Outcomes
sore throat, anaphylaxis, myalgia, death, fever, diarrhea, shock, respiratory failure, neurologic dysfunction, cough, anosmia, hyposmia, headache, chills, shortness of breath
SORE THROAT, ADVERSE REACTIONS, ANAPHYLAXIS, ADVERSE EVENT, SARS-COV-2 INFECTION, SHOCK, RESPIRATORY FAILURE, DISEASE, SECONDARY, ADVERSE REACTION, ACUTE RESPIRATORY DISTRESS SYNDROME
The primary outcome was the occurrence of PCR-positive symptomatic Covid-19 disease 14 days or more after the second injection. A SARS-CoV-2 RT-PCR test was requested for all participants with clinical symptoms suspicious of SARS-CoV-2 infection, including fever (temperature ≥ 38 °C), chills, cough, shortness of breath, myalgia, headache, sore throat, diarrhea, anosmia, or hyposmia. All suspected or confirmed cases were followed up daily until all symptoms were resolved.The secondary outcomes were severe cases of Covid-19 disease that had been hospitalized or died 14 days or more after the second injection, immediate reactions including anaphylaxis following vaccine injections, local and systemic adverse reactions within the first-week post-vaccination, and any Medically Attended Adverse Events (MAAEs) including Serious Adverse Events/Reactions (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring within the four months active follow-up. Severe Covid-19 cases were defined by one or more of the following criteria: respiratory rate above 30 per minute; heart rate at or exceeding 125 beats per minute; oxygen saturation at 93% or less while the participant was breathing ambient air at sea level or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen below 300 mm Hg; respiratory failure; acute respiratory distress syndrome; evidence of shock (systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg, or a need for vasopressors); clinically significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death.