1. General information

Type of report:Patient/non-health professionalPharmacistMedical DoctorOther health profess

May we contact you in the future for follow-up information?YesNo

2. Patient details

To whom does the report refer?AdultChild

*Complete Section 4: Parent information

3. History / patient medical history

Chronic illnesses:

Other illnesses:

Are you or have you ever been a smoker? YesNo

Do you drink alcohol frequently? YesNo

Do you use illicit drugs?YesNo

4. Parent information

Mother (complete this section for a child's report only)

Father (complete this section for a child's report only)

5. Pregnancy information

Is the patient pregnant? YesNo

Date of last menstrual period

Pregnancy outcome (multiple selection allowed) Normal (No fetal anomaly)Spontaneous miscarriageEctopic pregnancyBorn with fetal AEInduced abortionFetal deathElective abortionCongenital malformation

Is the patient breastfeeding? YesNo

If yes, please indicate

In case of an abnormal result of the current pregnancy, complete section 7.

6. Pregnancy history information (for previous pregnancies)

Past pregnancy results (Number of pregnancies)

Normal

Abortion

Birth defect / congenital anomaly

Fetal death

Other

Is there a family history of birth defects / congenital anomalies? YesNo

7. Details of adverse event / special situation during / after pregnancy

Adverse event

Start date

End date

Resultado*: (utilice la leyenda a continuación)

Criterios de gravedad**:(utilice la leyenda a continuación)

Reporter causality ***: (specify which of the medications used by the patient is related to the adverse event) (use legend below)

*Result: Recovered, Recovering, Not recovered, Recovered with sequelae, Death, Unknown.

** Severity criteria: Death, Disability or permanent impairment, Major medical event, Life-threatening, Congenital anomaly/birth defect, Hospitalization.

***Causality: Possibly related, Unrelated, Not assessable, Not reported.

8. Suspect drugs information

*Trimester exposed: Stopped before conception, First Trimester, Second Trimester, Third Trimester (can be more than one trimester).

**Action taken: Dose maintained, Drug discontinued, Dose increased, Dose reduced, Not applicable, Unknown.

10. Details of concomitant medications / Used in the past

11. Details of the adverse event occurring

12. Linked Cases (i.e., mother-child, twins)