Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Thyroid function test normal, Ventricular extrasystoles
Clinical narrative: Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with chest tightness; A little atelectasis in lower left lung; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left deltoid on 14Jan2021 09:00 at single dose for covid-19 immunization. Medical history included ongoing does not have a thyroid; allergies/intolerance to gluten and dairy, allergies to molds, dust and some seasonal allergies; all ongoing. Concomitant medication included levothyroxine from Feb2013 to unspecified date, from unspecified date and ongoing for "does not have a thyroid". The patient previously took codeine and experienced allergic reaction occurred at 13 years of age with unknown cough syrup with codeine, levaquin and experienced allergic reaction occurred probably while she was in her 20s (age in years). She had fallen asleep on the couch about 9:00 pm on 14Jan2021. She woke up about 9:30 pm on 14Jan2021 and had an elevated pulse with chest tightness. She had to go to the emergency room in response to elevated pulse with chest tightness. In the emergency room they were not able to do anything other than hydrate her and all of that but it took about 12-13 more hours for her elevated pulse to come down (15Jan2021). Her biggest question was that she saw where some reactions are fast heart beat but she was kind of surprised at how long after the dose was administered that she had onset of the elevated pulse. She saw Cardiologist 18Jan2021 related to this event and the Cardiologist was a little baffled by the event. She reported event as improved, although she still has a little bit of tightness in her chest which goes in a little bit of phases. The Cardiologist told her to still take the second dose as scheduled of the Pfizer COVID-19 Vaccine. She did not see her family doctor, she saw the Cardiologist only as referred after emergency room visit. She was not admitted to the hospital; she was treated and kept under observation in the emergency room for about 5.5 hours. She has a stress test scheduled for next week. She is planning to still get the second dose as scheduled of Pfizer COVID-19 Vaccine but she is a little scared to get it due to this adverse event. She thought the events were related with the vaccine, she had no problem prior to getting the vaccine. On 14Jan2021, pulse was 146 beats per minute which she checked with a pulse oximeter machine she has at home so she knows it is accurate; Chest x-ray: She reported that result of a little atelectasis in lower left lung was a little weird. On 18Jan2021, the EKG result was Normal sinus rhythm but throwing PVCs. She reported she knows her thyroid lab is normal because it was checked in the emergency room during visit starting 14Jan2021. The outcome of the events elevated pulse with chest tightness was recovering, other events was unknown.; 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.