Sex: U
Vaccine: RV1
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a child unk subject who received Rotavirus vaccine. On an unknown date, 14 days after receiving Rotavirus vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included rotavirus gastroenteritis with serious criteria of hospitalization and GSK medically significant, diarrhea and vomiting. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included rotavirus gastroenteritis (unknown), diarrhea (unknown) and vomiting (unknown). It was unknown if the investigator considered the rotavirus gastroenteritis, diarrhea and vomiting to be related to Rotavirus vaccine. Relevant Tests: Rotavirus stool test: Positive for G1P[8] strain. Additional information received: This case was reported in a literature article and it described the occurrence of a rotavirus infection in a child of unspecified gender between 8 months and 3 years of age who had received a ROTARIX (GlaxoSmithKline). The patient had been enrolled in a study whose exclusion criteria were the following: history of immune deficiency, having been previously enrolled for the same acute gastroenteritis episode within 3 days of the current presentation or having been transferred from another hospital. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the patient received at least 1 dose of ROTARIX (oral, dosage unknown; batch number not provided). On an unspecified date either between 1 November 2009 and 30 June 2010, or between 1 November 2010 to 30 June 2011, at least 14 days after the administration of the vaccine, the patient presented to hospital with acute gastrointestinal symptoms defined by the authors as at least 3 episodes of diarrhoea and/or 1 episode of vomiting within a 24-hour-period. It was unknown if the patient was admitted or only visited the Emergency Department. G1P[8] rotavirus strain was isolated in a reverse transcription polymerase chain reaction of a faecal sample. This case was considered as a possible vaccination failure. Treatment was unknown. The outcome of the event was unspecified. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "In conclusion, this assessment of a diverse sample of children <5 years of age subject to "real-world" conditions found significant vaccine effectiveness for complete courses of both RV5 and RV1 rotavirus vaccines. No indication of waning over time was observed at the detectable limits for either vaccine, nor was there any significant difference in vaccine performance by predominant circulating strains, including the G12 genotype, which is not homotypically covered by these vaccines. Each of these rotavirus vaccines in concurrent use performed well in preventing medically attended rotavirus acute gastroenteritis episode among young children".