Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lung neoplasm malignant
Clinical narrative: Patient was diagnosed with lung cancer in November of 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of LUNG NEOPLASM MALIGNANT (Patient was diagnosed with lung cancer in November of 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 081B21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 1991 and Colitis collagenous (Patient had an autoimmune disease called collagenous colitis for 10 years.). Concurrent medical conditions included Lung nodule (patient had lung nodule for years before getting the vaccine that they were watching.). Concomitant products included PREDNISONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LUNG NEOPLASM MALIGNANT (Patient was diagnosed with lung cancer in November of 2021) (seriousness criterion medically significant). The patient was treated with Surgery (The lung nodule removed) for Lung neoplasm malignant. At the time of the report, LUNG NEOPLASM MALIGNANT (Patient was diagnosed with lung cancer in November of 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Biopsy: abnormal (abnormal) Patient had two biopsies on lung nodule and diagnosed with lung cancer..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had third dose for the immunocompromised. Patient wanted to know whether she can take fourth dose and about the dosage form is.  Company comment:This spontaneous case concerns a 74-year-old female patient, with medical history of breast cancer, and lung nodule, who experienced the serious (medically significant) unexpected event of Lung neoplasm malignant. The patient received first 2 doses of mRNA 1273 COVID-19 vaccine with 29 days interval, and a 3rd dose of mRNA 1273 vaccine 6 months after. Patient had lung nodule years prior the vaccine, and approximately 2 months after the third dose, the lung nodule was biopsied twice and diagnosed as Lung Cancer. She underwent surgery to remove the lung nodules. The patient's history of breast cancer and the presence of the lung nodule years prior to the vaccine are confounders to the event Lung Cancer. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old female patient, with medical history of breast cancer, and lung nodule, who experienced the serious (medically significant) unexpected event of Lung neoplasm malignant. The patient received first 2 doses of mRNA 1273 COVID-19 vaccine with 29 days interval, and a 3rd dose of mRNA 1273 vaccine 6 months after. Patient had lung nodule years prior the vaccine, and approximately 2 months after the third dose, the lung nodule was biopsied twice and diagnosed as Lung Cancer. She underwent surgery to remove the lung nodules. The patient's history of breast cancer and the presence of the lung nodule years prior to the vaccine are confounders to the event Lung Cancer. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.