Tozinameran

Author Information

An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

In a case series, four patients (3 women and 1 boy, aged: 15−55 years) were described, who developed oral erythema multiforme following administration of tozinameran vaccine [routes and dosages not stated; not all outcomes stated].

Case 1: A 55-year-old woman presented with painful lesions on lips, hands, knees, feet and oral mucosa. A year before the presentation, she was diagnosed with mucous membrane pemphigoid (MMP), which was treated with corticosteroid-based therapy. Prior to the presentation, she received the first dose of tozinameran [BNT162b2; BioNTech/Pfizer] vaccine. Twenty-four hours after the first dose of the vaccine, no symptoms were observed, except for mild pain at the injection site. After 10 days, she developed squamous crusted lesions on the vermillion and labial skin. She also had oral mucosa painful erosive lesions and concentric targetoid plaques on forearms, knees, hands and heels. No involvement of genital mucous membranes was observed. Before vaccination, she was not taking any medication and no recent history of MMP lesions or herpes labialis was observed. Thereafter, she received the second dose of vaccination. Concomitantly, she also received an unspecified corticosteroid to contain the flare's spread. Immediately, after the second dose of vaccination, she developed new lesions on her hands. Hence, she was treated with prednisone and clobetasol [clobetasol propionate]. After discontinuation of corticosteroid-based therapy, the ELISA test showed negative. Based on findings, a diagnosis of erythema multiforme minor was made. Ten days after treatment, her lesions disappeared without any reoccurrences.

Case 2: A 15-year-old boy, who had a history of West Syndrome, received the first dose of tozinameran [BNT162b2; BioNTech/Pfizer] vaccine. Seven days after vaccination, he developed erosions, oral erythema and pseudo-membranes spread throughout the oral mucosa, along with severe pain and dysphagia. Several cutaneous lesions involving erythematous plaques affecting the whole body, in the particular on the trunk, neck and legs, were also observed. Based on findings, a diagnosis of erythema multiforme minor was made. No history of cutaneous autoimmune, herpetic diseases or any change in his usual epilepsy medical treatment was reported. After symptom onset, he received betamethasone and unspecified antihistamine medication. Ten days later, his symptoms persisted. Hence, he was treated with prednisone and clobetasol [clobetasol propionate]. After a week of treatment, he showed regression of cutaneous and mucosal lesions

Case 3: A 49-year-old woman received the second dose of tozinameran [BNT162b2; BioNTech/Pfizer] vaccine. After 24h, she presented with an intraoral burning sensation with later development of erythematous and bullous-like lesions on the mouth floor and tongue. No history of herpetic manifestation or any other diseases was reported. One week later, her symptoms spontaneously improved, while erythematous lesions spread on the mouth floor, dorsal tongue, gingival mucosae, soft palate arose and buccal mucosa, which caused severe dysphagia. No cutaneous lesions were observed. Hence, a diagnosis of erythema multiforme minor was made. Therefore, she was treated with prednisone and clobetasol [clobetasol propionate]. Post-treatment, her lesions healed with no reoccurrence.

Case 4: A 20-year-old woman, who had a history of lactose intolerance, spastic colon and celiac disease, received the first dose of tozinameran [BNT162b2; BioNTech/Pfizer] vaccine. After 18 days of vaccination, she presented with pain and bleeding from the mouth, dysphonia and dysphagia. The oral examination showed the presence of erosions on the gingival and lips mucosa, vermillion associated with persistent fever and squamous crusted lesions on labial skin. No cutaneous lesions were observed. She had been receiving valaciclovir and nystatin for 7 days. Examination for Covid-19 showed negative results. Hence, a diagnosis of erythema multiforme was made. Therefore, she was treated with prednisone for 3 weeks.