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VAERS Report 2156843

Case Report Section

Vaer Report Details

Age: NA

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: fm38c2


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-12-12
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

irregular periods; both times very heavy; off label use; interchange of vaccine product; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory agency. the reporter is the patient. regulatory number: gb-mhra-webcovid-202202191421373930-aem63. other case identifier(s): gb-mhra-adr 26625794. a 43 year-old female patient (not pregnant) received bnt162b2 (comirnaty), administration date 12dec2021 (lot number: fm38c2) as dose 3 (booster), single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose number unknown, manufacturer unknown), for covid-19 immunization; covid-19 vaccine astrazeneca (dose number unknown), for vaccination. the following information was reported: off label use (medically significant) with onset 12dec2021, outcome "unknown", described as "off label use"; interchange of vaccine products (medically significant) with onset 12dec2021, outcome "unknown", described as "interchange of vaccine product"; menstruation irregular (medically significant) with onset 28jan2022, outcome "not recovered", described as "irregular periods"; heavy menstrual bleeding (medically significant) with onset 28jan2022, outcome "not recovered", described as "both times very heavy ". the patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19feb2022) negative, notes: no - negative covid-19 test. additional information: patient has not had symptoms associated with covid-19. patient is not currently breastfeeding. after receiving booster vaccine in december patient's period in january was 5 days late and period in february 7 days early. both times very heavy for a 43-year-old woman. patient has not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial. the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). no follow-up attempts are possible. no further information is expected

Lab Data
test date: 20220219; test name: covid-19 virus test; test result: negative ; comments: no - negative covid-19 test
List of symptoms
menstruation irregular heavy menstrual bleeding interchange of vaccine products sars-cov-2 test off label use
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na