Received Feb 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | AS7162B | IM |
developed pneumonia; Asthma; liver problems; developed RSV; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (developed pneumonia) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) dosage was changed to 1 dosage form. 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. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (developed pneumonia) (seriousness criterion medically significant), ASTHMA (Asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV). At the time of the report, PNEUMONIA (developed pneumonia) had not resolved and ASTHMA (Asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV) outcome was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medication was reported. This case was linked to MOD-2025-782184 (Patient Link). Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.