REPORT FORM ON ADVERSE REACTION TO MEDICINAL PRODUCT, VACCINE, TUBERCULIN AND/OR LACK OF EFFICACY OF MEDICINAL PRODUCT AND/OR ADVERSE EVENT FOLLOWING IMMUNIZATION/ TUBERCULIN DIAGNOSTICS (AEFI)
    MEDICAL DOCUMENTATIONForm No 137/o

    І. PATIENT INFORMATION

    Full name (initials)Case history/ medical card NoDate of birth/ ageSexWeight (kg)Height (cm)

    ІІ. SUSPECTED AR/LE/AEFI

    Suspected AR/AEFI (describe each clinical manifestation of AR/AEFI with date and time of onset and end, and outcome/indication of LE)Date and time of onset of AR/LE/AEFI Date and time of end of AR/LE/AEFI Correction of AR/LE/AEFI:
    AR/LE/AEFI sequela
    Whether these AR/AEFI manifestations are considered serious (relate to AR/AEFI case in whole) If yes, specify, why AR/AEFI is considered serious (indicate one or several reasons): (date of death)

    ІІІ. INFORMATION ABOUT SUSPECTED MP, VACCINE, TUBERCULIN

    Suspected MP, vaccine, tuberculin (trade name, pharmaceutical form, manufacturer)Batch NoIndications (if possible by ICD-10)StrengthSingle doseFrequency of useMethod of administrationDate and time of start of therapyDate and time of end of therapy
    Measures taken related to suspected MP, vaccine, tuberculin for correcting AR/LE/AEFIRepeated prescription of suspected MP, vaccineIf yes, specify whether:Did the AR/LE reappear after reintroduction of suspected MP:

    ІІІа. ADDITIONAL INFORMATION IN CASE OF AEFI TO VACCINES OR TUBERCULIN

    Category of immunization or tuberculin diagnostics
    Category of AEFI
    Dose number (for vaccine)Shelf life
    Site of vaccine/tuberculin injection
    Method of administration of vaccine/tuberculin
    Data of patient history, who was conducted immunization/tuberculin diagnostics (vaccination history, occurrence of reaction to previously administered vaccine, tuberculin, availability of acute or exacerbation of chronic disease within 1 - 1,5 months before immunization/tuberculin diagnostics, use of immunosuppressive therapy within 1 month and blood products within 3 months before immunization/ tuberculin diagnostics, etc.)

    ІV. INFORMATION ABOUT CONCOMITANT MP

    (except for products used to correct AR/LE/AEFI sequela)

    Concomitant MP, (trade name, pharmaceutical form, manufacturer, batch No)Indications (if possible by ICD-10)StrengthSingle doseFrequency of useMethod of administrationDate of start of therapyDate of end of therapy
    Other important information (concomitant diagnoses, data of laboratory and instrumental studies, allergy history, pregnancy with term of pregnancy, mode of conception, pregnancy outcome indicated (if pregnancy ends, indicate date of delivery, type of delivery, etc.))
    V. INFORMATION ABOUT REPORTER
    VІ. INFORMATION ABOUT MEDICAL/ PHARMACEUTICAL PROFESSIONAL(if not the reporter)