Table1. Patient characteristics of the reported cases of fixed drug eruption following COVID-19 vaccination
Nationality Thailand4 Guyan5 Malta6 Tunisia7 France8
Gender Male Male Female Female Female
Age 74 66 26 40 54
Time when lesions started to appear 25 hours after the 1st dose Within 24 hours of receiving the 2nd dose 15 days after the 1st dose; subsequent lesion appeared 14 days after the 2nd dose 3 days after the 1st dose.
Subsequent lesions appeared 7 days after the 1st dose
24 hours after the 1st dose; subsequent lesion appeared 4 days after the 2nd dose.
COVID-19 vaccine type Adenoviral-vectored mRNA mRNA Adenoviral-vectored mRNA
Associated symptoms None reported Fever, myalgia None reported None reported None reported
Past medical history End stage renal disease, Atrial fibrillation, Ischemic stroke Hypertension, hyperlipidemia, diabetes, chronic kidney disease, coronary artery disease, idiopathic hypothyroidism None reported None reported Seasonal allergic rhinitis
Medication history None reported Amlodipine, aspirin, brimonidine solution, clopidogrel, famotidine, furosemide, gabapentin, insulin aspart and glargine, levothyroxine, lisinopril, metoprolol, pravastatin, tamsulosin Hydroxyzine prior to receiving the 2nd dose of vaccine.
Topical 1% hydrocortisone and terbinafine applied on the 2nd lesion was ineffective
None reported None reported
Skin Exam Multiple, well‐defined, round to oval, erythematous to violaceous plaques with central dusky appearances and bullous formation Extensive areas of painful violaceous patches many of which developed into large flaccid bullae 1st lesion: mildly pruritic, erythematous, annular patch 7 cm below the injection site in the same arm, developing central erosion surrounded by a halo over 2 days, then resolved spontaneously.
2nd lesion was a similar patch although with prominent vesiculation at the center which eventually ruptured and scabbed.
A well-defined bullous erythematous plaque sur-rounding the injection site, plus two other lesions on the upper and lower limbs A 3-4 cm-well-defined erythematous patch
Location Trunk and both extremities Abdomen, buttocks, and lower extremities Same arm in which injection had been done Upper and lower limbs Left wrist
Labs Unremarkable Hyperkalemia, hyperglycemia, mild transaminitis, serum CK of 347, and an incidental finding of mild AKI on CKD.
Normal serum Ab to bullous pemphigoid
Not discussed in the article Not discussed in the article Not discussed in the article
Pathology Subepidermal separation with superficial and deep perivascular inflammatory cell infiltration plus mixed inflammatory cells infiltrate composing of lymphohistiocytes and numerous eosinophils. Melanophages were seen in the upper dermis. Full-thickness epidermal necrosis and a very sparse lymphocytic inflammatory infiltrate Overall, lichenoid interface dermatitis was found.
Patchy lymphohistiocytic infiltrate in the upper dermis around skin adnexal structures, lymphocytic infiltration of the basal layer of epidermis, basal cell vacuolar damage, Civatte body formation and pigment incontinence, dermal-epidermal junction clefting
Epidermal necrosis, bullae formation, superficial and deep perivascular mixed infiltrate of lymphocytes, neutrophils and eosinophils, and dermal melanophages were detected Acute vacuolar interface changes and keratinocyte necrosis with superficial perivascular infiltrate of lymphocytes.
Final diagnosis Generalized bullous fixed drug eruption Extensive bullous fixed drug eruption Fixed drug eruption Generalized bullous fixed drug eruption Fixed drug eruption
Treatment Topical 0.25% desoximetasone cream Ibuprofen and high-dose oral prednisone, bullae drainage followed by mupirocin and Vaseline for wound care. Not discussed in the article Potent topical corticosteroids and hydroxyzine Topical beclomethasone dipropionate
Outcome Lesions gradually resolved within 2 weeks with subsequent post-inflammatory hyperpigmentation. Discharged from hospital after 7 days with prednisone taper and outpatient follow up recommendation Not discussed in the article Resolution of the lesion after a few days of treatment with subsequent development of post inflammatory hyperpigmentation Clearance of the lesion in 21 days without residual hyperpigmentation