Reports after seasonal influenza vaccination 2017/2018
In the period from October 1st, 2017 until April 1st, 2018, Lareb received 230 spontaneous reports concerning possible adverse events following immunization (AEFIs) after seasonal influenza vaccination. Analysis of these reports indicated no new ADRs or any other vaccine related safety concerns.
The 230 reports included a total of 967 AEFIs. Mostly reported were AEFIs that are already described in the vaccine’s Summary of Product Characteristics, such as injection site reaction, fever, myalgia and headache. The nature of the reported AEFIs was comparable with AEFIs reported on seasonal influenza vaccines in previous years.
Beside the spontaneous reporting systems, Lareb monitored the 2017/2018 seasonal influenza vaccine using Lareb Intensive Monitoring (LIM), which is a form of cohort event monitoring. Participants were invited to complete 3 online questionnaires. A total of 361 patients participated. 164 (45%) participants experienced at least one AEFI. In total, 488 AEFIs were reported. The reported AEFIs were comparable to AEFIs reported by the spontaneous reporting system.