Haemovigilance of Blood Donation and Transfusion-Related Adverse Events At A Tertiary Care Centre in North-East India: A Retrospective Observational Study

Abstract

Background: Haemovigilance enables systematic surveillance of adverse events associated with blood donation and transfusion. Institution-specific data are important for identifying local patterns and improving transfusion safety.

Methods: A retrospective observational study was conducted at a tertiary-care blood centre in North-East India. Donor and recipient haemovigilance records from January to December 2025 were analysed. Donor and recipient adverse-event frequencies, clinical characteristics, implicated blood components and outcomes were assessed.

Results: Among 51,258 blood donations, 41 donor adverse reactions were reported, corresponding to 80.0 reactions per 100,000 donations. Generalized reactions predominated, with dizziness being the most frequent manifestation (68.3%). Among recipients, 33 transfusion reactions were documented. Febrile non-haemolytic transfusion reactions (FNHTR) constituted 84.8% of reactions, while allergic reactions accounted for 15.2%. Packed red blood cells were implicated in 93.9% of recipient reactions. All documented donor and recipient reactions had favourable outcomes, with no deaths or permanent sequelae reported.

Conclusion: The haemovigilance profile was predominantly characterized by mild generalized donor reactions and FNHTR among recipients. Continued systematic surveillance, accurate denominator collection and timely reporting are essential for identifying preventable adverse events and improving transfusion safety.