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, 2 men and a woman, aged 21−33 years was described, who developed angioedema following administration of tozinameran vaccine [routes and dosages not stated].

Case 1: A 21-year-old man, who had chronic rhinitis, had received first dose of tozinameran vaccine [Pfizer-BioNTech; COVID-19 mRNA vaccine] without any adverse symptoms. Three weeks later, he received the second dose of tozinameran. After two-and-a-half days, he developed erythematous plaques and wheals on his thigh with subjective tongue swelling. The rash was noted as evanescent, and he was started on unspecified antihistamine treatment. Despite this, the rash persisted, and became more diffuse for more than 30h. Five days following his second dose, he developed dysphagia and marked swelling of the lips. He was then referred to the emergency department, where he was noted as normotensive and tachycardic. Physical examination revealed an urticarial rash on his face and neck and swelling of the posterior pharynx, upper lip, tongue and periorbital area. He started receiving epinephrine, methylprednisolone, famotidine, diphenhydramine and cetirizine. Within 8h, his angioedema began to improve, and within 24h, it resolved completely. Subsequently, in the 7 months, no further episodes were noted.

Case 2: A 33-year-old man had a history of type 1 diabetes mellitus, peanut allergy, allergic rhinitis and eosinophilic oesophagitis. He had received the first dose of tozinameran. Following 30h, he developed dysphagia, throat tightness and dyspnoea. He had self-administered epinephrine, and presented to the emergency department. He was noted as hypertensive and tachycardic. Physical examination showed dyspnoea, dysphonia and tripoding. Flexible laryngoscopy indicated grape-sized uvular swelling, along with oedema of the false vocal folds. He was started on epinephrine, diphenhydramine and methylprednisolone. His angioedema improved, and the epinephrine was weaned overnight. Six months later, he received the second dose of tozinameran with no further episodes of angioedema.

Case 3: A 33-year-old woman had a history of episodic idiopathic urticaria, venom hypersensitivity, asthma and Cushing syndrome, requiring unspecified corticosteroids. She had received the first dose of tozinameran. Following 1 day, she developed an erythematous, pruritic rash on her chest, throat tightness with dyspnoea, and presented to the emergency department. She was noted to be tachycardic, normotensive and mildly febrile. Physical examination showed tongue and lip angioedema, urticaria involving chest and arms with muffled voice and decreased breath sounds. Flexible laryngoscopy showed edematous vocal cords. She was intubated. She was started on epinephrine, famotidine, diphenhydramine and methylprednisolone therapy. The epinephrine was weaned after 8h, and her angioedema resolved within 14h. She was advised to not receive the second dose of tozinameran. Subsequently, in the 7 months, no further episodes of angioedema were noted.