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VAERS ID: 1000231

AGE: 41| SEX: F|State: TX

Description

currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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

Asthenia, Pain in extremity, Guillain-Barre syndrome, Paraesthesia, Hypoaesthesia, SARS-CoV-2 test negative, Immunoglobulin therapy, Pain

Vaccines

VAX DATE: 20 January 2021 | ONSET DATE: 25 January 2021 | DAYS TO ONSET: 5
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))

        RECVDATE:
        04 February 2021
        CAGE_YR:
        CAGE_MO:
        RPT_DATE:
        DIED:
        DATEDIED:
        L_THREAT:
        Y
        ER_VISIT:
        HOSPITAL:
        Y
        HOSPDAYS:
        6
        X_STAY:
        DISABLE:
        RECOVD:
        N
        LAB_DATA:
        Test Date: 20210125; Test Name: Nasal Swab; Test Result: Negative
        V_ADMINBY:
        WRK
        OTHER_MEDS:
        CUR_ILL:
        HISTORY:
        Medical History/Concurrent Conditions: Breast cancer; GERD; Hyperlipidemia
        PRIOR_VAX:
        SPLTTYPE:
        USPFIZER INC2021086498
        FORM_VERS:
        2
        TODAYS_DATE:
        02 February 2021
        BIRTH_DEFECT:
        OFC_VISIT:
        ER_ED_VISIT:
        Y
        ALLERGIES:
        V_FUNDBY:
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