Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Myocardial infarction, Nausea, Pruritus, Skin burning sensation
Clinical narrative: Patient declined second vaccination due to adverse; nausea; stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack; stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack; chest pain; blisters on head becoming infected; skin on entire body became red; skin on entire body became red, itchy; entire body having a burning sensation; scalp became purple and developed multiple blisters; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) and MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included MRSA wound infection. Concurrent medical conditions included Anginal pain, Heart failure, Post-traumatic stress disorder, COPD, Neuropathy, Mucous discharge, Yeast infection (under breasts and abdomen fold), Acid reflux (esophageal), Cholesterol total abnormal NOS, Sleep problem, Depression and Cardiac assistance device user (implantable defibrillator). Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX) for Acid reflux (esophageal), NITROGLYCERIN for Anginal pain, METOPROLOL and ISOSORBIDE DINITRATE (ISOSORBIDE [ISOSORBIDE DINITRATE]) for Anginal pain and Heart failure, IPRATROPIUM and MONTELUKAST for COPD, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, FLUOXETINE and BUPROPION for Depression, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disorder, POTASSIUM and BUMETANIDE;POTASSIUM for Heart failure, GUAIFENESIN for Mucous discharge, GABAPENTIN for Neuropathy, CABERGOLINE for Pituitary disorder NOS, TERAZOSIN HYDROCHLORIDE (PROZOSIN) for Post-traumatic stress disorder, DULOXETINE HYDROCHLORIDE (DOXETIN) for Sleep disorder, NYSTATIN for Yeast infection.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (skin on entire body became red), PRURITUS (skin on entire body became red, itchy), SKIN BURNING SENSATION (entire body having a burning sensation) and BLISTER (scalp became purple and developed multiple blisters). On 05-Apr-2021, the patient experienced BLISTER INFECTED (blisters on head becoming infected). On 18-May-2021, the patient experienced CHEST PAIN (chest pain). On 30-May-2021, the patient experienced ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) (seriousness criterion medically significant) and NAUSEA (nausea). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Patient declined second vaccination due to adverse). The patient was treated with NITROGLYCERIN (intravenous) on 30-May-2021 for Arrhythmia and Heart attack, at a dose of 1 dosage form and CEFRADINE (LINDEX [CEFRADINE]) (topical) for Scalp blister, at a dose of 1 dosage form. At the time of the report, ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack), MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack), ERYTHEMA (skin on entire body became red), PRURITUS (skin on entire body became red, itchy), SKIN BURNING SENSATION (entire body having a burning sensation), BLISTER (scalp became purple and developed multiple blisters), BLISTER INFECTED (blisters on head becoming infected) and NAUSEA (nausea) outcome was unknown, CHEST PAIN (chest pain) had not resolved and INTENTIONAL DOSE OMISSION (Patient declined second vaccination due to adverse) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Troponin: normal (normal) normal. On 30-May-2021, Troponin: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that on 18-MAY-2021 she experienced chest pain and went to the emergency room via ambulance. Patient did not receive any medication in emergency room and was discharged 17 hours later because her Troponin levels were normal. On 30-MAY-2021 patient had stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was having an arrhythmia and/or heart attack. The patient was air lifted to the hospital. The patient stated that she was put on a Nitroglycerin IV drip and antiemetics in the emergency room. The patient's troponin levels came back normal and was discharged after 12 hours in the emergency room. At the time of report, on 02-JUN-2021, patient stated that she still had chest pain, and the pain remained 3 out of 10.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  further information has been requested. For the event "Intentionally missed dose" causality assessment is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  further information has been requested. For the event "Intentionally missed dose" causality assessment is not aplicable.