Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Depression, Emotional distress, Feeling abnormal, Impaired work ability
Clinical narrative: Immediately 6 hours after the first dose had symptoms similar to a heart attack; Involuntary muscle spasms; pain head to toe; Brain fog affecting his mental health; Depression; Brain fog affecting his mental health, causing depression; Unable to work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MARIJUANA, DULOXETINE HYDROCHLORIDE (CYMBALTA) and NALTREXONE for an unknown indication.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack) (seriousness criterion hospitalization prolonged), MUSCLE CONTRACTIONS INVOLUNTARY (Involuntary muscle spasms), PAIN (pain head to toe), FEELING ABNORMAL (Brain fog affecting his mental health), DEPRESSION (Depression), EMOTIONAL DISTRESS (Brain fog affecting his mental health, causing depression) and IMPAIRED WORK ABILITY (Unable to work). The patient was hospitalized on 17-May-2021 due to CARDIAC DISCOMFORT. At the time of the report, CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack), MUSCLE CONTRACTIONS INVOLUNTARY (Involuntary muscle spasms), PAIN (pain head to toe), FEELING ABNORMAL (Brain fog affecting his mental health), DEPRESSION (Depression), EMOTIONAL DISTRESS (Brain fog affecting his mental health, causing depression) and IMPAIRED WORK ABILITY (Unable to work) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was hospitalized on 17MAY2021 and again on 19MAY2021.  No treatment information mentioned.  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. however, the patient is a marijuana user and the psychiatric disorder in this report could be confounded by the use of this drug as repeated marijuana use can result in worsening depression symptoms , emotional distress and brain fog.; 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. however, the patient is a marijuana user and the psychiatric disorder in this report could be confounded by the use of this drug as repeated marijuana use can result in worsening depression symptoms , emotional distress and brain fog.