Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Pericardial effusion, Pleural effusion
Clinical narrative: Had water around her heart and had to be drained; Had water around her lung and had to be drained; sudden she had this breathing issue/She could not breathe, she just couldn't breathe, and she never ever had a breathing problem in her life; Firmly believes that the shot made her sick; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (Had water around her heart and had to be drained), PLEURAL EFFUSION (Had water around her lung and had to be drained) and DYSPNOEA (sudden she had this breathing issue/She could not breathe, she just couldn't breathe, and she never ever had a breathing problem in her life) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leg operation (minor) on 12-May-2021. Concurrent medical conditions included Blood pressure abnormal since 2001.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ILLNESS (Firmly believes that the shot made her sick). On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (sudden she had this breathing issue/She could not breathe, she just couldn't breathe, and she never ever had a breathing problem in her life) (seriousness criterion hospitalization). In August 2021, the patient experienced PERICARDIAL EFFUSION (Had water around her heart and had to be drained) (seriousness criteria hospitalization and medically significant) and PLEURAL EFFUSION (Had water around her lung and had to be drained) (seriousness criterion hospitalization). The patient was hospitalized on sometime in August 2021 due to DYSPNOEA, PERICARDIAL EFFUSION and PLEURAL EFFUSION. The patient was treated with PREDNISONE for Adverse event, at a dose of 20 milligram once a day and BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BREZTRI AEROSPHERE) for Adverse event, at a dose of twice in the morning and twice at night. At the time of the report, PERICARDIAL EFFUSION (Had water around her heart and had to be drained), PLEURAL EFFUSION (Had water around her lung and had to be drained) and ILLNESS (Firmly believes that the shot made her sick) was resolving and DYSPNOEA (sudden she had this breathing issue/She could not breathe, she just couldn't breathe, and she never ever had a breathing problem in her life) had not resolved.            Concomitant product include blood pressure medication for the last 20years.  Reporter stated patient had a minor leg surgery on 12-May-2021 that had nothing to do with anything.  Around the end Aug-2021, Patient was put in the hospital, she had water around her lung and her heart and had to be drained, that. patient could not breathe and never ever had a breathing problem in her life. It was really really bad. Mentioned there was no way she would ever take a booster ever. Mentioned breathing problems still on going, had to be drained, was getting a little bit better. She had ECG. All records were in the hospital.  Company comment: This case concerns a  82-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea, Pericardial Effusion, and Pleural Effusion. The event of Dyspnea occurred approximately 14 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), while Pericardial Effusion and Pleural Effusion occurred approximately 3 months after requiring a drain. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  82-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea, Pericardial Effusion, and Pleural Effusion. The event of Dyspnea occurred approximately 14 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), while Pericardial Effusion and Pleural Effusion occurred approximately 3 months after requiring a drain. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.