Adverse Event Reporting for Medications and Vaccines Before and During the COVID-19 Pandemic: An Observational and Retrospective Study

Objective: Compare the profile of suspected adverse events (AE) reports associated with medicines and vaccines before and during the COVID-19 pandemic. Method: An observational, retrospective study was conducted using data extracted from the VigiMed database. Spreadsheets were reviewed and processed, starting with the exclusion of the lines that had incomplete and uninterpretable data on the following variations related to the patient, related to the AE, related to the medication/vaccine and related to the notifier. Following database extract, reports were categorized into two groups: Group 1 (G1), before the pandemic; and Group 2 (G2), during the pandemic. Categorical variables were compared using absolute and relative frequency. Results: There was no difference between the notification profiles in the two groups about the sex and age of the individuals affected by AE related to medicines and vaccines. The notifiers in G1 were predominantly pharmacists (77.5%) while in G2, it was the consumers (55.9%). With respect to the products that were the target of the notifications, in G1 the most prevalent classes were analgesics, antibiotics and antineoplastics. In G2, there were vaccines against COVID-19 and immunosuppressants. About reports of suspected fatal AE related to medicines and vaccines, the most prevalent products in G1 were antimicrobials and antiepileptics, while G2 included antineoplastics, COVID-19 vaccines and immunosuppressants. Conclusion: The comparative of AE to drugs and vaccines notifications revealed that the COVID-19 pandemic contributed to a change in the profile of the notifiers, as well as in the type of product targeted by the notifications most frequently reported. These findings highlight the landscape of pharmacovigilance during public health emergencies.