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
• passive surveillance
• rotavirus
• rotavirus vaccine
• vaccine safety
• vaers