Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Catheterisation cardiac, Cholecystitis infective, Gallbladder oedema
Clinical narrative: heart attack; Admitted to hospital 3Feb2021 oxygen satuation 77; BP elevated; fluid was drained from her gall bladder and antibiotics were started; lot of fluid in her stomach / the fluid was drained from her gall bladder; 2nd dose of vaccine is overdue by 66 days; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes mellitus, Hypertension, AFib, Congestive heart failure and Pacemaker complication. Concomitant products included AMIODARONE, AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], BUMETANIDE, BUSPIRONE, CYANOCOBALAMIN, APIXABAN (ELIQUIS), VITAMIN D2, ESCITALOPRAM OXALATE (LEXAPRO), GLIPIZIDE, LISINOPRIL, LOSARTAN POTASSIUM (COZAAR), LOSARTAN, MAGNESIUM OXIDE, METOPROLOL, PRAVASTATIN and SPIRONOLACTONE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder) (seriousness criterion hospitalization), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (BP elevated) (seriousness criterion hospitalization) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) (seriousness criterion hospitalization). On 10-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days). At the time of the report, GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) was resolving and PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Blood pressure measurement: elevated (High) elevated. On 03-Feb-2021, Oxygen saturation: 77 (Low) low. On 10-Feb-2021, Catheterisation cardiac: abnormal (abnormal) a blockage was found. On 10-Feb-2021, Myocardial necrosis marker: elevated (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included cholecystostomy and antibiotics for infection. The coronary artery blockage was deemed to be medically treated.  Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of  66 days delay for mRNA-1273, lot # unknown. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of  66 days delay for mRNA-1273, lot # unknown. Further information has been requested.