Vaer Report Details
Age: 36 years old
Gender: Female
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Type: Coronavirus 2019 vaccine
Manufacturer: PFIZER
Lot: fk6304
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- 2022-01-13
- Date of Onset
- 0
- Number of days (onset date – vaccination date)
- 0
- Adverse Event Description
-
in the evening fainting; alteration of the cycle already from the second administration; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority. regulatory number: it-minisal02-842794. a 36 year-old female patient received bnt162b2 (comirnaty), intramuscular, administered in arm left, administration date 13jan2022 15:30 (lot number: fk6304, expiration date: 31jan2022) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "allergy to nsaids" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs; "food allergy" (unspecified if ongoing). the patient's concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1), for covid-19 immunization; comirnaty (dose 2), for covid-19 immunization, reaction(s): "irregular menstrual cycle". the following information was reported: syncope (medically significant) with onset 13jan2022, outcome "not recovered", described as "in the evening fainting"; menstruation irregular (non-serious) with onset 13jan2022, outcome "not recovered", described as "alteration of the cycle already from the second administration". reporter comment: allergies to non-steroidal anti-inflammatory drugs and food, cycle problems after second and third dose until now additional information: impact on quality of life (9/10) no follow-up attempts are possible. no further information is expected.; reporter's comments: allergies to non-steroidal anti-inflammatory drugs and food, cycle problems after second and third dose until now; sender's comments: linked report(s) : it-pfizer inc-202200332085 same patient, different vaccine dose/event
- Lab Data
-
na
- List of symptoms
-
menstruation irregular syncope
- 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