Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extrasystoles, Feeling abnormal, Myalgia, Myocarditis
Clinical narrative: Feeling abnormal; Somnolence; Chest pain; wondered if I had myocarditis; redness at the site of biceps; Occasional palpitations,episode of palpitations for about 20 minutes; dry eyes; inner aspects of arm, biceps were swollen and red; Myalgia; Pyrexia/low grade fever; Swelling,neck swelling; Extrasystoles; Back achiness; Pain; chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (wondered if I had myocarditis) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical information was provided.  Concomitant products included VITAMIN B COMPLEX, PROBIOTICS NOS, BIOTIN, VITAMIN C [ASCORBIC ACID] and ASCORBIC ACID, COPPER, TOCOPHERYL ACETATE, XANTOFYL, ZINC (OCUVIT [ASCORBIC ACID;COPPER;TOCOPHERYL ACETATE;XANTOFYL;ZINC]) for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced BACK PAIN (Back achiness), PAIN (Pain) and CHILLS (chills). On 08-May-2021, the patient experienced EXTRASYSTOLES (Extrasystoles). On 09-May-2021, the patient experienced SWELLING (Swelling,neck swelling). On an unknown date, the patient experienced MYOCARDITIS (wondered if I had myocarditis) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling abnormal), SOMNOLENCE (Somnolence), CHEST PAIN (Chest pain), ERYTHEMA (redness at the site of biceps), PALPITATIONS (Occasional palpitations,episode of palpitations for about 20 minutes), DRY EYE (dry eyes), PERIPHERAL SWELLING (inner aspects of arm, biceps were swollen and red), MYALGIA (Myalgia) and PYREXIA (Pyrexia/low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL) at an unspecified dose and frequency; ACRIVASTINE (BENADRYL [ACRIVASTINE]) at an unspecified dose and frequency and PREDNISONE at a dose of Prednisone 40 milligram 5 days. At the time of the report, MYOCARDITIS (wondered if I had myocarditis), BACK PAIN (Back achiness), PAIN (Pain), FEELING ABNORMAL (Feeling abnormal), SOMNOLENCE (Somnolence), CHEST PAIN (Chest pain), EXTRASYSTOLES (Extrasystoles), ERYTHEMA (redness at the site of biceps), SWELLING (Swelling,neck swelling), PALPITATIONS (Occasional palpitations,episode of palpitations for about 20 minutes), DRY EYE (dry eyes), PERIPHERAL SWELLING (inner aspects of arm, biceps were swollen and red), MYALGIA (Myalgia), PYREXIA (Pyrexia/low grade fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant  medication use information were provided by reporter that includes bone health.  7May2021 she received the 2nd dose and that night on Saturday as she woke up to an episode of palpitations for about 20 minutes and had a low grade fever. Says around that Sunday into Monday following receiving the 2nd dose the inner aspects of arm, biceps were swollen and red.   Nurse went to the emergency room for swelling of both arms and palpitations and states when she was in the ER the nurse felt the underside of her neck which was swollen also. Says she was given solu-medrol, Benadryl and was prescribed 40mg of Prednisone for 5 days. By day 4 of the prednisone she reports she had very dry eyes.   Nurse states she "wondered if I had myocarditis" and went to cardiologist and the doctor did an echocardiogram and stress test, which the results were inconclusive. Now she needs a nuclear scan, which the insurance company will not cover, agent provided program information  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. No further information is expected at this time.   This case was linked to MOD-2021-114592 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Followed up received on 13-JUL-2021 that contains significant information that includes laboratory data ( stress test, echocardiogram and nuclear scan ), treatment medication updated that includes Treatment 40mg of Prednisone for 5 days, solu-medrol, and Benadryl. events were updated. that includes myocarditis; 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. No further information is expected at this time.