Age: 93.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, COVID-19 immunisation, Colitis, Interchange of vaccine products, Pericardial effusion
Clinical narrative: pericardial effusion; Pneumonia; colitis; UTI; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of PERICARDIAL EFFUSION (pericardial effusion) and PNEUMONIA (Pneumonia) in a 93-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Jan-2023, the patient experienced COVID-19 (tested positive for COVID). On an unknown date, the patient experienced PERICARDIAL EFFUSION (pericardial effusion) (seriousness criterion medically significant), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), COLITIS (colitis), URINARY TRACT INFECTION (UTI), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, PERICARDIAL EFFUSION (pericardial effusion), PNEUMONIA (Pneumonia), COLITIS (colitis), URINARY TRACT INFECTION (UTI), COVID-19 (tested positive for COVID), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.  Company comment: This spontaneous case concerns a 93 year old female patient with no reported medical history, who experienced the unexpected serious (medically significant) events of Pericardial effusion and Pneumonia, unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine. The patient received a dose of co suspect Pfizer COVID 19 vaccine on an unknown date. Thus, an interchange of vaccine products and COVID-19 immunisation (Revaccination with different COVID-19 vaccine) were noted in the case. Patient tested positive for SARS-CoV-2 test after completing vaccination with Pfizer and Moderna vaccines. Since then she had colitis, urinary tract infection, pneumonia and pericardial effusion. Treatment was reported as palliative care. No information on risk factors, detailed clinical course, other relevant investigations and outcome was available in the report. Elderly age of the patient could be a risk factor for the events. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.