Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Myocarditis/ Pain and pressure in my chest/ Dizziness when standing/ Extremely elevated heart rate that would go up to 140 after a little bit of walking; Pain in left shoulder and neck; Pain, numbness and tingling in left arm; Pain, numbness and tingling in left arm; Pain in left shoulder and neck; Pain, numbness and tingling in left arm; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (Myocarditis/ Pain and pressure in my chest/ Dizziness when standing/ Extremely elevated heart rate that would go up to 140 after a little bit of walking) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastroesophageal reflux disease (Gastrointestinal Reflux) and COVID-19 (Date of positive COVID-19 test was early June with mild symptoms. Patient received treatment with Infusion. Patient was not hospitalized for COVID-19 infection.) in June 2022. Concurrent medical conditions included Food allergy (Green peppers) and Arthritis.    On 18-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced NECK PAIN (Pain in left shoulder and neck), PARAESTHESIA (Pain, numbness and tingling in left arm), HYPOAESTHESIA (Pain, numbness and tingling in left arm), ARTHRALGIA (Pain in left shoulder and neck) and PAIN IN EXTREMITY (Pain, numbness and tingling in left arm). On 23-Nov-2022, the patient experienced MYOCARDITIS (Myocarditis/ Pain and pressure in my chest/ Dizziness when standing/ Extremely elevated heart rate that would go up to 140 after a little bit of walking) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis/ Pain and pressure in my chest/ Dizziness when standing/ Extremely elevated heart rate that would go up to 140 after a little bit of walking), NECK PAIN (Pain in left shoulder and neck), PARAESTHESIA (Pain, numbness and tingling in left arm), HYPOAESTHESIA (Pain, numbness and tingling in left arm), ARTHRALGIA (Pain in left shoulder and neck) and PAIN IN EXTREMITY (Pain, numbness and tingling in left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2022, Electrocardiogram: Abnormal. On an unknown date, Heart rate: 140.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered MYOCARDITIS (Myocarditis/ Pain and pressure in my chest/ Dizziness when standing/ Extremely elevated heart rate that would go up to 140 after a little bit of walking), NECK PAIN (Pain in left shoulder and neck), PARAESTHESIA (Pain, numbness and tingling in left arm), HYPOAESTHESIA (Pain, numbness and tingling in left arm), ARTHRALGIA (Pain in left shoulder and neck) and PAIN IN EXTREMITY (Pain, numbness and tingling in left arm) to be related.    Patient received first dose of Moderna on 09-Feb-2021 (Batch/Lot #021B21A)and second dose on 05-Mar-2021 (Batch/Lot # 014M20A) and first booster on 22-Apr-2022 (Batch/Lot #R506MZ119(illegible/unsure)) through intramuscular route for COVID-19 Vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medication was not provided. Patient underwent relevant investigations which include Nuclear medicine stress test on 15 or 16 of Nov 2022, Cardiac monitor for 2 weeks and echocardiogram on 9 Nov, EKG on 02Nov2022 and CT on 15 or 16 of Nov2022 with no results being reported. AE caused the patient to seek medical care but treatment information was not reported. Patient stated that vaccine was the cause for symptoms/ events reported.  Company comment: This spontaneous case concerns a 59-year-old male patient with no relevant medical history reported, who experienced the expected, serious (medically significant) event of myocarditis starting 2 days after the first dose of mRNA-1273.222. The patient experienced pain and pressure in his chest, numbness and tingling in left arm, pain in left shoulder and neck, dizziness when standing, and elevated heart rate that would go up to 140 bpm after walking. Diagnostic tests included ECG (result: abnormal), cardiac monitor for two weeks (result unknown), Nuclear medicine stress test (result unknown), echocardiogram (result unknown), and a CT (result unknown). Treatment included an unspecified infusion. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MODERNATX, INC.-MOD-2022-680803 (E2B Linked Report). This case was linked to MOD-2022-681024, MOD-2022-680999 (Patient Link). Sender's Comments: This spontaneous case concerns a 59-year-old male patient with no relevant medical history reported, who experienced the expected, serious (medically significant) event of myocarditis starting 2 days after the first dose of mRNA-1273.222. The patient experienced pain and pressure in his chest, numbness and tingling in left arm, pain in left shoulder and neck, dizziness when standing, and elevated heart rate that would go up to 140 bpm after walking. Diagnostic tests included ECG (result: abnormal), cardiac monitor for two weeks (result unknown), Nuclear medicine stress test (result unknown), echocardiogram (result unknown), and a CT (result unknown). Treatment included an unspecified infusion. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. MODERNATX, INC.-MOD-2022-680803:Husband case (Reporter case).