Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: heavy menstrual bleeding/excessive menstrual bleeding; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW0198), via an unspecified route of administration, administered in arm right on 07Jul2021 11:00 as dose 1, single for covid-19 immunization. The patient has no medical history. The patient has no history of previous immunizations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccines received on the same day as the Pfizer covid-19 vaccine. Concomitant medications included calcium for women's health taken for years and ongoing; and multivitamin for health taken for years and ongoing. The patient reported heavy menstrual bleeding/excessive menstrual bleeding on Jul2021, following administration of the first dose of the Pfizer BioNTech Covid-19 Vaccine. The patient was not sure if the bleeding began a couple of days before her vaccine or a couple of days after, but the bleeding has since gotten heavier. The excessive menstrual bleeding had worsened. She denied history of previous bleeding events to this degree or use of blood thinners. She has not yet spoken with her doctor about this. Since the vaccination, she has been having menstrual bleeding that has gotten heavier and has been excessive. She has never had anything like this in her life. She connects this as a side effect from the first dose of the vaccine. She will probably not take the second dose. She has spoken to the pharmacist about this. She was not sure when she started bleeding; she doesn't do a good job keeping up with it. The bleeding started either a day or two before or after getting the vaccine. She asked for information regarding whether this has happened to other recipients of the vaccine, if this could be caused by the vaccine, and how long symptoms may last. She wondered if she should get the second dose of the Pfizer BioNTech Covid-19 vaccine after experiencing this event. She asked if the vaccine was still effective if the second dose was given later than 21 days after the first dose. Regarding her questions, she was responded with "The authorized EUA Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine does not list menstrual changes as adverse reaction from clinical studies and post authorization experience. Pfizer has received reports of menstrual cycle (period) changes since the Pfizer-BioNTech COVID-19 Vaccine was authorized for use. These cases have not been proven to be a result of vaccination of the Pfizer-BioNTech COVID-19 Vaccine. The North American Society of Pediatric and Adolescent Gynecology (NASPAG) is an organization that provides leadership in education, research and gynecologic care to improve the reproductive health of young people. NASPAG states that: There have been anecdotal and media reports of irregular menstrual cycles, including skipped periods, prolonged periods, spotting after COVID-19 vaccines in adults and similar changes in menstrual cycles have been reported after COVID-19 infection. This is not surprising because infections, immune reactions, and fevers can cause short-term, self-limited changes in cycles. However, further studies are needed to verify these changes in people who have received COVID-19 vaccines. In teens, it is also important to note the natural variability in cycles due to the normal maturation process and the large range of normal menstrual cycles in the first few years after the onset of menses." The patient was also told that Pfizer cannot predict how long the adverse event may last. In relation to getting the second dose of the vaccine, the patient was responded with: "As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision." Regarding the query if the vaccine was still effective if the second dose was given later than 21 days after the first dose, the patient was responded with: "The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series. In the Pfizer-BioNTech COVID-19 Vaccine clinical study, the second dose was allowed to be given 19-23 days after the first dose. The second dose of Pfizer-BioNTech vaccine should be administered as close to the recommended interval as possible. But if it is not possible to give the second dose at 3-weeks and a delay cannot be avoided, it may be given up to 6 weeks (42 days) after the first dose." She further asked if there was a suggested course of action that she should take due to the event and her main concern was whether to take the second dose if this a reaction that could become permanent- it was a deciding factor; if it was a temporary side effect, that would be helpful to know. She has not seen a doctor but was thinking about going. She is scheduled to take the second dose today, 28Jul2021. Physician office visit and emergency room visit were not required. The outcome of the event was not recovered.  Follow-up (30Jul2021): Follow-up attempts are completed. No further information is expected.