Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Eosinophil count, Pleural effusion
Clinical narrative: Could not stop coughing/had to go to the ER; diagnosed with pleural effusion, meaning they got fluid build up around their lung; Leading to the procedures noticed having pain in their chest and it hurt to roll over to the side while in bed; Shortness of breath/got progressively worse/Around August2021 they noticed it was getting worse at an increased rate; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath/got progressively worse/Around August2021 they noticed it was getting worse at an increased rate), COUGH (Could not stop coughing/had to go to the ER) and PLEURAL EFFUSION (diagnosed with pleural effusion, meaning they got fluid build up around their lung) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A. and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) and MONTELUKAST for Asthma, PRAVASTATIN and IRBESARTAN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-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 DYSPNOEA (Shortness of breath/got progressively worse/Around August2021 they noticed it was getting worse at an increased rate) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced COUGH (Could not stop coughing/had to go to the ER) (seriousness criterion hospitalization) and PLEURAL EFFUSION (diagnosed with pleural effusion, meaning they got fluid build up around their lung) (seriousness criterion hospitalization). In September 2021, the patient experienced CHEST PAIN (Leading to the procedures noticed having pain in their chest and it hurt to roll over to the side while in bed). The patient was hospitalized on 07-Sep-2021 due to COUGH. The patient was treated with PREDNISONE in September 2021 for Pleural effusion, at an unspecified dose and frequency; PREDNISONE in October 2021 for Pleural effusion, at an unspecified dose and frequency and Surgery for Pleural effusion. At the time of the report, DYSPNOEA (Shortness of breath/got progressively worse/Around August2021 they noticed it was getting worse at an increased rate), COUGH (Could not stop coughing/had to go to the ER), PLEURAL EFFUSION (diagnosed with pleural effusion, meaning they got fluid build up around their lung) and CHEST PAIN (Leading to the procedures noticed having pain in their chest and it hurt to roll over to the side while in bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Eosinophil count: high (High) fluid contained some blood and a high count of eosinophils. In October 2021, Eosinophil count: high (High) Fluid containing even more blood in it. In October 2021, White blood cell count: high (High) high.         The patient was also treated with antibiotics and 54321 packets after the first procedure.  On10-Sep-2021 HCP performed a procedure where they had 2.5L of fluid taken out from the left lung. 27-Oct-2021, they repeated the procedure in their right lung and 2L of fluid were taken out of their right lung.  Company comment: This case concerns a 69-year-old male patient with no relevant medical history, who experienced the unexpected events of Dyspnea, Cough and Pleural Effusion. The event of Dyspnea occurred approximately 2 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and continuing up to 3 months. The events Cough and Chest pain occurred approximately 6 months after receiving the second dose with outcome of hospitalization. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 69-year-old male patient with no relevant medical history, who experienced the unexpected events of Dyspnea, Cough and Pleural Effusion. The event of Dyspnea occurred approximately 2 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and continuing up to 3 months. The events Cough and Chest pain occurred approximately 6 months after receiving the second dose with outcome of hospitalization. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.