Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pulmonary embolism, Pulmonary function test
Clinical narrative: mild side effects ( after both doses); died of a pulmonary embolism/shower of tiny blood clots" in her lungs; she hurt her knee exercising.; She had torn her minescous.; shortness of breath/trouble catching my breath/looked like she stopped breathing; she felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (died of a pulmonary embolism/shower of tiny blood clots" in her lungs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient never a smoker and did not had any unhealthy habits.Since Covid started in March 2020, she never got sick once. Never a cold or sniffles.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FATIGUE (she felt tired). In September 2021, the patient experienced DYSPNOEA (shortness of breath/trouble catching my breath/looked like she stopped breathing). In October 2021, the patient experienced JOINT INJURY (she hurt her knee exercising.) and MENISCUS INJURY (She had torn her minescous.). On 26-Apr-2022, the patient experienced PULMONARY EMBOLISM (died of a pulmonary embolism/shower of tiny blood clots" in her lungs) (seriousness criteria death and medically significant). On an unknown date, the patient experienced IMMUNISATION REACTION (mild side effects ( after both doses)). The patient died on 26-Apr-2022. The reported cause of death was Pulmonary embolism. An autopsy was performed. At the time of death, IMMUNISATION REACTION (mild side effects ( after both doses)), DYSPNOEA (shortness of breath/trouble catching my breath/looked like she stopped breathing), JOINT INJURY (she hurt her knee exercising.), MENISCUS INJURY (She had torn her minescous.) and FATIGUE (she felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Pulmonary function test: normal (normal) Normal. On 26-Apr-2021, Heart rate: never got a pulse (abnormal) never got a pulse. On 26-Apr-2021, Oxygen saturation: no reading showed (abnormal) no reading showed. On an unknown date, Blood iron: low (Low) Low iron. On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) normal.         No concomitant product was provided. The patient was in medical field as a certified registered nurse anesthetist. She experienced mild side effects post shot. In Sep 2021she and her husband went to state. She complained of shortness of breath the first day out there, but that was it. She felt fine the rest of the trip. In Oct 2021, she hurt her knee exercising. She had torn her meniscus. The tear was so small, the orthopedic doctor said surgery was not required. He suggested her to take 12 weeks off. She rested her knee for 12 weeks to let it heal. On 05 Apr 2021 she told her daughter that she was experiencing shortness of breath when going up the stairs. She went to a pulmonologist. The blood work she had gotten done was to test to see if she was genetically predisposed to any clotting disorders. All of those came back negative. On Monday 25 April 2021 pulmonary functions test done. That night she told she felt tired, but that was normal for her after a work day. On April 26, at 7:58 am ambulance called as she had trouble breathing. She reached hospital around 8:30 am. In emergency room it was told that she passed. She had trouble catching breath. Her heart and lungs sounded fine. The pulse oximeter and no reading, she was still talking and suddenly stopped talking and then shortly thereafter, looked like she stopped breathing. Her husband started doing CPR. At one point while he was doing CPR on her, her eyes popped back open and she started to lift her head up, but then it fell back to the floor and her eyes closed again. The medics in the ambulance never got a pulse on her and the ER doctor never got a pulse on her in the hospital. The autopsy was done. The medical examiner found a shower of tiny blood clots in her lungs and told her she died of a pulmonary embolism. Medical examiner thought that a big clot formed in her sleep Monday night. The reporter believed that the vaccine made her and sedentary. Patient died on 26 Apr 2022 around 8:30 am.  Company Comment This spontaneous case concerns a 63-year-old female patient with relevant medical history of knee injury and prolonged rest, who experienced the unexpected serious(death) AESI of Pulmonary embolism, 1-year 3months after receiving the 2nd dose of mRNA-1273 vaccine. Immediately after the shot, the patient had experienced mild symptoms (unspecified). Seven months later she had brief episode of shortness of breath. A month later she suffered knee injury with a small meniscal tear. An orthopaedician saw her, ruled out the need for surgery and advised rest for 12 weeks. The patient rested her knee for the said period and by the end, developed shortness of breath while climbing stairs. She consulted a pulmonologist and was screened for any genetic predisposition for clotting disorders  they all were negative.  Pulmonary function test was done which turned out to be normal. The same night she complained of tiredness, but later resolved. The next day she was found unconscious, CPR was attempted at home but by the time the ambulance and medics arrived, she did not have any pulse or O2 saturation. An autopsy was done which revealed pulmonary embolism. Details of concurrent conditions, concomitant medications, detailed clinical course, further investigation reports and treatment were not provided. The patient has received the two primary doses of mRNA-1273 vaccine. Age of the patient could be a risk factor. Medical history of knee injury and prolonged rest remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-584085.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with relevant medical history of knee injury and prolonged rest, who experienced the unexpected serious(death) AESI of Pulmonary embolism, 1-year 3months after receiving the 2nd dose of mRNA-1273 vaccine. Immediately after the shot, the patient had experienced mild symptoms (unspecified). Seven months later she had brief episode of shortness of breath. A month later she suffered knee injury with a small meniscal tear. An orthopaedician saw her, ruled out the need for surgery and advised rest for 12 weeks. The patient rested her knee for the said period and by the end, developed shortness of breath while climbing stairs. She consulted a pulmonologist and was screened for any genetic predisposition for clotting disorders  they all were negative.  Pulmonary function test was done which turned out to be normal. The same night she complained of tiredness, but later resolved. The next day she was found unconscious, CPR was attempted at home but by the time the ambulance and medics arrived, she did not have any pulse or O2 saturation. An autopsy was done which revealed pulmonary embolism. Details of concurrent conditions, concomitant medications, detailed clinical course, further investigation reports and treatment were not provided. The patient has received the two primary doses of mRNA-1273 vaccine. Age of the patient could be a risk factor. Medical history of knee injury and prolonged rest remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Pulmonary embolism