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Farm Comunitarios. 2023 Jan 02;15(1):22-40. doi: 10.33620/FC.2173-9218.(2023).04

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

Mera-Gallego R1, León-Rodríguez L2, González-Blanco M3, Mera-Gallego I4, García-Rodríguez P5, López-Cantorna D3, Fornos-Pérez JA6, Andrés-Rodríguez NF7
1. Community pharmacist in Vigo (Pontevedra). Berbés Research and Teaching Group. 2. Doctor of Pharmacy. Community pharmacist in Ourense. Berbés Research and Teaching Group. 3. Community pharmacist in Vigo. Berbés Research and Teaching Group. 4. Community pharmacist in Maella (Zaragoza). Berbés Research and Teaching Group. 5. Community pharmacist in Cangas do Morrazo (Pontevedra). Berbés Research and Teaching Group. 6. Doctor of Pharmacy. Community pharmacist in Cangas do Morrazo (Pontevedra). Berbés Research and Teaching Group. 7. Doctor of Pharmacy. Berbés Research and Teaching Group.
Mera-Gallego R, León-Rodríguez L, González-Blanco M, Mera-Gallego I, García-Rodríguez P, López-Cantorna D, Fornos-Pérez JA, Andrés-Rodríguez NF. Pharmacovigilance of vaccines against COVID-19 in community pharmacies. Results with the first dose. Farm Comunitarios. 2023 Jan 02;15(1):22-40. doi: 10.33620/FC.2173-9218.(2023).04
Abstract : 

Aim: Detection, reporting and monitoring of suspected Adverse Drug Reactions (ADR) in users of community pharmacies and their impact on health and daily life.

Methods: 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).

Results: 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.

Conclusions: 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.

Keywords : 
COVID-19, SARS-CoV-2, vaccines, pharmacovigilance, adverse drug reaction, community pharmacist
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Editor: © SEFAC. Sociedad Española de Farmacia Clínica, Familiar y Comunitaria. 
Copyright© SEFAC. Sociedad Española de Farmacia Clínica, Familiar y Comunitaria. This article is available from url https://www.farmaceuticoscomunitarios.org/. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-nd/4.0/deed.en

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