Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Computerised tomogram, Headache, Illness
Clinical narrative: Sick for 1-2 days; headache; trance of pericardial effusion; Abdominal pain; overall weakness; When working cracking sound/body crack; Fever; body pain; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (trance of pericardial effusion), ABDOMINAL PAIN (Abdominal pain), ASTHENIA (overall weakness), JOINT NOISE (When working cracking sound/body crack) and ILLNESS (Sick for 1-2 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00813212A and 010021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Abdominal pain (abdominal pain on right side), Blood pressure (About 5-7 years ago, Patient had high blood pressure) and Chest discomfort (used to felt something in the throat goin to the chest, like to the heart, but no longer.). Previously administered products included for Product used for unknown indication: CIPRO. Past adverse reactions to the above products included Heart pounding with CIPRO. Concurrent medical conditions included Blood sugar increased (Recently, mentioned as 202 (year was not clear) had high blood pressure) and Allergic reaction to antibiotics (allergy to CIPRO).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), ASTHENIA (overall weakness), JOINT NOISE (When working cracking sound/body crack), MYALGIA (body pain) and PYREXIA (Fever). On 11-May-2021, the patient experienced PERICARDIAL EFFUSION (trance of pericardial effusion). On an unknown date, the patient experienced ILLNESS (Sick for 1-2 days) and HEADACHE (headache). At the time of the report, PERICARDIAL EFFUSION (trance of pericardial effusion), ABDOMINAL PAIN (Abdominal pain), ASTHENIA (overall weakness), MYALGIA (body pain), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown and JOINT NOISE (When working cracking sound/body crack) and ILLNESS (Sick for 1-2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Computerised tomogram: trance of pericardial effusion (abnormal) It did not show any problem, but at the end of the report it showed one short sentence: trance of pericardial effusion.         No concomitant medication information was provided. No treatment medication was provided. Symptoms were appeared during the night. Patient felt so sick, had no high fever, abdominal pain, headache, body crack, body aches which were related to 2nd dose and lasted for 2-3 days cracking. Patient mentioned never tested positive for COVID. Mentioned that in the past had sometime abdominal pain on the right site, but never experience all this things before. About 5-7 years ago, patient mention having high blood pressure, used to feel something in the throat goin to the chest, like to the heart, but no longer. and recently had been diagnosed with high blood sugar, no need for medication.  Company comment: This spontaneous case concerns a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious event of Pericardial effusion after mRNA- 1273 vaccine. The event occurred approximately 43 days after the second dose of mRNA- 1273 vaccine. Trace amounts of pericardial fluid were noted on a CT scan, performed due to an episode of Abdominal pain and Pyrexia. The patient did not experienced cardiac symptoms and did not require medical interventions. Pericardial effusion was automatically upgraded as serious. However, given that trace amounts of pericardial fluid are often a physiologic finding and no medical intervention was required, it was assessed as non-serious. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious event of Pericardial effusion after mRNA- 1273 vaccine. The event occurred approximately 43 days after the second dose of mRNA- 1273 vaccine. Trace amounts of pericardial fluid were noted on a CT scan, performed due to an episode of Abdominal pain and Pyrexia. The patient did not experienced cardiac symptoms and did not require medical interventions. Pericardial effusion  was automatically upgraded as serious. However, given that trace amounts of pericardial fluid are often a physiologic finding and no medical intervention was required, it was assessed as non-serious. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.