Age: 0.1
Sex: F
Vaccine: DTP, HEP, HIBV, OPV, PPV, RV1
Symptoms: Gastroenteritis
Clinical narrative: This case was reported in a literature article and described the occurrence of gastroenteritis in a 7-week-old female subject who received Rotavirus vaccine. Co-suspect products included Oral polio vaccine and QUINVAXEM. On an unknown date, 1 day after receiving Rotavirus vaccine and 10PN-PD-Dit vaccine, the subject developed gastroenteritis. Serious criteria included hospitalization. The outcome of gastroenteritis was recovered/resolved. It was unknown if the investigator considered the gastroenteritis to be related to Rotavirus vaccine and 10PN-PD-Dit vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of gastroenteritis in a 7-week-old female who was vaccinated with ROTARIX (GlaxoSmithKline), either SYNFLORIX (GlaxoSmithKline) or PREVNAR (Pfizer); bivalent oral poliovirus vaccines (bOPV) (Sanofi Pasteur) and QUINVAXEM (Crucell). The patient was the part of an open-label randomized controlled multicenter study which targeted full-term infants between 20 May 2013 and 15 August 2013. The patient was a part of control group. The patient was healthy on physical examination with no obvious medical conditions and no known chronic medical disorders. No information on patient's family history was provided. No information on patient's concurrent condition or concomitant medications were provided. The patient was part of group 2 (control group) who should receive bOPV at 6, 10 and 14 weeks. On an unspecified date between 20 May and 15 August 2013, at the age of 7 week, the patient received one dose of ROTARIX, one dose of bOPV, unspecified dosage of either SYNFLORIX or PREVNAR and unspecified dosage of QUINVAXEN (administration route and site unspecified; batch number not provided, for all). 1 day after vaccination with ROTARIX, bOPV, either SYNFLORIX or PREVNAR and QUINVAXEM, the patient developed gastroenteritis. This case was considered serious due to hospitalisation. The treatment was unknown. The patient recovered fully without any sequelae. The authors did not comment on the causality relationship for gastroenteritis with ROTARIX, either SYNFLORIX or PREVNAR and QUINVAXEM. However the authors considered the event to be possibly related to bOPV vaccines. The authors stated that "Our prospective evaluation of humoral and intestinal immunity showed antibody responses after bOPV with one or two doses of IPV were non-inferior to those of tOPV or bOPV-only schedules for serotypes 1 and 3, and were superior to bOPV-only schedules for serotype 2. More than 90% of bOPV vaccines seroconverted or were primed to type 2 by one dose of IPV, IPV also induced small but statistically significant increases in intestinal immunity to type 2 compared with bOPV alone, suggesting some enhancement of intestinal protection. As the world prepares to move to routine bOPV-IPV immunization schedules during 2016-19, with mOPV2 intended for outbreak response, our study serves as a surrogate of future vaccination strategies and provides important evidence for the formulation of national, regional, and global policies in this final, historic phase of polio eradication." This is 1 of the 2 valid cases reported in the same literature article.