Published: 5 March 2015

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Rotavirus Vaccination - Summary of Adverse Event Reports Received in the First Six Months of Funding

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Prescriber Update 36(1): 8
March 2015

The Centre for Adverse Reactions Monitoring (CARM) has been closely monitoring reports of adverse events associated with vaccination with rotavirus vaccine.

The RotaTeq brand of rotavirus vaccine was funded from 1 July 2014. As of 31 December 2014 CARM had received 112 reports describing 236 adverse events associated with RotaTeq. The majority of reports were submitted by nurses (81.3%) and described events after the first dose (81%).

The most frequently reported adverse events were gastrointestinal (110/236 reports) and the three most common reactions were diarrhoea (36), vomiting (27) and abdominal pain (14). In addition there has been one report describing blood in the stool; a known adverse effect.¹

The most serious adverse effect associated with rotavirus vaccination is intussusception. To date the Ministry of Health has been made aware of one case where a child showed symptoms consistent with intussusception following RotaTeq vaccination. Vaccinators are reminded that parents need to be informed of this risk and what to do if their child displays signs of intussusception. More information can be found on the Ministry of Health website ( www.health.govt.nz/your-health/conditions-and-treatments/diseases-and-illnesses/rotavirus) and the Medsafe website (www.medsafe.govt.nz/consumers/educational-material/rotavirusQandA.asp).

Other events frequently reported with rotavirus vaccination included: irritability (14), fever (14) and persistent crying (8) with 19 reports of crying - various. More information on events reported with rotavirus vaccination can be found on the Medsafe website (www.medsafe.govt.nz/Projects/B1/ADRSearch.asp).

Please continue to report adverse events and medication errors associated with rotavirus vaccination to CARM. Your reports help CARM and Medsafe monitor the safety of RotaTeq and helps us understand the profile of this medicine in New Zealand.

References

1. Merck Sharp & Dohme NZ Ltd. 2013 RotaTeq Data Sheet 3 July 2013 URL: www.medsafe.govt.nz/profs/Datasheet/r/RotaTeqsusp.pdf (accessed 16 January 2015).