Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Pericardial effusion, Pulmonary oedema
Clinical narrative: FLUID IN LUNGS; FLUID IN HEART; COVID VACCINE AFFECTED A LOT; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (FLUID IN LUNGS) and PERICARDIAL EFFUSION (FLUID IN HEART) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On 27-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (FLUID IN LUNGS) (seriousness criterion medically significant), PERICARDIAL EFFUSION (FLUID IN HEART) (seriousness criterion medically significant) and IMMUNISATION REACTION (COVID VACCINE AFFECTED A LOT). At the time of the report, PULMONARY OEDEMA (FLUID IN LUNGS) and PERICARDIAL EFFUSION (FLUID IN HEART) outcome was unknown and IMMUNISATION REACTION (COVID VACCINE AFFECTED A LOT) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This spontaneous case reported by a consumer, concerns an elderly male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant events of PULMONARY OEDEMA (FLUID IN LUNGS) (AESI) and PERICARDIAL EFFUSION (FLUID IN HEART), unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that on an unknown date, patient also received IBRUTINIB (IMBRUVICA), at an unknown dose for an unknown indication. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an elderly male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant events of PULMONARY OEDEMA (FLUID IN LUNGS) (AESI) and PERICARDIAL EFFUSION (FLUID IN HEART), unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that on an unknown date, patient also received IBRUTINIB (IMBRUVICA), at an unknown dose for an unknown indication. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.