Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary embolism; tested positive for Covid/shortness of breath/severe cough/headache; tested positive for Covid/shortness of breath/severe cough/headache; This is a spontaneous report from a contactable nurse (patient). The nurse reported similar events for herself and her daughter. This is the first of two cases.   A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the first dose administered in the right arm on 14Mar2021 (Batch/Lot Number: EN6208) and the second dose administered in the left arm on 03Apr2021 at 10:45 (Batch/Lot Number: ER8737), both intramuscular as a single dose for COVID-19 immunization.  Medical history included diabetes and high blood pressure both diagnosed 5 years ago, GERD and hypercholesteremia, all ongoing. The patient was a former smoker but has been smoke-free for 15 years. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for hypercholesterolaemia from an unspecified start date and ongoing; lisinopril (manufacturer unknown) taken for high blood pressure from an unspecified start date and ongoing; metformin (manufacturer unknown) taken for diabetes from an unspecified start date and ongoing and omeprazole (manufacturer unknown) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing.  The patient did not have any prior vaccinations within 4 weeks of the COVID vaccine. The patient reported that she and her daughter had their second dose of the vaccine on 03Apr2021. The patient tested positive for Covid. The patient developed shortness of breath on Sunday, 11Apr2021, and ended up with a pulmonary embolism. The patient doesn't know if she was possibly infected before they got the second vaccine and were asymptomatic and unknown or did they get infected when got they got the vaccine with thousands of other people. At the time of the report, the patient was mostly resolved and they are all home. She became short of breath, had severe cough and headache and she went to the ER and on the CAT scan they discovered she had a small pulmonary emboli. She was hospitalized from 11Apr2021-12Apr2021. The patient was given Eliquis and monoclonal antibodies as treatment for the events. The patient stated that she will be on Eliquis for the next month because of the pulmonary embolism. The patient did not need any additional therapies for COVID-19. The patient did not have any pre-existing diseases that worsened during the SARS-CoV2 infection. The outcome of the event 'tested positive for Covid/shortness of breath/severe cough/headache' was not recovered while the outcome of the event pulmonary embolism was recovering. The relatedness of the suspect drug to the reactions  was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears reasonable that the suspect drug did not contribute to the development of the reported event pulmonary embolism, that most likely was related to the concurrent development of COVID-19. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021413236 same reporter and drug, similat event, different patient