Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Heavy menstrual bleeding, Impaired quality of life, Mental disorder, Polymerase chain reaction
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 39-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 20Jan2021 14:00 (at age of 39-years-old) as dose 2, single for COVID-19 immunization at hospital. Medical history included adenomyosis, allergies to egg, peanut and clarithromycin allergy. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 20Jan2021 14:00, the patient experienced bleeding every day and have been having extremely heavy nonstop menstrual cycles since getting the vaccine. On an unknown date, the patient experienced disrupted my mental health and disrupted my life in such a way that i have stopped exercising. It was reported as she was having extremely heavy non stop menstrual cycles since getting the vaccine. She was placed on progesterone to make it stop then was placed on a progesterone iud to make the bleeding stop and it still has not stopped. It has been 6 months and the patient was still bleeding every day since getting the vaccine. To the point that it has disrupted her mental health and disrupted her life in such a way that she had stopped exercising and/or been able to wear clothes that she used to for fear that she was going to bleed through them or ruin her clothes. Laboratory tests included polymerase chain reaction on 25May2021: negative (nasal swab). The patient received treatment with progesterone pills and iud replacement. The clinical outcome of the events bleeding every day and have been having extremely heavy nonstop menstrual cycles since getting the vaccine was not recovered and the events disrupted my mental health and disrupted my life in such a way that i have stopped exercising was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Hemorrhage 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.