route of administration, anatomical location and lot number were not reported).Following this third vaccination, on approximately August 2022, when the patient woke up she was bending down and fell on her bed and her head was spinning. She went to the hospital on approximately August 2022, they did blood work and immediately admitted her into the hospital as she was at a platelet count of 3,000 per mL (normal platelet range 150,000 to 450,000 per mL of blood). They quickly started to give her steroids intravenously. After several days in the hospital, she was given a referral to a hematologist and was sent home with a prescription of 70 mg of prednisone.   On 17-AUG-2022, the patient was diagnosed with immune thrombocytopenic purpura (ITP). Unfortunately, they were unable to treat her with steroids due to concerns with its impact on the fetus and likely complications. On 15-OCT-2022, the patient's pregnancy was terminated (abortion induced) and her platelet count was 179.000 (unit not reported), moreover, she was taken off the steroids due to it causing high blood pressure, joint pain, swelling in her feet and weight gain. Once steroid taper was completed on 07-FEB-2023, the patient had a nosebleed that lasted from 11:00 to 19:00. Then, she went to the hospital where they checked her platelets and saw that she was at 2.000 (unit not provided), they immediately admitted her and started steroids intravenously every four hours. Prior to the nosebleed, she had rash-like marks on her chest and throat.  Since an unspecified date in February 2023, the patient has been on steroids. On 08-MAY-2023, the patient was diagnosed with lupus and she was advised by the hematologist to not do any lupus treatments yet as she was undergoing treatment for the ITP, the patient must now go every Friday for blood work to check her platelets. On 19-APR-2024, also reported as currently, her platelet count was 61.000 (unit not reported) platelets when she should be between 150.000-300.000. She has had dizziness, tiredness, swollen feet and a swollen face for the past eight months that will not subsided. As a result of her post-vaccination symptoms, the patient had been unable to engage in activities that a normal young person would enjoy.  At the reporting time, the patient had not recovered from the events lupus, ITP, hypertension,  joint pain, swelling in her feet and weight gain. The outcome of the event abortion induced was unknown.  The reporter considered the event ITP to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter did not provide a causality assessment for the events lupus, hypertension,  joint pain, swelling in her feet, weight gain and abortion induced and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events ITP and lupus were determined to be medically significant. The events ITP, lupus and abortion induced were determined to be disabling.