Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, RV1, UNK, VARCEL
Symptoms: Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing
Clinical narrative: Complex Febrile Convulsions; Influenza A; This 15-month-old female subject was enrolled in a study  The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 18-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 26-APR-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 15-FEB-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 26-APR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 18-OCT-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 18-OCT-2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular, left thigh) on 18-OCT-2019, for prophylaxis.   Concurrent medical conditions included reactive airways disease.   On 08-JAN-2020, 82 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 257 days after receiving DTPa-HBV-IPV and Hiberix and 327 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 influenza a virus infection (Verbatim: Influenza A). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 complex febrile convulsion (Verbatim: Complex Febrile Convulsions) on 13-JAN-2020 with serious criteria of hospitalization. The subject was treated with oxygen, budesonide, salbutamol (Albuterol), sodium chloride, paracetamol (Tylenol), oseltamivir phosphate (Tamiflu) and lorazepam (Ativan). The outcome of influenza a virus infection was resolved on 18-JAN-2020. The outcome(s) of the additional event(s) included complex febrile convulsion (resolved on 13-JAN-2020).   Relevant Tests: On 13-JAN-2020 Chest X-Ray No acute cardiopulmonary findings On 14-JAN-2020 CT (Computerised tomogram) Head; No acute pathology seen on the brain On 14-JAN-2020 Influneza Virus A RNA; Positive..   The investigator considered that there was no reasonable possibility that the influenza a virus infection and complex febrile convulsion may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13.  The company considered that there was no reasonable possibility that the influenza a virus infection and complex febrile convulsion may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13.   Linked case(s) involving the same subject:  US2020029362   GSK Receipt Date: 18-FEB-2020 15 Month girl with history of Reactive Airway Disease and family history of febrile seizures, transferred from ED (emergency department) for 2 complex seizures in 24hrs, found to be influenza A positive. Prior to seizure, subject had cough, congestion and fevers. First seizure occurred 13JAN2020 at daycare, she became unresponsive and had jerking arm movements, followed by emesis and groggy post ictal period with full return to baseline. In the ED (emergency department) had a second seizure approximately 8 minutes in duration requiring Ativan with R arm shaking and unresponsiveness. Febrile to 102.5, labs and head CT normal. Transferred to hospital for further management. During her admission she had no further seizure activity. Neurological exams improved throughout the day on 14JAN2020, early in the day she was drowsy and ataxic, likely due to Ativan administration. No signs of encephalopathy. No further fevers. Further imaging and lumbar puncture deferred secondary to reassuring improvement of neurologic exam and return to baseline per parents. On the day of discharge she developed mild wheezing and intermittent subcostal retractions consistent with her known reactive airway disease symptoms. Exam improved significantly after normal albuterol dose. Subject started on Tamiflu, would continue 5 day course BID. On day of discharge, bilateral tympanic membranes were mild erythematous and had copious earwax, but no bulging, purulent or serous fluid behind tympanic membrane was visualized. Subject admitted to hospital on 13JAN2020 and discharged on 15JAN2020. This child did not experience any infections, trauma or complications at birth. The child's APGARS were 9 at 1 minute after and 9 at 5 minutes after birth. No seizures were experienced by this child prior to occurrence.  Follow-up information received on 12th May 2022 this follow-up was consider as non-significant. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The seizure was witnessed by study personnel or other health care professional. The date of first seizure was 13/Jan/2020 and time of first seizure was 17:30. Fever at the time or immediately before generalized convulsive seizure: 102.5 degrees Fahrenheit. Duration of seizure in minutes (approximately): 6 minutes. Number of generalized convulsive seizures: 2. No past history of similar events. Familial history of similar events: Yes, but the event was not already reported. Type of Seizure: Febrile seizure. Diagnostic certainty level: Level 1; Witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations.  Summary of changes: No new information updated.  Follow up information was received on 08-AUG-2024 The subject was received D5 Nacl 0.9% as treatment dose 40 ml/hr, CO via Intravenous on 14-JAN-2020 for complex febrile convulsions The subject was received D5-Nacl 0.9% with KCL as treatment dose 40 ml/hr, CO via Intravenous from 14-JAN-2020 to 15-JAN-2020 for complex febrile convulsions. Summary of changes: Event complex Febrile Convulsions seriousness criteria GSK Medically Significant removed, treatment medication Ativan unit updated from mg to ml, Tylenol frequency updated from Once only to Once daily and narrative updated.  Follow up information was received on 14-JAN-2025 Summary of changes: General narrative comments and unit update for oxygen.; Sender's Comments: A case of Influenza and Febrile convulsion 82 days after receiving 4th doses of Bexsero vs Placebo and Prevnar 13, 1st doses of M-M-R II and Varivax, 257 days after receiving 3rd doses of DTPa-HBV-IPV and Hiberix, and 327 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 15-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausability (for Bexsero vs Placebo, Rotarix lyophilized formulation,  M-M-R II, Varivax and Prevnar 13) and alternative etiology (Influenza A positive) and alternative risk factors (h/o Reactive Airway Disease, family history of febrile seizures and fever contributed by underlying infection). US-GLAXOSMITHKLINE-US2020029362: