Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Bacterial test positive, Culture urine, Febrile convulsion, Pyrexia, Urinary casts
Clinical narrative: FEBRILE SEIZURE; Initial information received on 22-Jun-2022 and 29-Jun-2022 (both processed together) regarding a solicited valid serious case received from a physician, in the scope of company sponsored study.   This case involves a 1 year old female subject who experienced febrile seizure, during the study participation.  The subject's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 24-Aug-2021, the subject received a first dose of suspect investigational MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE VS MENVEO via intramuscular route in the upper right thigh. On the dame day, the subject received first dose of non-investigational, DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) (batch UJ601AAA) via intramuscular route in upper right thigh, first dose of non-investigational PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch DR7167) via intramuscular route in lower left thigh, first dose of non-investigational ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (batch T026932) via oral route and first dose of non-investigational HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) (batch 53YL7) via intramuscular route in lower right thigh, as prophylactic vaccination.   On 27-Oct-2021, the subject received a second dose of suspect investigational MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE VS MENVEO via intramuscular route in the upper right thigh. On the dame day, the subject received a second dose of non-investigational, DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) (batch UJ601AAA) via intramuscular route in upper right thigh, a second dose of non-investigational PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch DR7167) via intramuscular route in lower left thigh, and a second dose of non-investigational ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (batch T026932) via oral route, as prophylactic vaccination.   On 27-Dec-2021, the subject received a third dose of suspect investigational MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE VS MENVEO via intramuscular route in the upper right thigh. On the dame day, the subject received a third dose of non-investigational, DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) (batch UJ601AAA) via intramuscular route in upper left thigh, a third dose of non-investigational PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch DR7167) via intramuscular route in lower left thigh, a third dose of non-investigational ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (batch 1741377) via oral route and a second dose of non-investigational HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) (batch K329E) via intramuscular route in lower right thigh, as prophylactic vaccination.  On 20-Jun-2022, the subject received a fourth dose of suspect investigational MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE VS MENVEO via intramuscular route in the upper right thigh. On the dame day, the subject received a fourth dose of non-investigational PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch DR7167) via intramuscular route in upper left thigh, a first dose of non-investigational MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMR II) (batch T028935/U031355) via subcutaneous route in right upper arm and a first dose of VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX) (batch T04150/U006135) via subcutaneous route in left upper arm, as prophylactic vaccination.  On 21-Jun-2022, i.e.  one day after the last dose and 9 months 28 days following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE VS MENVEO, the subject was hospitalized. Hyaline Casts were noted high under Low power field (LPF) in urine specimen. Urine Bacteria test and Urine Mucous Threads were also abnormal. Urine culture reflex criteria showed more than 5 WBCs (White Blood Cells).   The subject was diagnosed with febrile seizure (Febrile convulsion). The subject was considered resolved the same day and was hence discharged on the same day.   Maximum intensity was reported as grade 2. The event was assessed as an AESI (Adverse Event of Special Interest) but was not an MAAE (Medically Attended Adverse Event).   The event appeared after visit 04.   Action taken with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE VS MENVEO was not applicable.  The patient was treated with IBUPROFEN for Pyrexia.   The event did not cause discontinuation of study vaccine.   Febrile seizure was considered to be related to MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE VS MENVEO by the reporter and reportable by the company based on company causality assessment.  Relationship between febrile seizure and the study procedure was not related by the reporter and not reportable by the company based on company causality assessment.  The study code has been broken for regulatory purposes since the event seizure is unexpected according to the current investigator's brochure.; Sender's Comments: Company comment done on 01-Jul-2022: This case involved a 1 year-old female study participant who experienced febrile seizure (PT= Febrile convulsion), grade 2, the next day after receiving the fourth dose of the study vaccine  MENINGOCOCCAL A-C-Y-W135 ( T CONJUG) VS MENVEO MENINGOCOCCAL A-C-Y-W135 (T CONJUG) administered concomitantly with routine pediatric vaccines (Prevenar, MMR II and Varivax). The patient was hospitalized for this event .The patient was treated with IBUPROFEN for Pyrexia and discharged from the hospital on the same day The reported event is temporarily  associated with the administration of the study vaccine and three other routine pediatric vaccines (Prevenar, MMR II and Varivax).  Based on the available information, the exact causality of the event cannot be determined. Therefore, the sponsor conservatively assessed this event as related to study product in agreement with the investigator.