Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tachycardia, Thrombosis, Transient ischaemic attack
Clinical narrative: hospitalized on day 13 with TIA stroke symptoms and high d dimer; sudden hypothyroid; hypertension 156/100; tachycardia 156; 3 doses of IV steroids and multiple imaging for other clots; hospitalized on day 13 with TIA stroke symptoms and high d dimer; developed a DVT 2 days after the vaccine in my left leg; Had an anaphylactic reaction within 30 minutes of the vaccine/severe autoimmune reaction to the vaccine; tongue tingling, swelling; tongue tingling, swelling; moderate throat swelling; itchy rash; Covid toes; sudden bruising; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Fc3181, expiry date not reported) via an unspecified route of administration, administered in right arm on 30Jul2021 16:45 (at the age of 40 years old), as dose 1, single for covid-19 immunisation. Medical history included gulf war illness, asthma, allergies, Ehler danlos, known allergies to penicillins, and being monitored for autoimmune disease but not diagnosed. The patient had covid prior vaccination (date unspecified). Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole, sertraline, celecoxib (CELEBREX), and pregabalin (LYRICA), all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took anthrax vaccine as immunization and experienced neurocardiogenic syncope; and patient had known allergies to doxycycline, clindamycin, duloxetine hydrochloride (CYMBALTA), and higher doses of sertraline. The patient was covid tested post vaccination which included oral swab negative on 12Aug2021. Patient had an anaphylactic reaction within 30 minutes of the vaccine (30Jul2021 05:15 PM) with tongue tingling, swelling, moderate throat swelling. These reactions continued for 2 weeks and throat and tongue kept swelling off and on. Patient also developed an itchy rash and covid toes and sudden bruising on 30Jul2021 05:15 PM. Patient was hospitalized with TIA stroke symptoms and high d dimer, sudden hypothyroid, hypertension 156/100 and tachycardia 156, that all began on 12Aug2021 (also reported as on day 13). Patient received 3 doses of IV steroids and multiple imaging for other clots (12Aug2021). Patient believed patient developed a DVT on 01Aug2021, also reported as 2 days after the vaccine, in the left leg but it had seemed to resolve with aspirin so patient did not go to the ER until patient had stroke symptoms on 12Aug2021. Doctors contributed my symptoms to a severe autoimmune reaction to the vaccine (anaphylactic reaction). Adverse events (AEs) resulted in emergency room/department or urgent care, hospitalization for 3 days (12Aug2021 to 15Aug2021), life threatening illness (immediate risk of death from the event), and disability or permanent damage. Therapeutic measures were taken as a result of the events reported which included mag sulfate, high dose solu-medrol, aspirin, and atorvastatin. The event "developed a DVT 2 days after the vaccine in left leg" was recovered on an unspecified date in 2021. The outcome of the other events reported was not recovered.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events paraesthesia oral ,swollen tongue,  pharangeal swelling, ill defined disorder, contusion, transient ischaemic attack, hypothyroidism, hypertension, tachycardia, thrombosis, deep vein thrombosis,and cerebrovascular accident cannot be 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.