Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
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 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (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. Concomitant product use was not provided by the reporter. Patient had 5 doses of Moderna vaccines and had asthma, liver problems, developed RSV, developed pneumonia and it had taken 15 months for lungs but still not fully healed. Reporter causality was not reported. Treatment information was not provided. This case was linked to MOD-2025-782183 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2025: Live significant follow-up received: Patient age, event verbatim and outcome updated and reference ID added.; Reporter's Comments: Company comment: Pneumonia and respiratory syncytial virus infection were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.