Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Contusion, Fatigue, SARS-CoV-2 test
Clinical narrative: she is experiencing bruising, when she bumps herself and gets these lumps on leg and hand; tired; heart flutters coming and going; experienced an hour after real severe chest pains and was not sure if she was trying to have a heart attack or anxiety; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart flutters coming and going) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (positive for Covid19 at the end of Oct2020) in October 2020. Concurrent medical conditions included Anxiety (anxiety attack years ago) and Heart murmur.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced CARDIAC FLUTTER (heart flutters coming and going) (seriousness criterion medically significant), CHEST PAIN (experienced an hour after real severe chest pains and was not sure if she was trying to have a heart attack or anxiety) and FATIGUE (tired). On an unknown date, the patient experienced CONTUSION (she is experiencing bruising, when she bumps herself and gets these lumps on leg and hand). At the time of the report, CARDIAC FLUTTER (heart flutters coming and going), CHEST PAIN (experienced an hour after real severe chest pains and was not sure if she was trying to have a heart attack or anxiety), CONTUSION (she is experiencing bruising, when she bumps herself and gets these lumps on leg and hand) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported not being on any medication for any other health conditions. Patient reported she was not taking any medication for side effects.  Company comment This case concerns a 66-year-old female patient with medical history of anxiety, heart murmur and COVID-19, who experienced the serious unexpected AESI event of cardiac flutter and other non-serious events. Inappropriate schedule of product administration was considered an additional event. The event cardiac flutter occurred on the same day after the booster dose of mRNA-1273. The event contusion occurred 2 weeks before she got the booster dose. The events medical history of anxiety, heart murmur and COVID-19 remains a confounder for cardiac flutter and COVID-19 remains a confounder for contusion. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-404995 (Patient Link).; Sender's Comments: This case concerns a 66-year-old female patient with medical history of anxiety, heart murmur and COVID-19, who experienced the serious unexpected AESI event of cardiac flutter and other non-serious events. The event cardiac flutter occurred on the same day after the booster dose of mRNA-1273. The event contusion occurred 2 weeks before she got the booster dose. The events medical history of anxiety, heart murmur and COVID-19 remains a confounder for cardiac flutter and COVID-19 remains a confounder for contusion. The benefit-risk relationship of mRNA-1273 is not affected by this report.