Spain has already started the booster shot vaccination campaign, in which doses of the Pfizer and Moderna vaccines will be used. Two medicines for which new side effects have been registered, according to the ninth pharmacovigilance report of the Spanish Agency for Medicines and Health Products (AEMPS).
New confirmed side effects of the Pfizer vaccine
1. Erythema multiforme. It is an inflammatory skin reaction characterized by target skin lesions, with a darker center surrounded by paler rings. The pharmacovigilance system, the PRAC, of the European Medicines Agency (EMA) has concluded that it may be an adverse reaction and should be included in the SmPC and package insert. In Spain, until October 3, 2021, two notifications of erythema multiforme have been registered after the administration of Pfizer; Until that date, about 49.6 million doses of this vaccine had been administered.
2. Paresthesias and hypoesthesias. The PRAC has concluded that paraesthesias (unusual skin sensation such as tingling or chills) and hypoesthesias (decreased skin sensitivity) should be added as possible adverse reactions in the Comirnaty SmPC and package insert. In Spain, until October 3, 2021, 1,010 notifications of paresthesias and hypoesthesias have been registered after the administration of Pfizer. H
3. Asthenia, lethargy, decreased appetite and nocturnal hyperhidrosis. In the context of reviewing data from ongoing clinical trials, the following possible adverse reactions have also been added to the SmPC and package insert: asthenia (lack of energy or strength), lethargy (state of indifference and inactivity), decreased appetite and nocturnal hyperhidrosis (excessive sweating). These possible side effects are considered to be rare (occurring in less than 1 in 100 people).
New confirmed side effects of the Moderna vaccine
1. Erythema multiforme. The PRAC has also concluded that there is a possible mechanism by which Moderna’s vaccine can cause erythema multiforme, therefore, it should be included in its summary of product characteristics and package insert. In Spain, until October 3, 2021, a notification of erythema multiforme has been registered after the administration of Moderna. To date, about 8.8 million doses of this vaccine have been administered.
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