Brazil Asks Janssen to Add Adverse Events to Vaccine Package

Sept. 17, 2021, 9:42 PM

Brazilian health regulator requested Janssen-Cilag to change its Covid-19 vaccine package in order to add adverse events identified during the monitoring of shot administration, the agency known as Anvisa says in a statement.

  • Among the adverse events reported, Anvisa cites lymphadenopathy (increased size and/or number of lymph nodes), paresthesia (numbness in some part of the body) and hypoesthesia (decreased skin sensitivity), tinnitus (ringing in the ear), as well like diarrhea and vomiting
  • Janssen-Cilag has up to 30 days to include the information in the vaccine packaged insert distributed in Brazil: Anvisa

Original Story:
Anvisa pede inclusão de evento adverso ...

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