Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Grip strength, Hypoaesthesia, Immunisation reaction
Clinical narrative: doctor think his heart has gotten bigger; Don't have his sense of taste; Had a very bad reaction to the vaccine; Product dose omission; the first day he felt just kind of tired; He had heart inflammation; He lost 10 pounds right away; He's got swelling in his arm and legs; lost the feeling at the end of the fingers/the very tip of his fingers don't have any feeling/His fingertips are weird; Couldn't figure out how to keep playing, his sticks won't work; and his heart wasn't feeling right/it was like a heavy weight, or a ball in your heart/it is not a heart pain, it is like he had a bowling ball in his heart; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (He had heart inflammation) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (had 2 heart attacks in the last year and a half), COVID-19 in December 2019 and Angioplasty (had 3 heart stent in the last year and a half.). Concomitant products included ATENOLOL, LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.  In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced CARDITIS (He had heart inflammation) (seriousness criterion medically significant), WEIGHT DECREASED (He lost 10 pounds right away), PERIPHERAL SWELLING (He's got swelling in his arm and legs), HYPOAESTHESIA (lost the feeling at the end of the fingers/the very tip of his fingers don't have any feeling/His fingertips are weird), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't figure out how to keep playing, his sticks won't work), CARDIAC DISCOMFORT (and his heart wasn't feeling right/it was like a heavy weight, or a ball in your heart/it is not a heart pain, it is like he had a bowling ball in his heart), FEELING ABNORMAL (Feeling bad) and FATIGUE (the first day he felt just kind of tired). On an unknown date, the patient experienced CARDIOMEGALY (doctor think his heart has gotten bigger), AGEUSIA (Don't have his sense of taste), IMMUNISATION REACTION (Had a very bad reaction to the vaccine) and PRODUCT DOSE OMISSION ISSUE (Product dose omission). At the time of the report, CARDITIS (He had heart inflammation), WEIGHT DECREASED (He lost 10 pounds right away), PERIPHERAL SWELLING (He's got swelling in his arm and legs), HYPOAESTHESIA (lost the feeling at the end of the fingers/the very tip of his fingers don't have any feeling/His fingertips are weird), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't figure out how to keep playing, his sticks won't work), CARDIAC DISCOMFORT (and his heart wasn't feeling right/it was like a heavy weight, or a ball in your heart/it is not a heart pain, it is like he had a bowling ball in his heart), FEELING ABNORMAL (Feeling bad), CARDIOMEGALY (doctor think his heart has gotten bigger), AGEUSIA (Don't have his sense of taste), IMMUNISATION REACTION (Had a very bad reaction to the vaccine) and FATIGUE (the first day he felt just kind of tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Grip strength: decreased (abnormal) decreased.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Patient had COVID in Dec-2019 for which he never got a test but he confirmed as COVID because he lost sense of smell and taste and had a pretty bad fever for about 2 days and upper respiratory symptoms for which he did not take any treatment.  Lab Data includes chest x-ray with awaiting results.  Other concomitant medications include blood thinners and diuretics.  Treatment information was not provided.  Company Comment - This case concerns a  53 year-old, male subject with a history of COVID-19, Heart attack (had 2 heart attacks in the last year and a half), COVID-19 in December 2019 and Angioplasty who experienced the expected  event of FATIGUE and the unexpected events of   IMMUNIZATION REACTION, CARDITIS, WEIGHT DECREASED, PERIPHERAL SWELLING, HYPOAESTHESIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CARDIAC DISCOMFORT, FEELING ABNORMAL, CARDIOMEGALY, PRODUCT DOSE OMISSION ISSUE and AGEUSIA. The events occurred in the same month when he received the first dose of [Spikevax]. The rechallenge was not applicable (he did not take second dose). The events were considered related to the study drug per the reporter's assessment. The medical history of HEART DISEASE, use of concomitant medication ATENOLOLremains as confounders. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a  53 year-old, male subject with a history of COVID-19, Heart attack (had 2 heart attacks in the last year and a half), COVID-19 in December 2019 and Angioplasty who experienced the expected  event of FATIGUE and the unexpected events of   IMMUNIZATION REACTION, CARDITIS, WEIGHT DECREASED, PERIPHERAL SWELLING, HYPOAESTHESIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CARDIAC DISCOMFORT, FEELING ABNORMAL, CARDIOMEGALY, PRODUCT DOSE OMISSION ISSUE and AGEUSIA. The events occurred in the same month when he received the first dose of [Spikevax]  The rechallenge was not applicable (he did not take second dose) The events were considered related to the study drug per the reporter's assessment  The medical history of HEART DISEASE, use of concomitant medication ATENOLOLremains as confounders The benefit-risk relationship of the vaccine is not affected by this report