Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 025C20A | IM |
shadows in her lungs; lung cancer; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (lung cancer) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 025C20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In September 2024, the patient experienced LUNG NEOPLASM MALIGNANT (lung cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced LUNG DISORDER (shadows in her lungs). The patient was treated with Pembrolizumab (Keytruda) for Cancer, at an unspecified dose and frequency. At the time of the report, LUNG NEOPLASM MALIGNANT (lung cancer) and LUNG DISORDER (shadows in her lungs) was resolving. No concomitant medications were provided. The patient had received 2nd dose of Moderna Covid-19 vaccine in Feb-2022. The other batch/lot numbers were reported as 017M20A, 066K214 and A43914B. The patient found out she had lung cancer in Sep-2024 after her last vaccine on 06-Apr-2024. The patient also had Keytruda for the cancer, but the doctor took her off because it was making shadows in her lungs. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-790634 (Patient Link).; Reporter's Comments: Due to lack of biological plausibility, the causality of the event lung cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.