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.
ABSTRACT
Background/Introduction: Adverse events following immunisation (AEFIs) are unpleasant/unintended medical occurrences (sign, symptom, laboratory finding, disease) observed after immunisation, with or without causal association with vaccine usage [1]. They are expected to occur acutely after the administration of an injectable, as is reported in the summary of product characteristics (SmPC) of the mRNA-1273 vaccine [2]. However, there are also some reports of delayed injection-site reactions as AEFIs of mRNA vaccines against SARS-CoV-2 [3-6]. The occurrence of large local reactions may impact adherence to vaccination, particularly to the second dose, compromising the efficacy of the vaccine. Objective/Aim: To describe a case series of 15 patients with delayed large local reactions (dLLR) to the mRNA-1273 vaccine. Methods: We analysed a case series of 15 patients presenting dLLR to the mRNA-1273 vaccine, which were reported to the Porto Pharmacovigilance Centre between May 21 and June 2021 by a physician at a COVID-19 vaccination centre. We analysed: (1) age and sex of the patient;(2) type of AEFIs-Preferred Term (PT) hierarchy level coding, according to the MedDRA (Medical Dictionary for Regulatory Activities);(3) time to onset after immunisation;and (4) therapeutic prescribed. Results: Almost all the cases were observed in women (n = 14). The median age for all patients was 53 years (range 27-73). According to the PT, six types of AEFIs were reported: vaccination site erythema (n = 15), vaccination site warmth (n = 14), extensive swelling of vaccination limb (n = 9), vaccination site pain (n = 2), vaccination site pruritus (n = 1) and vaccination site oedema (n = 1). In ten patients, the reactogenic reaction included three AEFIs: erythema and warmth at the vaccination site with extensive swelling of the limb. The median time to onset was 7 days after the first dose (range 6-14). Seven patients received treatment for their symptoms: antihistamine (n = 7), corticosteroid (n = 3), NSAID (2), cryotherapy (n = 2) and antibiotic (n = 1);for eight patients the treatment remains unknown. Conclusion: We report a series of dLLR after the mRNA-1273 vaccine, which probably represents an AEFI not yet described in the SmPC. The pathophysiological mechanism underlying this dLLR remains unclear, although the clinical criteria for these reactions are consistent with delayed-type hypersensitivity. Further insight on the occurrence of this clinical situation is crucial to further characterise the safety of this and other SARS-CoV-2 vaccines and to define strategies to inform the population in order to promote adherence to vaccination.
ABSTRACT
The COVID-19 pandemic is the defying crisis of our time. Since mass vaccination has not yet been established, countries still have been facing many issues due to the viral spread. Even in cities with high seroprevalence, intense resurgent waves of COVID-19 have been registered, possibly due to viral variants with greater transmission rates. Accordingly, we develop a new Model Predictive Control (MPC) framework that is able to determine social distancing guidelines and altogether provide estimates for the future epidemiological characteristic of the contagion. For such, the viral dynamics are represented through a Linear Parameter Varying (LPV) version of the Susceptible-Infected-Recovered-Deceased (SIRD) model. The solution of the LPV MPC problem is based on a Sequential Quadratic Program (SQP). This SQP provides convergent estimates of the future LPV scheduling parameters. We use real data to illustrate the efficiency of the proposed method to mitigate this contagion while vaccination is ongoing. Copyright (C) 2021 The Authors.