The Caribbean Regulatory System assists CARICOM and CARPHA Member States in monitoring the safety and quality of medicines and vaccines through its system of voluntary reporting. After using a medicine or getting a vaccine, persons who experience an unexpected side effect or reaction should seek medical care, and inform the health worker of the use of any recent medicines or vaccines. Health professionals, sponsors, patients, and caregivers may submit case reports to VigiCarib, which will be sent to the respective Ministries of Health of the Member State. From there the national authority will follow up according to national policies. Reporting of these events will help national authorities and global systems to identify previously unknown safety issues, or issues that may be unique to certain populations.
Reporting Suspected Quality Defects, Treatment Failures, and Fake Medical Products
The following types of reports may also be submitted to VigiCarib for submission to the respective Ministry of Health: Quality defects of medical products, Treatment failures due to possible quality issues, Suspected falsified or counterfeit medical products. Reports may be submitted by health professionals or product sponsors. Patients or consumers who suspect a quality problem with a medical product, are encouraged to speak a physician or pharmacist for assistance before submitting a report.
Please see list of reporting forms below:
This form is intended for persons living in the Caribbean Community (CARICOM) or in other CARPHA Member States, who would like to submit a report of an unexpected or serious adverse event or adverse reaction that occurred with you or with someone you are a guardian for, after receiving a vaccine. Completion of this form is voluntary, and the information is sent to the country's Ministry of Health for follow up according to national policies. The patient's name does not need to be stated (initials may be used), but the name and contact of the reporter will be needed.
If the event being reported has not been medically confirmed, the person who is affected is advised to seek medical care or assistance from a health professional. The report will be considered as 'preliminary' or 'unconfirmed', and it will be sent to the ministry of health for verification, as per national policies, procedures and criteria. CARPHA is not responsible for case follow-up at the local level.
We understand that you may not have all the details at the time of making the report, but the most important details we need are: a way to identify the patient (e.g. initials, alias), age of patient, description of the reaction / event, name of the vaccine, date they got the vaccine, name and contact for the reporter, and country where you got the vaccine. Of course, if you have more details (like other conditions the person has), please add them.
If you have any questions about this form, you may email us at firstname.lastname@example.org.
Reports of suspected adverse drug reactions, and reports of suspect substandard / falsified / unregistered medicines may be submitted confidentially to VigiCarib using any of the following methods :
The VigiCarib Reporting form in Word;
VigiCarib Vaccine AEFI Form at: https://form.jotform.co/210037487099865
The VigiCarib Online Form at: https://form.jotform.co/72934157245864; or
E-Reporting (for reports of suspected adverse drug reactions from St Vincent and the Grenadines): https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=VC