Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac ablation, Cardioversion, Poor quality product administered, Product colour issue, Pulmonary oedema
Clinical narrative: He then found out he had fluid in his lungs; Ablation of the heart; Cardioversion; the vaccine given to him is "gold" in color; He reports that the vaccine given to him is "gold" in color and was given him through an "inoculator; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY OEDEMA (He then found out he had fluid in his lungs), CARDIOVERSION (Cardioversion) and CARDIAC ABLATION (Ablation of the heart) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1) in May 2021, MODERNA COVID-19 VACCINE (Dose 2) in June 2021, MODERNA COVID-19 VACCINE (Moderna Booster 1) on 03-Dec-2021, MODERNA COVID-19 VACCINE (Moderna Booster 2) on 19-May-2022 and MODERNA COVID-19 VACCINE (Moderna Booster 3) on 14-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 24-Oct-2022, the patient received sixth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (He reports that the vaccine given to him is "gold" in color and was given him through an "inoculator). On 28-Oct-2022, the patient experienced PULMONARY OEDEMA (He then found out he had fluid in his lungs) (seriousness criteria hospitalization and medically significant). On 19-Dec-2023, the patient experienced CARDIOVERSION (Cardioversion) (seriousness criterion hospitalization). On 29-Dec-2023, the patient experienced CARDIAC ABLATION (Ablation of the heart) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT COLOUR ISSUE (the vaccine given to him is "gold" in color). The patient was hospitalized for 11 days due to CARDIAC ABLATION and CARDIOVERSION. At the time of the report, PULMONARY OEDEMA (He then found out he had fluid in his lungs) was resolving and CARDIOVERSION (Cardioversion), CARDIAC ABLATION (Ablation of the heart), POOR QUALITY PRODUCT ADMINISTERED (He reports that the vaccine given to him is "gold" in color and was given him through an "inoculator) and PRODUCT COLOUR ISSUE (the vaccine given to him is "gold" in color) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient reported that he got a total of 6 (2 initial and 4 booster dose) vaccines from Moderna. Patient experienced suffocation feeling on the 28-OCT-2022. He then found out he had fluid in his lungs. Thus, he shared that the fluid in his lungs was removed. He reported that the vaccine given to him was "gold" in color and was given him through an "inoculator" which he correlated to the events he experienced.   Furthermore, On 06-Dec-2023, the patient drove himself to emergency room and underwent series of operation including Cardioversion and Ablation of the heart on 19-Dec-2023 and 29-Dec-2023. He was hospitalized for 11 days.   The patient was given 4 unspecified medicines since then.  Company Comments: This spontaneous case concerns a 64-year-old male patient, with no medical history information reported, who experienced the unexpected serious (hospitalization, medically significant event) event of pulmonary oedema and unexpected serious (hospitalization) events of cardiac ablation and cardioversion. The event of pulmonary edema occurred 4 days after sixth dose of mRNA-1273. As reported subject had suffocation feeling  and then found out he had fluid in his lungs and stated that the fluid in his lungs was removed. Treatment medication was not reported, examination were not reported either. It was also reported that approx. one year after 6th dose patient drove himself to the emergency room and underwent series of operations (Cardioversion and Ablation of the heart) and was hospitalized for 11 days. No indication for mentioned procedures or any diagnostic findings were provided. The subject also reported that he received poor quality product administered "the vaccine given to him is gold in color". The event of pulmonary edema was resolving at the time of report. Considering implausible temporal relation, with events occurring more than 1 year after 6th dose of mRNA-1273 the events of cardiac ablation and cardioversion are assessed as not related to mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2024: Live non-significant follow-up received on 07-Mar-2024: Reference number updated.; Sender's Comments: Company Comments: This spontaneous case concerns a 64-year-old male patient, with no medical history information reported, who experienced the unexpected serious (hospitalization, medically significant event) event of pulmonary oedema and unexpected serious (hospitalization) events of cardiac ablation and cardioversion. The event of pulmonary edema occurred 4 days after sixth dose of mRNA-1273. As reported subject had suffocation feeling  and then found out he had fluid in his lungs and stated that the fluid in his lungs was removed. Treatment medication was not reported, examination were not reported either. It was also reported that approx. one year after 6th dose patient drove himself to the emergency room and underwent series of operations (Cardioversion and Ablation of the heart) and was hospitalized for 11 days. No indication for mentioned procedures or any diagnostic findings were provided. The subject also reported that he received poor quality product administered "the vaccine given to him is gold in color". The event of pulmonary edema was resolving at the time of report. Considering implausible temporal relation, with events occurring more than 1 year after 6th dose of mRNA-1273 the events of cardiac ablation and cardioversion are assessed as not related to mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.