Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Inappropriate schedule of product administration, Inflammatory marker test, Myocarditis, Suspected COVID-19
Clinical narrative: Myocarditis; spike protein went to her mother's blood stream and attacked; After the second shot, the symptoms really started to snowball; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) and SUSPECTED COVID-19 (spike protein went to her mother's blood stream and attacked) in a 66-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 Acute kidney injury. Concurrent medical conditions included Hypertension, Atrial fibrillation and Urinary retention.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION COMPLICATION (After the second shot, the symptoms really started to snowball) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and SUSPECTED COVID-19 (spike protein went to her mother's blood stream and attacked) (seriousness criteria hospitalization prolonged and life threatening). At the time of the report, MYOCARDITIS (Myocarditis), SUSPECTED COVID-19 (spike protein went to her mother's blood stream and attacked) and VACCINATION COMPLICATION (After the second shot, the symptoms really started to snowball) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: crohn's disease (abnormal) Crohn's disease. On an unknown date, Inflammatory marker test: high (High) Extremely high..         Relevant concomitant product usage were not reported by the reporter. Patient was reported as dead and later was revived after 6 minutes of CPR. Treatment included Chemotherapy, CPR (cardiopulmonary resuscitation), PEA (pulseless electrical activity), ECMO (extracorporeal membrane oxygenation) Machine.  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. However, underlying medical history of hypertension and atrial fibrillation are contributory factors to the events.   This case was linked to MOD-2021-293807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: reporter initial name provided.; 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. However, underlying medical history of hypertension and atrial fibrillation are contributory factors to the events.