Sex: M
Vaccine: COVID19
Symptoms: Breast cancer metastatic, Cardiac assistance device user, Cardiac disorder, Heart rate abnormal, Positron emission tomogram
Clinical narrative: 6 weeks after patient taking the Moderna COVID shot, patient was admitted to the hospital because said heart was pausing, flatlined.; has severe pulmonary hypertension; Patient has a pacemaker; has no electrical impulse in heart; rash/ was scratching and  whole back was covered with spots, which is a rash to  caller.; Metastatic breast cancer stage IV B; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BREAST CANCER METASTATIC (Metastatic breast cancer stage IV B), HEART RATE ABNORMAL (6 weeks after patient taking the Moderna COVID shot, patient was admitted to the hospital because said heart was pausing, flatlined.) and PULMONARY HYPERTENSION (has severe pulmonary hypertension) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) tablet for Metastatic breast cancer.    The patient's past medical history included Throat cancer (patient has a damaged throat from a cancer treatment 33 years ago).   In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2023, the patient started PALBOCICLIB (IBRANCE) (Oral use) 125 milligram once a day. In 2021, the patient experienced HEART RATE ABNORMAL (6 weeks after patient taking the Moderna COVID shot, patient was admitted to the hospital because said heart was pausing, flatlined.) (seriousness criteria hospitalization and medically significant). In June 2023, the patient experienced BREAST CANCER METASTATIC (Metastatic breast cancer stage IV B) (seriousness criterion medically significant). On an unknown date, the patient experienced PULMONARY HYPERTENSION (has severe pulmonary hypertension) (seriousness criterion medically significant), CARDIAC ASSISTANCE DEVICE USER (Patient has a pacemaker), CARDIAC DISORDER (has no electrical impulse in heart) and RASH (rash/ was scratching and  whole back was covered with spots, which is a rash to  caller.). At the time of the report, BREAST CANCER METASTATIC (Metastatic breast cancer stage IV B), HEART RATE ABNORMAL (6 weeks after patient taking the Moderna COVID shot, patient was admitted to the hospital because said heart was pausing, flatlined.), PULMONARY HYPERTENSION (has severe pulmonary hypertension), CARDIAC ASSISTANCE DEVICE USER (Patient has a pacemaker), CARDIAC DISORDER (has no electrical impulse in heart) and RASH (rash/ was scratching and  whole back was covered with spots, which is a rash to  caller.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2023, Positron emission tomogram: was not only in 1 lymph node, but 2 lymph nodes under the arm, and in pelvic bone, in the right ramus of pubic area..  The patient was taking medications for heart and lungs.    It was reported that patient got the Moderna COVID shots at the end of Jan-2021 and the end of Feb-2021, and by mid Apr-2021 patient was in the hospital. Patient took Ibrance and had a real difficult time swallowing, like almost had to do Heimlich maneuver on patient.  It was reported that for one month was breast cancer, next month was under the arm, and the next month was in the bone, that was how fast it was going. First time noticed was in Jun 2023, but no one said anything, then saw again in Jul 2023 and was in breast and under left arm in 1 lymph node. Then in Aug2023 did PET scan, was not only in 1 lymph node, but 2 lymph nodes under the arm, and in pelvic bone, in the right ramus of pubic area. Patient had a pacemaker, had no electrical impulse in heart, has had a cardioversion. Had a septostomy in June and thought as closed up now. The patient was going in on day of report for bloodwork. In Apr2023 had 2 iron infusions and in Sep2023 patient had 2 more iron infusions. Reporter stated patient just had a lot of issues.  Company Comment: This is a Spontaneous case concerning a male patient of an unknown age with no relevant medical history reported, who experienced the serious (per medically significant) unexpected events of Breast cancer metastatic, Heart rate abnormal (Hospitalization) and Pulmonary hypertension. The event of heart rate abnormal (reported as heart was pausing, flatlined) occurred about 6 weeks after a dose of mRNA-1273 for COVID-19 Vaccination and pulmonary hypertension on an unknown onset date and latency. Breast cancer metastatic occurred about 2 years and a half after Moderna vaccination. Based on the lack of pharmacological plausibility, natural etiopathogenesis of the event and the non-suggestive long latency, causality for event of breast cancer metastatic remains not suspected. It was reported that the patient had a pacemaker, had no electrical impulse in heart, has had a cardioversion and had a septostomy. The benefit-risk relationship of mRNA-1273 is not affected by this report.