Name of the medicine and/or active substance Indication(s)
Batch number Expiration date Start date of administration End date of administration
Dosage, route of administration, pharmaceutical form Action taken with the drug Dose increasedDose reducedDrug withdrawnRe-administeredNo action takenUnknown
Please provide the full name and telephone number or email address of the reporting person.
Last and first name Address (street, city, country)
Phone number Email Reporter Qualification PhysicianPharmacistAuthor of medical publicationOther healthcare professionalNon-healthcare professionalPatient Reported to medicine regulatory authorities YesNoNot known
Initials Date of birth or age Weight (kg) Height (cm)
Is the pregnancy still ongoing? -YesNo Gestational age in weeks Expected date of delivery Date of delivery
Pregnancy diagnosis UltrasoundPregnancy testGynecological examination Were there any medical events during the pregnancy? YesNo
Medical and obstetric-gynecological history* If medical events occurred, please describe below any complications, infections, illnesses during pregnancy and exposure to medicines
*mother's health problems, medications used, smoking, alcohol abuse, allergies, information about previous pregnancies, number of children
Vaginal deliveryCesarean sectionInstrumental deliveryMiscarriageTermination of pregnancyIntrauterine fetal deathTerm birthPreterm birthNot provided If term birth - gestational age (in weeks) If preterm birth - please provide gestational age (in weeks)
If termination of pregnancy, was it recommended by a doctor? -YesNo If termination of pregnancy was recommended by a doctor, please specify
Please provide details of abnormal condition or complications during/after delivery. Please describe symptoms, diagnosis, tests and indicate the probable cause of the event
Healthy newbornComplications in the newbornCongenital anomaly/birth injuryStillbirthMultiple pregnancyInfant death after birth
Apgar score:
At 1 minute of life At 5 minutes At 10 minutes
Additional information about the child's condition
If an event occurred (in mother, fetus, newborn), is there a reasonable possibility that it could have been caused by a drug used during pregnancy? -YesNo If yes, please provide the name of the drug and the reason for its use
