Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: Caller reports not having a period in 10 to 12 years. Caller said she had the shot about dinner time that day and in the middle of the night I woke up and I was spotting; Been having this spotting issue ever since receiving the booster dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Oct2021 (Lot number: FF8839, Expiration Date: 31Dec2021) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Patient history: Diabetes (From: Unspecified To: Ongoing); "Blood pressure" (unspecified if ongoing), notes: The caller state she is on blood pressure medication and diabetes medicine. Concomitant medication(s) included: JARDIANCE taken for diabetes mellitus (ongoing); METFORMIN taken for diabetes mellitus (ongoing); GLYBURIDE taken for diabetes mellitus (ongoing); LISINOPRIL [LISINOPRIL DIHYDRATE] taken for blood pressure measurement (ongoing); METOPROLOL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer Covid Vaccine, Lot Number: EL9267, Expiry Date: May2021, Anatomical Location:  Left arm , No. of Previous Doses: First dose, ), administration date: 19Feb2021, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Vaccine Name: Pfizer Covid Vaccine, Lot Number: EN6202, Expiry Date: 30Jun2021, Anatomical Location:  left arm, No. of Previous Doses: Second dose), administration date: 12Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Caller reports not having a period in 10 to 12 years. Caller said she had the shot about dinner time that day and in the middle of the night I woke up and I was spotting"; INTERMENSTRUAL BLEEDING (non-serious) with onset 15Oct2021, outcome "not recovered", described as "Been having this spotting issue ever since receiving the booster dose". The event "been having this spotting issue ever since receiving the booster dose" was evaluated at the emergency room visit.  Additional information: Pfizer covid 19 vaccine/Comirnaty booster dose. Reporter reports that after she received the booster dose, she had spotting issues. Reporter confirmed she was referring to menstrual cycle spotting. Reporter reports not having a period in 10 to 12 years. Reporter said she had the shot about dinner time that day and in the middle of the night she woke up and she was spotting. She visited a urgent medical center the next day. Reporter reports having an upcoming gynecology appoint which she shouldn't have to pay for. Reporter completed a safety report with agency before the transfer. After responding to reporters first inquiry she said. This really angers me. If you search the internet this happening to 30-something thousand women. Reporter said, You might not get covid and die, but if it's doing things to your body. Reporter also said, you're just writing this down, don't want to take ownership of it. CDC doesn't acknowledge this stuff either, I've already talked with them. They might have a lawsuit on their hands. Don't know how much they're making. Don't know what they're doing to your body. Encouraged her to continue following up with her medical team. Thanked her for sharing her experience with Pfizer. The patient taking Pfizer Covid Vaccine because said the patient needed the booster dose. Additional Context: The reporter was a patient calling about the booster dose Pfizer Covid Vaccine. The patient had been having this spotting issue ever since receiving the booster dose Pfizer Covid Vaccine. The patient was asking if the spotting was one of the side effects of the Pfizer Covid Vaccine. Reporter details: The patient does not wish to provide email. The patient does not wish to provide name, address, telephone number or email. The patient states she called last called the CDC. Been having this spotting issue ever since receiving the booster dose vaccine: The patient states the spotting began the same day caller received the booster dose Pfizer Covid Vaccine, 15Oct2021. The spotting was ongoing. Agent asks if worsening, persisting or improving and the patient states she would think the spotting had stopped and then spotting occurs again. The patient was going to the Gynecologist on 15Nov2021 for an appointment. The patient was on medication for other things but doesn't know if that has anything to do with the Pfizer Covid Vaccine. The patient state she was on blood pressure medication and diabetes medicine. The patient would like to get this stuff straightened out, the patient was not happy about this. The patient wants to find out, Pfizer will probably say the spotting had nothing to do with the Pfizer Covid Vaccine but the caller wants to get to the bottom of this. The CDC told the caller the spotting has nothing to do with the Pfizer Covid Vaccine and there was no reports related to this but the caller does not believe this because it is on internet.  Time the Vaccination Was Given: First dose: 1300, second dose: 1300, booster dose: 1200 to 1300. No, patient states she does not take shots. The caller went to urgent treatment center. No prior vaccinations within 4 weeks. Relevant Tests: none.  No follow-up attempts are possible. No further information is expected.