Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, RV1, UNK, VARCEL
Symptoms: Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative
Clinical narrative: gastroenteritis; febrile seizure; This 17-month-old male subject was enrolled in a study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 12-SEP-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 27-DEC-2018, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 12-MAR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 12-MAR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 12-SEP-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 12-SEP-2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular, left thigh) on 12-SEP-2019, for prophylaxis.   On 01-FEB-2020 03:34, 142 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 401 days after receiving Rotarix lyophilized formulation and 326 days after receiving DTPa-HBV-IPV and Hiberix, the subject developed mild - grade 1 febrile seizure (Non-serious, Verbatim: febrile seizure). Additional event(s) included mild - grade 1 gastroenteritis (Verbatim: gastroenteritis) on 01-FEB-2020 03:36 with serious criteria of hospitalization. The subject was treated with ibuprofen, paracetamol (Acetaminophen), salbutamol (Albuterol) and ondansetron (Zofran). The outcome of febrile seizure was resolved on 02-FEB-2020 14:51. The outcome(s) of the additional event(s) included gastroenteritis (resolved on 02-FEB-2020 14:51).   Relevant Tests: On 01 Feb 2020 Subject had influenza test done on earlier in the ER (emergency room) with negative result.  Urine culture had no growth.  Blood culture had no growth.  Stool culture had moderate growth if normal stool flora.   Diagnostic results (reference ranges are provided in parenthesis if available): Band neutrophil count- 01-FEB-2020 18 percent, (0.00-8.00). Basophil count- 01-FEB-2020 1 percent, (0.00-2.00). Blood albumin- 01-FEB-2020 3.7 µG/DL, (3.40-4.80). Blood alkaline phosphatase- 01-FEB-2020 205 unit/litre, (32.00-350.00). Blood bilirubin- 01-FEB-2020 0.9 mg/dL, (0.00-1.00). Blood calcium- 01-FEB-2020 9.3 mg/dL, (8.90-10.30). Blood chloride- 01-FEB-2020 102 mEq/L, (101.00-111.00). Blood creatine- 01-FEB-2020 0.3 mg/dL, (0.70-1.20). Blood glucose- 01-FEB-2020 107 mg/dL, (70.00-100.00). Blood potassium- 01-FEB-2020 4.1 mEq/L, (3.60-5.10). Blood sodium- 01-FEB-2020 135 mEq/L, (136.00-145.00). Blood urea- 01-FEB-2020 9 mg/dL, (6.00-20.00). Carbon dioxide- 01-FEB-2020 23 mEq/L, (22.00-32.00). Eosinophil count- 01-FEB-2020 1 percent, (0.00-5.00). Haematocrit- 01-FEB-2020 32.5 percent, (35.00-45.00). Haemoglobin- 01-FEB-2020 11.3 g/dL, (11.00-15.00). Lymphocyte count- 01-FEB-2020 24 percent, (20.00-50.00). Mean cell haemoglobin- 01-FEB-2020 26.9 pg, (24.00-28.00). Mean cell haemoglobin concentration- 01-FEB-2020 34.8 g/dL, (31.50-35.50). Mean cell volume- 01-FEB-2020 77.4 fL, (75.00-85.00). Mean platelet volume- 01-FEB-2020 8.6 fL. Monocyte count- 01-FEB-2020 10 percent, (0.00-10.00). Protein total- 01-FEB-2020 6.2 µG/DL, (6.10-8.00). Red blood cell count- 01-FEB-2020 4.20 M /mm3, (4.10-5.30). White blood cell count- 01-FEB-2020 10.7 K/MM3, (5.00-11.00). pH urine- 01-FEB-2020 6.0 (5.00-7.00).    The investigator considered that there was no reasonable possibility that the febrile seizure and gastroenteritis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Hiberix, M-M-R II, Varivax and Prevnar 13.  The company considered that there was no reasonable possibility that the febrile seizure and gastroenteritis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Hiberix, M-M-R II, Varivax and Prevnar 13.   Linked case(s) involving the same subject:  US2022081864   GSK Receipt date: 10-MAR-2020  Subject presented to the ER (emergency room) on 01Feb2020 post seizure following a febrile seizure with vomiting and diarrhea. Flu test was done at this visit. With negative results and no further seizure symptoms, subject was released to go home with a script for Zofran for the gastroenteritis.  Subject returned to the ER (emergency room)approximately 15 hours later after another febrile seizure.  It was deemed he would be admitted for observation and further tests.  UA and blood tests were ordered, as well as urine and blood cultures. No further seizures took place through the night.  Subject was released the following day with the diagnosis of complex febrile seizure likely secondary to gastroenteritis.  Parent had not stated subject had further seizures since discharge.  Subject was admitted on 01 Feb 2020, discharged on 02 Feb 2020.  The blood culture, urine culture, stool culture and influenza test were all done on 01 Feb 2020. Parent informed subject had a previous seizure 12 Dec 2019. December seizure was not a SAE (serious adverse event), but will discuss with provider about adding as a separate AE (adverse event). Question Responses from Query previously.  1.  Did the subject lose consciousness  No 2.  Was the seizure generalised/localised generalized 3. Were any medical investigations performed?  Not that are reported 4.  Please update the child's birth and family history. There are no changes.  Mother describes similar seizure (01Feb2020) to that of 12 Dec 2019 which was also a febrile seizure. Child had tonic-clonic activity of arms and legs with stiffness and eyes rolled back. Postictal confusion and lethargy for 1 hour.  Seizure no. 1 The seizure was witnessed by study parents or relatives. The date of first seizure was 1/Feb/2020 and time of first seizure was 03:34. Fever at the time or immediately before generalized convulsive seizure: 103.0 degrees Fahrenheit. Duration of seizure in minutes (approximately): 5 minutes. Number of generalized convulsive seizures: 1. There was past history of similar events - Type of Seizure was generalized seizure, arms & legs stiff, eyes rolled back, fever. Familial history of similar events: No Diagnostic certainty level: Level 1; Witnessed sudden loss of consciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations. No Familial history of similar events. This case contains an event assessed by the investigator as a non-serious adverse event of special interest (AESI). On 03Mar2021 investigator reported event discription as generalized seizure, arms & legs stiff, eyes rolled back. Seizure no.2: The date of generalized seizure was 12/Dec/2019. Fever at the time or immediately before generalized convulsive seizure was 105.0 Fahrenheit. Duration of seizure was approximately 5 minutes. Number of generalized convulsive seizures -1. There were no past history of similar events, no familial history of similar events. Diagnostic certainty level was Level 1; Witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations.  Follow up information received on 04-AUG-2022.  This follow up was considered significant.  Summary of changes: The investigator text were updated.  Follow up information received on 10-JAN-2025 Summary of changes: General narrative comment updated.  Upon internal review the case was updated on: 13-JAN-2025 : suspect product Bexsero / Placebo vaccination date updated 12/Mar/2019 to 12/Sep/2019, TTO updated, suspect product Pediarix updated.  Follow up information received on 13-JAN-2025 Reported medications name ibuprofen 100mg/5mL, acetaminophen 160mg/5ml suspension and albuterol 0.63mg/3ml nebulizer Summary of changes: General narrative comment updated.  Upon internal review the case was updated on 16-Jan-2025 Suspect vaccine coding updated.; Sender's Comments: A case of gastroenteritis and febrile convulsion, 142 days after receiving Bexsero vs Placebo (4th dose) , M-M-R II (1st dose)  Prevnar (4th dose) and Varivax (1st dose), 326 days after receiving DTPa-HBV-IPV (3rd dose) and Hiberix (3rd dose) and 401 days after receiving Rotarix (2nd dose) in a 17-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternate etiology (gastroenteritis) for the event febrile convulsion. US-GLAXOSMITHKLINE-US2022081864: