Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Fatigue, Headache, Palpitations, Pyrexia
Clinical narrative: Heart palpitations; Heart skipping a beat; Headaches; Fatigue; Mild fever; Pain at the site of the injection; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03May2021 12:20 (lot number: EW0161) at the age of 39-years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (ongoing); "ADHD" (ongoing); and "Palpitations" (unspecified if ongoing), notes: once every 2 years in the past 8-10 years. Concomitant medications included: SERTRALINE taken for anxiety (ongoing); METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing); PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE] taken as supplementation therapy (ongoing); and MINIPIL [LEVONORGESTREL] taken for contraception (ongoing). Vaccination history included: BNT162B2 (batch/lot number: ER8732, in left arm at 15:25 as dose 1, single), administration date: 12Apr2021, when the patient was 39-years-old, for COVID-19 immunisation. The following information was reported: PALPITATIONS (disability) with onset 07Nov2021 06:00, outcome "not recovered", described as "Heart palpitations"; EXTRASYSTOLES (disability) with onset 07Nov2021 06:00, outcome "not recovered", described as "Heart skipping a beat"; HEADACHE (disability) with onset 07Nov2021 06:00, outcome "recovered" (14Nov2021), described as "Headaches"; FATIGUE (non-serious) with onset 07Nov2021 06:00, outcome "recovered" (10Nov2021), described as "Fatigue"; PYREXIA (non-serious) with onset 07Nov2021 06:00, outcome "recovered" (08Nov2021), described as "Mild fever"; and VACCINATION SITE PAIN (non-serious) with onset 07Nov2021 06:00, outcome "not recovered", described as "Pain at the site of the injection". The events "heart palpitations" and "heart skipping a beat" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2021) negative. Therapeutic measures were taken as a result of palpitations, extrasystoles, headache, fatigue, pyrexia, and vaccination site pain and included treatment with TYLENOL.  Clinical course: The patient experienced heart palpitations (heart skipping a beat), headaches for one week, fatigue for three days, mild fever for one day, and pain at the site of the injection. She has experienced these palpitations once every 2 years in the past 8-10 years. They have been very rare such that she could not even "catch" them when she tried to check her pulse. Since the shot however, she knew that her heartbeat was delayed & then going faster. She has been able to document them using her watch's ECG app/ function. She has no COVID prior to vaccination and has no known allergies. There were no other vaccines in four weeks. Her maternal grandfather had high blood pressure and heart arrhythmia.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. 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.