Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Coronary arterial stent insertion, Heart valve operation, Product dose omission issue
Clinical narrative: valve replacement surgery/2 arteries stents surgery; valve replacement surgery; 2 arteries stent surgery; 9 months have gone by since her first shot; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (valve replacement surgery/2 arteries stents surgery), HEART VALVE OPERATION (valve replacement surgery) and CORONARY ARTERIAL STENT INSERTION (2 arteries stent surgery) in an 82-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.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (9 months have gone by since her first shot). On an unknown date, the patient experienced CARDIAC DISORDER (valve replacement surgery/2 arteries stents surgery) (seriousness criterion medically significant), HEART VALVE OPERATION (valve replacement surgery) (seriousness criterion medically significant) and CORONARY ARTERIAL STENT INSERTION (2 arteries stent surgery) (seriousness criterion medically significant). The patient was treated with Surgery (One valve replacement and 2 arteries stents) for Cardiac disorder. On 04-Nov-2021, PRODUCT DOSE OMISSION ISSUE (9 months have gone by since her first shot) had resolved. At the time of the report, CARDIAC DISORDER (valve replacement surgery/2 arteries stents surgery), HEART VALVE OPERATION (valve replacement surgery) and CORONARY ARTERIAL STENT INSERTION (2 arteries stent surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.  she was supposed to get the second dose but she had 3 serious heart operations: one valve replacement and 2 arteries stents. So she got scared and 9 months have gone by since her first shot  Company Comment:This case of product dose omission issue concerns an 82-year-old, female patient with no medical history reported, who experienced the unexpected and serious events of heart valve operation NOS and coronary arterial stent insertion. The events occurred after the first dose of Moderna COVID-19 vaccine was administered (exact date unknown). The rechallenge was not applicable considering the nature of the events and that they occurred after the first dose not having administered the second dose. Patient´s age remains as a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-376153, MOD-2021-376633 (Patient Link).; Sender's Comments: This case of product dose omission issue concerns an 82-year-old, female patient with no medical history reported, who experienced the unexpected and serious events of heart valve operation NOS and coronary arterial stent insertion. The events occurred after the first dose of Moderna COVID-19 vaccine was administered (exact date unknown). The rechallenge was not applicable considering the nature of the events and that they occurred after the first dose not having administered the second dose. Patient´s age remains as a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.