Report #2832081

Overview

Sex

Male

Age

0.3 yrs

State

—

Recovered

Recovered

Vaccinated

Aug 27, 2019

Onset

Oct 3, 2019

Days to onset

37

Hospital days

1

Symptoms (36)

Symptom narrative

Subarachnoid hemorrhage; This 5-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 27th August 2019, for prophylaxis. On 3rd October 2019 08:33, 37 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed moderate - grade 2 subarachnoid hemorrhage. Serious criteria included hospitalization and GSK medically significant. Bexsero vs Placebo co-administered with PCV and routine vaccines was continued with no change. The outcome of subarachnoid hemorrhage was recovered/resolved on 4th October 2019 14:56. The investigator considered that there was no reasonable possibility that the subarachnoid hemorrhage may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. Relevant Tests: On 03 Oct 2019, Brain CT 3D without Contrast Small amount of high density within the left sylvian fissure consistent with subarachnoid(or less likely subpial) hemorrhage. No significant mass effect. On 03 Oct 2019, Urine toxicology screen for Marijuana, Cocaine Amph/Methamph Barbiturates Methadone Opiates Phencyclidine Benzos ALL Negative. Diagnostic results (unless otherwise stated, normal values were not provided): On 3rd October 2019, Alanine aminotransferase result was 47.00 IU/L (normal low: 17.00, normal high: 63.00), Amylase result was 24.00 IU/L (normal low: 0.00, normal high: 11.00), Basophil percentage result was 1 percent (normal low: 0.00, normal high: 2.00), Basophil percentage result was 1.0 percent (normal low: 0.00, normal high: 2.00), Blood chloride result was 108.00 mmol/L (normal low: 98.00, normal high: 107.00), Blood creatine result was 0.20 mmol/L (normal low: 0.10, normal high: 0.60), Blood glucose result was 89.00 mg/dL (normal low: 57.00, normal high: 117.00), Blood potassium result was 4.20 mmol/L (normal low: 4.10, normal high: 5.30), Blood sodium result was 139 mmol/L (normal low: 136.00, normal high: 146.00), Blood urea result was 6.00 mg/dL (normal low: 6.00, normal high: 18.00), Computerised tomogram head result was see text, Eosinophil percentage result was 2.00 percent (normal low: 0.00, normal high: 3.00), Haematocrit result was 33.90 percent (normal low: 29.00, normal high: 41.00), Haemoglobin result was 11.60 g/dL (normal low: 9.50, normal high: 13.50), Lipase result was 42.00 IU/L (normal low: 73.00, normal high: 393.00), Lymphocyte percentage result was 33.00 percent (normal low: 33.00, normal high: 63.00), Mean cell haemoglobin result was 25.40 pg (normal low: 27.00, normal high: 33.00), Mean cell haemoglobin concentration result was 34.0 g/dL (normal low: 31.00, normal high: 35.00), Mean cell volume result was 74.40 fL (normal low: 74.00, normal high: 108.00), Mean platelet volume result was 7.5 fL (normal low: 6.80, normal high: 10.40), Monocyte count result was 0.58 x10e9/L (normal low: 0.05, normal high: 1.10), Monocyte percentage result was 8 percent (normal low: 5.00, normal high: 12.00), Neutrophil percentage result was 34.00 percent (normal low: 19.00, normal high: 39.00), Platelet count result was 346 (normal low: 156.00, normal high: 359.00), Red blood cell count result was 4.56 (normal low: 3.10, normal high: 4.50), Red cell distribution width result was 12.40 percent (normal low: 11.80, normal high: 15.20), Skeletal survey result was no evidence for acute or healing fractures, Urine analysis result was Normal and White blood cell count result was 7.0 x10e9/L (normal low: 5.00, normal high: 17.00). GSK Receipt Date- 04-OCT-2019 Previously healthy 5 month old presented to Hospital ED evening of 10/3/2019 after closed head injury.Child rolled off a bed falling onto wood floor. Immediately cried no loss of consciousness Normal neuro exam noted area of ecchymosis on temporal scalp CT Scan showed small subarachnoid hemorrhage. Admitted to PICU for medical monitoring. Seen by neurosurgery and trauma team. Had CBC urinalysis urine toxicology screen, clotting factors and skeletal survey all within normal limits. Doing well today may be discharged home. 10/4/2019 15:25 EDT discharged to home. Follow up information received on 11-Mar-2025 End of study Unblinding completed. Upon internal review the case was updated on 17-Mar-2025. Study drugs updated.; Sender's Comments: A case of subarachnoid hemorrhage, 37 days after receiving 2nd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines in a 5-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology of fall based on medical history. US-GLAXOSMITHKLINE-US2019191983:

Lab data

Test Date: 20191003; Test Name: Alanine aminotransferase; Result Unstructured Data: (Test Result:47.00,Unit:IU/L,Normal Low:17.00,Normal High:63.00); Test Date: 20191003; Test Name: Amylase; Result Unstructured Data: (Test Result:24.00,Unit:IU/L,Normal Low:0.00,Normal High:11.00); Test Date: 20191003; Test Name: Basophils; Test Result: 1.0 %; Test Date: 20191003; Test Name: Basophils; Test Result: 1 %; Test Date: 20191003; Test Name: Chloride; Result Unstructured Data: (Test Result:108.00,Unit:mmol/L,Normal Low:98.00,Normal High:107.00); Test Date: 20191003; Test Name: Creatine; Result Unstructured Data: (Test Result:0.20,Unit:mmol/L,Normal Low:0.10,Normal High:0.60); Test Date: 20191003; Test Name: Blood glucose; Test Result: 89.00 mg/dl; Test Date: 20191003; Test Name: Potassium; Result Unstructured Data: (Test Result:4.20,Unit:mmol/L,Normal Low:4.10,Normal High:5.30); Test Date: 20191003; Test Name: Sodium; Result Unstructured Data: (Test Result:139,Unit:mmol/L,Normal Low:136.00,Normal High:146.00); Test Date: 20191003; Test Name: Blood urea nitrogen; Test Result: 6.00 mg/dl; Test Date: 20191003; Test Name: Brain CT 3D; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191003; Test Name: Eosinophils; Test Result: 2.00 %; Test Date: 20191003; Test Name: Hematocrit; Test Result: 33.90 %; Test Date: 20191003; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:11.60,Unit:g/dL,Normal Low:9.50,Normal High:13.50); Test Date: 20191003; Test Name: Lipase; Result Unstructured Data: (Test Result:42.00,Unit:IU/L,Normal Low:73.00,Normal High:393.00); Test Date: 20191003; Test Name: Lymphocytes; Test Result: 33.00 %; Test Date: 20191003; Test Name: Mean corpuscular hemoglobin; Test Result: 25.40 pg; Test Date: 20191003; Test Name: Mean cell hemoglobin concentration; Result Unstructured Data: (Test Result:34.0,Unit:g/dL,Normal Low:31.00,Normal High:35.00); Test Date: 20191003; Test Name: Mean corpuscular volume; Test Result: 74.40 fL; Test Date: 20191003; Test Name: Mean Platelet Volume; Test Result: 7.5 fL; Test Date: 20191003; Test Name: Monocytes; Result Unstructured Data: (Test Result:0.58,Unit:x10e9/L,Normal Low:0.05,Normal High:1.10); Test Date: 20191003; Test Name: Monocytes; Test Result: 8 %; Test Date: 20191003; Test Name: Neutrophils; Test Result: 34.00 %; Test Date: 20191003; Test Name: Platelet count; Result Unstructured Data: (Test Result:346,Unit:unknown,Normal Low:156.00,Normal High:359.00); Test Date: 20191003; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:4.56,Unit:unknown,Normal Low:3.10,Normal High:4.50); Test Date: 20191003; Test Name: Red Cell Distribution Width; Test Result: 12.40 %; Test Date: 20191003; Test Name: Skeletal survey; Result Unstructured Data: (Test Result:no evidence for acute or healing fractures,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191003; Test Name: Routine urinalysis; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191003; Test Name: White blood cell count; Result Unstructured Data: (Test Result:7.0,Unit:x10e9/L,Normal Low:5.00,Normal High:17.00); Comments: On 03 Oct 2019, Brain CT 3D without Contrast Small amount of high density within the left sylvian fissure consistent with subarachnoid(or less likely subpial) hemorrhage. No significant mass effect. On 03 Oct 2019, Urine toxicology screen for Marijuana, Cocaine Amph/Methamph Barbiturates Methadone Opiates Phencyclidine Benzos ALL Negative.