Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Trismus
Clinical narrative: "found fluid around the heart; heart pushing against the ribs; she had pain in her left chest/She went to Ultrasound on her heart and found fluid/Her heart felt/heart pushing against the ribs; her jaw felt locked; fever; This spontaneous case was reported by a patient and describes the occurrence of PERICARDIAL EFFUSION ("found fluid around the heart) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M7) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    Concurrent medical conditions included Temporal arteritis and Polymyalgia rheumatica (Patient has a high SED rate laboratory value).   On 04-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 an unknown date, the patient received dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced CHEST DISCOMFORT (heart pushing against the ribs), CHEST PAIN (she had pain in her left chest/She went to Ultrasound on her heart and found fluid/Her heart felt/heart pushing against the ribs), TRISMUS (her jaw felt locked) and PYREXIA (fever). On an unknown date, the patient experienced PERICARDIAL EFFUSION ("found fluid around the heart) (seriousness criterion medically significant). At the time of the report, PERICARDIAL EFFUSION ("found fluid around the heart), CHEST DISCOMFORT (heart pushing against the ribs), CHEST PAIN (she had pain in her left chest/She went to Ultrasound on her heart and found fluid/Her heart felt/heart pushing against the ribs), TRISMUS (her jaw felt locked) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal, Had an ultrasound on the heart and found fluid around the heart.         Weight was about 175-178 pounds.  No concomitant medication was provided.  Patient had an ultrasound on her heart and found fluid around the heart. Patient had reaction to the Moderna dose started 8 to 9 hours after her dose.  It was reported that SED rate checked every three months . The SED rate was not high and theSED rate checked before receiving the Moderna Covid 19 Vaccine, the SED rate was checked after receiving the Moderna Covid 19 Vaccine. If the caller has a flare up, the flare up is treated with Prednisone. The caller was not taking Prednisone at the time of receiving the Moderna Covid 19 Vaccine.  Treatment medication was not provided by the reporter.  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 is a spontaneous case concerning a 77-year-old female patient with Temporal arteritis and Polymyalgia rheumatica, who experienced the serious (medically significant) unexpected event Pericardial effusion. Patient had chest pain and chest discomfort on the same day after receiving the second dose of mRNA-1273. Due to this symptoms saw a cardiologist one month later and a cardiac ultrasound showed "fluid around the heart". Additional diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list and medical judgement. Advanced age and medical conditions could be contributor factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 77-year-old female patient with Temporal arteritis and Polymyalgia rheumatica, who experienced the serious (medically significant) unexpected event Pericardial effusion. Patient had chest pain and chest discomfort on the same day after receiving the second dose of mRNA-1273. Due to this symptoms saw a cardiologist one month later and a cardiac ultrasound showed "fluid around the heart". Additional diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list and medical judgement. Advanced age and medical conditions could be contributor factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.