Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Headache, Oligomenorrhoea, Premenstrual pain, Stress
Clinical narrative: Premenstrual cramps; the  vaccine severely alters my menstrual cycle; it created spotting; definitely not feeling well because of the side effect; major pain; headache; stress; This is a spontaneous report received from a Consumer or other non HCP, Program ID:   A 48-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 48 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE lot#EN6199), administration date: 04Mar2021, for COVID-19 immunization, reaction(s): "Menstruation delayed", "Cramps menstrual"; BNT162b2 (DOSE 2, SINGLE, lot # ER8732), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "Menstruation delayed", "Premenstrual cramps", "Menstrual cramps", "Headache", "Stress", "Pain"; BNT162b2 (DOSE 3, BOOSTER (SINGLE), lot#FH8020, exp.date 31Jan2022, intramuscular, left deltoid), administration date: 16Oct2021, for COVID-19 immunization, reaction(s): "Cramps menstrual", "Menstruation delayed"; BNT162b2 (DOSE 4, BOOSTER (SINGLE), lot#FK9896), administration date: 04Mar2022, for immunization, reaction(s): "Menstruation delayed", "Cramps menstrual"; influenza vaccine (lot 279841), administration date: 21Oct2021, for immunization; flulaval quad (Lot #K45Z2, exp.date 30Jun2022, via intramuscular route at left deltoid.), administration date: 12Dec2021, for immunization. The following information was reported: PREMENSTRUAL PAIN (non-serious), outcome "unknown", described as "Premenstrual cramps"; MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "the  vaccine severely alters my menstrual cycle"; INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "it created spotting"; MALAISE (non-serious), outcome "unknown", described as "definitely not feeling well because of the side effect"; PAIN (non-serious), outcome "unknown", described as "major pain"; HEADACHE (non-serious), outcome "unknown"; STRESS (non-serious), outcome "unknown". The event "premenstrual cramps" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of premenstrual pain. Therapeutic measures were not taken as a result of menstruation delayed, intermenstrual bleeding, malaise, pain.  Additional information: No other conditions and investigations. The patient experienced similar side effects that her menstrual cycle was again delayed with just very painful cramps after each vaccinations. The patient surely healthy. She took a multivitamins and that's about it; no natural herbs, no medication, nothing no homeopathic, just multivitamins. The cycle took 49 days. Her doctor office said there were no such things as side effects like from COVID vaccine like this. But she had medical articles that had been put out that even transgender women who had never had a menstrual cycle has had an onset of bleeding or women who had menopause and haven't had a cycle for many years all of a sudden have had bleeding of menstrual cycle. There was a plenty of scientific proof that it had changed menstrual cycle for females and so she was calling because she was afraid. The patient further reported this as a side effect from the omicron booster (clarified as Pfizer covid-19 Bivalent vaccine) shot of the Pfizer covid-19 vaccine and this happened to patient the second time when she got the second vaccination. It was delaying her menstrual cycle and caused her severe cramping which created spotting. The patient added that she was not feeling well because of the side effect and unfortunate to see a doctor. She said that she didn't have appointment until January. It was very frustrating that she could not see a doctor for 2 months even after getting a side effect and having an expensive health insurance. The patient stated that she would not be in that situation if she did not receive the vaccination and she knew a lot of other women having situation with menstrual (further not clarified). Whenever she receives the Pfizer Covid vaccine, her menstrual cycle was severely delayed. She had been vaccinated five times. She was tired that her cycle was severely altered when she got the vaccination. She had reported this issue for several years to numerous primary care doctors. Unfortunately, many doctors did not believe that the Covid vaccine could alter a menstrual cycle. Basically, the doctors dismissed the claims. According to her, prior to getting vaccinated, many of women did not have these symptoms. It was very costly in time and finances to get ultrasounds done and going to specialist trying to remedy or menstrual cycle due to getting vaccinated for COVID-19. Many women, including herself, were having their menstrual periods skip for a month or severely delaying it by 45 days 49 days or longer. Unfortunately, she had severe menstrual cramps and headaches while waiting for her period to start. There's nothing worse than having cramping for a couple of weeks until the period starts again because you were vaccinated. Prior to this vaccination, the patient had no health issues. She had to go to the doctors, because the cramps were so bad, and they had to prescribe narcotics. Prior to being vaccinated for COVID-19, her periods were very regular and relatively pain-free. It's getting to the point that she no longer wanted to be vaccinated for the COVID-19 because of the stress and the pain she experienced. However, because she was teaching at three schools (kindergarten through fifth grade), she was in contact with well over 2000 students plus staff and had to protect herself from getting COVID-19. On 17Jan2024, reporter stated that lots of women are having problems. It messes up all your menstrual cycle, you get severe cramping like you are starting your period and you never do.  Follow-up (30Nov2022): new information received from a same contactable consumer, Program ID [159558]. This consumer (Patient) reported that: updated information included: Follow-up Activities Possible updated, vaccine Administration date and facility details updated and Lot  number was added new events added, treatment received updated and additional information added.  Follow-up (13Nov2023): Follow-up attempts are completed. No further information is expected.  Follow-up (13Dec2023): This is a spontaneous follow-up report received from the same Consumer or other non HCP. Updated information includes: reaction data (updated verbatim terms; new events: Headache and Stress; treatment information; and physician office visit), and clinical course details.  Follow-up attempts are completed. No further information is expected.  Follow-up (17Jan2024): This is a spontaneous follow-up report received from a Consumer or other non HCP, Program ID: . Updated information included: vaccination details and historical vaccine; menstrual cycle abnormal updated to menses delayed, Cramps menstrual updated to Premenstrual cramps.  Follow-up (20Feb2024): This is a spontaneous follow-up report received from the same Consumer or other non HCP. Updated information included: vaccination details and historical vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400025500 Same patient, vaccine, similar event and different dose (1st);US-PFIZER INC-202400048835 Same patient, vaccine, similar event and different dose (3rd);US-PFIZER INC-202201341107 Same patient, vaccine, similar event and different dose (2nd);US-PFIZER INC-202400048836 Same patient, vaccine, similar event and different dose (4th);US-PFIZER INC-PV202300204066 Same patient, vaccine, similar event and different dose (6th);