Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Gait disturbance, SARS-CoV-2 test
Clinical narrative: Breakthrough case of covid-19; Chest discomfort; Stomach discomfort; Difficulty breathing; Could not walk; Fluid around his heart; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort), DYSPNOEA (Difficulty breathing), GAIT DISTURBANCE (Could not walk), FLUID RETENTION (Fluid around his heart) and COVID-19 (Breakthrough case of covid-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Stomach discomfort) (seriousness criterion hospitalization), DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization) and FLUID RETENTION (Fluid around his heart) (seriousness criterion hospitalization). On 30-Oct-2021, the patient experienced COVID-19 (Breakthrough case of covid-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of efficacy). The patient was hospitalized from 27-Oct-2021 to 03-Nov-2021 due to ABDOMINAL DISCOMFORT, CHEST DISCOMFORT, COVID-19, DYSPNOEA, FLUID RETENTION and GAIT DISTURBANCE. The patient was treated with Rehabilitation therapy for COVID-19. At the time of the report, CHEST DISCOMFORT (Chest discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort), DYSPNOEA (Difficulty breathing), GAIT DISTURBANCE (Could not walk), FLUID RETENTION (Fluid around his heart), COVID-19 (Breakthrough case of covid-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided. On 27OCT2021, he went to the emergency room because he had chest discomfort, difficulty breathing, and stomach discomfort. While in the emergency room he had blood took for laboratory work, was gave an IV, and was admitted to the hospital. He was told he had fluid around his heart. After admission, on 30-OCT-2021, he received a covid-19 test in anticipation of transfer to a rehab facility as he could not walk. The test came back positive, indicating a breakthrough case of covid-19, and he was admitted to the hospital's covid-19 ward on 2-NOV-2021. While there they gave him resovir and some of those higher powered drugs to treat it. When he was discharged, the doctor at the covid-19 ward said that he should wait 3 months for the booster. He was released from the hospital on 3-NOV-2021. He was given additional medications while hospitalized, but did not recall which medications those included. CC : This case concerns a 72 year old male with relevant medical history of Congestive heart failure, who experienced Serious ( Hospitalization ) , unexpected, ADR event of Covid 19 which occurred 8 months 7 days after vaccination with the 2nd dose of Moderna Covid 19 vaccine. Non- serious event of Drug ineffective,  occurred.  Additional Serious ( Hospitalization ) , unexpected events of chest discomfort, abdominal discomfort , dyspnea, gait disturbance , and fluid retention occurred 8 months 5 days post vaccination with the 2nd dose. The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be given. The age and medical condition of the patient can be considered as confounders . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 72 year old male with relevant medical history of Congestive heart failure, who experienced Serious ( Hospitalization ) , unexpected, ADR event of Covid 19 which occurred 8 months 7 days after vaccination with the 2nd dose of Moderna Covid 19 vaccine. Non- serious event of Drug ineffective,  occurred.  Additional Serious ( Hospitalization ) , unexpected events of chest discomfort, abdominal discomfort , dyspnea, gait disturbance , and fluid retention occurred 8 months 5 days post vaccination with the 2nd dose. The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be given. The age and medical condition of the patient can be considered as confounders . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.