Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Flushing, Headache, Tachycardia
Clinical narrative: Tachycardia; tightness in chest; shortness of breath; headache; Lightheaded; Flushing of the face; Elevated blood pressure; This is a spontaneous report from a contactable nurse. This nurse reported for a 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318) intramuscular to deltoid right on 05Feb2021 10:45 at single dose for covid-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and asthma. She was allergic to shellfish, latex (asthma) and foods. Concomitant medications included drospirenone and ethinyl estradiol; oxybutynin, MULTIVITAMIN, probiotics and colecalciferol (VITAMIN D3); drospirenone, ethinylestradiol betadex clathrate (YAZ). On 05Feb2021 10:45, the patient had tightness in chest, shortness of breath, headache, lightheaded, flushing of the face and elevated blood pressure. AE resulted in doctor or other healthcare professional office/clinic visit. The patient took Benadryl as a treatment for the events. As of 10Mar2021, Patient received vaccine at 10:45. Patient came to ask for help at 11:05, it was reported the patient require medical intervention Corticosteroids; Other (please specify), Pepcid. the patient seen in the Emergency Department. the patient not hospitalized. the patient not admitted to an Intensive Care Unit. It was reported signs and symptoms involved organ involvement includes Multiorgan: Yes, Cardiovasccular (tachycardia Vitals taken at hospital); Respiratory (tightness in chest shortness of breath); Patient has started taking metoprolol for elevated blood pressure and hydroxyzine.  On 05Feb2021, the patient underwent electrocardiogram (EKG) and results was unknown. The patient did not receive any recent vaccines for any other conditions or for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported or around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient provided information regarding the reported adverse events with the use of the product. It was considered that there was no causal effect for Pfizer product to the adverse event. Outcome of the event tachycardia was unknown and rest of the events was recovering.  Follow-up (10Mar2021): New information received from a contactable Nurse reported for a patient in response to HCP letter sent included: Case upgraded to serious, Suspect drug details (anatomical location), Medical history details (foods allergy, latex (asthma)), New lab test (EKG), New event (tachycardia) and Clinical information.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the serious events cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.