Persistent maculopapular rash after the first dose of Pfizer‐BioNTech COVID‐19 vaccine

To The Editor,

The ongoing global pandemic COVID‐19 led regulatory agencies to recently issue an emergency authorization for two effective COVID‐19 vaccines from Pfizer‐BioNTech and Moderna. Both vaccines use a novel technology of administering vaccination, namely a lipid nanoparticle‐formulated, nucleoside‐modified mRNA vaccine encoding the spike glycoprotein of SARS‐CoV‐2 for subsequent antigen presentation and immune system activation. ¹

Although this novel vaccine technology is purported to be generally safe, the adverse effects and especially skin effects of mRNA vaccines are not yet completely characterized. In phase III clinical trial of Pfizer‐BioNTechCOVID‐19 vaccine ² and in the first post‐market morbi–mortality report, ³ the main skin manifestations reported are anaphylaxis skin symptoms like urticaria and diffuse erythematous rash and non‐anaphylaxis allergic symptoms as an injection‐site reaction, pruritus and rash without any semiological description. ² , ³ , ⁴

Recently, it was reported a case of a pruritic erythematous macular morbilliform eruption in a patient after each of the two injections of the Pfizer‐BioNTechCOVID‐19 vaccine with spontaneous resolution in 24 h. ⁵ Herein, we report a case of a different persistent maculopapular eruption onset for a few hours after the first injection of the Pfizer‐BioNTech COVID‐19 vaccine associated with liver damage, not described before.

A 55‐year‐old male hospital nurse, with no past medical history and no drug allergy, received the first dose of the Pfizer‐BioNTech COVID‐19 vaccine. Three hours after vaccination, the patient experienced injection‐site soreness in the deltoid region with localized pruritic erythematous eruption which later spread on the face, trunk, upper extremities and thighs. During week 3, facing this persistent and unchanged eruption the patient presented at the dermatological consultation wondering about the safety of the second dose of vaccine. Clinical examination confirmed a maculopapular exanthema with 30% of body surface area involved (Fig. 1). Oral and genital mucosa was preserved and there was no fever, arthralgia or other systemic symptoms. HIV, HBV, HCV, CMV, EBV and measles serologies were negative and blood test only showed slight hepatic cytolysis (ASAT and GGT 2N). A punch biopsy was performed and haematoxylin and eosin‐stained sections showed slight lymphocytic perivascular infiltrate, compatible with non‐severe maculopapular toxidermia late biopsied.

Figure 1.

Maculopapular eruption: (a) Upper back (b) Right shoulder (c) Left shoulder (d) Chest.

It was decided not to perform the second dose because of the persistence of the rash, the liver damage and the known risk of more severe reaction after a first sensibilization, and the case was reported at the pharmacovigilance authority.

The rash persisted over a month with a gradual improvement over the days with dermocorticoid treatment in parallel with the improvement of liver enzymes.

The particular interest of our case is the early development of the rash with localized onset and its persistence over time with liver involvement, which led not to perform the second dose of vaccine. This is an example of the important role that healthcare providers and the dermatologists, in particular, play in the safety of these new vaccines by being vigilant in recognizing and reporting adverse events to the competent pharmacovigilance authority, but also in describing the emerging reactions to help better understand them, which could have an implication for the vaccination strategy.

Funding source

No funding sources to declare.

Conflicts of interest

M Ackerman, D Henry, A Finon, R Binois, E Esteve: No conflict of interest to declare.