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VAERS Report 2157391

Case Report Section

Vaer Report Details

Age: NA

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: fn1448


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-01-31
Date of Onset
375
Number of days (onset date – vaccination date)
375
Adverse Event Description

left, lateral region of the middle third calf, with apparently perforating venous branch thrombosis; this is a non-interventional study report from the agency regulatory authority-web. regulatory number: it-minisal02-844345. a 61 year-old female patient received bnt162b2 (comirnaty), intramuscular, administration date 31jan2021 (lot number: fn1448) as dose 1, single for covid-19 immunisation. relevant medical history included: "venous thrombosis deep (limbs)" (unknown if ongoing), notes: previous dvt right upper limb venipuncture site; "saphenectomy" (unknown if ongoing), notes: right. family history included: "familial risk factor" (unknown if ongoing), notes: paternal family history of venous pathology. the patient's concomitant medications were not reported. the following information was reported: venous thrombosis (medically significant) with onset 10feb2022, outcome "not recovered", described as "left, lateral region of the middle third calf, with apparently perforating venous branch thrombosis". the patient underwent the following laboratory tests and procedures: ultrasound doppler: thrombosis of venous branch, notes: on the left lateral region of the calf middle third, present thrombosis of venous branch, apparently perforates; ultrasound scan: 3.5 mm, notes: compression ultrasonography:3.5 mm extended & lt; 5 cm. therapeutic measures were taken as a result of venous thrombosis included clexane 4000ui 0.4 ml. sender's comment: the report comes from the regulatory authority study. all the data in our possession has already been entered. the reporter's assessment of the causal relationship of the "left, lateral region of the middle third calf, with apparently perforating venous branch thrombosis" with the suspect product(s) bnt162b2 was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected.; sender's comments: based on the current available limited information in the case provided, the causal association between the event venous thrombosis and the use of suspect product bnt162b2 cannot be fully 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

Lab Data
test name: venous doppler lowe limbs; result unstructured data: test result:thrombosis of venous branch; comments: on the left lateral region of the calf middle third, present thrombosis of venous branch, apparently perforates; test name: diagnostic ultrasound; result unstructured data: test result:3.5 mm; comments: compression ultrasonography:3.5 mm extended & lt; 5 cm
List of symptoms
ultrasound doppler ultrasound scan venous thrombosis
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na