Local and systemic adverse reactions following COVID-19 vaccine

The mass vaccination against novel coronavirus infection (COVID-19) requires to dynamically evaluate risks of adverse events following immunization to prevent them and develop vaccination tactics for various population groups. We describe a clinical case of reaction following administration of the second dose of the heterologous recombinant adenovirus based COVID-19 vaccine Gam-COVID-Vac (Sputnik V) in 48-year-old female healthcare worker. No adverse events after administration of the first dose were recorded. After vaccination, the patient complained of weakness, malaise, headache, loss of appetite, and nausea that lasted for a single day. Reaction at the injection site appeared 10 hours after vaccination manifested as pruritic erythema, induration area up to 1.5 cm size, sharp pain, which resolved within 24 hours. On the second day post-vaccination, an inflammation area up to 1.5 cm size within the Bacillus Calmette–Guérin (BCG) scar site was noted and manifested as erythema, induration, painful to palpate, pruritus located 2 cm away from the injection site. BCG scar reaction with dull pain and severe pruritus lasted for three weeks. Erythema and induration at the BCG scar site resolved two months after the onset, which were resolved by using antihistaminic agent. The patient was vaccinated according to the Russian Federation Immunization Program, not associated with any adverse events following immunization. The patient had comorbidities such as vasomotor rhinitis, urolithiasis, stomach, duodenal ulcer, type 2 diabetes, arterial hypertension, and her body mass index of 35.2. The patient permanently receives antihypertensive and antihyperglycemic drugs, and has allergic reaction in the form of urticaria to Berodual. The patient has menopause during two years, but a five-day postmenopausal bleeding three days after vaccination with the second dose was noted. Thus, a high-quality surveillance of any local and systemic reactions associated with vaccination is needed to reveal adverse events to the vaccines against COVID-19 and elaborate a safe immunization program for preventing COVID-19.