Centre National de Pharmacovigilance, 9 Avenue du Dr Zouhaier Essafi 1006, Tunis, Tunisia.
Unité de Recherche, Faculté de Médecine, Université Tunis El Manar, UR17ES12.15 Rue Djebel Lakhdhar, La Rabta, 1007, Tunis, Tunisia.
Curr Drug Saf. 2024;19(4):465-468. doi: 10.2174/1574886318666230725101846.
Pfizer/BioNTech (BNT162b2) is a COVID-19 vaccine with a reassuring safety profile. The main adverse reactions are mild local reactions. Cutaneous reactions are generally minor. The most common cutaneous reaction reported was a local injection-site reaction.
Here we present 2 cases of erythema multiform (EM) following BNT162b2 vaccination with positive rechallenge. The 1 case was about a 51-year-old woman who developed 5 days after the 1st dose of the mRNA Pfizer/BioNTech (BNT162b2) a macular, erythematous, roundshaped lesions on the hands, knees and soles. She experienced a positive rechallenge one month later. In the 2 case, a 55-year-old man presented 6 days following the 2 shot of the mRNA Pfizer/ BioNTech (BNT162b2), targetoid eruption on the upper and lower members. The patient reported that he had the same skin lesions in ankles and soles few days following the 1 shot of the same vaccine.
Few cases of EM following COVID-19 vaccination were reported in the literature and positive rechallenge in only one case. Rechallenge was not performed in most cases. Our two cases are particular because of the positive rechallenge in both patients. This is the gold standard to confirm that the vaccine was the culprit agent in inducing EM.
辉瑞/生物科技(BNT162b2)是一种具有可靠安全性的 COVID-19 疫苗。主要不良反应为轻度局部反应。皮肤反应一般较轻。报告的最常见皮肤反应是局部注射部位反应。
我们在此介绍 2 例 BNT162b2 疫苗接种后出现多形红斑(EM)的病例,且均为阳性再激发。1 例为 51 岁女性,在接种第 1 剂辉瑞/生物科技(BNT162b2)mRNA 疫苗后 5 天,手部、膝盖和脚底出现红斑、圆形斑疹。1 个月后,她出现阳性再激发。在第 2 例中,1 名 55 岁男性在接种辉瑞/生物科技(BNT162b2)mRNA 疫苗第 2 剂后 6 天,出现四肢靶形皮疹。患者报告说,在接种同一种疫苗第 1 剂后几天,他的脚踝和脚底也出现了同样的皮肤损伤。
文献中报道了少数 COVID-19 疫苗接种后出现 EM 的病例,且仅在 1 例中出现阳性再激发。在大多数情况下,未进行再激发。我们的两例病例比较特殊,因为两名患者均出现阳性再激发。这是确认疫苗是引起 EM 的罪魁祸首的金标准。