Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: tiredness; left chest pain; left arm pain; Not feeling strong; Joint pain; really bad Headache; body achiness/ muscle pains,; slept all day/ very sleepy; tired; not feeling strong; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body achiness/ muscle pains,), SOMNOLENCE (slept all day/ very sleepy), FEELING ABNORMAL (Not feeling strong), FATIGUE (tiredness) and ARTHRALGIA (Joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (heart attack in 1995 and 2018) in 1995 and Pacemaker insertion (cardiac) (left chest). Concurrent medical conditions included Chronic fatigue syndrome and Fibromyalgia. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), ALPRAZOLAM (XANAX) for Anxiety, HYDRALAZINE for Blood pressure management, EVOLOCUMAB (REPATHA) and ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder, VITAMIN C [ASCORBIC ACID], ASPIRIN [ACETYLSALICYLIC ACID], BISOPROLOL FUMARATE (ZEBETA), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]), VITAMIN B6, PARACETAMOL (TYLENOL EXTRA STRENGTH), NITROGLYCERIN, MULTIVITAMIN [VITAMINS NOS] and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 31-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (body achiness/ muscle pains,), SOMNOLENCE (slept all day/ very sleepy), FATIGUE (tired), FEELING ABNORMAL (not feeling strong) and CHILLS (chills). On 02-Apr-2021, the patient experienced HEADACHE (really bad Headache). On 07-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling strong) and ARTHRALGIA (Joint pain). On 23-Apr-2021, the patient experienced FATIGUE (tiredness). 23-Apr-2021, the patient experienced CHEST PAIN (left chest pain) and PAIN IN EXTREMITY (left arm pain). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 500 milligram. On 02-Apr-2021, MYALGIA (body achiness/ muscle pains,) had resolved. On 03-Apr-2021, HEADACHE (really bad Headache) had resolved. At the time of the report, SOMNOLENCE (slept all day/ very sleepy) had resolved, FEELING ABNORMAL (Not feeling strong), FATIGUE (tiredness) and ARTHRALGIA (Joint pain) had not resolved and CHEST PAIN (left chest pain), FATIGUE (tired), FEELING ABNORMAL (not feeling strong), CHILLS (chills) and PAIN IN EXTREMITY (left arm pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Electrocardiogram: normal (normal) EKG looked good. On 21-Apr-2021, Echocardiogram: inconclusive (Inconclusive) Echocardiogram looked better than before.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Customer reported received first dose of Moderna COVID-19 vaccine on 31Mar2021 at 1130 in left upper arm. On 02Apr2021, developed really bad headache, sore left arm, intermittent body achiness, tiredness and pain around pacemaker site on left chest. Consumer confirms past history of fibromyalgia, fatigue syndrome, heart attack in 1995 and 2018, and pacemaker on left chest. On 03Apr2021 through 05Apr2021, consumer reports having no symptoms, 'had some pretty good days'. On 06Apr2021 consumer reports having worsened headache, left arm pain, worsened body achiness, left chest pain and slept all day. On 09Apr2021 at 0900, consumer reports went to the emergency room with complaint of persistent left chest pain that didn't feel right and was kept in observation until 8PM until cardiac enzymes blood work went down, EKG looked good. Consumer reports being cleared for any heart problems, 'they could tell I had soreness in my chest around the pacemaker'. On 21Apr2021, consumer reports seeing Cardiologist, pacemaker was checked and was doing good, an echocardiogram was done on 21Apr2021, doctor said it looked better than before. Consumer reports overall, the reported symptoms of tiredness, left chest pain, left arm pain, and body achiness are not as bad as they were in the beginning, and have improved. Consumer reports the 2nd dose of Moderna COVID- 19 vaccine is scheduled for 28Apr2021. Expiration Date: 01JAN1900   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Reporter's address, Patient's Age and Race, Patient's past medical history,