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JPP · Lens · Delayed Extensive Local Reaction to the mRNA-1273 Vaccine against SARS-CoV-2: A Case Report

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Article · Volume 13, Issue 4 · pp. 401–403

Delayed Extensive Local Reaction to the mRNA-1273 Vaccine against SARS-CoV-2: A Case Report

Renato Ferreira-da-Silva1,2,3, Inês Ribeiro-Vaz1,2,3, Ana Marta Silva1,2,3, Fernando Nunes4, Manuela Morato5, Jorge Junqueira Polónia1,3,6, Paulo Guedes4

  1. 1Porto Pharmacovigilance Centre, Faculty of Medicine of the University of Porto, Porto, Portugal.
  2. 2Department of Community Medicine, Health Information and Decision, Faculty of Medicine of the University of Porto, Porto, Portugal.
  3. 3CINTESIS – Center for Health Technology and Services Research, Porto, Portugal.
  4. 4Local Health Unit of Matosinhos, EPE, Matosinhos, Portugal.
  5. 5LAQV/REQUIMTE, Laboratory of Pharmacology, Department of Drug Sciences, Faculty of Pharmacy of the University of Porto, Porto, Portugal.
  6. 6Department of Medicine, Faculty of Medicine of the University of Porto, Porto, Portugal.

Abstract

In response to the COVID-19 pandemic, two mRNA vaccines (Comirnaty and Spikevax) received emergency use authorization from the European Medicines Agency. This case report aimed to report a delayed adverse reaction to the mRNA-1273 vaccine against COVID-19 from a Portuguese vaccination center. A case report was performed with medical observation and reported to the Portuguese Pharmacovigilance System, then investigated based on the WHO-UMC Causality Categories. A 66-year-old female patient with a clinical history of dyslipidemia, essential arterial hypertension, obesity, multinodular goitre and cholecystectomy, who presented delayed large cutaneous hypersensitivity reaction following Spikevax COVID-19 mRNA (mRNA-1273) vaccine administration. Our clinical findings (time and clinical appearance), along with evidence of previously reported histological findings, are strongly suggestive of T-cell-mediated hypersensitivity. There is no contraindication to the inoculation of subsequent doses in patients developing these clinical conditions, and vaccination should continue to be strongly encouraged.

Keywords: SARS-CoV2; Viral vaccines; COVID-19 vaccines; Adverse drug reactions; Case report

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