Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Palpitations, Product use issue
Clinical narrative: headache; fatigue; fever; dose received: 3; Other vaccine same date vaccine date 13Nov2021; experiencing persistent heart palpitations that happen approximately once per minute; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 18:10 (Lot number: 3230BD) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 13Nov2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "ADHD" (unspecified if ongoing); "birth control" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "palpitations" (ongoing), notes: palpitations once every 2 years in the past 8-10 years.; "Nutritional supplementation" (unspecified if ongoing). Family history included: "high blood pressure" (unspecified if ongoing), notes: Maternal grandfather had high blood pressure.; "heart arrhythmia" (unspecified if ongoing), notes: Maternal grandfather had heart arrhythmia. Concomitant medication(s) included: SERTRALINE taken for anxiety (ongoing); METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing); MINI PILL taken for contraception (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 for nutritional supplementation (ongoing). Vaccination history included: Bnt162b2 (Dose no: 1 , lot number=ER8732, administration time=03:15 PM, vaccine location=Left arm), administration date: 12Apr2021, when the patient was 39 years old, for COVID-19 Immunization; Bnt162b2 (Dose no: 2, lot number=EW0161,  , administration time=12:15 PM, vaccine location=Left arm), administration date: 03May2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 13Nov2021 18:30, outcome "unknown", described as "dose received: 3"; PRODUCT USE ISSUE (medically significant) with onset 13Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 13Nov2021"; PALPITATIONS (medically significant) with onset 2021, outcome "not recovered", described as "experiencing persistent heart palpitations that happen approximately once per minute"; HEADACHE (medically significant) with onset 14Nov2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 14Nov2021, outcome "recovered" (2021), described as "fatigue"; PYREXIA (non-serious) with onset 14Nov2021, outcome "recovered" (2021), described as "fever". The event "experiencing persistent heart palpitations that happen approximately once per minute" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Aug2021) negative, notes: Before the sy started. It was unknown if therapeutic measures were taken as a result of palpitations. Therapeutic measures were taken as a result of headache. Flu shot at the same time as the third COVID vaccine. The patient had not received any other vaccines in four weeks. The patient had no COVID prior vaccination and had not been tested for COVID post vaccination. The patient had no known allergies. The patient received the covid vaccine on 13Nov2021 (booster) and started experiencing persistent heart palpitations that happen approximately once per minute. They happen for 3-5 hours and subside for approximately 1 hour and start again. They appear to worsen when she nurse her infant son and / or when she was stressed (her toddles screaming and / or her older kids doing something that may be dangerous). She had experienced these palpititions 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 (vaccine) however she knew that her heart beat delayed and then going faster. She have been able to document them using her watch ECG app / function.  Follow-up (22Dec2021): This is a spontaneous follow-up report from a contactable other HCP. This other HCP reported in response to HCP letter sent in a cross-reference case which included new events (palpitations aggravated, headache, fatigue, pyrexia), relevant medical history, concomitant medication, treatment drug details, lab data and additional information in narrative.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.