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Death of six-year-old child: Infarmed confirms notification of suspicion of adverse reaction to vaccine

The death of a six-year-old boy in Lisbon on Sunday following “notification of a suspected adverse reaction” to the Covid vaccine is under investigation.

Medicines authority Infarmed has said: “We confirm that we received the notification of a suspected adverse reaction today (Monday), and this is being treated by Infarmed in conjunction with the regional unit of pharmacological vigilance of Lisbon, Setúbal and Santarém.”

“Additional data is being collected” by the Hospital de Santa Maria, which made the notification “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 collect all clinical information”, Infarmed’s statement continues.

What this means in simple terms is that the child’s clinical history (if relevant) needs to be understood.

From information already available, it appears the little boy entered Santa Maria hospital on Saturday in ‘cardiorespiratory arrest’.

He had received the first dose of Pfizer mRNA Covid vaccine the week previously.

On admission, the child was found to be positive for SARS-CoV-2.

As reports admit this morning, “if the cause of death is proved to be related to the vaccine, it will be the first case of a fatal adverse reaction in this age group in Portugal”.

Should this be the case, it is the kind of tragedy certain pediatricians have attempted in the past to avoid by advising parents that it could still be too soon, in their opinions, to be inoculating healthy young children against a virus which leaves them, in the main, completely unscathed (click here).

Up till December 31, there were 116 deaths associated to the taking of the vaccines in Portugal – out of a total of 19.6 million doses administered. This works out at a ratio of 0.006 deaths per 1,000 vaccines – and up till this week, those deaths occurred in much older age groups (the average age being 77).

The incident has been communicated to the EudraVigilance (European data collection) system, which manages and analyses information on suspicions of adverse reactions to medications authorised or in clinical trials in the European Economic Space.

As for Santa Maria Hospital, it released a statement yesterday saying: “The child had the first dose of vaccine against Covid-19, which CHULN (the central university hospital of Lisbon north) has communicated to Infarmed and the general health directorate (DGS)”.

The DGS has not yet made any kind of comment on this incident.

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