Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test positive, Thrombosis
Clinical narrative: The patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, administered on Right deltoid on 06Jan2021 and Her second dose was 19Feb2021); The patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, administered on Right deltoid on 06Jan2021 and Her second dose was 19Feb2021); superficial blood clot; This is a spontaneous report from a contactable other HCP. This 31-Year-Old female other HCP(patient) reported that she received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK6201, Expiry Date: Unknown), via an unspecified route of administration, administered on Right deltoid on 19Feb2021 (vaccinated at the age of 31 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231, Expiry Date: Unknown), via an unspecified route of administration, administered on Right deltoid on 06Jan2021 at 12:00 PM (vaccinated at the age of 31 years) as DOSE 1, SINGLE for covid-19 immunization. COVID-19 vaccine was administered in hospital. Medical history included varicose vein and allergy to Penicillin. Concomitant medication(s) received within 2 weeks of vaccination included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) and buspirone. The patient was not pregnant at the time of vaccination and at the time of report. Prior to vaccination, patient was not diagnosed with COVID. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was exposed to covid the same week, she was given the 1st vaccine. She was tested positive for covid via a nasal swab on 11Jan2021 and her 1st vaccine was given on 06Jan2021. Her second dose was 19Feb2021.On 21Feb2021 (2 days after the second dose), she developed her first superficial blood clot. Since then she had 4 total. The AE resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of superficial blood clot. She had to have a laser vein treatment since. She also had multiple ultrasounds. She always had varicose veins but they had never given me any trouble until after the vaccines and covid. The outcome of event was unknown.  Device Date : 23Jun2021  Information on lot/batch number was available. Additional information has been requested.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.; 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 thrombosis,Inappropriate schedule of vaccine administered and off label use 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.