Candidate vaccine manufacturing contamination adverse events signatures

Serious adverse events (SAEs) occur post COVID-19 immunization for some vaccinees. In a retrospective study of VAERS menstrual adverse events (AEs) post immunization, statistical differences were observed for different manufacturing lots of COVID-19 Pfizer-BioNTech and COVID-19 Moderna vaccines. Manufacturing contaminants (e.g., endotoxins) are likely causative candidates consistent with the observed data for menstrual AEs. Are there possible pattern signatures of safety signal associated with these candidate manufacturing contaminants? This retrospective study identified candidate pattern signatures for the most frequently reported AEs to VAERS for identified COVID-19 vaccines lots associated with these menstrual AEs. Six candidate pattern signatures were identified: hemorrhage (female), gynecologic (including hemorrhage pattern), myopericarditis (male-biased), MCHPV, neuropathy, and fetus patterns (female). The hemorrhage (only) pattern was identified in six vaccines (4 influenza). The gynecologic pattern was identified in seven vaccines (3 COVID-19 and 3 HPV). And, the myopericarditis pattern was identified in 14 vaccines (5 COVID-19 vaccines including 2 bivalent and 3 Smallpox vaccines). The four MCHPV AEs are elevated primarily with HPV vaccines. One or more of the five MCneuropathy AEs were elevated in 11 vaccines. One or more of the MCfetus AEs were elevated in 11 vaccines.