A report describes a case of a 66-year-old female with delayed large cutaneous hypersensitivity reaction following Spikevax COVID-19 mRNA (mRNA-1273) vaccine administration. The patient was autonomous and cognitively whole, a former smoker with a history of dyslipidemia, essential arterial hypertension, obesity, multinodular goiter, and cholecystectomy (bile lithiasis). Her regular medications included olmesartan + hydrochlorothiazide (20 + 12.5 mg) and simvastatin 20 mg, all once a day.

On D7, after receiving the first dose of the vaccine, she experienced severe pain, heat, and redness at the inoculation site. She denied the occurrence of fever and took self-medication with ibuprofen 600 mg every 12 h, plus applied ice to the reaction site. 

On D9, a physician evaluated her and diagnosed erythema with well-defined limits (measuring 6 cm in diameter) with heat to the touch around the inoculation site located on the external face of the anterolateral region of the upper third of the left upper limb. 

It was suspected as a case of adverse reaction and was reported to the Portuguese Pharmacovigilance System, which then assessed it based on the WHO-UMC Causality Categories. The clinical event transpired with a reasonable time relationship to drug intake, and a causal link with concomitant diseases or other drugs was unlikely.

The patient received symptomatic treatment, including topical steroids, oral antihistamines, and cool compresses and/or ice. She was recommended to maintain ibuprofen 600 mg every 12 h for two more days, ice application, and bilastine 20 mg t.i.d. 

Six days after symptom onset, on D13, the patient reported complete resolution of the symptoms. She received the second dose of the vaccine 28 days after the administration of the first dose (D28), along with taking bilastine 20 mg of the day before vaccination (D27) and for three more days after (until D31). After the second vaccine dose, she did not document any complications.

Ferreira-da-Silva R, Ribeiro-Vaz I, Silva AM, et al. Delayed Extensive Local Reaction to the mRNA-1273 Vaccine against SARS-CoV-2: A Case Report. Journal of Pharmacology and Pharmacotherapeutics. 2023;0(0). doi:10.1177/0976500X221147748