Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pneumonia, Pyrexia, Ultrasound scan, Venous thrombosis limb
Clinical narrative: leg swelling; ultrasound showed an occlusive clot in her femoral artery; femoral vein clot; had pneumonia; fever; developed chills; then chest pain; shortness of breath; This is a spontaneous report from a contactable physician. An 82-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19), dose 2 intramuscularly administered in the right arm on 04Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization.  Medical history included hypertension, hypothyroidism and osteoporosis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19) on an unspecified date for Covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); calcium; acetylcysteine, calcium levomefolate, mecobalamin (METAFOLBIC PLUS); losartan; hydrochlorothiazide; denosumab (PROLIA) and trazodone; all indication, start and stop date were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that in the evening of the vaccination (04Mar2021), she developed chills and fever, then chest pain and shortness of breath. The physician obtained a CXR (chest x-ray) on the patient on 04Mar2021 and found that she had pneumonia. She was treated with levofloxacin and prednisone. The physician rechecked her in one week and gave her Kenalog injection and Rocephin injection. The physician rechecked her on 22Mar2021 and she was improved, but she returned to the office 12Apr2021 with left leg swelling. The ultrasound on 12Apr2021 showed an occlusive clot in her femoral artery. The patient was admitted to the hospital (Apr2021) for 1 day and placed on heparin, then sent home on Eliquis. The adverse events resulted in doctor or other healthcare professional office/clinic visit and the patient received treatment which included antibiotics and steroids for pneumonia and blood thinners for the femoral vein clot. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events leg swelling, occlusive clot in her femoral artery and femoral vein clot were recovered on Apr2021 while the outcome of the other events was recovered on 22Mar2021.  Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events peripheral swelling, peripheral artery thrombosis and venous thrombosis limb and the suspect drug BNT162B2 cannot be excluded.The case will be reassessed once new information is available.  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 Committees, and Investigators, as appropriate.