Influenza is a major public health burden, mainly prevented by vaccination. Recommendations on
influenza vaccine composition are updated annually and constant benefit-risk monitoring is therefore needed. We conducted near-real-time enhanced passive surveillance (EPS) for the
influenza vaccine,
Fluarix Tetra, according to European Medicines Agency guidance, in 10 volunteer general practices in England using
Fluarix Tetra as their principal
influenza vaccine brand, from 1-Sep to 30-Nov-2016. The EPS method used a combination of routinely collected data from electronic health records (EHR) and a customized adverse events reporting card (AERC) distributed to participants vaccinated with
Fluarix Tetra. For participants vaccinated with a different
influenza vaccine, data were derived exclusively from the EHR. We reported weekly and cumulative incidence of pre-defined adverse events of interest (AEI) occurring within 7 days post-vaccination, adjusted for clustering effect. Of the 97,754 eligible participants, 19,334 (19.8%) received
influenza vaccination, of whom 13,861 (71.7%) received
Fluarix Tetra. A total of 1,049 participants receiving
Fluarix Tetra reported AEIs; 703 (67%) used the AERC (adjusted cumulative incidence rate 4.96% [95% CI: 3.92-6.25]). Analysis by individual pre-specified AEI categories identified no safety signal for
Fluarix Tetra. A total of 62 individuals reported an AEI with a known brand of non-GSK
influenza vaccine and 54 with an unknown brand (adjusted cumulative incidence rate 2.59% [1.93-3.47] and 1.77% [1.42-2.20], respectively). In conclusion, the study identified no safety signal for
Fluarix Tetra and showed that the AERC was a useful tool that complemented routine pharmacovigilance by allowing more comprehensive capture of AEIs.