Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Peripheral swelling, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; DVT/PE; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; This is a spontaneous report from a contactable Physician. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 22Mar2021 (at the age of 44-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 19Apr2021 as single dose for COVID-19 immunisation. Medical history included obesity s/p Gastric bypass, iron deficiency anemia, gastritis, depression, remote history of lung surgery for empyema/lobectomy. Patient is allergic to Lanzoprazole and Vantin. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her usual home medications (unspecified) within 2 weeks of vaccination. On 28May2021, the patient was presented to hospital after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli. The seriousness of all the events was reported as serious (hospitalization/Prolonged hospitalization). The reporting physician stated that it was unclear regarding the relatedness between second dose of vaccine and the events, but the patient does not have any other known history to provoke DVT/PE. The patient underwent lab tests and procedures which included SARS-CoV-2 Test: Negative (Nasal swab) on 28May2021. Since the vaccination, the patient tested for COVID-19. The device (unspecified) date was reported as 29May2021. The patient received anticoagulation as treatment for pulmonary embolism. The outcome of all the events was reported as unknown.  Information about batch no/lot no has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pulmonary embolism, deep vein thrombosis, dyspnoea  and peripheral swelling cannot be totally excluded. 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.