Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, RV1, UNK, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: Single febrile seizure; This 12-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 04-NOV-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 02-MAY-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 22-FEB-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 02-MAY-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 04-NOV-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 04-NOV-2019, for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis.   Concurrent medical conditions included upper respiratory tract infection.   On 17-NOV-2019 19:00, 13 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 199 days after receiving DTPa-HBV-IPV and Hiberix and 268 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 febrile seizure (Verbatim: Single febrile seizure). Serious criteria included clinically significant/intervention required. The outcome of febrile seizure was resolved on 17-NOV-2019 20:03.   The investigator considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Varivax. Other possible cause(s) of the febrile seizure included medical condition and concurrent medication.   The company considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Varivax.   Linked case(s) involving the same subject:  US2021205450, US2021205451   GSK Receipt Date: 19-NOV-2019 Subject reported a temperature of 100.7F in their report the evening of 17Nov2019 and then subject experienced a febrile seizure (not tonic-clonic, simply blank stare and unresponsiveness for 2 to 3 minutes). Subject did not go to the emergency room for this but did have a visit with the PCP (Primary care provider) on 18Nov2019. According to the PCP's exam, subject has an upper respiratory infection. It was not known definitively if the fever and associated febrile seizure was a result of the URI or a reaction to MMR vaccination (timing of reaction falls within parameters of a possible reaction to MMR vaccine). Investigator reported SAE as Single febrile seizure. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). On 17th November 2019 19:00, 13 days after 1st dose of M-M-R II (non GSK product, taken as prophylaxis), the subject experienced febrile seizure. On 10 Dec 2020 New information regarding Seizure. Date of first Seizure: 17 Nov 2019 Time of first Seizure: 19:00. No Fever at the time or immediately before generalized convulsive seizure. 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 vaccination: No. Diagnostic certainty level: Level 5; Not a case of generalized convulsive seizure.  Upon internal review case was updated on 27-NOV-2024. Suspect MMR II vaccine was coded as suspect with GSK dictionary and other vaccines recoded as per updated drug coding convention, narrative was updated.; Sender's Comments: A case of Febrile convulsion, 13 days after receiving the 4th dose of Bexsero vs Placebo, the 1st dose of M-M-R II and the 1st dose of Varivax, 199 days after receiving the 3rd dose of DTPa-HBV-IPV and the 3rd dose of Hiberix and 268 days after receiving the 2nd dose of Rotarix lyophilized formulation, in a 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering alternative etiology ( family history for similar event is positive; possible reaction to MMR vaccination; upper respiratory tract infection). US-GLAXOSMITHKLINE-US2021205450: US-GLAXOSMITHKLINE-US2021205451: