Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Thyroid function test, Vaccination site reaction
Clinical narrative: Low heart rate; Developed left COVID arm; Left arm still itching; Pain I am feeling cannot be normal; just yuck; Left arm rash, can still see the outline of the rash on left arm; Still have fatigue from the shot itself; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (Low heart rate) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL and ESTRADIOL for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRADYCARDIA (Low heart rate) (seriousness criterion medically significant), VACCINATION SITE REACTION (Developed left COVID arm), PRURITUS (Left arm still itching), PAIN (Pain I am feeling cannot be normal), FEELING ABNORMAL (just yuck), RASH (Left arm rash, can still see the outline of the rash on left arm) and FATIGUE (Still have fatigue from the shot itself). At the time of the report, BRADYCARDIA (Low heart rate), VACCINATION SITE REACTION (Developed left COVID arm), PRURITUS (Left arm still itching), PAIN (Pain I am feeling cannot be normal), FEELING ABNORMAL (just yuck), RASH (Left arm rash, can still see the outline of the rash on left arm) and FATIGUE (Still have fatigue from the shot itself) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Alanine aminotransferase: elevated (High) Elevated. On 03-Jun-2021, Heart rate: 48 (Low) Low heart rate, sleeping heart rate is 48. On 03-Jun-2021, Thyroid function test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 03Jun2021, the patient reported that she went to her doctor the week prior. The patient had blood work done (not further specified) and that her liver numbers were wacky. It was noted that the doctor recommended the patient switch from atenolol to metoprolol due to low heart rate and advised that the patient not receive the second shot. The patient noted that she had not yet started the metoprolol due to availability and had been cutting the atenolol tablets in half.   On 09Jun2021, the patient reported that repeat lab work was been done and that she had an appointment to see an endocrinologist next week. No further information was given regarding this visit.   Treatment included a cream (not further specified) for the rash.  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.; 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.