Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash, Urticaria, Vertigo
Clinical narrative: post bleeding in the shoulder; Really sore; no energy, felt drained; Feeling jittery; hives; itched; Fluttering/ heart fluttering; nervous; COVID shoulder; slight rash on shoulder, neck, chest and slightly on belly; Dizzy/lightheaded; vertigo; tingling throughout the body like arms; tightness around the chest; couldn't move my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Fluttering/ heart fluttering) and HAEMORRHAGE (post bleeding in the shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sensitivity to epinephrine.) and Vascular disorder (Patient does have Bleeding disorder). Concomitant products included COLECALCIFEROL (VITAMIN D3), PROBIOTICS NOS, PYRIDOXINE HYDROCHLORIDE (VITAMIN B6), MAGNESIUM and ARGININE for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced CARDIAC FLUTTER (Fluttering/ heart fluttering) (seriousness criterion medically significant), DIZZINESS (Dizzy/lightheaded), VERTIGO (vertigo), PARAESTHESIA (tingling throughout the body like arms), CHEST DISCOMFORT (tightness around the chest), MOBILITY DECREASED (couldn't move my shoulder), NERVOUSNESS (nervous), INJECTION SITE PAIN (COVID shoulder) and RASH (slight rash on shoulder, neck, chest and slightly on belly). On 21-Aug-2021, the patient experienced URTICARIA (hives) and PRURITUS (itched). On 22-Aug-2021, the patient experienced ASTHENIA (no energy, felt drained) and FEELING JITTERY (Feeling jittery). On an unknown date, the patient experienced HAEMORRHAGE (post bleeding in the shoulder) (seriousness criterion medically significant) and MYALGIA (Really sore). At the time of the report, CARDIAC FLUTTER (Fluttering/ heart fluttering), HAEMORRHAGE (post bleeding in the shoulder), DIZZINESS (Dizzy/lightheaded), VERTIGO (vertigo), PARAESTHESIA (tingling throughout the body like arms), URTICARIA (hives), PRURITUS (itched), NERVOUSNESS (nervous), INJECTION SITE PAIN (COVID shoulder) and RASH (slight rash on shoulder, neck, chest and slightly on belly) had resolved and CHEST DISCOMFORT (tightness around the chest), MOBILITY DECREASED (couldn't move my shoulder), ASTHENIA (no energy, felt drained), FEELING JITTERY (Feeling jittery) and MYALGIA (Really sore) outcome was unknown.        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.   No treatment information was provided  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.