Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies positive, Contusion, SARS-CoV-2 test
Clinical narrative: Development of Lupus anticoagulant factor; bruising; This is a spontaneous report received from contactable reporter(s) (Physician) via COVACES. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Other medical history: Cholesterol; "Prostate" (unspecified if ongoing), notes: Other medical history: Prostate; "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose number: 2, product: COVID 19, brand: Pfizer, administration date: 05Feb2021 , location: Left arm, facility: Hospital), administration date: 05Feb2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (dose number: 1, product: COVID 19, brand: Pfizer, administration date: 14Jan2021 , location: Left arm, facility: Hospital), administration date: 14Jan2021, when the patient was 70-year-old, for Covid-19 Immunization. No other vaccine in four weeks.  The following information was reported: ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (disability, life threatening) with onset May2022, outcome "not recovered", described as "Development of Lupus anticoagulant factor"; CONTUSION (disability, life threatening) with onset May2022, outcome "not recovered", described as "bruising". Clinical course: Development of Lupus anticoagulant factor noted and developed bruising after vaccine injection. Adverse events development of Lupus anticoagulant factor and bruising resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event), disability or permanent damage. The events "development of lupus anticoagulant factor" and "bruising" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Covid test post vaccination. Patient never had any abnormal blood tests prior to vaccine, or any bleeding abnormalities. Therapeutic measures were not taken as a result of antiphospholipid antibodies positive, contusion.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; 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 serious events, ANTIPHOSPHOLIPID ANTIBODIES POSITIVE, CONTUSION  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.