Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Extra dose administered, Fatigue, Heavy menstrual bleeding, Off label use
Clinical narrative: Felt fatigued; Had body aches/pains; Site injection pain; heavy flow for 3 days; Started having menstrual cramps & flow; I received my 3rd dose of the Pfizer vaccine (not a booster per my physician but a 3rd dose because I have Immunogammaglobulemia); I received my 3rd dose of the Pfizer vaccine (not a booster per my physician but a 3rd dose because I have Immunogammaglobulemia); This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 50-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in arm left on 09Sep2021 at 13:00 (01:00 PM) (at the age of 50-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history included juvenile type I diabetes (1972), IgG disorder/immunogammaglobulemia, diabetic peripheral neuropathy, emphysema, RA, fibromyalgia, degnerative disc and joint disease, gastroparesis, retinopathy; allergy to hazel nuts, shrimp, bee stings. The patient received concomitant medications within 2 weeks of vaccination which included insulin glargine (LANTUS); insulin human (NOVOLIN R); levothyroxine sodium (LEVOTHYROXIN); modafinil; acetylsalicylic acid (ASPIR), all drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID prior vaccination. Patient was COVID tested post vaccination. The patient previously took acetaminophen, bactrim, flonase, cymbalta and experienced allergy for all the drugs. The patient previously took first and second dose of bnt162b2 for COVID-19 immunization and experienced menstrual cramps and flow. On 09Sep2021 at 13:00 (01:00 PM), the patient experienced I received my 3rd dose of the pfizer vaccine (not a booster per my physician but a 3rd dose because I have immunogammaglobulemia). On 09Sep2021 at 17:00 (05:00 PM), the patient experienced felt fatigued, had body aches/pains, site injection pain, heavy flow for 3 days, started having menstrual cramps and flow. Reported Event: I received my 3rd dose of the Pfizer vaccine (not a booster per my physician but a 3rd dose because I have Immunogammaglobulemia) & then felt fatigued, had body aches/pains, & site injection pain (all expected side effects and not adverse) but started having menstrual cramps and flow (adverse I believe) that same evening with increased flow through 13Sep21. I've had a normal 6 day medium to light flow period per month for the last 20 years always 21 days apart with no spotting or unexpected bleeding except for prior Covid-19 vaccinations, so this is not coincidental since its happened with each of the 3 doses. The last day of my last normal period was 02Sep2021 and this was totally unexpected as well as heavy flow for 3 days, lessening to medium thereafter but still ongoing at day 6 today and expecting it may continue for weeks. The patient underwent lab tests and procedures which included nasal swab was unknown results (pixel COVID test, result: pending) on 14Sep2021. No treatment was received for the events. Outcome of the event heavy flow for 3 days was not recovered; extra dose administered, off label use was unknown; outcome of remaining events was recovered with sequelae. Device date was 14Sep2021.  Follow-Up (PRD/SRD 16Sep2021): Follow-up attempts are completed. No further information is expected.