AI Article Synopsis
- A study in Jiangsu Province, China, assessed the safety of the varicella vaccine (VarV) by monitoring adverse events following immunization (AEFI).
- Results showed a higher incidence rate of AEFI after the first vaccine dose compared to the second, with common reactions making up 90.96% of reported events and very few serious adverse events noted.
- The vaccine is considered safe, with over 96% of AEFIs occurring within three days of administration, and no adverse events related to vaccine quality or fatalities recorded.
Article Abstract
Unlabelled: To assess the safety of varicella vaccine (VarV) by conducting post-marketing surveillance on adverse events following immunization (AEFI) in Jiangsu Province, China.
Methods: We utilized the AEFI Information System of mainland China to monitor and categorize adverse reactions associated with VarV.
Results: The incidence rate of AEFI was significantly higher after the first dose (48.79/100,000 doses) compared to the second dose (45.18/100,000 doses) (χ = 4.63, P = 0.031). Regional variations in AEFI incidence were observed within Jiangsu Province. Common reactions comprised 90.96% of AEFIs, while rare reactions and coincidental events accounted for 6.59% and 0.51%, respectively. Notably, there were no adverse events linked to vaccine quality, program errors, psychogenic reactions, or fatalities. Over 96% of AEFIs occurred within three days of VarV administration, with redness at the injection site (2.6 cm to 5 cm in diameter) being the most frequently observed symptom.
Conclusion: VarV demonstrates a commendable safety profile. Although there was a slight increase in AEFI incidence between 2022 and 2023, common vaccine reactions were predominantly observed, and the rates of rare reactions remained very low.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403869 | PMC |
| http://dx.doi.org/10.1186/s12879-024-09903-y | DOI Listing |
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