Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Headache, Heavy menstrual bleeding, Pain
Clinical narrative: excessive headache; being emotional; pain; she is going on 12 days of continuous bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (Pfizer Covid-19 Vaccine- Solution for injection), administered in arm left, administration date 12Mar2022 14:15 (Lot number: FK9894) at the age of 29 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing), notes: PCOS Very mild, diagnosed at the age of maybe 16.; "Birth Control" (unspecified if ongoing). Concomitant medication(s) included: ISIBLOOM taken for contraception, start date: Dec2021. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14Mar2022, outcome "not recovered", described as "she is going on 12 days of continuous bleeding"; HEADACHE (non-serious), outcome "unknown", described as "excessive headache"; AFFECT LABILITY (non-serious), outcome "unknown", described as "being emotional"; PAIN (non-serious), outcome "unknown", described as "pain". Therapeutic measures were not taken as a result of heavy menstrual bleeding. Therapeutic measures were taken as a result of headache, affect lability, pain. Additional information: Caller was a consumer who wanted to report an adverse event for Pfizer-BioNTech COVID-19 vaccine. Caller stated that she had been experiencing a menstrual period for 12 days now, that started after receiving a dose of the vaccine. Caller stated that her menstrual periods were always shorter. Caller reported to be in pain, having a headache and being emotional. Caller wanted to know if this side effect has been reported and if she should see a doctor. Comments: PCOS Very mild, diagnosed at the age of maybe 16. Isibloom: Birth Control, started last year, restarted in Dec2021; Dosage text: 0.15mg, every day, once a day, by mouth. Indication for Use in Case to regulates period and doesn't want to have a baby. Caller sent a message because, clarifies she sent an email on day twelve of her period, this is odd to her, because she usually goes up to five days, the only thing new in her life was the vaccine. was this a side effect of the vaccine? Is this common? Does she need to go to see a doctor? Clarifies vaccine as the Pfizer Covid-19 Vaccine, she got the vaccine on Saturday, she got her period two days later, she uses a period tracker which said her period was coming the week later. Her period started two days later, and she is going on 12 days of continuous bleeding. Event: Ten days is max for a period, so she waited until day eleven to email Pfizer and today day twelve to call.  Received the vaccine on the 12Mar2022, she began spotting on 13Mar2022, full period on 14Mar2022, Caller mentions she also had an excessive headache on and off last week for two or three days, she doesn't quite get a head ache with her period. Pain is on the right side of her head. Treatment: she took Ibuprofen, didn't help, 200mg or 250mg, took 2 tablets, by mouth. Caller doesn't have the product with her, Lot and Expiration is unknown. Heavy period: no treatment, she doesn't like to take medication, now not as heavy. The period went heavy, small, heavy again, now short, a lot of clotting, if wiping the sees a lot of blood. She is scheduled next week for the next dose. Received after 1415, Indication: Has to go to a wedding and needed the shot, she doesn't think the shot is the reason for the period, but that's why she calling, she can't go a month or two on bleeding. No adverse events required a visit to: Emergency Room/Physician Office. No vaccination received  prior vaccinations (within 4 weeks), no  list of any other vaccinations within four weeks prior to the first administration date of the suspected vaccine(s), there was a product complaint to report took Ibuprofen for headache, didn't help; Product strength and count size dispensed: 200mg or 250mg, took 2 tablets, by mouth. Caller doesn't have the product with her, Lot and Expiration is unknown. Family Medical History Relevant to AE(s): mom has high blood pressure, dad has glaucoma.  No follow-up attempts are possible. No further information is expected.  Follow-up (25Mar2022): New information received from the same contactable Consumer. This 29-year-old female consumer (patient) reported that included: Reporter address, Patient Details (Height, weight, race information). Relevant Med History. Conmed. Vaccine facility information. Event onset date. New event (pain), Drug(s) Information and Additional Information.  No follow-up attempts are possible. No further information is expected.  Follow-Up (29Mar2022): Follow-up attempts are completed. No further information is expected.