Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Mean cell volume increased, Mitral valve prolapse, Musculoskeletal stiffness, Myalgia
Clinical narrative: Aortic stenosis; Mitral valve prolapse; Minimal COPD; when she walks she stumbles; Grade 1 diastolic dysfunction; Entire body Ached; has trouble chopping vegetables; flu; Diarrhea; Dizziness/Lightheadedness; Right hand fingers and right arm ached; Body ache; Since April she feels so sick; Continues to have trouble breathing/Still short of breath/trouble breathing with any exertion/Shortness of breath/she still has trouble breathing after her Primary Series; Continues to have high blood pressure/blood pressure high, Since the 2nd dose her BP has been so high; Stiff neck; Fatigue/severely fatigued/exhausted; Chills; Headache; made her heart pound, heartbeat was a little more rapid; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021. The most recent information was received on 22-Mar-2022 and was forwarded to Moderna on 22-Mar-2022.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Continues to have trouble breathing/Still short of breath/trouble breathing with any exertion/Shortness of breath/she still has trouble breathing after her Primary Series) and HYPERTENSION (Continues to have high blood pressure/blood pressure high, Since the 2nd dose her BP has been so high) in a 70-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), Breast cancer (had lumpectomy, radiation and took a "chemo pill" for 5 years.) in 2000, Benign lung neoplasm (found 2 years prior, was a little bigger.) in 2019, Non-alcoholic steatohepatitis, Mastectomy (Bilateral mastectomy scars with no erythema nodules or masses.) and Knee surgery NOS (Patient wore leg brace for a month after knee surgery.). Previously administered products included for Product used for unknown indication: Pnumococcal on 29-Dec-2020 and Fluzone on 22-Sep-2021. Past adverse reactions to the above products included No adverse event with Fluzone; and No adverse reaction with Pnumococcal. Concurrent medical conditions included COPD (Diagnosed 15 years ago. Well managed on Albuterol inhaler.), Asthma (since childhood takes Albuterol for that), Depression, Sleep disorder, GERD, High cholesterol, Bipolar disorder since 1991 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, POLYETHYLENE GLYCOL 3350 and AMLODIPINE 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 15-Mar-2021, the patient experienced PALPITATIONS (made her heart pound, heartbeat was a little more rapid). 15-Mar-2021, the patient experienced HEADACHE (Headache). On 16-Mar-2021, the patient experienced CHILLS (Chills). On 22-Mar-2021, the patient experienced DYSPNOEA (Continues to have trouble breathing/Still short of breath/trouble breathing with any exertion/Shortness of breath/she still has trouble breathing after her Primary Series) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiff neck) and FATIGUE (Fatigue/severely fatigued/exhausted). 22-Mar-2021, the patient experienced HYPERTENSION (Continues to have high blood pressure/blood pressure high, Since the 2nd dose her BP has been so high) (seriousness criterion medically significant). In April 2021, the patient experienced ILLNESS (Since April she feels so sick). On an unknown date, the patient experienced AORTIC STENOSIS (Aortic stenosis), MITRAL VALVE PROLAPSE (Mitral valve prolapse), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Minimal COPD), GAIT DISTURBANCE (when she walks she stumbles), DIASTOLIC DYSFUNCTION (Grade 1 diastolic dysfunction), PAIN (Entire body Ached), COORDINATION ABNORMAL (has trouble chopping vegetables), INFLUENZA (flu), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness/Lightheadedness), PAIN IN EXTREMITY (Right hand fingers and right arm ached) and MYALGIA (Body ache). 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, DYSPNOEA (Continues to have trouble breathing/Still short of breath/trouble breathing with any exertion/Shortness of breath/she still has trouble breathing after her Primary Series), HYPERTENSION (Continues to have high blood pressure/blood pressure high, Since the 2nd dose her BP has been so high), AORTIC STENOSIS (Aortic stenosis), MITRAL VALVE PROLAPSE (Mitral valve prolapse), MUSCULOSKELETAL STIFFNESS (Stiff neck), COORDINATION ABNORMAL (has trouble chopping vegetables), INFLUENZA (flu), ILLNESS (Since April she feels so sick) and FATIGUE (Fatigue/severely fatigued/exhausted) had not resolved, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Minimal COPD), GAIT DISTURBANCE (when she walks she stumbles), DIASTOLIC DYSFUNCTION (Grade 1 diastolic dysfunction), PALPITATIONS (made her heart pound, heartbeat was a little more rapid), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness/Lightheadedness), PAIN IN EXTREMITY (Right hand fingers and right arm ached) and MYALGIA (Body ache) outcome was unknown, PAIN (Entire body Ached) was resolving and HEADACHE (Headache) had 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, 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, SARS-CoV-2 test: negative (Negative) Co-vid Test- negative. 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 had 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.MD said the echo cardiogram was normal. In 2021, Oxygen saturation: 96% (normal) after walk laps over 6 minutes ( 95-97%). In 2021, Pulmonary function test: abnormal (abnormal) showed mild COPD. On an unknown date, Echocardiogram: normal (normal) was were negative.patient's bloodwork returned as normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, flu test was done, and result was found to be neagative.  Patient was not diagnosed with myocarditis or pericarditis and there was no history of COVID-19 infection.  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. Company comment: This spontaneous case concerns a 70- year-old, female patient with history of COPD, Asthma, High cholesterol and Benign lung neoplasm, who experienced the unexpected, serious (Medically significant) events of Dyspnoea and Hypertension. The events occurred 7 days after administration of second dose of mRNA-1273. The interval between the first and second dose of mRNA-1273 was noted to be 30 days. The patient reports that she still has high blood pressure and trouble breathing after her Primary Series of the Moderna Covid-19 vaccine. On an unknown date, Cardiac Lab values (ECG, cardiac test, cardiac enzymes), Echocardiogram and a Stress test were done with negative results, Blood pressure was also taken on an unknown date with elevated results. The patient's medical history of Asthma and COPD could be a confounder to the event Dyspnoea, while the patient's medical history of High cholesterol could be a confounder to the event Hypertension. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-269067 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2022: Significant Follow Up Appended; Secondary reporter added, patient age updated and weight added, concomitant medication added, Seriousness medically important added for events dyspnoea, hypertension, added events dyspnoea exertional, coordination and influenza, outcome updated for the event dyspnoea.; Sender's Comments: This spontaneous case concerns a 70- year-old, female patient with history of COPD, Asthma, High cholesterol and Benign lung neoplasm, who experienced the unexpected, serious (Medically significant) events of Dyspnoea and Hypertension. The events occurred 7 days after administration of second dose of mRNA-1273. The interval between the first and second dose of mRNA-1273 was noted to be 30 days. The patient reports that she still has high blood pressure and trouble breathing after her Primary Series of the Moderna Covid-19 vaccine. On an unknown date, Cardiac Lab values (ECG, cardiac test, cardiac enzymes), Echocardiogram and a Stress test were done with negative results, Blood pressure was also taken on an unknown date with elevated results. The patient's medical history of Asthma and COPD could be a confounder to the event Dyspnoea, while the patient's medical history of High cholesterol could be a confounder to the event Hypertension. The benefit-risk relationship of mRNA-1273 is not affected by this report.