VAERS ID: 2331030

AGE: | SEX: F|STATE: FR

Description

Arrhythmia; Unusual bleeding (ovulation bleeding for two days) and from the third month, it was not regular at all; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-PEI-CADR2022274251 (RA). Other Case identifier(s): DE-CADRPEI-2022274251 (RA Webportal), DE-PEI-202200074898 (RA). A 36-year-old female patient received BNT162b2 (COMIRNATY), on 27Nov2021 as dose 3 (booster), single (Lot number: SCVY8) for covid-19 immunisation. The patient's relevant medical history included: "Iodine allergy" (unspecified if ongoing); "Hyperthyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (Dose 1., Strength: 0.3ml, Lot/Batch no: EX8680), administration date: 11May2021, for covid-19 immunisation; comirnaty (Dose 2, Strength: 0.3ml, Lot/Batch no: FD7958), administration date: 22Jun2021, for covid-19 immunisation. The following information was reported: ARRHYTHMIA (medically significant) with onset 23Dec2021, outcome "not recovered"; INTERMENSTRUAL BLEEDING (non-serious) with onset 23Dec2021, outcome "not recovered", described as "Unusual bleeding (ovulation bleeding for two days) and from the third month, it was not regular at all". Clinical course: So far none, it had to be monitored, cycle was previously always consistent and the patient never had bleeding at ovulation time. The causality assessment for suspect drug to event Arrhythmia was reported as follows: Source of assessment RA Result of Assessment B. Indeterminate. The causality assessment for suspect drug to event Intermenstrual bleeding was reported as follows: Source of assessment RA Result of Assessment D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200875330 same patient, drug, reporter but dose '2' was administered beyond 42 days of dose '1'.;

Symptoms

Arrhythmia, Intermenstrual bleeding

Vaccines

VAX DATE: 11-27-2021| ONSET DATE: 12-23-2021| DAYS TO ONSET: 26
NameDose #TypeManufacturerLotRouteSite
COVID19 (COVID19 (PFIZER-BIONTECH)) 3 COVID19 PFIZER\BIONTECH SCVY8 Unknown Unknown

RECVDATE:06-24-2022
RPT_DATE:
CAGE_YR:
CAGE_MO:
DIED:U
DATEDIED:
L_THREAT:U
ER_VISIT:U
HOSPITAL:U
HOSPDAYS:
X_STAY:U
DISABLE:U
RECOVD:N
LAB_DATA:
V_ADMINBY:OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:Medical History/Concurrent Conditions: Hyperthyroidism; Iodine allergy
PRIOR_VAX:
SPLTTYPE:DEPFIZER INC202200846845
FORM_VERS:2
TODAYS_DATE:06-23-2022
BIRTH_DEFECT:U
OFC_VISIT:U
ER_ED_VISIT:U
ALLERGIES:
V_FUNDBY:

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