Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Peripheral swelling, Pulmonary thrombosis, Tenderness
Clinical narrative: Deep vein thrombosis left leg; blood clots in bilateral lungs; i had left calf swelling and tenderness; i had left calf swelling and tenderness; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID:  The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 59 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure treated for 10 years" (unspecified if ongoing), notes: high blood pressure treated for 10 years; "anxiety" (unspecified if ongoing); "sleep apnea with CPAP" (unspecified if ongoing); "Covid-19", start date: Aug2021 (unspecified if ongoing), notes: I also had a bad case of COVID Aug2021. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine brand = Pfizer / BioNTech, Vaccine brand unknown= False, Administration date= 13Jul2022, Vaccine administration time= 12:00 PM, Vaccine lot number=2908, Vaccine lot unknown = False, Vaccine dose number=4, Vaccine dose number unknown=False , Vaccine location=Left arm), administration date: 13Jul2022, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (Vaccine brand = Pfizer / BioNTech, Vaccine brand unknown= False, Administration date= 24Sep2021, Vaccine lot number= 30/55BA, Vaccine lot unknown = False, Vaccine dose number=3, Vaccine dose number unknown=False , Vaccine location= Right arm), administration date: 24Sep2021, when the patient was 58-year-old, for Covid-19 immunization; BNT162b2 (Vaccine brand = Pfizer / BioNTech, Vaccine brand unknown= False, Administration date= 13Jan2021, Vaccine lot number= EK9231, Vaccine lot unknown = False, Vaccine dose number=2, Vaccine dose number unknown=False , Vaccine location= Right arm), administration date: 13Jan2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Vaccine brand = Pfizer / BioNTech, Vaccine brand unknown= False, Administration date= 22Dec2020, Vaccine lot number= EK5730, Vaccine lot unknown = False, Vaccine dose number=1, Vaccine dose number unknown=False , Vaccine location= Left arm), administration date: 22Dec2020, when the patient was 57-year-old, for Covid-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 23Oct2022, outcome "recovering", described as "Deep vein thrombosis left leg"; PULMONARY THROMBOSIS (medically significant) with onset 23Oct2022, outcome "recovering", described as "blood clots in bilateral lungs"; PERIPHERAL SWELLING (non-serious), TENDERNESS (non-serious) all with onset 23Oct2022, outcome "recovering" and all described as "i had left calf swelling and tenderness". The events "deep vein thrombosis left leg" and "blood clots in bilateral lungs" required emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary thrombosis.  Clinical course: Patient was not pregnant, No Other medications in two weeks, No known allergies. Description of Event Outcome I received the bivalent vaccine on 06Oct2022 on 21Oct2022 I traveled by car 3 hours. stopping twice. I attended a college football game on 22Oct Lots of sitting and standing and walking. On Sunday 23Oct i had left calf swelling and tenderness. It progressed. I went to the ER on 24Oct and had blood clots in the left leg and in both lungs. I am fine but wanted you to be aware. I also had a bad case of COVID Aug2021. Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events and the suspect drug BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug 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.