Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram, Headache, Hypertension
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AORTIC STENOSIS (aortic stenosis) and MITRAL VALVE PROLAPSE (mitral valve prolapse) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M21A) 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) and Benign lung neoplasm in 2019. Concurrent medical conditions included COPD, Asthma (since childhood), Depression, Sleep disorder, Acid reflux (esophageal) and High cholesterol. 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.   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) (unknown route) dosage was changed to at an unspecified dose. On 16-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and MUSCULOSKELETAL STIFFNESS (Stiff neck). 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) and COORDINATION ABNORMAL (has trouble chopping vegetables). The patient was treated with UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) ongoing since an unknown date for Asthma, at an unspecified dose and frequency; PREDNISONE for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. On 16-Mar-2021, CHILLS (Chills) and HEADACHE (Headache) 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) and COORDINATION ABNORMAL (has trouble chopping vegetables) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased. On an unknown date, Computerised tomogram: abnormal (abnormal) negative for cancer, , sugar spots found on her lungs 2 years prior were a little bit bigger. On an unknown date, Echocardiogram: abnormal (abnormal) mitral valve prolapse and aortic stenosis. On an unknown date, Oxygen saturation: 96 (normal) after walk laps over6 minutes ( 95-97).         Patient stated that she is calling to provide an update on her condition. She stated that she forgot to mention on her previous call 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. She then saw a Pulmonologist on 9Jun2021. She stated that she smoked for 40 years, so the pulmonologist wanted to do a cat 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, 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 did did not need to be on supplemental oxygen. He then did an echocardiogram and diagnosed her with mitral valve prolapse and aortic stenosis. She stated that her blood pressure is now high and she is seeing a cardiologist on 19Jul2021. She stated that she thinks the vaccine accelerated these things and she's been in a living  for 3 months. She stated that she used to only had to use her albuterol inhaler 3 or 4 times a year. She pants just sitting in chair and has trouble chopping vegetables.  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. There is confounding by chronic obstructive pulmonary disease, asthma and history of smoking.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Treatment medication, reported events updated.  Case became serious.; 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. There is confounding by chronic obstructive pulmonary disease, asthma and history of smoking.