Adverse reactions following MPox (monkeypox) vaccination: An overview from the Dutch and global adverse event reporting systems.

ABSTRACT

AIMS: The spreading of MPox (monkeypox) virus led to a vaccination campaign in the Netherlands for individuals at high risk of infection. This overview elucidates the characteristics of the reported adverse events following immunization (AEFI) following active immunization against monkeypox and thereby provides insight on the safety profile in daily practice. METHODS: Data were collected from the spontaneous reporting system of the Netherlands Pharmacovigilance Centre Lareb. Furthermore, the global database of the World Health Organization was consulted on globally reported AEFI following smallpox or monkeypox immunization in 2022. RESULTS: Until 15 November 2022, 148 unique individual case safety reports (ICSRs) regarding monkeypox vaccination were received at Lareb. Two ICSRs reported a serious outcome (1.4%). A total of 2205 ICSRs were received in the global database in 2022, of which 131 reports (5.9%) concerned a serious reaction. Reported AEFI in both databases mainly included injection site reactions and general systemic reactions commonly observed after vaccination. CONCLUSION: The pattern of reported AEFI for monkeypox vaccines both in the Dutch and global ICSR database is generally in accordance with the manufacturer's product information and consists largely of injection site reactions and nonserious AEFI related to systemic reactogenicity.