COVID-19 vaccination including 198 patients with history of severe anaphylactic reaction - own observations.

ABSTRACT

INTRODUCTION: The SARS-CoV-2 pandemic has taken a heavy toll of 4 million deaths. We were all looking forward to the authorisation of safe vaccines. Soon after vaccination programmes started, the reports about anaphylaxis began to emerge. Growing anxiety has urged regulatory agencies and academic societies to issue adequate recommendations regarding patient eligibility to vaccination. AIM OF THE STUDY Observation of patients who had a history of a severe anaphylactic reaction and/or anaphylactic shock and were vaccinated against COVID-19. MATERIAL AND METHODS: A single-centre, prospective, observational study was conducted at the Department of Infectious Diseases and Paediatrics at Stefan Zeromski Specialist Hospital in Krakow, Poland. Adult patients with a history of a severe anaphylactic reaction and/or anaphylactic shock and patients without it were administered the Comirnaty vaccine by Pfizer-BioNTech or the ChAdOx1-S vaccine by AstraZeneca in a two-dose schedule at the department. The patients were then observed at the department for 60 minutes. A week after each vaccination dose, the patients were contacted by telephone in order to collect data about a late allergic reaction. RESULTS: In total, 403 patients were enrolled. For the Pfizer BioNTech Comirnaty vaccine, the study group (i.e. patients with a history of severe anaphylactic reactions to various substances, other than those present in the vaccine) included 151 patients, and there were 161 controls. For the AstraZeneca ChAdOx1-S vaccine, the study group included 47 patients, and 44 patients formed the control group. Nine cases of severe anaphylactic reactions were reported 3 in the study groups (1.5%) and 6 in the control groups (3%). Anaphylactic shock after vaccine administration occurred in one patient from the control group. CONCLUSIONS: COVID-19 vaccination with using Pfizer-BioNTech Comirnaty and AstraZeneca ChAdOx1-S is safe also for patients with a history of a severe anaphylactic reaction and/or anaphylactic shock. Severe anaphylactic reactions and anaphylactic shock, although rare, may also develop in patients without a prior history of allergic conditions. The Personnel od vaccination centres should be therefore trained to provide medical help. Incorrect patient exclusions delay the attainment of the goal determined for the vaccination programme.