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Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42 USC \u00a7241(d), 5 USC \u00a7552a, and 44 USC \u00a73501 et seq.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0and consent to participate"}},{"value":"Data from the VAERS system is available to everyone through the VAERS Wonder database available at:\n                      \n                      . Anyone with internet access may use this site and conduct basic analysis to confirm some of the findings described in the manuscript. However there are data in this manuscript which come from review of medical records of the patients who experienced an adverse event. The data cannot be shared openly to protect patient privacy.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and materials"}},{"value":"Not applicable","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"PLM and MMO originated the study, supervised its implementation, conducted the analysis, and led the writing of the manuscript summarizing the findings. PM, CE, PB, KW, NN, and MT assisted in one or more aspects, including study design, review of VAERS reports and medical records, technical advice, administrative support, and writing of the report. All authors read and approved the final version.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}