Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ST segment depression, Fatigue, Heart rate
Clinical narrative: EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself).  A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient  saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA).  The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; 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 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.