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

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.