Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy trachea, Bronchitis, Metastases to soft tissue, Metastases to spine, Metastases to the mediastinum
Clinical narrative: metastases to her mediastinum; metastases to her soft tissue of her neck; metastases to her thoracic spine and lumbar spine; found to have a tumor, they ruled out lymphoma, but suspected to have a small cell lung carcinoma/Had biopsy and debulking of tracheal tissue and they were unable to diagnose origin of cancerous cells; began having respiratory issues and was treated for bronchitis; This spontaneous case was reported by a nurse and describes the occurrence of NEOPLASM MALIGNANT (found to have a tumor, they ruled out lymphoma, but suspected to have a small cell lung carcinoma/Had biopsy and debulking of tracheal tissue and they were unable to diagnose origin of cancerous cells), METASTASES TO THE MEDIASTINUM (metastases to her mediastinum), METASTASES TO SOFT TISSUE (metastases to her soft tissue of her neck) and METASTASES TO SPINE (metastases to her thoracic spine and lumbar spine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced BRONCHITIS (began having respiratory issues and was treated for bronchitis). In July 2022, the patient experienced NEOPLASM MALIGNANT (found to have a tumor, they ruled out lymphoma, but suspected to have a small cell lung carcinoma/Had biopsy and debulking of tracheal tissue and they were unable to diagnose origin of cancerous cells) (seriousness criterion medically significant). On an unknown date, the patient experienced METASTASES TO THE MEDIASTINUM (metastases to her mediastinum) (seriousness criterion medically significant), METASTASES TO SOFT TISSUE (metastases to her soft tissue of her neck) (seriousness criterion medically significant) and METASTASES TO SPINE (metastases to her thoracic spine and lumbar spine) (seriousness criterion medically significant). The patient was treated with Immunotherapy (autoimmune therapy and a newchemotherapy) for Neoplasm malignant; Immunotherapy (autoimmune therapy and a new chemotherapy) for Metastases to the mediastinum; Immunotherapy (autoimmune therapy and a new chemotherapy) for Metastases to soft tissue and Immunotherapy (autoimmune therapy and a new chemotherapy) for Metastases to spine. At the time of the report, NEOPLASM MALIGNANT (found to have a tumor, they ruled out lymphoma, but suspected to have a small cell lung carcinoma/Had biopsy and debulking of tracheal tissue and they were unable to diagnose origin of cancerous cells), METASTASES TO THE MEDIASTINUM (metastases to her mediastinum), METASTASES TO SOFT TISSUE (metastases to her soft tissue of her neck), METASTASES TO SPINE (metastases to her thoracic spine and lumbar spine) and BRONCHITIS (began having respiratory issues and was treated for bronchitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy trachea: unable to diagnose the origin of the cancerous cells.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that 2 months after the most recent booster dose she began having respiratory issues and was treated for bronchitis. At the beginning of June she was found to have a tumor, they ruled out lymphoma, but she was suspected to have a small cell lung carcinoma. She then had a biopsy and debulking of her tracheal tissue. She now has metastases to her mediastinum, soft tissue of her neck, thoracic spine, and lumbar spine.  She was also currently taking autoimmune therapy and a new chemotherapy.   This spontaneous case concerns a 71-year-old female patient, with no medical history reported, who experienced the serious (Medically Significant) unexpected events of Neoplasm malignant (reported as found to have a tumor, they ruled out lymphoma, but suspected to have a small cell lung carcinoma/Had biopsy and debulking of tracheal tissue and they were unable to diagnose origin of cancerous cells), metastases to mediastinum, metastases to soft tissue and metastases to spine approximately 8 months after receiving a booster dose of mRNA-1273 vaccine. The patient received first and second doses of mRNA-1273 vaccine at 28 days interval. 2 months after the most recent booster dose she began having respiratory issues and was treated for bronchitis. 5 months later,  she was found to have a tumor, lymphoma was ruled out, but she was suspected to have a small cell lung carcinoma. She then had a biopsy and debulking of her tracheal tissue. Origin of the cancerous cells was unable to be found. She now has metastases to her mediastinum, soft tissue of her neck, thoracic spine, and lumbar spine.  She was also currently taking autoimmune therapy and a new chemotherapy. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old female patient, with no medical history reported, who experienced the serious (Medically Significant) unexpected events of Neoplasm malignant (reported as found to have a tumor, they ruled out lymphoma, but suspected to have a small cell lung carcinoma/Had biopsy and debulking of tracheal tissue and they were unable to diagnose origin of cancerous cells), metastases to mediastinum, metastases to soft tissue and metastases to spine approximately 8 months after receiving a booster dose of mRNA-1273 vaccine. The patient received first and second doses of mRNA-1273 vaccine at 28 days interval. 2 months after the most recent booster dose she began having respiratory issues and was treated for bronchitis. 5 months later,  she was found to have a tumor, lymphoma was ruled out, but she was suspected to have a small cell lung carcinoma. She then had a biopsy and debulking of her tracheal tissue. Origin of the cancerous cells was unable to be found. She now has metastases to her mediastinum, soft tissue of her neck, thoracic spine, and lumbar spine.  She was also currently taking autoimmune therapy and a new chemotherapy. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.