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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 D6, Fornos-Pérez JA7, Andrés-Rodríguez NF8
1. Farmacéutica comunitaria en Vigo (Pontevedra). Grupo Berbés de Investigación y Docencia. 2. Doctora en Farmacia. Farmacéutica comunitaria en Ourense. Grupo Berbés de Investigación y Docencia. 3. Farmacéutica comunitaria en Vigo. Grupo Berbés de Investigación y Docencia. 4. Farmacéutica comunitaria en Maella (Zaragoza). Grupo Berbés de Investigación y Docencia. 5. Farmacéutica comunitaria en Cangas do Morrazo (Pontevedra). Grupo Berbés de Investigación y Docencia. 6. Farmacéutico comunitario en Vigo. Grupo Berbés de Investigación y Docencia. 7. Doctor en Farmacia. Farmacéutico comunitario en Cangas do Morrazo (Pontevedra). Grupo Berbés de Investigación y Docencia. 8. Doctor en Farmacia. Grupo Berbés de Investigación y Docencia
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 reactions (AR) 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 AR. 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 AR: 236 (53.0%) Comirnaty®, 157 (82.6%) Vaxzevria®, 69 (66.3%) Spikevax® and 33 (80.5) Janssen®.

1,367 AR 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 AR, 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.

AR 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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