Information on electronic reporting of adverse drug reactions
Electronic reporting of Individual Case Safety Reports (ICSRs)
The marketing authorisation holders should report ICSRs occurring in the territory of Latvia directly to the EudraVigilance Human Post Authorisation Module (EVPM) with the message receiver identifier EVHUMAN.
The marketing authorization holders shall electronically submit ICSRs to the Eudravigilance database:
- regarding serious suspected adverse drug reactions -within 15 days
- regarding non-serious suspected adverse drug reactions -within 90 days
Contact information for reporting ICSRs:
farmakovigilance.zva.gov.lv or info@zva.gov.lv; mobile phone: +371 25771980.
Statistics of adverse drug reaction reports
The State Agency of Medicines of Latvia (SAM) has been maintaining the database for adverse drug reactions observed in Latvia since 2001, and since 2004 the reported information is being forwarded to the European Union database EudraVigilance for identification of new risks with medicines. Every year SAM analyses the information entered into the database in Latvia and the reporting activity in Latvia.
In 2025, State Agency of Medicines of the Republic of Latvia recorded 477 adverse drug reaction reports in its national database, including vaccine side effect reports. All data was processed and submitted to the EudraVigilance system. Of these reports, 196 were classified as serious.
Compared to 2024, more reports came from healthcare professionals (317), while patient-submitted reports dropped to 160 (down from 216 the previous year).
The most represented age group was 36–50 year olds (104 reports), followed by 51–65 year olds (92 reports). Reports on children under 2 were minimal — just 3 cases — and 79 reports did not include age at all.
Women accounted for the majority of cases at 69% (331 reports), men made up about 28% (133 reports), with the remaining 13 reports leaving gender unspecified.
When it comes to the types of side effects reported, the most common categories (classified using MedDRA terminology) were general disorders and administration site reactions (152 reports), gastrointestinal disorders (113), nervous system disorders (109), and skin and subcutaneous tissue disorders (108). It is worth noting that a single report can include multiple side effects, so these figures overlap.
