The second monitoring committee dedicated to monitoring adverse reactions reported with COVID-19 vaccines was held on January 14, 2021 with the network of Regional Pharmacovigilance Centers (CRPV).
Six serious adverse effects with a favorable outcome were observed in France with the Comirnaty vaccine from Pfizer / BioNTech during this third week of vaccination: 4 cases of allergic reactions and 2 cases of tachycardia.
The ANSM was also informed of the death of a person residing in a nursing home and vaccinated against Covid-19 on January 13 with the Comirnaty vaccine. No immediate adverse effects were observed following vaccination. The death occurred approximately two hours after the vaccination. The patient did not show physical signs of allergic reactions. In view of these elements, the medical history and the heavy treatment of the person, there is nothing to conclude that this death is related to the vaccination.
About thirty cases of non-serious adverse effects linked to the Comirnaty vaccine have also been recorded in the national pharmacovigilance database.
Following the occurrence of cases of facial paralysis in other countries with the Comirnaty vaccine, an expertise was requested from a pharmacovigilance center. Analysis of these foreign cases confirms that these disorders occur extremely rarely with an incidence that does not exceed that observed each year in winter in the general population.
The first weekly report on all cases reported in France will be published next week at the end of the third monitoring committee. A report will then be published every week.
The ANSM, in conjunction with the CRPV network, can communicate at any time if a safety signal is identified.
To find out more about pharmacovigilance monitoring, the objectives and the scope of the survey available on our website .