Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Haemoglobin normal, Hyperthermia, Influenza serology negative, Nasal congestion, Platelet count normal
Clinical narrative: This case was reported by a physician via a GSK representative and described the occurrence of vaccination failure in a 7-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On unknown dates, the subject received 1st dose and 2nd dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced vaccination failure and rotavirus. The subject was hospitalised. At the time of reporting, the outcome of the vaccination failure and rotavirus were unspecified. The subject was administered two doses of ROTARIX. At the age of seven months, the subject was admitted to the hospital after developing rotavirus, and was reported as a product failure. No additional information was provided. Follow-up information was received on 25 January 2010, via physician. Previous and/or concurrent vaccination included PENTACEL (non-gsk) ;non-GSK manufacturer; intramuscular; unknown given on May 2009 and 28 July 2009; ENGERIX B; GlaxoSmithKline; intramuscular; unknown given on May 2009; PREVNAR (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 29 May 2009 and 28 July 2009. On 29 May 2009 and 28 July 2009 the subject received 1st and 2nd dose of ROTARIX (oral). On 2 October 2009, four months after vaccination with the 1st dose of ROTARIX and 66 days after 2nd dose of ROTARIX, the subject experienced vaccination failure, gastroenteritis, dehydration, fever, hyperthermia, nasal congestion and rhinorrhea. On 04 October 2009, approximately four months after vaccination with the 1st dose of ROTARIX and 68 days after 2nd dose of ROTARIX, the subject was diagnosed with rotavirus. On 05 October 2009, approximately four months after vaccination with the 1st dose of ROTARIX and 69 days after 2nd dose of ROTARIX, the subject experienced diarrhea. The subject was hospitalised for 5 days. The subject was treated with treated with antibiotics, hydration therapy, ceftriaxone, ROCEPHINE and intravenous fluid(s) (IV fluids). The discharge summary stated the subject was admitted after a two day history of fever and symptoms of upper respiratory infection. The fever had been up to 105 and was 100.4 at presentation. Blood culture was obtained as well as catheterized urine for urinalysis and culture. She was started on intravenous (IV) fluids and Ceftriaxone pending results of cultures. The subject continued to be febrile and have copious mucoid nasal discharge. Chest x-ray showed mild increased perihilar markings, consistent with a viral process. On second hospital day, she developed diarrhea. Eventually the stool became liquid and watery. Her C-reactive protein went up to 3.9. The subject's stool Rotavirus antigen tested positive on 05 October 2009. It was noted that the subject had her immunization up to date including completed dose of rotavirus vaccine orally. After 48 hours she was afebrile and remained afebrile thereafter. She initially had multiple watery stools and by the third hospital day this "slacked off" and on 08 October she had two loose tools within 18 hours. ROCEPHIN was discontinued. Regular diet consisted of formula with starchy baby food which she tolerated well and did not result in increased frequency of bowel movements. Respiratory status also improved, as well as activity. She was discharged in stable condition on 08 October 2009, diagnosis of purulent rhinitis, Gastroenteritis, secondary to rotavirus and fever with elevated C - reactive protein. On 20 October 2009, the rotavirus, gastroenteritis, dehydration, fever, diarrhea, hyperthermia, nasal congestion and rhinorrhea were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.