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Farm Comunitarios. 15(3):5-16. doi: 10.33620/FC.2173-9218.(2023).21

Pharmacovigilance of vaccines against COVID-19 in community pharmacies. Results after the second dose and comparison between both

Mera-Gallego R1, 2, León-Rodríguez L3, 2, Barreiro Juncal M1, 2, Pérez Molina L1, 2, Guisado Barral B4, 2, Busto Domínguez I5, 2, Andrés-Rodríguez NF6, 2, Fornos-Pérez JA7, 2
1. Community pharmacist in Vigo. 2. Berbés Research and Teaching Group. 3. PhD Pharmacy. Community pharmacist in Ourense. 4. Community pharmacist in Crecente (Pontevedra). 5. Technical Department of the Official College of Pharmacists of Pontevedra. 6. PhD Pharmacy. 7. PhD Pharmacy. Community Pharmacist in Cangas do Morrazo (Pontevedra).
Mera-Gallego R, León-Rodríguez L, Barreiro M, Pérez L, Guisado B, Busto I, Andrés-Rodríguez NF, Fornos-Pérez JA. Pharmacovigilance of vaccines against COVID-19 in community pharmacies. Results after the second dose and comparison between both. Farm Comunitarios. 15(3):5-16. doi: 10.33620/FC.2173-9218.(2023).21
Abstract : 

Aim: Detection and tracing of suspicious adverse reactions (ARs) in community pharmacies after the second of COVID-19 vaccine dose. Comparison between doses.

Methods: Design: prospective observational study.

Subjects: vaccinated against COVID-19, of legal age, who consent to participate.

Variables: number and percentage of participants with ARs. Number, type and frequency of ARs. Impact on their daily life. Relations between variables.

Approved by the Galician Ethical Committee of Research with medicines.

Results: 693 participants with the 2nd dose, 63.6% women. Age 56.8 years. 312 (45.0%) vaccinated, 49.4% women and 37.3% men (p<0.0001), reported at least one AR: 43.9% with Comirnaty®, 37.7% with Vaxzevria®, 63.0% with Spikevax®.

There were 972 ARs, 75.2% in women and 24.8% in men (p<0.0001). Mean 1.4/vaccinated (maximum 11). The most prevalent AR: pain at injection site 197 (28.4%), tiredness/fatigue 141 (20.3%), myalgia 112 (16.2%), headache 95 (13.7%), fever 84 (12.1%).

51 participants with ARs needed professional help: 10 from the doctor, 6 in the emergency room, 3 in hospitals (1 referral), 33 in the pharmacy. 70 (15.1%) were prevented from their daily activity. 201 Ars from vaccinated persons were reported.

Number of people vaccinated with ARs and the number of ARs were less with the 2nd dose (p<0.05).

Inverse relationship (p<0.05) between “age” and “number of vaccinated with ARs”, “need for professional care” and “prevented daily activity”.

Conclusions: The number of vaccinated participants with ARs and their number was also high with the second dose, although lower than with the first. Women and younger people are predictive of increased risk of AR after vaccination against COVID-19.

Keywords : 
Covid-19; SARS-CoV-2; vaccine; 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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