Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Seizure; This 11-month-old female subject was enrolled in a blinded study titled. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 02-MAY-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 02-MAY-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 02-MAY-2019, for prophylaxis. Co-suspect products included Rota (Rotarix) for prophylaxis and Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 14-OCT-2019 20:00, 165 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix, the subject developed moderate - grade 2 seizure (Verbatim: Seizure). Serious criteria included clinically significant/intervention required. Bexsero vs Placebo was continued with no change. The outcome of seizure was resolved on 14-OCT-2019 20:02. The investigator considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix. The company considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix. Linked case(s) involving the same subject: US2019208712, US2021205451 GSK receipt date: 30-SEP-2021 INVESTIGATOR TEXT Subject had 8 day history of congestion and rhinorrhea. Parent used nasal saline rinse for congestion. Subject then had episode of decreased responsiveness, drooling, and looking upward with shaking which lasted less than 2 minutes. Subject was febrile (99.6 F axilla) upon arrival at ED which parents had not been aware of. Subject was observed in ED, given motrin, tylenol, and oral fluids. Subject had no seizure activity in the ED and was discharged home with instructions to control fever with antipyretics and follow up with pediatrician. Subject's father and paternal grandmother have a history of febrile seizures. Additional details: This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Date of first Seizure: 17 Nov 2019 Time of first Seizure: 19:00. Subject having Fever at the time or immediately before generalized convulsive seizure. Body temperature at the time of generalized convulsive seizure was 100.7 degrees Fahrenheit Duration of seizure in minutes: 3 Minutes Number of generalized convulsive seizures: 1 Past history of similar events: yes Type of Seizure: Febrile seizure associated with upper respiratory infection and fever. Fever History: yes. Familial history of similar events: Yes Type of Seizure: Febrile seizures experienced by both subject's father and paternal grandparents. Fever History: Yes Following a previous vacccination: No. Diagnostic certainty level:Level 5; Not a case of generalized convulsive seizure. The investigator considered that there was no reasonable possibility that the seizure may have been caused by Prevnar13 and Rotarix. On 14th October 2019 20:00, 234 days after receiving Rotarix, the subject developed moderate - grade 2 seizure. On 14th October 2019 20:00, 165 days after receiving Prevenar 13, the subject developed moderate - grade 2 seizure. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix, Rotarix, Prevenar 13 from World-MKT to World-INV. Device Rotarix ORAL APPLICATOR DEVICE, Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of seizure, 165 days after receiving 3rd dose of Bexsero vs Placebo, Pediarix, Hiberix, in a 11-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (upper respiratory tract infection) and alternative risk factor ( past H/o seizures and family H/o seizure in subject's father and paternal grandmother). US-GLAXOSMITHKLINE-US2019208712: US-GLAXOSMITHKLINE-US2021205451: