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VAERS ID: 1000431

AGE: 39| SEX: F|State: FR

Description

convulsive crisis afebrile/seizures; loss of consciousness; Dizziness; loss of alertness; This is a spontaneous report from a non-contactable healthcare professional. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: ES3002, expiration: 01Apr2021), intramuscular in left arm on 13Jan2021 at a single dose for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient experienced dizziness, convulsive crisis afebrile, loss of consciousness, loss of alertness, and seizures on 13Jan2021 three minutes at the time of vaccination. Outcome of the events were unknown. The events were assessed as serious (hospitalization); ESAVI type. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Symptoms

Depressed level of consciousness, Dizziness, Loss of consciousness, Seizure

Vaccines

VAX DATE: 12 January 2021 | ONSET DATE: 12 January 2021 | DAYS TO ONSET: 0
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 1
  • OT
  • LA
  • ES3002

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
U
LAB_DATA:
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
Medical History/Concurrent Conditions: Allergy
PRIOR_VAX:
SPLTTYPE:
MXPFIZER INC2021069200
FORM_VERS:
2
TODAYS_DATE:
01 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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