Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Hormone level abnormal, Menstrual disorder, Menstruation delayed, Palpitations
Clinical narrative: Patient has been suicidal because of this; Her mood plummeted likely because of hormones; Her mood plummeted likely because of hormones; Patient missed her period, she was 2 weeks late; Bleeding ever since; heart palpitations daily; It has completely taken her quality of life; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 13:30 (Lot number: VA7485) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC; KETAMINE; REXULTI; PROPRANOLOL. The following information was reported: SUICIDAL IDEATION (disability, medically significant) with onset 06Aug2021 12:00, outcome "not recovered", described as "Patient has been suicidal because of this"; DEPRESSED MOOD (disability), HORMONE LEVEL ABNORMAL (disability) all with onset 06Aug2021 12:00, outcome "not recovered" and all described as "Her mood plummeted likely because of hormones"; MENSTRUATION DELAYED (disability) with onset 06Aug2021 12:00, outcome "not recovered", described as "Patient missed her period, she was 2 weeks late"; MENSTRUAL DISORDER (disability) with onset 06Aug2021 12:00, outcome "not recovered", described as "Bleeding ever since"; PALPITATIONS (disability) with onset 06Aug2021 12:00, outcome "not recovered", described as "heart palpitations daily"; QUALITY OF LIFE DECREASED (disability) with onset 06Aug2021 12:00, outcome "not recovered", described as "It has completely taken her quality of life". The events "patient has been suicidal because of this", "her mood plummeted likely because of hormones", "her mood plummeted likely because of hormones", "patient missed her period, she was 2 weeks late", "bleeding ever since", "heart palpitations daily" and "it has completely taken her quality of life" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Jan2022) negative, notes: Nasal swab. Therapeutic measures were not taken as a result of suicidal ideation, depressed mood, hormone level abnormal, menstruation delayed, menstrual disorder, palpitations, quality of life decreased. Additional information: patient did not receive other vaccine in four weeks. Patient did not have Covid-19 prior to vaccination. Patient had no known allergies. The patient (reporter) stated there was absolutely no other reason for this other than the vaccine.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Suicidal ideation, Depressed mood, Hormone level abnormal, MENSTRUATION DELAYED, MEN-STRUAL DISORDER, PALPITATIONS, and QUALITY OF LIFE DECREASED and BNT162B2.  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.