Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound Doppler
Clinical narrative: In total she's had five blood clots/ three in her right leg and two in her left leg; had some pain in her toe; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 20Jul2022, this case contains serious adverse reaction(s) and all safety information is processed together.  This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 2, single (Lot number: EN6203) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "heart attack", start date: 2018 (unspecified if ongoing), notes: Had stents in her heart placed. He put her on plavix, aspirin 81mg and 2 heart pills; "pain" (unspecified if ongoing); "Left mastectomy", start date: 1999 (unspecified if ongoing), notes: done 23 years ago and she had chemo; "Broken hip", start date: 12Aug2018 (unspecified if ongoing), notes: was in the hospital on the 12Aug2018 and was sent to a nursing home on the 15Aug2018.; "Blood thinner" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL taken for myocardial infarction (ongoing); PLAVIX taken for anticoagulant therapy, start date: 2018; ASPIRIN [ACETYLSALICYLIC ACID] taken for anticoagulant therapy, myocardial infarction, start date: 2018 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Batch/lot number: EL9265, injection right arm), administration date: 01Feb2021, when the patient was 76-year-old, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant, life threatening) with onset 2021, outcome "unknown", described as "In total she's had five blood clots/ three in her right leg and two in her left leg"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "had some pain in her toe". The event "had some pain in her toe" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound Doppler: blood clots, notes: they were able to see she had blood clots. Therapeutic measures were taken as a result of thrombosis.  Clinical course: After the second dose she had some pain in her toe, and went to see the doctor because her toe was sore. With the doppler they were able to see she had blood clots. They called the cardiologist and the cardiologist said that they can put some stents in her legs and they put 3 stents in in the right leg in Jul2021. They did some more stents in her left leg in Sep2021 at the heart center. Caller said that her previous cardiologist, (name withheld), did the stents in Jul2021 and Sep2021. She was thinking if she takes the vaccine again she does not want to get another clot. She is nervous about taking it and wants to know if the blood clots are reported side effects.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Thrombosis and Pain in extremity. 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.,Linked Report(s) : US-PFIZER INC-202200993577 same patient, different drug dose, similar event;