Signature patterns of vaccine adverse events
Some vaccine recipients can develop serious adverse events (SAEs) following coronavirus disease 2019 (COVID-19) immunization. In a retrospective study of the Vaccine Adverse Event Reporting System (VAERS) menstrual AEs following immunization, statistically significant differences were observed for multiple manufacturing lots of the COVID-19 Pfizer–BioNTech and the COVID-19 Moderna vaccines. Other candidate manufacturing contaminants associated with AEs may be detectable by comparing normalized frequency rates between predicted higher-contamination lots or vaccines and lower-contamination lots or vaccines. This retrospective study identified candidate pattern signatures for the most frequently reported AEs in VAERS for identified COVID-19 vaccine lots associated with these menstrual AEs, as well as differences in AE frequencies between three human papillomavirus (HPV) vaccines. Six candidate AE patterns (AEPs) were identified: hemorrhage (female), gynecologic including hemorrhage pattern, myopericarditis (male-biased), HPV vaccine-associated, neuropathy, and fetus patterns. The hemorrhage pattern was identified in six vaccines, including four influenza vaccines. The gynecologic pattern was identified in seven vaccines, including three COVID-19 and three HPV vaccines. The myopericarditis pattern was identified in 14 vaccines, including five COVID-19 vaccines, with two bivalent COVID-19 vaccines and three smallpox vaccines. The myopericarditis pattern appears to be associated with possible contaminant microbial protein activation of immune responses and live attenuated virus vaccines. The four AEPHPV AEs were elevated primarily among HPV vaccines. One or more of the five AEPneuropathy AEs were elevated in 11 vaccines, while one or more of the AEPfetus AEs were elevated in 11 vaccines.

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