BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMRYST

    MDR report key: 17922952 · Received October 11, 2023

    Report

    Report Number
    MW5146841
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    May 22, 2022
    Report Date
    October 5, 2023
    Manufacturer
    PEAR THERAPEUTICS, INC.
    Product Code
    QVO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE DEVELOPED TETANUS, SEVERE NECK PAIN, SEIZURES, ANXIETY, AND INSOMNIA FROM THE COVID VACCINE. THE COVID TESTS BY ROCHE WERE EVIDENTLY COVERED IN A BIOLFILM THAT INTRODUCED BACTERIA INTO THE NASAL CAVITY. SOMRYST IS COUNTER INDICATED FOR SEIZURES WHICH THE PROVIDER KNEW. SEIZURE DISORDER, CANNOT USE SOMRYST, SERVICE DOG FOR SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768008 SOMRYST COMPUTERIZED BEHAVIORAL THERAPY DEVICE FOR INSOMNIA QVO PEAR THERAPEUTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Disability