mRNA-1273/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 conducted in Spain, 20 female patients aged 25−60 years were described who developed acute onset supraclavicular lymphadenopathy after receiving COVID-19 vaccination with tozinameran or mRNA-1273.

All the women were healthcare workers. Out of the 20 woman, 19 women received COVID-19 vaccination with IM tozinameran [Comirnaty, Pfizer-BioNTech]. The lot numbers of tozinameran were EJ6134 (2 women), EK9788 (10 women), EL8723 (3 women), EM0477 (2 women), EM6950 (1 woman) and EP9598 (1 woman). The remaining one woman received COVID-19 vaccination with IM mRNA-1273 [Moderna] lot number 300042460. Two of these 20 women had a history of developing COVID-19 infection prior to the COVID-19 vaccination. However, within 24 hours to 24 days, all the women developed supraclavicular lymphadenopathy. Of the 19 women who received the vaccination with tozinameran, 14 women developed the adverse reaction after the first dose and five women after the second dose. The one woman who received vaccination with mRNA-1273, developed the adverse reaction after receiving the first dose. All the lymphadenopathies were notable for inflammatory symptoms (pain and swelling), were round and mobile. Confirmatory tests for the diagnosis were performed in five women. The confirmatory tests included ultrasonography and fine-needle aspiration puncture in four women and ultrasonography, mammography and fine-needle aspiration puncture in one woman. Subsequently, all the 20 women were referred to a hospital in Spain.

The condition improved in five women and completely resolved within 5−16 days in the remaining 15 women. All the women who developed the adverse reaction after receiving the first dose, later completed the vaccination schedule by receiving the second dose.