Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Echocardiogram abnormal, Fatigue, Gait disturbance, Haematocrit normal
Clinical narrative: blood pressure high, Since the 2nd dose her BP has been so high; when she walks she stumbles; Grade 1 diastolic dysfunction; Dizziness/Lightheadedness; made her heart pound, heartbeat was a little more rapid; aortic stenosis; mitral valve prolapse; Stiff neck; headache; Fatigue/severely fatigued/exhausted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC STENOSIS (aortic stenosis), MITRAL VALVE PROLAPSE (mitral valve prolapse), MUSCULOSKELETAL STIFFNESS (Stiff neck), HYPERTENSION (blood pressure high, Since the 2nd dose her BP has been so high) and GAIT DISTURBANCE (when she walks she stumbles) 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, 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 (Diagnosed 15 years ago. Well managed on Albuterol inhaler.), Asthma (since childhood), Depression, Sleep disorder, GERD, High cholesterol, Drug allergy (Bactrim( Sulfamethoxazole-trimethoprim), hives) and Bipolar disorder since 1991. 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 MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (headache) and FATIGUE (Fatigue/severely fatigued/exhausted). On an unknown date, the patient experienced AORTIC STENOSIS (aortic stenosis), MITRAL VALVE PROLAPSE (mitral valve prolapse), HYPERTENSION (blood pressure high, Since the 2nd dose her BP has been so high), GAIT DISTURBANCE (when she walks she stumbles), DIASTOLIC DYSFUNCTION (Grade 1 diastolic dysfunction), DIZZINESS (Dizziness/Lightheadedness) and PALPITATIONS (made her heart pound, heartbeat was a little more rapid). 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 40 mg once a day; PREDNISONE for Adverse event, at an unspecified dose and frequency 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), MUSCULOSKELETAL STIFFNESS (Stiff neck), HYPERTENSION (blood pressure high, Since the 2nd dose her BP has been so high), HEADACHE (headache) and FATIGUE (Fatigue/severely fatigued/exhausted) had not resolved and GAIT DISTURBANCE (when she walks she stumbles), DIASTOLIC DYSFUNCTION (Grade 1 diastolic dysfunction), DIZZINESS (Dizziness/Lightheadedness) and PALPITATIONS (made her heart pound, heartbeat was a little more rapid) outcome was unknown.      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, Cardiac stress test: normal (normal) Normal. 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 (normal) 98.2. On 07-Apr-2021, Platelet count: 208 (normal) 208. On 07-Apr-2021, Spirometry: normal (normal) Had a spirometry test and showed no COPD. On 07-Apr-2021, White blood cell count: 5.9 (normal) 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 (Low) 35.7 degrees Celsius. On 03-May-2021, Heart rate: 49 (Low) 49. In 2021, Blood pressure measurement: high (High) Since the 2nd dose her BP has been so high. 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.   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 except causality is unlikely for the events of COPD, Mitral valve prolapse and Aortic stenosis .  The patient's multiple history could be possible confounding factors.   This case was linked to MOD-2021-269067 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information contained laboratory tests: Stress test and Spirometry added; 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 except causality is unlikely for the events of COPD, Mitral valve prolapse and Aortic stenosis .  The patient's multiple history could be possible confounding factors.