PharmaCovigilance: Role of the Pharmacist During COVID-19 Vaccination Campaign

• Published in: Drug safety 2022-10, Vol.45 (10), p.1193-1193
• Main Authors: Martignoni, I, Bragantini, D, Cicco, P, Gianfilippi, G, Gambera, M
• Format: Article
• Language: English
• Subjects: Adverse events; Asthenia; Coronaviruses; COVID-19; COVID-19 vaccines; Data collection; Employees; Fever; Headache; Headaches; Health care; Immunization; Medical personnel; Muscle pain; Muscles; Pain; Pharmacology; Pharmacovigilance; Pharmacy; Side effects; Syncope; Vaccines; Websites
• ISSN: 0114-5916; 1179-1942

Introduction: COVID-19 vaccination campaign at Pederzoli Hospital (Veneto, Italy) started in January 2021 using the two approved m-RNA vaccines. The vaccination schedule included 2 doses and one booster. Objective: The Pharmacy unit created a digital form in order to collect information on the incidence of the adverse events after the anti-covid vaccination. Methods: The Pharmacy Unit created a simplified digital form including a set of questions about the occurrence of adverse events. To improve the adherence to this pharmacovigilance program, the digital form was uploaded on the hospital website and all the employees received a remainder about this vaccine adverse event reporting system via e-email regularly. The data collected from the electronic spreadsheet were analyzed by the Health Department in order to produce a report in the dedicated national website (Vigifarmaco). Results: From January 2021 to April 2022 1076 employees received the first dose, 965 received the second dose, and 1019 received the third dose. 323 adverse events reporting forms have been collected after the first dose (30% of those who received it). 291 forms (30%) were collected after the second dose. 12 forms (1.2%) were collected after the third dose. The most reported adverse events after the first dose were: local pain (38% of reported adverse events), muscle pain 15%; asthenia 12%, headache 11%. Moreover, 6 employees reported fever above 38.5 °C and 19 employees reported fever between 37.5 °C and 38.5 °C. The most reported adverse events after the second dose were: local pain 19%, muscle pain 18%; asthenia 15%, headache 13%. An employee reported a syncope. In addition,35 reported fever above 38.5 ° C and in 70 fever between 37.5 °C and 38.5 °C. After the third dose, 10 reported headache, 9 local pain, and 8 asthenia and muscle aches. Only 2 employees reported fever above 38.5 °C and 5 fever between 37.5 °C and 38.5 °C. Conclusion: The active role of the Hospital Pharmacy Unit during the vaccination campaign of the health care workers of our hospital permitted to collect data regarding the side effects of these new vaccines and nonetheless made the health care workers about more aware about the importance of vaccine adverse event reporting system. The use of this digital form supported the pharmacovigilance program creating a useful and "user friendly" tool which may be tailored to new future projects.