Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Clostridium difficile colitis, Decreased appetite, Diarrhoea
Clinical narrative: The tumor is now growing around her trachea and esophagus; hepatoid adenocarcinoma of the lung; The tumor is now growing around her trachea and esophagus; C. diff; The tumor is now growing around her trachea and esophagus; seizures; edema from the tumors in her head.; took imaging showing 3 tumors in her; coughing up blood; shortness of breath; Fever; Chills; aches / pain; lack of appetite; lack of energy; Nausea; Diarrhea; felt super sick again; couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of LUNG ADENOCARCINOMA (hepatoid adenocarcinoma of the lung), SEIZURE (seizures), BRAIN OEDEMA (edema from the tumors in her head.), METASTASES TO TRACHEA (The tumor is now growing around her trachea and esophagus), PYREXIA (Fever), CHILLS (Chills), PAIN (aches / pain), DECREASED APPETITE (lack of appetite), ASTHENIA (lack of energy), NAUSEA (Nausea), DIARRHOEA (Diarrhea), ILLNESS (felt super sick again), BEDRIDDEN (couldn't get out of bed), HAEMOPTYSIS (coughing up blood), DYSPNOEA (shortness of breath), TRACHEAL NEOPLASM (The tumor is now growing around her trachea and esophagus), CLOSTRIDIUM DIFFICILE COLITIS (C. diff), METASTASES TO OESOPHAGUS (The tumor is now growing around her trachea and esophagus) and BRAIN NEOPLASM (took imaging showing 3 tumors in her) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Ex-smoker (Patient had quit smoking 14 years ago.).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (Fever) (seriousness criteria hospitalization, medically significant and life threatening), CHILLS (Chills) (seriousness criteria hospitalization, medically significant and life threatening), PAIN (aches / pain) (seriousness criteria hospitalization, medically significant and life threatening), DECREASED APPETITE (lack of appetite) (seriousness criteria hospitalization, medically significant and life threatening), ASTHENIA (lack of energy) (seriousness criteria hospitalization, medically significant and life threatening), NAUSEA (Nausea) (seriousness criteria hospitalization, medically significant and life threatening), DIARRHOEA (Diarrhea) (seriousness criteria hospitalization, medically significant and life threatening), ILLNESS (felt super sick again) (seriousness criteria hospitalization, disability, medically significant and life threatening) and BEDRIDDEN (couldn't get out of bed) (seriousness criteria hospitalization, disability, medically significant and life threatening). In May 2021, the patient experienced HAEMOPTYSIS (coughing up blood) (seriousness criteria hospitalization, disability, medically significant and life threatening) and DYSPNOEA (shortness of breath) (seriousness criteria hospitalization, disability, medically significant and life threatening). On 06-Jul-2021, the patient experienced BRAIN NEOPLASM (took imaging showing 3 tumors in her) (seriousness criteria hospitalization, disability, medically significant and life threatening). On 04-Oct-2021, the patient experienced SEIZURE (seizures) (seriousness criteria hospitalization, disability, medically significant and life threatening) and BRAIN OEDEMA (edema from the tumors in her head.) (seriousness criteria hospitalization, disability, medically significant and life threatening). On an unknown date, the patient experienced LUNG ADENOCARCINOMA (hepatoid adenocarcinoma of the lung) (seriousness criteria hospitalization, disability, medically significant and life threatening), METASTASES TO TRACHEA (The tumor is now growing around her trachea and esophagus) (seriousness criteria hospitalization, disability, medically significant and life threatening), TRACHEAL NEOPLASM (The tumor is now growing around her trachea and esophagus) (seriousness criteria hospitalization, disability, medically significant and life threatening), CLOSTRIDIUM DIFFICILE COLITIS (C. diff) (seriousness criteria hospitalization, disability, medically significant and life threatening) and METASTASES TO OESOPHAGUS (The tumor is now growing around her trachea and esophagus) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was treated with METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) for C.difficile colitis, at an unspecified dose and frequency; FENTANYL for Pain, at an unspecified dose and frequency and PEMBROLIZUMAB (KEYTRUDA) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, LUNG ADENOCARCINOMA (hepatoid adenocarcinoma of the lung), SEIZURE (seizures), BRAIN OEDEMA (edema from the tumors in her head.), METASTASES TO TRACHEA (The tumor is now growing around her trachea and esophagus), PYREXIA (Fever), CHILLS (Chills), PAIN (aches / pain), DECREASED APPETITE (lack of appetite), ASTHENIA (lack of energy), NAUSEA (Nausea), DIARRHOEA (Diarrhea), ILLNESS (felt super sick again), BEDRIDDEN (couldn't get out of bed), HAEMOPTYSIS (coughing up blood), DYSPNOEA (shortness of breath), TRACHEAL NEOPLASM (The tumor is now growing around her trachea and esophagus), CLOSTRIDIUM DIFFICILE COLITIS (C. diff), METASTASES TO OESOPHAGUS (The tumor is now growing around her trachea and esophagus) and BRAIN NEOPLASM (took imaging showing 3 tumors in her) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Biopsy lung: lung adenocarcinoma (abnormal) Lung adenocarcinoma. On an unknown date, Chest X-ray: golf ball sized mass (abnormal) golf ball sized mass.         No concomitant medication reported.  Patient's HCP prescribed her antibiotics, which did not help and on returning a week later she received a Chest X-ray which showed a golf ball sized mass. She then went to a cancer center post 06 Jul 2021 where they biopsied the mass in her lung, and took image showing 3 tumors in her brain. She was told she had limited treatment options, but started radiation for the 3 spots on her brain and chemotherapy for the mass on her lung. She also tried using Keytruda and immunology treatments. The cancer is a hepatoid adenocarcinoma of the lung. The tumor was growing around her trachea and esophagus.   The neurologist in the ER said that the seizures were a result of edema from the tumors in her head. She continued to be in the ER and had been placed on a breathing tube.  Patient had quit smoking 14 years ago.  Company Comment: This case concerns a 74 year old female patient with medical history of ex-smoker, who experienced serious unexpected events of lung adenocarcinoma, metastases to trachea, metastases to esophagus , brain tumor and seizure after second dose of mRNA-1273. The events occurred approximately 2 months after second dose. The re-challenge is not applicable as we are not expecting another dose. The events were considered related to the product as per the reporter's assessment. The benefit-risk relationship of Spikevax in not affected by this report.   This case was linked to MOD-2021-341271.; Sender's Comments: This case concerns a 74 year old female patient with medical history of ex-smoker, who experienced serious unexpected events of lung adenocarcinoma, metastases to trachea, metastases to esophagus , brain tumor and seizure after second dose of mRNA-1273. The events occurred approximately 2 months after second dose. The re-challenge is not applicable as we are not expecting another dose. The events were considered related to the product as per the reporter's assessment. The benefit-risk relationship of in not affected by this report.