Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypercholesterolaemia, Magnetic resonance imaging, Nausea, Paralysis
Clinical narrative: Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move; tremor increased; post COVID syndrome & orthostatic hypertension.; post COVID syndrome & orthostatic hypertension.; Lymph node pain; Tilt Table Testing confirmed Covid-induced POTS; mild injection site pain; COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain).; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID; dizzy; Fatigue; vasovagal response; Passed out; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:30 (Lot Number: EL9261) (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant.  Medical history included infectious mononucleosis (Recent mono) in 2020 (Spring), urinary tract infection (UTI) in 2020 (Summer), venous Insufficiency on Dec2020, shingles in past on an unspecified date, lactose & gluten intolerance from an unknown date and unknown if ongoing, COVID-19 from Jun2020 to an unknown date  (I had recovered from mild COVID in Jun and Oct2020 that required no hospitalization and was managed with DAYQUIL, XYZAL, Prednisone, Vit D and melatonin). Concomitant medications included ibuprofen at 2400 mg and 800 mg; pregabalin (LYRICA); progesterone; bifidobacterium bifidum/bifidobacterium lactis/bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus (PROBIOTIC), all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient experienced mild injection site pain, COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain), dizzy, fatigue, vasovagal response, passed out, nausea, throwing up, tremor increased, chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move, post COVID syndrome and orthostatic hypertension, tilt table testing confirmed COVID-induced POTS (postural orthostatic tachycardia syndrome) and lymph node pain, all on 05Feb2021 at 11:00.  All events were serious disabling and required hospitalization. The patient underwent lab tests and procedures which included computerized tomogram (CT): unknown results on an unspecified date, D-dimer: 1300 is very elevated, it shows that I have a lot of inflammation in my body or I could have the clot, 1300, almost 3 times the normal value; magnetic resonance imaging head (MRI): unknown results on an unspecified date, SARS-COV-2 test (nasal swab): negative on 19Feb2021, tilt table test: COVID-induced pots on 05Feb2021 . Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the event passed out was unknown and not recovered for all the other events.; 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 reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  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.