Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Influenza like illness, Syncope, Vaccination site pain
Clinical narrative: collapsed on the floor; couldn't breathe; her heart function was at 30%; When she does physical activity it tires her; weak/so weak she could barely move/weak/She is weak and she cannot work/has been out of work for a month/She couldn't run or lift weights for a few days; felt like she had the flu; Arm was a little sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (collapsed on the floor), DYSPNOEA (couldn't breathe), CARDIAC DYSFUNCTION (her heart function was at 30%), ASTHENIA (weak/so weak she could barely move/weak/She is weak and she cannot work/has been out of work for a month/She couldn't run or lift weights for a few days), INFLUENZA LIKE ILLNESS (felt like she had the flu), FATIGUE (When she does physical activity it tires her) and VACCINATION SITE PAIN (Arm was a little sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included Accident (Car Accident when she was young). Concurrent medical conditions included ADHD and Allergy to vaccine (reactions to the flu shot).    On 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm was a little sore) (seriousness criterion hospitalization). On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu) (seriousness criterion hospitalization). On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weak/so weak she could barely move/weak/She is weak and she cannot work/has been out of work for a month/She couldn't run or lift weights for a few days) (seriousness criterion hospitalization). On 19-Jun-2021, the patient experienced SYNCOPE (collapsed on the floor) (seriousness criteria hospitalization and medically significant), CARDIAC DYSFUNCTION (her heart function was at 30%) (seriousness criteria hospitalization and medically significant) and FATIGUE (When she does physical activity it tires her) (seriousness criterion hospitalization). 19-Jun-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization). The patient was treated with METOPROLOL for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; ATORVASTATIN CALCIUM (LIPITOR) for Adverse event, at an unspecified dose and frequency; ALBUTEROL [SALBUTAMOL] for Adverse event, at a dose of emergency inhaler; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE + SALMETEROL) for Adverse event, at an unspecified dose and frequency; LOSARTAN for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency; FOLIC ACID for Adverse event, at an unspecified dose and frequency; THIAMINE (VITAMIN B1 [THIAMINE]) for Adverse event, at an unspecified dose and frequency; LORAZEPAM for Adverse event, at an unspecified dose and frequency and GLUCOSAMINE for Adverse event, at an unspecified dose and frequency. On 05-Apr-2021, VACCINATION SITE PAIN (Arm was a little sore) had resolved. On 05-May-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu) outcome was unknown. At the time of the report, SYNCOPE (collapsed on the floor), DYSPNOEA (couldn't breathe), CARDIAC DYSFUNCTION (her heart function was at 30%), ASTHENIA (weak/so weak she could barely move/weak/She is weak and she cannot work/has been out of work for a month/She couldn't run or lift weights for a few days) and FATIGUE (When she does physical activity it tires her) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Cardiac function test: back upto 50% % (Inconclusive) back upto 50%. On 19-Jun-2021, Blood pressure measurement: 137 (Inconclusive) Inconclusive. On 19-Jun-2021, Cardiac function test: 30 % (Inconclusive) Inconclusive. On 19-Jun-2021, Catheterisation cardiac: no blockage (normal) no blockage.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not provided.  The patient was in the hospital for 10 days. The patient underwent echocardiogram and electrocardiogram (results not provided).  As treatment, the patient was also given oxygen.  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.   This case was linked to MOD-2021-255593 (Patient Link).; Sender's Comments: 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.