Safety assessment
redness, fatigue, fever, diarrhea, swelling, rash, pain, cough, pruritus, muscle pain, headache, nausea, vomiting
ADVERSE EVENTS, EVENT, ALLERGIC REACTION, INDURATION
For active surveillance, immediate adverse events were observed on the study site during 30 minutes following vaccination. Face-to-face or telephone visits were assigned on the 14th day and 30th day to collect solicited and unsolicited adverse events after vaccination. Solicited adverse events are defined as symptoms specified in the protocol occurring within 14 days after vaccination. Unsolicited adverse events refer to symptoms specified in the protocol occurring from Day 15 to Day 30, or other symptoms which were not specified in the protocol occurring within 30 days after vaccination. Solicited systemic adverse events included nausea, vomiting, diarrhea, fever, allergic reaction, fatigue, skin and mucosa abnormality, cough, headache, decreased appetite, and muscle pain; solicited local adverse events included rash, pain, swelling, pruritus, redness, and induration. Any adverse events were graded according to the guidelines issued by the National Medical Products Administration (NMPA) [For passive surveillance, AEFI data were extracted from the CNAEFIS within 3 months after vaccination. AEFI refers to a reaction or event that occurs after vaccination and is suspected to be related to vaccination [