“We confirm that we received the notification of a suspected adverse reaction and that it is being treated by Infarmed together with the Regional Pharmacovigilance Unit of Lisbon, Setúbal and Santarém”, said the National Medicines Authority to Lusa.
According to the national regulator, “additional data are being collected by the notifier for the analysis and assessment of the imputation of causality, since the apparent temporal relationship is not the only determinant in the assessment of causality, it is necessary to proceed with the collection of all clinical information”.
This review precedes its reporting to the European EudraVigilance database, the system for managing and analyzing information on suspected adverse drug reactions that have been authorised or under study in clinical trials in the European Economic Area.
The Centro Hospitalar Universitário Lisboa Norte (CHULN) announced that a six-year-old boy who tested positive for SARS-CoV-2 died on Sunday (16 January) at Hospital Santa Maria and that the causes of death are being analysed.
The hospital said, in a statement, that the child was admitted to the Hospital de Santa Maria on Saturday with “a condition of cardiorespiratory arrest”.
“The child had the first dose of the vaccine against Covid-19, and CHULN notified the case to Infarmed and the Directorate-General for Health”, says the statement.
According to data from the DGS, since the beginning of the pandemic, three children between zero and nine years of age have died.