The Spanish System of Pharmacovigilance of Human Use Medicines (SEFV-H), from the Spanish Agency of Medicines and Medical Devices (AEMPS), received a total of 37,944 notifications of suspected adverse reactions to medicines or adverse events following vaccination in 2024, which represents a 9.9% decrease compared to 2023 (42,333).
In 2024, the overall notification rate is estimated at 38 cases per 100,000 inhabitants. The most notified suspected adverse reactions during the year were focused on gastrointestinal disorders, skin and subcutaneous tissue disorders, and the nervous system. 49% of them were reported directly to the SEFV-H, while the rest were mostly notified through the pharmaceutical industry.
Out of all the cases reported, 95.9% were spontaneous notifications. For cases reported through the pharmaceutical industry, this percentage was 56.4%. The remaining cases came from organized information collection systems, such as observational studies, patient monitoring programs, or access to medication through compassionate use.
Regarding severity, 12,284 cases were classified as serious (resulting in death, hospitalization, incapacity, congenital defects, or medically relevant outcomes), representing 32.4% compared to 28.1% the previous year. For cases reported to the SEFV-H, the percentage of serious cases was 35.3%, while for cases reported through the pharmaceutical industry, this percentage was 29.3%.
12.5% of the 18,626 cases reported to the SEFV-H described adverse reactions unknown for the suspected medicine, based on its technical sheet. Serious and unknown notifications accounted for 6.2%. These figures represent an increase compared to the previous year, where 8.3% described unknown reactions and 4.5% were both serious and unknown.
The majority of the notifications received by the SEFV-H were made by healthcare professionals, with 65.3% by medical professionals, 15.6% by pharmaceutical professionals, and 9.4% by nursing professionals. This distribution has changed from the previous year, as in 2023 nursing professionals reported more than pharmaceutical professionals (nursing with 19.9% versus pharmaceutical with 10.3%).
