Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Pharyngeal disorder, Pulmonary oedema
Clinical narrative: Lung edema/Fluid in lungs; Ear discomfort/Ear felt like it had liquid; Pharyngeal disorder/Throat problems; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (Lung edema/Fluid in lungs), PHARYNGEAL DISORDER (Pharyngeal disorder/Throat problems) and EAR DISCOMFORT (Ear discomfort/Ear felt like it had liquid) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In March 2022, the patient experienced PHARYNGEAL DISORDER (Pharyngeal disorder/Throat problems) (seriousness criterion medically significant). On an unknown date, the patient experienced PULMONARY OEDEMA (Lung edema/Fluid in lungs) (seriousness criterion medically significant) and EAR DISCOMFORT (Ear discomfort/Ear felt like it had liquid) (seriousness criterion medically significant). At the time of the report, PULMONARY OEDEMA (Lung edema/Fluid in lungs), PHARYNGEAL DISORDER (Pharyngeal disorder/Throat problems) and EAR DISCOMFORT (Ear discomfort/Ear felt like it had liquid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided  Company comment:  This is a spontaneous case concerning  a  49-year-old, male patient with Concurrent medical of Crohn's disease, who experienced the unexpected serious (medically significant) events of Pulmonary oedema, Pharyngeal disorder, Ear discomfort. The events occurred on unspecified date of March 2022. It was noted that First dose of mRNA-1273 COVID 19 Vaccine was given on 23-Feb-2021, while the Second dose was administered on 25-Mar-2021 and also noted that Adalimumab, a Solution for injection in pre-filled pen was given on an urecalled date. The events were reported as not resolved. The concurrent medical of Crohn's disease and use of concomitant medication Adalimumab remains a confounder for event Pharyngeal disorder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company comment:  This is a spontaneous case concerning  a  49-year-old, male patient with Concurrent medical of Crohn's disease, who experienced the unexpected serious (medically significant) events of Pulmonary oedema, Pharyngeal disorder, Ear discomfort. The events occurred on unspecified date of March 2022. It was noted that First dose of mRNA-1273 COVID 19 Vaccine was given on 23-Feb-2021, while the Second dose was administered on 25-Mar-2021 and also noted that Adalimumab, a Solution for injection in pre-filled pen was given on an urecalled date. The events were reported as not resolved. The concurrent medical of Crohn's disease and use of concomitant medication Adalimumab remains a confounder for event Pharyngeal disorder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.