Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Lung neoplasm, Mean cell volume normal, Mitral valve prolapse, Musculoskeletal stiffness
Clinical narrative: aortic stenosis; mitral valve prolapse; A little activity winds the patient; blood pressure high; has trouble chopping vegetables; Flu; Shortness of breath; Stiff neck; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC STENOSIS (aortic stenosis), MITRAL VALVE PROLAPSE (mitral valve prolapse) and DYSPNOEA (Shortness of breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ex-smoker (smoked for 40 years), Benign lung neoplasm in 2019, Breast cancer (had lumpectomy, radiation and took a "chemo pill" for 5 years.) in 2000, Bipolar disorder since 1991, Non-alcoholic steatohepatitis, Mastectomy (Bilateral mastectomy scars with no erythema nodules or masses.) and Knee surgery NOS. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE POLYSACCH 23V on 29-Dec-2020. Concurrent medical conditions included COPD, Asthma (since childhood), Depression, Sleep disorder, GERD, High cholesterol and Drug allergy (Bactrim( Sulfamethoxazole-trimethoprim), hives). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), ALBUTEROL [SALBUTAMOL] for COPD, BUPROPION and VALPROATE SEMISODIUM (DIVALPROEX) for Depression, FENOFIBRATE and PRAVASTATIN for High cholesterol, CLONAZEPAM for Sleep disorder, CALCIUM CARBONATE, CHOLECALCIFEROL and POLYETHYLENE GLYCOL 3350 for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (Chills). On 22-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced AORTIC STENOSIS (aortic stenosis) (seriousness criterion medically significant), MITRAL VALVE PROLAPSE (mitral valve prolapse) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (A little activity winds the patient), HYPERTENSION (blood pressure high), COORDINATION ABNORMAL (has trouble chopping vegetables) and INFLUENZA (Flu). The patient was treated with UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) (oral) from 07-Apr-2021 to 09-Apr-2021 for Asthma, at a dose of 1 dosage form; PREDNISONE (oral) from 30-May-2021 to 04-Jun-2021 for Adverse event, at a dose of 20 mg twice a day and IBUPROFEN for Symptomatic treatment, at a dose of 1 dosage form. On 16-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, AORTIC STENOSIS (aortic stenosis), MITRAL VALVE PROLAPSE (mitral valve prolapse), DYSPNOEA (Shortness of breath), MUSCULOSKELETAL STIFFNESS (Stiff neck), DYSPNOEA EXERTIONAL (A little activity winds the patient), HYPERTENSION (blood pressure high), COORDINATION ABNORMAL (has trouble chopping vegetables), INFLUENZA (Flu), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Blood calcium: 10.4 (High) 10.4. On 07-Apr-2021, Blood chloride: 108 (normal) 108. On 07-Apr-2021, Blood potassium: 4.2 (normal) 4.2. On 07-Apr-2021, Blood pressure measurement: 142/88 (High) 142/88. On 07-Apr-2021, Blood sodium: 145 (normal) 145. On 07-Apr-2021, Carbon dioxide: 26.3 (normal) 26.3. On 07-Apr-2021, Chest X-ray: normal (normal) Upright frontal and lateral chest  X-Ray; No acute cardiopulmonary process. On 07-Apr-2021, Haematocrit: 41.9 (Inconclusive) 41.9. On 07-Apr-2021, Haemoglobin: 14.4 (High) 14.4. On 07-Apr-2021, Mean cell volume: 98.2 (Inconclusive) 98.2. On 07-Apr-2021, Platelet count: 208 (Inconclusive) 208. On 07-Apr-2021, White blood cell count: 5.9 (Inconclusive) 5.9. On 21-Apr-2021, Ultrasound abdomen: abnormal (abnormal) Gall bladder filled with stones and sludge without evidence of cholecystitis.. On 03-May-2021, Blood pressure measurement: 169/74 (High) 169/74 Right arm. On 03-May-2021, Body temperature: 35.7 (Inconclusive) 35.7 degrees Celsius. On 03-May-2021, Heart rate: 49 (Inconclusive) 49. In 2021, Blood pressure measurement: increased (High) increased. In 2021, Computerised tomogram: abnormal (abnormal) negative for cancer; sugar spots found on her lungs 2 years prior were a little bit bigger. In 2021, Echocardiogram: abnormal (abnormal) mitral valve prolapse and aortic stenosis. In 2021, Oxygen saturation: 96% (normal) after walk laps over 6 minutes ( 95-97%). In 2021, Pulmonary function test: abnormal (abnormal) showed mild COPD.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that her primary care physician put her on Prednisone 40mg daily for 5 days. She stated that she was more comfortable, but it did not help her breathing. Patient was seen by a Pulmonologist on 9Jun2021. She stated that she smoked for 40 years, so the pulmonologist wanted to do a CT scan to rule out lung cancer and none was found. He did find that the "sugar spot on her lungs," which was found 2 years prior, and was a little bigger but not concerning to him. He took her oxygen level (96) and then had her walk laps around his office for 6 minutes. Her oxygen level then ranged between 95-97%, so she did not need to be on supplemental oxygen. He then did an echocardiogram and diagnosed her with mitral valve prolapse and aortic stenosis.  The patient stated that her blood pressure is now high and she is seeing a cardiologist on 19-Jul-2021. She stated that she thinks the vaccine accelerated these things and she's been in a living hell for 3 months. She stated that she used to only have to use her albuterol inhaler 3 or 4 times a year. She said that she pants just sitting in chair and has trouble chopping vegetables. Physician did a Covid test, CBC, PFT, Liver Ultrasound, and tested the patient's liver functions. The patient reported having never been diagnosed with Mitral Valve Prolapse or Aortic Stenosis before the vaccines. She was diagnosed on June 9, 2021 as a result of her Echocardiogram, but she had been feeling effects as of March 22,2021.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's multiple history could be possible confounding factors.   This case was linked to SE-MODERNATX, INC.-MOD-2021-104539 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Correspondence email attached. AE outcome updated. Medical and allergy history updated. Further laboratory investigations updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's multiple history could be possible confounding factors.