Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypoxia, Pulmonary oedema
Clinical narrative: lungs filled with fluid; hypoxia; dyspnea/hard for him to breath; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY OEDEMA (lungs filled with fluid) and HYPOXIA (hypoxia) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concurrent medical conditions included Blood pressure abnormal (Blood pressure disorder), Diabetes and Heartbeats increased (rapid heart beat). Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PULMONARY OEDEMA (lungs filled with fluid) (seriousness criterion medically significant), HYPOXIA (hypoxia) (seriousness criterion medically significant) and DYSPNOEA (dyspnea/hard for him to breath). At the time of the report, PULMONARY OEDEMA (lungs filled with fluid), HYPOXIA (hypoxia) and DYSPNOEA (dyspnea/hard for him to breath) outcome was unknown.            It was reported that patient was taking Blood pressure medication, Diabetes medication and Medicine to stop rapid heart beat as a concomitant medication.  It was reported that on 14-Mar-2021 patient experienced hypoxia and dyspnea, lungs were filled with fluid and it was hard for the patient to breath. Patient was afraid of getting booster dose.  As a treatment fluid drained from the lungs. No information provided about treatment medication.  Company comment  This spontaneous case reported by a patient, concerns a 68 year old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious (medically significant) events of PULMONARY OEDEMA (lungs filled with fluid) HYPOXIA and the non serious event of DYSPNOEA, about 08 days after receiving the 2 dose of mRNA1273 vaccine in the covid 19 vaccination series. Patient previously had the 1 dose of Moderna vaccine about 30 days prior to the 2 dose and had a Heart attack and quadruple bypass surgery which, along with his concurrent medical conditions, Blood pressure abnormal, Diabetes and Heartbeats increased, could be considered as risk factors. It was reported that on 14-Mar-2021 patient experienced hypoxia and dyspnea, lungs were filled with fluid and it was hard for the patient to breath. Fluid was drained from the lungs. No information was provided about treatment medication. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-608596 (Patient Link).; Sender's Comments: This spontaneous case reported by a patient, concerns a 68 year old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious (medically significant) events of PULMONARY OEDEMA (lungs filled with fluid) HYPOXIA and the non serious event of DYSPNOEA, about 08 days after receiving the 2 dose of mRNA1273 vaccine in the covid 19 vaccination series. Patient previously had the 1 dose of Moderna vaccine about 30 days prior to the 2 dose and had a Heart attack and quadruple bypass surgery which, along with his concurrent medical conditions, Blood pressure abnormal, Diabetes and Heartbeats increased, could be considered as risk factors. It was reported that on 14-Mar-2021 patient experienced hypoxia and dyspnea, lungs were filled with fluid and it was hard for the patient to breath. Fluid was drained from the lungs. No information was provided about treatment medication. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.