Tozinameran

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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, a 67-year-old man and a 70-year-old man were described, who developed interstitial lung disease (ILD) following treatment with tozinameran [dosages and routes not stated].

Case 1: A 67-year-old man was admitted to hospital with severe COVID-19 pneumonia requiring intubation from July 2020 to October 2020. He was a smoker and had a history of hypertension and diabetes. Later, he was suspected with mild chronic interstitial pneumonia. In July 2021, he presented to hospital with one day history of dry cough. Anamnesis revealed that, one day prior he received tozinameran [mRNA-based SARS-CoV-2 vaccine; BNT162b2]. During admission, his body temperature was 37.5°C and peripheral oxygen saturation was 89%. An electrocardiogram showed sinus rhythm and blood investigations revealed elevated alveolar damage and inflammatory markers. His pulmonary function test showed reduced forced vital capacity was 2.52L. The CT scan revealed bilateral diffuse ground-glass opacities. An acute interstitial pneumonia secondary to tozinameran was suspected. A bronchoalveolar lavage a total cell count of 8.7105/ml. The histopathological examination showed alveolitis with lymphocyte infiltration. Based on all these findings, an acute lymphocytic alveolitis related tozinameran was made. Thereafter, he was treated with unspecified corticosteroids. Later, he discharged home as his symptoms rapidly improved.

Case 2: A 70-year-old man was was admitted to hospital and diagnosed with cryptogenic organizing pneumonia (COP) in September 2020. Later, he received prednisolone till January 2021. He received two doses of tozinameran in June and July 2021. Two days later, he developed fever and dyspnoea. His laboratory parameters showed lactose dehydrogenase 248 IU/L, CRP 3.21 mg/dL and surfactant protein D 173 ng/mL. His chest radiography revealed an infiltrative shadow in the right lower lobe. A diagnosis of acute interstitial pneumonia secondary to tozinameran was made. Later, he was treated with prednisone over a period of 2 months. Eventually, his condition improved.