Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Might die due to this cardiac condition; No energy/had to sit down; Soreness to arm after 1st dose; Fatigued, exhausted all the time; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Might die due to this cardiac condition), DYSPNOEA (Shortness of breath), ASTHENIA (No energy/had to sit down), PAIN IN EXTREMITY (Soreness to arm after 1st dose) and FATIGUE (Fatigued, exhausted all the time) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 17-Jan-2020, Hemochromatosis (used to get phlebotomies to alleviate some of the symptoms) and Heart enlarged (confirmed by sonogram). Concurrent medical conditions included Sleep apnea, Holter monitoring (Heart monitor) since 12-Apr-2021 and Long COVID. Concomitant products included LOSARTAN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Might die due to this cardiac condition), ASTHENIA (No energy/had to sit down), PAIN IN EXTREMITY (Soreness to arm after 1st dose) and FATIGUE (Fatigued, exhausted all the time). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Shortness of breath, at a dose of 1 dosage form and IVABRADINE at an unspecified dose and frequency. At the time of the report, NEAR DEATH EXPERIENCE (Might die due to this cardiac condition), ASTHENIA (No energy/had to sit down), PAIN IN EXTREMITY (Soreness to arm after 1st dose) and FATIGUE (Fatigued, exhausted all the time) outcome was unknown and DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Heart rate: increases (High) With movement heart rate increases.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication reported also included high blood pressure medication. It was reported that  after the vaccination on an unspecified date, patient took tetanus vaccine.  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. Patient is diagnosed with an enlarged heart and long COVID  which can confound the event.   This case was linked to MOD-2021-089719 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received included concomitant medication Losartan's dose On 11-Jun-2021: Follow-up received included new event(might die due to cardiac condition), and updated the outcome of the event dyspnea(from unknown to not resolved).; 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. Patient is diagnosed with an enlarged heart and long COVID  which can confound the event.