FDA Lists Adverse Events to Tripedia DTaP Vaccine

The FDA document for the Tripedia DTaP vaccine (Diphtheria, Tetanus and Pertussis) notes (page 11) the occurrence of adverse events, including: Autism, SIDS, Guillain-Barre’ syndrome, anaphylactic reaction, cellulitis, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and apnea…among other things. Per the document, “Events were included in this list because of the seriousness or frequency of reporting.” However, it notes that “Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine.”
On page 1: “The vaccine is formulated without preservatives, but contains a trace amount of thimerosal [(mercury derivative), (≤0.3 μg mercury/dose)] from the manufacturing process. Each 0.5 mL dose also contains, by assay, not more than 0.170 mg of aluminum and not more than 100 μg (0.02%) of residual formaldehyde.”
Related:
* Form DH 681 (Religious Expemption Form)
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