Reports of lower respiratory tract infection following dose 1 of RotaTeq and Rotarix vaccines to the Vaccine Adverse Event Reporting System (VAERS), 2008-2016
- PMID: 29993327
- PMCID: PMC6314423
- DOI: 10.1080/21645515.2018.1491509
Reports of lower respiratory tract infection following dose 1 of RotaTeq and Rotarix vaccines to the Vaccine Adverse Event Reporting System (VAERS), 2008-2016
Abstract
A 2018 manufacturer post-licensure safety study identified a possible association between Rotarix (RV1) rotavirus vaccine and lower respiratory tract infections (LRTI) in infants within 0-6 days following receipt of RV1 dose 1. We reviewed reports to the Vaccine Adverse Event Reporting System (VAERS) of LRTI occurring 0-6 days and 0-29 days post vaccination following RotaTeq (RV5) or Rotarix (RV1) vaccinations in conjunction with either Prevnar (PCV7) or Prevnar 13 (PCV13), in infants aged 6 to 15 weeks. There was no significant difference in LRTI reports to VAERS in the 0-6 days and 0-29 days following receipt of either RV5 or RV1 given with either pneumococcal vaccine.
Keywords: Adverse event; Rotavirus vaccine; VAERS; Vaccine safety; passive surveillance; rotavirus.
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