Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, Febrile convulsion, Gastroenteritis rotavirus, Immunoglobulin therapy, Inflammation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 2-year-old female patient who received ROTARIX lyophilized formulation (batch number A41CB416A, expiry date 3rd September 2015). Co-suspect products included ROTARIX and ROTARIX. On 24th September 2014, the patient received the 1st dose of ROTARIX lyophilized formulation (oral) 1 ml. On 26th November 2014, the patient received the 2nd dose of ROTARIX (oral). On 26th January 2015, the patient received the 3rd dose of ROTARIX (oral). On 26th January 2015, not applicable after receiving ROTARIX lyophilized formulation and ROTARIX, not applicable after receiving ROTARIX lyophilized formulation and ROTARIX and an unknown time after receiving ROTARIX, the patient experienced extra dose administered. In February 2017, the patient experienced mutism (serious criteria hospitalization), nuclear magnetic resonance imaging abnormal (serious criteria hospitalization) and inflammation (serious criteria hospitalization). On 19th February 2017, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria hospitalization and GSK medically significant), viral encephalitis (serious criteria hospitalization and GSK medically significant), vomiting and fever. On 20th February 2017, the patient experienced febrile seizure (serious criteria hospitalization and GSK medically significant). On 21st February 2017, the patient experienced ataxia (serious criteria hospitalization), difficulty in standing and mobility decreased. The patient was treated with dexamethasone and immunoglobulins NOS (IVIG). On an unknown date, the outcome of the vaccination failure, diarrhea rotavirus, difficulty in standing, mobility decreased and extra dose administered were unknown and the outcome of the febrile seizure, nuclear magnetic resonance imaging abnormal, vomiting and fever were recovered/resolved and the outcome of the ataxia, mutism, viral encephalitis and inflammation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus, febrile seizure, ataxia, mutism, viral encephalitis, nuclear magnetic resonance imaging abnormal, vomiting, fever, difficulty in standing and mobility decreased to be related to ROTARIX lyophilized formulation, ROTARIX and ROTARIX. Additional details were reported as follows: On 19th February 2017, 879 days, 816 days and 755 days after 3 doses of vaccinations, the patient had fever, vomiting and loose stools. The vomiting had resolved on the next day and the loose stools were definitely diarrhea. On 20th February 2017, 880 days, 817 days and 756 days after 3 doses of vaccinations, the patient had a seizure in the evening and was admitted to the emergency room. The patient was diagnosed with febrile seizure and was sent home. The next day, 881 days, 818 days and 757 days after vaccinations, the patient could not sit or stand. While at the doctor's office for a follow-up appointment from the previous days seizure the patient had another seizure. At this time the patient was no longer running a fever. The patient was sent to the emergency room again where she had a 3rd seizure. The patient was admitted to the hospital and numerous tests were run. The first magnetic resonance imaging (MRI) showed an abnormality in the splenium of the corpus callosum. A spinal tap was performed it was determined to be clear. A friend of the caller found a study linking the abnormality found on the magnetic resonance imaging (MRI) with rotavirus, and the patient's stool was tested and positive for rotavirus. The caller did not know if the spinal tap was tested for rotavirus. The patient was initially diagnosed with acute cerebellar ataxia, but that was later changed to rotavirus cerebellitis. The treating health care professional told the caller the two terms were interchangeable. The patient was treated with dexamethasone and intravenous immunoglobulin (IVIG). A 2nd magnetic resonance imaging (MRI) showed no abnormality, but the patient still had inflammation in the cerebellum and they are waiting for it to go away. At the time of reporting the patient was still in the hospital and had to learn how to sit up, stand, regain her balance, walk and talk. The patient was experiencing ataxia and mutism as a result of the cerebellitis. The caller was told that this should not have happened since her daughter was vaccinated against rotavirus. At the time of follow up, reporter called back stating that her daughter received a 3rd dose of ROTARIX on the clinic that administered the dose was not able to provide a reason for the 3rd dose, and would not provide the lot number. The reporter was not sure about the name of the responsible physician and was confused between the two physicians. The reporter knew the nurse that worked at the immunization clinic, she specifically gave some vaccines to the patient, but it was not  clear if she administered ROTARIX or it was someone else in the clinic.