Paul-Ehrlich-Institute reported cases
From the beginning of the vaccination campaign in Germany on 27th of December 2020 through 31stof July 2021, n=131,671 suspected cases of any kind of adverse reactions or vaccination complications have been reported to the Paul-Ehrlich-Institut, thereof n=390 cases of suspected anaphylaxis [7], in the context of vaccination with the mRNA vaccines Comirnaty® (BioNTech Manufacturing GmbH) and Spikevax® (MODERNA BIOTECH SPAIN, S.L.) as well as the vector vaccines Vaxzevria® (AstraZeneca AB) and COVID-19 vaccine Janssen®. By August 1st 2021, according to data from the Robert Koch Institute 92,376,787 vaccinations had been administered, including 68,962,481 vaccinations with Comirnaty®, 8,506,260 vaccinations with Spikevax®, 12,491,937 vaccinations with Vaxzevria®, and 2,416,109 vaccinations with COVID-19 vaccine Janssen®.
Concerning reported allergic reactions, the 390 cases with suspected anaphylactic reactions reported until 31st of July 2021, were assessed by the Paul-Ehrlich-Institute as Brighton Collaboration (BC) levels 1-4 (level 1 corresponds to the highest, levels 2 and 3 to lower degrees of diagnostic certainty, and level 4 are reports of suspected anaphylaxis with incomplete information on clinical symptoms) [4]. The number of reported cases of suspected anaphylaxis are specified according to vaccine and applied dose in table 5.
Based on these data, a suspected hypersensitivity to SARS-CoV-2 vaccines results to be 2.7 cases of allergic reactions per 1 one million vaccine applications (considering the Brighton collaboration criteria 1-3). These data are presented in spontaneous reporting and over- or underreporting may be possible.