Pharmacovigilance of vaccines against COVID-19 in community pharmacies. Results with the first dose

Abstract

Detection, reporting and monitoring of suspected Adverse Drug Reactions (ADR) in users of community pharmacies and their impact on health and daily life. Design: prospective observational. Subjects: people vaccinated against COVID-19, of legal age, who signed informed consent. Variables: number and percentage of participants who had at least one ADR. Number, type and frequency of possible reactivity. Impact on your daily life. The study was approved by CEIm-G (Exp. 2021-007). 10 pharmacies from Pontevedra and 2 from Ourense collaborated. 781 cases, 488 (62.5%) women. Age 56.8 (SD=17.9) years. 389 (49.8%) in risk group.495 (63.4%) vaccinated, 321 women (65.8%) and 174 (59.4%) men, reported at least one ADR: 236 (53.0%) Comirnaty®, 157 (82.6%) Vaxzevria®, 69 (66.3%) Spikevax® and 33 (80.5) Janssen®.1,367 ADR were recorded. The most prevalent: pain at the injection point 375 (48.0%), tiredness/fatigue 170 (21.8%), chills 118 (15.1%), headache 117 (15.0%), muscle pain 112 (14.3%) and fever 98 (12.5%).Of the 495 respondents with ADR, 77 (15.6%) needed professional help: from the family doctor 30 (39.0%), 9 (11.7%) in the emergency department, 1 (1.3%) in the hospital and 37 (48.1%) in the pharmacy. 118 (15.1%) were unable to carry out their daily activity.ADR were reported from 264 (53.3%) vaccinated. The number of vaccinated people who reported having suffered RA was high. Pain at the injection site the most prevalent. Half were treated at the pharmacy. Although they were generally mild, they markedly affected his daily life.