Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Heart palpitations; increased heart rate; SOB; chest pain; throat closing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 12:00 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PALPITATIONS (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "Heart palpitations"; HEART RATE INCREASED (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "increased heart rate"; DYSPNOEA (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "SOB"; CHEST PAIN (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "chest pain"; THROAT TIGHTNESS (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "throat closing". The events "heart palpitations", "increased heart rate", "sob", "chest pain" and "throat closing" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (19Nov2021) increased. Therapeutic measures were taken as a result of palpitations, heart rate increased, dyspnoea, chest pain, throat tightness. The patient received treatment with Epi pen, iv fluid, fantomide, Benadryl and prednisone.  Clinical course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: Heart palpitations, increased heart rate, SOB, chest pain, throat closing. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. It was reported that Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.