Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Dysphagia, Lung neoplasm malignant, Metastases to lymph nodes
Clinical narrative: Was diagnosed with lung cancer / Had the lung cancer cut out, it went into her lymph nodes; Blood pressure shot up to 170/ her blood pressure went into the 150s & 160s/ Blood pressure fluctuated; Was diagnosed with myocarditis; She then had the lung cancer cut out, it went into her lymph nodes; She couldn't swallow very well; The glands in her throat were swollen & she couldn't swallow very well.; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (Was diagnosed with lung cancer / Had the lung cancer cut out, it went into her lymph nodes), BLOOD PRESSURE FLUCTUATION (Blood pressure shot up to 170/ her blood pressure went into the 150s & 160s/ Blood pressure fluctuated), METASTASES TO LYMPH NODES (She then had the lung cancer cut out, it went into her lymph nodes) and MYOCARDITIS (Was diagnosed with myocarditis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Patient has a 30 year history of hypertension but no heart disease.). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure fluctuation, POTASSIUM CHLORIDE (K-TAB), ATENOLOL, MAGNESIUM OXIDE (MAGOX) and FOLIC ACID for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced LUNG NEOPLASM MALIGNANT (Was diagnosed with lung cancer / Had the lung cancer cut out, it went into her lymph nodes) (seriousness criteria hospitalization and medically significant), BLOOD PRESSURE FLUCTUATION (Blood pressure shot up to 170/ her blood pressure went into the 150s & 160s/ Blood pressure fluctuated) (seriousness criteria hospitalization and medically significant), MYOCARDITIS (Was diagnosed with myocarditis) (seriousness criteria hospitalization and medically significant) and PHARYNGEAL SWELLING (The glands in her throat were swollen & she couldn't swallow very well.). On an unknown date, the patient experienced METASTASES TO LYMPH NODES (She then had the lung cancer cut out, it went into her lymph nodes) (seriousness criterion medically significant) and DYSPHAGIA (She couldn't swallow very well). The patient was treated with Radiotherapy (Chemotherapy) for Lung neoplasm malignant and Radiotherapy (Chemotherapy) for Metastases to lymph nodes. At the time of the report, LUNG NEOPLASM MALIGNANT (Was diagnosed with lung cancer / Had the lung cancer cut out, it went into her lymph nodes), METASTASES TO LYMPH NODES (She then had the lung cancer cut out, it went into her lymph nodes), MYOCARDITIS (Was diagnosed with myocarditis), PHARYNGEAL SWELLING (The glands in her throat were swollen & she couldn't swallow very well.) and DYSPHAGIA (She couldn't swallow very well) outcome was unknown and BLOOD PRESSURE FLUCTUATION (Blood pressure shot up to 170/ her blood pressure went into the 150s & 160s/ Blood pressure fluctuated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: 143 (abnormal) Was down to 143 the next morning after hospitalization, 150-160 (abnormal) Two days after overnight stay, blood pressure went into 150s and 160s. and 170 (abnormal) Blood pressure shot up to 170. In May 2021, X-ray: abnormal (abnormal) Diagnosed myocarditis and a spot on her lung that was lung cancer.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After getting the 2nd dose, she was diagnosed with myocarditis & lung cancer. About a week & a half or 2 weeks after the 2nd dose she was at work & her blood pressure shot up to 170. She went to Hospital, they did an x-ray, & diagnosed her with myocarditis & saw the spot on her lung that turned out to be cancer. Her Two days after the overnight stay at Hospital her blood pressure went into the 150s & 160s, she went to Facility, she rested, they observed her, & her blood pressure went down.  Company comment: This case concerns a 60-years-old female patient, with reported medical history of Hypertension, who experienced the serious expected AESI of Myocarditis and the serious unexpected events of Lung neoplasm malignant, Blood pressure fluctuation and Metastases to lymph nodes. Additionally, other non-serious events were also reported.  The events occurred on an unknown date after the administration of the second dose of mRNA-1273 vaccine.  The events Myocarditis, Lung neoplasm malignant and Blood pressure fluctuation were assessed with the seriousness criteria of Hospitalization and Medically Significant and the event of Metastases to lymph nodes was assessed with the seriousness criteria of Medically Significant. At the time of the report, the outcome for the events was Unknown for all the events except for the event of Blood pressure fluctuation which was Not Recovered/Not Resolved. It was reported that the patient was admitted to the hospital where a chest X-ray was performed, and Myocarditis was diagnosed.  Additionally, a lung opacity was detected and finally diagnosed as cancer.  Patient had chemotherapy as treatment.  Reported medical history of Hypertension remains as a confounder for the event of Blood pressure fluctuation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-451654.; Sender's Comments: This case concerns a 60-years-old female patient, with reported medical history of Hypertension, who experienced the serious expected AESI of Myocarditis and the serious unexpected events of Lung neoplasm malignant, Blood pressure fluctuation and Metastases to lymph nodes. Additionally, other non-serious events were also reported.  The events occurred on an unknown date after the administration of the second dose of mRNA-1273 vaccine.  The events Myocarditis, Lung neoplasm malignant and Blood pressure fluctuation were assessed with the seriousness criteria of Hospitalization and Medically Significant and the event of Metastases to lymph nodes was assessed with the seriousness criteria of Medically Significant. At the time of the report, the outcome for the events was Unknown for all the events except for the event of Blood pressure fluctuation which was Not Recovered/Not Resolved. It was reported that the patient was admitted to the hospital where a chest X-ray was performed, and Myocarditis was diagnosed.  Additionally, a lung opacity was detected and finally diagnosed as cancer.  Patient had chemotherapy as treatment.  Reported medical history of Hypertension remains as a confounder for the event of Blood pressure fluctuation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.