Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations, Uterine haemorrhage
Clinical narrative: Had extreme uterine bleeding; Palpitations; increased pulse rate; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 27Sep2021 08:00 (Lot number: 772589) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; LO LOESTRIN FE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK5730, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 06Jan2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "uterine bleeding"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EK5730, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 06Jan2021, when the patient was 47  old, for Covid-19 immunization, reaction(s): "palpitations"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 16Dec2020, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: UTERINE HAEMORRHAGE (medically significant) with onset Oct2021, outcome "recovered", described as "Had extreme uterine bleeding"; PALPITATIONS (non-serious) with onset Oct2021, outcome "recovered", described as "Palpitations"; HEART RATE INCREASED (non-serious) with onset Oct2021, outcome "recovered", described as "increased pulse rate". The events "had extreme uterine bleeding", "palpitations" and "increased pulse rate" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (Oct2021) increased. Therapeutic measures were taken as a result of uterine haemorrhage, palpitations, heart rate increased. Additional information: There was no other vaccine in four weeks. Patient Had extreme uterine bleeding last week of Jan2021 and first week of Oct2021 after the vaccine doses; required a Depo Provera shot to get the bleeding to stop. At that time patient did not know this could be related to vaccine; also had some heart palpitations after 2nd Covid shot but did not attribute to the shot until she received the booster dose in September and began having constant heart palpitations and increased pulse rate; saw a cardiologist for work up; was indeed having palpitations was placed on Metoprolol. Recently read an article stating these could be related to the vaccine and thought she should report. Patient did not have covid prior vaccination, did not have covid tested post vaccination. Known allergies were reported as No.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering a plausible drug-event temporal relationship, a causal association between the reported uterine bleeding and the suspect product BNT162B2 cannot be completely excluded. Case will be reassessed once with additional information. 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.