Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (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 / RL |
| 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 |
Lower Respiratory Tract Infection (LRTI); Upper Respiratory Infection (URI); This 9-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular, left thigh) on 15-FEB-2019, for prophylaxis. The subject received DTPa-HBV-IPV on an unknown date. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 07-DEC-2018, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 15-FEB-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 07-MAY-2019, 81 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines and Hiberix, an unknown time after receiving DTPa-HBV-IPV and 151 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 lower respiratory tract infection (Verbatim: Lower Respiratory Tract Infection (LRTI)). Serious criteria included hospitalization and GSK medically significant. Additional event(s) included moderate - grade 2 upper respiratory tract infection (Verbatim: Upper Respiratory Infection (URI)) on 07-MAY-2019 with serious criteria of hospitalization. The subject was treated with ceftriaxone sodium (Ceftriaxone), ipratropium bromide (Ipratropium), ibuprofen sodium (Ibuprofen), prednisolone sodium phosphate (Orapred) and salbutamol sulfate (Albuterol). Rotarix lyophilized formulation was continued with no change. The outcome of lower respiratory tract infection was resolved on 09-MAY-2019. The outcome(s) of the additional event(s) included upper respiratory tract infection (resolved on 09-MAY-2019). Relevant Tests: On 08May2019 Chest X-ray results: left lung has patchy opacity in the midportion superimposed on the fourth anterior rib. Mild airway thickening is noted. Cardiac and mediastinal contours are normal. No pneumothorax or pleural effusion. No acute osseous abnormality. On an unknown date in May 2019, NRBC AB WAM = 0.03 10e3/uL (range = 0.03-0.12). Diagnostic results (reference ranges are provided in parenthesis if available): Anion gap-In MAY-2019 13 mmol/L, (7-15). Basophil count- 08-MAY-2019 0.20 %, (0.00-1.00). Blood calcium- 08-MAY-2019 9.4 mg/dL, (9.00-11.00). Blood chloride- 08-MAY-2019 109 mmol/L, (98.00-107.00). Blood creatine- 08-MAY-2019 0.18 (0.20-0.50). Blood glucose- 08-MAY-2019 153 mg/dL, (60.00-100.00). Blood potassium- 08-MAY-2019 3.4 mmol/L, (3.50-5.50). Blood sodium- 08-MAY-2019 140 mmol/L, (131.00-140.00). Blood urea- 08-MAY-2019 11 mg/dL, (6.00-17.00). Carbone dioxide- 08-MAY-2019 18 mmol/L, (22.00-32.00). Chest X-ray- 08-MAY-2019 see text. Eosinophil count- 08-MAY-2019 0.70 %, (0.00-4.00). Granulocyte count- 08-MAY-2019 0.06 x10e3/mcL, (0.00-0.22). Haematocrit- 08-MAY-2019 31.90 %, (33.00-45.00). Haemoglobin- 08-MAY-2019 10.40 g/dL, (10.50-13.50). Influenza virus test-In MAY-2019 negative. Mean cell haemoglobin- 08-MAY-2019 27.40 pg, (23.00-31.00). Mean cell haemoglobin concentration- 08-MAY-2019 32.60 g/dL, (31.00-37.00). Mean cell volume- 08-MAY-2019 83.90 fL, (75.00-86.00). Mean platelet volume- 08-MAY-2019 9.30 fL, (8.60-13.00). Monocyte count- 08-MAY-2019 6.90 %, (0.00-10.00). Neutrophil count- 08-MAY-2019 75.00 %, (15.00-45.00) and 08-MAY-2019 10.97 x10e3/mcL, (1.50-5.00). Platelet count- 08-MAY-2019 543.00 x10e3/mcL, (150.00-420.00). Red blood cell count- 08-MAY-2019 3.8 x10E6/mcL, (3.50-5.50). Red cell distribution width- 08-MAY-2019 13.60 %, (11.00-16.00). Respiratory syncytial virus test-In MAY-2019 negative. White blood cell count- 08-MAY-2019 14.63 x10e3/mcL, (5.50-18.00). The investigator considered that there was no reasonable possibility that the lower respiratory tract infection and upper respiratory tract infection may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the lower respiratory tract infection and upper respiratory tract infection may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. INVESTIGATOR TEXT 5/8/19: Subject presented to the clinic with increased work of breathing, decreased activity and urine output for 24 hours. PI saw her immediately and performed physical, also monitoring O2 stats. Subject also had elevated temperature of 100.2F. Initial sat 90-91%; was given 3 nebs, 10 mg steroid burst. After first neb PI felt that the subject was in respiratory distress and called EMS. After 3rd neb treatment, air flow appeared to be improved, but with continued considerable retractions and wheezing felt subject should be transported to ER. ER ordered chest x-ray and labs. Chest X-ray results: "left lung has patchy opacity in the midportion superimposed on the fourth anterior rib. Mild airway thickening is noted. Cardiac and mediastinal contours are normal. No pneumothorax or pleural effusion. No acute osseous abnormality." Negative for Influenza and RSV Metabolic Panel: Sodium = 140 Potassium = 3.4 Chloride = 109 Co2 total = 18 Anion Gap = 13 Glucose = 153 BUN = 11 Calcium = 9.4 Creatinine = 0.18 CBC Panel: WBC Count = 14.63 RBC Count = 3.8 Hemoglobin = 10.4 Hematocrit = 31.9 MCV = 83.9 MCH = 27.4 MCHC = 32.6 RDW-CV = 13.6 Platelet Count = 543 MPV = 9.3 Prelim Neut AB WAM = 10.97 NRBC WAM = 0 NRBC AB WAM = 0.03 Segmented Neutrophil WAM = 75.0 Immature Granulocytes WAM = 0.4 Lymphocyte WAM = 16.8 Monocyte WAM = 6.9 Eosinophil WAM = .7 Basophil WAM = .2 Neutrophil WAM = 10.97 IMM Granulocyte AB WAM = 0.06 Lymphocyte ABS WAM = 2.46 Monocyte WAM = 1.01 Eosinophil WAM = 0.10 Basophil WAM = 0.03 No premature birth or history of chest injury. Findings were concerns for pneumonia, subject was treated with IV and antibiotics. ER Physician felt he need to be admitted for observation overnight. 5/9/19: Subject was discharged with diagnosis of Viral Upper (URI) and Lower Respiratory Tract (LRTI) Infections. Instructions to follow up with PCP 5/13 or 5/14 or with ER if needed. Upon internal review the case was updated on 18-Mar-2025. Comparator vaccines updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of the Lower respiratory tract infection and Upper respiratory tract infection, 81 days after receiving Placebo and 3rd dose of DTPa-HBV-IPV and Hiberix, 2nd dose of Rotarix lyophilized formulation, and Prevenar 13 in a 9-month-old male subject. Placebo case following unblinding, causality assessment non applicable. Report is inconsistent with causal relation to the vaccine product, considering an implausible time to onset and absence of biological plausibility.
Test Date: 201905; Test Name: Anion GAP; Result Unstructured Data: (Test Result:13,Unit:mmol/L,Normal Low:7,Normal High:15); Test Date: 20190508; Test Name: Basophils; Test Result: 0.20 %; Test Date: 20190508; Test Name: Calcium; Test Result: 9.4 mg/dl; Test Date: 20190508; Test Name: Chloride; Result Unstructured Data: (Test Result:109,Unit:mmol/L,Normal Low:98.00,Normal High:107.00); Test Date: 20190508; Test Name: Creatine; Result Unstructured Data: (Test Result:0.18,Unit:unknown,Normal Low:0.20,Normal High:0.50); Test Date: 20190508; Test Name: Blood glucose; Test Result: 153 mg/dl; Test Date: 20190508; Test Name: Potassium; Result Unstructured Data: (Test Result:3.4,Unit:mmol/L,Normal Low:3.50,Normal High:5.50); Test Date: 20190508; Test Name: Sodium; Result Unstructured Data: (Test Result:140,Unit:mmol/L,Normal Low:131.00,Normal High:140.00); Test Date: 20190508; Test Name: Blood urea nitrogen; Test Result: 11 mg/dl; Test Date: 20190508; Test Name: Carbone dioxide; Result Unstructured Data: (Test Result:18,Unit:mmol/L,Normal Low:22.00,Normal High:32.00); Test Date: 20190508; Test Name: Chest X-ray; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Date: 20190508; Test Name: Eosinophils; Test Result: 0.70 %; Test Date: 20190508; Test Name: Granulocyte count; Result Unstructured Data: (Test Result:0.06,Unit:x10e3/mcL,Normal Low:0.00,Normal High:0.22); Test Date: 20190508; Test Name: Hematocrit; Test Result: 31.90 %; Test Date: 20190508; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:10.40,Unit:g/dL,Normal Low:10.50,Normal High:13.50); Test Date: 201905; Test Name: Influenza; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20190508; Test Name: Mean corpuscular hemoglobin; Test Result: 27.40 pg; Test Date: 20190508; Test Name: Mean cell hemoglobin concentration; Result Unstructured Data: (Test Result:32.60,Unit:g/dL,Normal Low:31.00,Normal High:37.00); Test Date: 20190508; Test Name: Mean corpuscular volume; Test Result: 83.90 fL; Test Date: 20190508; Test Name: Mean Platelet Volume; Test Result: 9.30 fL; Test Date: 20190508; Test Name: Monocytes; Test Result: 6.90 %; Test Date: 20190508; Test Name: Neutrophils; Result Unstructured Data: (Test Result:10.97,Unit:x10e3/mcL,Normal Low:1.50,Normal High:5.00); Test Date: 20190508; Test Name: Segmented Neutrophil Count; Test Result: 75.00 %; Test Date: 20190508; Test Name: Platelet count; Result Unstructured Data: (Test Result:543.00,Unit:x10e3/mcL,Normal Low:150.00,Normal High:420.00); Test Date: 20190508; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:3.8,Unit:x10E6/mcL,Normal Low:3.50,Normal High:5.50); Test Date: 20190508; Test Name: Red Cell Distribution Width; Test Result: 13.60 %; Test Date: 201905; Test Name: RSV; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20190508; Test Name: White blood cell count; Result Unstructured Data: (Test Result:14.63,Unit:x10e3/mcL,Normal Low:5.50,Normal High:18.00); Comments: On 08May2019 Chest X-ray results: left lung has patchy opacity in the midportion superimposed on the fourth anterior rib. Mild airway thickening is noted. Cardiac and mediastinal contours are normal. No pneumothorax or pleural effusion. No acute osseous abnormality. On an unknown date in May 2019, NRBC AB WAM = 0.03 10e3/uL (range = 0.03-0.12)