Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: covid 19,She went to the ER and was diagnosed with Covid-19 /mild fever, all of her shots she had a fever/headache/fatigue; bad shortness of breath. Her primary healthcare provider told her she might have a pulmonary embolism; covid with Pneumonia/3 days after, she had shortness of breath; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (covid 19,She went to the ER and was diagnosed with Covid-19 /mild fever, all of her shots she had a fever/headache/fatigue), PULMONARY EMBOLISM (bad shortness of breath. Her primary healthcare provider told her she might have a pulmonary embolism) and COVID-19 PNEUMONIA (covid with Pneumonia/3 days after, she had shortness of breath) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced PULMONARY EMBOLISM (bad shortness of breath. Her primary healthcare provider told her she might have a pulmonary embolism) (seriousness criteria disability and medically significant) and COVID-19 PNEUMONIA (covid with Pneumonia/3 days after, she had shortness of breath) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced COVID-19 (covid 19,She went to the ER and was diagnosed with Covid-19 /mild fever, all of her shots she had a fever/headache/fatigue) (seriousness criterion disability). At the time of the report, COVID-19 (covid 19,She went to the ER and was diagnosed with Covid-19 /mild fever, all of her shots she had a fever/headache/fatigue), PULMONARY EMBOLISM (bad shortness of breath. Her primary healthcare provider told her she might have a pulmonary embolism) and COVID-19 PNEUMONIA (covid with Pneumonia/3 days after, she had shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: Positive. In September 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient was diagnosed with COVID-19 in Jun-2022 and in Sep-2022.  The patient was a runner and now she could not run as much as she did before.  No treatment medications were reported.  Company comment: This spontaneous case concerns an 83-years-old, female patient with no medical history reported, who experienced unexpected serious (medically significant and disability) events of pulmonary embolism (AESI), Covid-19 pneumonia and unexpected serious (medically significant )event of COVID-19 that occurred in context to a dose of mRNA1273 vaccine. Vaccination dose number and vaccination schedule is not disclosed.The outcome of the events were reported as not resolved.  Patient was SARS-CoV-2 test positive with COVID-19, where Patient did not require hospitalization or supplementary oxygen therapy. After 3 months patient was initially diagnosed as pulmonary embolism however diagnosed with COVID-19 pneumonia with positive SARS-CoV-2 test positive. It was reported that the patient was a runner and now she could not run as much as she did before. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Live Follow-up document received includes reporter details and events were added.; Sender's Comments: This spontaneous case concerns an 83-years-old, female patient with no medical history reported, who experienced unexpected serious (medically significant and disability) events of pulmonary embolism (AESI), Covid-19 pneumonia and unexpected serious (medically significant )event of COVID-19 that occurred in context to a dose of mRNA1273 vaccine. Vaccination dose number and vaccination schedule is not disclosed. The outcome of the events were reported as not resolvedPatient was SARS-CoV-2 test positive with COVID-19, where Patient did not require hospitalization or supplementary oxygen therapy. After 3 months patient was initially diagnosed as pulmonary embolism however diagnosed with COVID-19 pneumonia with positive SARS-CoV-2 test positive. It was reported that the patient was a runner and now she could not run as much as she did before. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness based on medical judgement.