Sex: U
Vaccine: COVID19-2
Symptoms: Iron deficiency, Loss of personal independence in daily activities, Pulmonary embolism, Tachycardia
Clinical narrative: I have pulmonary embolism from the COVID vaccine; Depleting her iron stores; my iron was 7, it is supposed to be over 20; my life 4 months has been really bad; My heart rate would go up every time I walked, took a shower; I couldn't even stand, just standing my heart rate would be 112; my heart rate would be 112, 115 and this has been going on; Depleting her iron stores; my iron was 7, it is supposed to be over 20; my life 4 months has been really bad; Short of breath; Chest pain; I have hypertension but it is a result of one of my cancer treatment (Unspecified medication); This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (I have pulmonary embolism from the COVID vaccine) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOPOTECAN for Ovarian cancer.    Concurrent medical conditions included Ovarian cancer. Concomitant products included METOPROLOL for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and TOPOTECAN (unknown route) at an unspecified dose. On an unknown date, the patient experienced PULMONARY EMBOLISM (I have pulmonary embolism from the COVID vaccine) (seriousness criterion medically significant), IRON DEFICIENCY (Depleting her iron stores; my iron was 7, it is supposed to be over 20; my life 4 months has been really bad), TACHYCARDIA (My heart rate would go up every time I walked, took a shower; I couldn't even stand, just standing my heart rate would be 112; my heart rate would be 112, 115 and this has been going on), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Depleting her iron stores; my iron was 7, it is supposed to be over 20; my life 4 months has been really bad), DYSPNOEA (Short of breath), CHEST PAIN (Chest pain) and HYPERTENSION (I have hypertension but it is a result of one of my cancer treatment (Unspecified medication)). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (I have pulmonary embolism from the COVID vaccine), IRON DEFICIENCY (Depleting her iron stores; my iron was 7, it is supposed to be over 20; my life 4 months has been really bad), TACHYCARDIA (My heart rate would go up every time I walked, took a shower; I couldn't even stand, just standing my heart rate would be 112; my heart rate would be 112, 115 and this has been going on), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Depleting her iron stores; my iron was 7, it is supposed to be over 20; my life 4 months has been really bad), DYSPNOEA (Short of breath), CHEST PAIN (Chest pain) and HYPERTENSION (I have hypertension but it is a result of one of my cancer treatment (Unspecified medication)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: iron was 7, it is supposed to be over 20. On an unknown date, Heart rate: just standing heart rate would be 112 and 115.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Patient had 5 doses of it, but then patient had taken of it and after received 2 doses then had2 week off and then received 3 doses weekly. That was about 3 month ago, 4 month ago patient had noticed that heart rate would go up everytime while walking and took a shower. As long as patient was sitting sedentary, it was fine. Patient could not even stand, just standing heart rate would be 112 and had a portable ox to check it. Consumer stated that it was chemotherapy. It was given intravenously. Patient had many lab test and was on experiment.  Company comment: This is a spontaneous case concerning a patient of unknown age with relevant medical history of ovarian cancer, who experienced the unexpected serious (medically significant) AESI of pulmonary embolism. The event occurred after a dose of mRNA-1273.222 vaccine. Patient started treatment with Eliquis. No further information disclosed about diagnostic tests performed or treatments received. The medical history remains as a confounder. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.; Reporter's Comments: This is a spontaneous case concerning a patient of unknown age with relevant medical history of ovarian cancer, who experienced the unexpected serious (medically significant) AESI event of pulmonary embolism. The event occurred after a dose of mRNA-1273.222 vaccine. Patient started treatment with Eliquis. No further information disclosed about diagnostic tests performed or treatments received. The medical history remains as a confounder. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.