Received Apr 30, 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 |
Viral Syndrome; Pneumonia; This 8-month-old female subject was enrolled in a blinded study titled Phase IIIB, Observer-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 07-JAN-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 07-JAN-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 02-NOV-2018, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 07-JAN-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 07-JAN-2019, for prophylaxis. On 16-MAR-2019, 68 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13 and Hiberix and 134 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 pneumonia (Verbatim: Pneumonia). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 viral syndrome (Verbatim: Viral Syndrome) on 23-MAR-2019 with serious criteria of hospitalization. The subject was treated with zinc oxide, salbutamol (Albuterol), oxygen, cefotaxime sodium (Omnicef), sodium chloride, sodium chloride (Normal Saline), paracetamol (Tylenol Infants), ibuprofen (Children'S Motrin) and ceftriaxone. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13 and Hiberix was no change. The outcome of pneumonia was resolved on 02-APR-2019. The outcome(s) of the additional event(s) included viral syndrome (resolved on 02-APR-2019). Relevant Tests: On 25-Mar-2019 Myelocytes percent was 1 percent (normal range0-0), PLTS, BLD,QL,MAN was increased, PLTS MORPH was normal, Polychromasia was 1 plus normal range n/a, Dacrocytes, BLD QL, LMICRO was 1 plus normal range n/a, diff Panel MAN DIFF was normal normal range n/a, blood culture result showed no growth (normal range no growth), ANION GAP4 SERPL was 12 normal range 5-16mEq/L, GLUCOSE was 102 normal range 60-159 md/dL, CRATININE was less than 0.20 normal range 0.20-0.40 mg/dL. On 27-Mar-2019 Myelocytes percent was 3 percent (normal range0-0), PLTS, BLD,QL,MAN was confirmed normal range n/a, PLTS MORPH was (normal ranges normal), Hypochromia was 1 plus normal range n/a, Toxic Granuels, Bld QL, Micro was 2 plus normal range n/a, diff Panel MAN DIFF was normal normal range n/a, blood culture result showed no growth (normal range no growth), WBC MANUAL DIFFERENTIAL, REFLUX was abnormal normal range normal, CBC W/AUTOMATED DIFFERENTIAL was abnormal normal range normal. On 25Mar2019 X-Ray chest performed findings showed "right upper lobe consolidation with air brochograms and possible synpneumonic effusion". On 28-Mar-2019 ParaInfluenza Virus 3 RNA, PCR exam Findings result showed, "Positive". normal findings would be negative.. Diagnostic results (reference ranges are provided in parenthesis if available): Band neutrophil count- 25-MAR-2019 16 percent, (0.00-5.00) and 27-MAR-2019 5 percent, (0.00-5.00). Blood chloride- 25-MAR-2019 98 mEq/L, (100.00-111.00). Blood potassium- 25-MAR-2019 4.8 mEq/L, (3.50-5.30). Blood sodium- 25-MAR-2019 137 mEq/L, (135.00-145.00). Blood urea- 25-MAR-2019 7 mg/dL, (7.00-27.00). C-reactive protein- 25-MAR-2019 15.6 mg/dL, (0.00-0.90) and 27-MAR-2019 7.3 mg/dL, (0.00-0.90). Carbon dioxide- 25-MAR-2019 27 mEq/L, (20.00-24.00). Haematocrit- 25-MAR-2019 10.9 g/dL, (10.50-13.50) and 27-MAR-2019 11.5 g/dL, (10.50-13.50). Haemoglobin- 25-MAR-2019 33 percent, (33.00-39.00) and 27-MAR-2019 35 percent, (33.00-39.00). Lymphocyte percentage- 25-MAR-2019 31 percent, (20.00-70.00) and 27-MAR-2019 28 percent, (20.00-70.00). Mean cell volume- 25-MAR-2019 82 fL, (70.00-86.00) and 27-MAR-2019 83 fL, (70.00-86.00). Monocyte percentage- 25-MAR-2019 6 percent, (0.00-12.00) and 27-MAR-2019 9 percent, (0.00-12.00). Neutrophil percentage- 25-MAR-2019 46 percent, (16.00-60.00) and 27-MAR-2019 55 percent, (16.00-60.00). Platelet count- 25-MAR-2019 502 K/uL, (140.00-400.00) and 27-MAR-2019 458 K/uL, (140.00-400.00). Red blood cell count- 25-MAR-2019 4.03 M/uL, (4.00-5.20) and 27-MAR-2019 4.22 M/uL, (4.00-5.20). Red blood cell sedimentation rate- 25-MAR-2019 85 mm/hr, (0.00-20.00). Red cell distribution width- 25-MAR-2019 13.2 percent, (12.00-16.50) and 27-MAR-2019 13.2 percent, (12.00-16.50). White blood cell count- 25-MAR-2019 21.7 K/uL, (6.00-17.00) and 27-MAR-2019 18.6 K/uL, (6.00-17.00). The investigator considered that there was no reasonable possibility that the pneumonia and viral syndrome may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13 and Hiberix. The company considered that there was no reasonable possibility that the pneumonia and viral syndrome may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13 and Hiberix. Additional Information: GSK receipt date: 08-MAY-2019 Eight month old with coughing and fevers that started on 16 Mar 2019. She was seen by her primary doctor on 20 Mar 2019 and was diagnosed with an upper respiratory infection, no medications prescribed at this time, Mom was instructed to use a humidifier and give Tylenol or Motrin to reduce fevers. She returned to the clinic on 23 Mar 2019 for continuing fevers, cough, rhinorrhea and diarrhea. Per Mom her oral intake had decreased, though the physician diagnosed her with ongoing upper respiratory symptoms and viral syndrome. Due to worsening symptoms of cough, persistent fevers and decrease urine output she was advised by a physician to get care in the Emergency room on 25 Mar 2019. In the Emergency room she presented with respiratory distress and hypoxia requiring oxygen via nasal cannula. The child was admitted to the hospital with the diagnosis of pneumonia. Also labs were drawn and blood cultures were taken. While in the hospital she required only the first night oxygen and weaned herself to room air with good saturations. But she required several days of additional hospitalization for poor oral intake and large diarrhea output. Intravenous hydration was started, antibiotics were given and Tylenol and Motrin was administered for fevers and pain. On 30 Mar 2019, the child was discharged home, as her "stool output had decreased, she was taking fluids orally without problems and did not need oxygen" to maintain saturations. A blood culture was drawn on 27 Mar 2019 that showed "no growth to date" on the day of discharge. The child went home and finished off her course of antibiotics. By 02 Apr 2019, she was playful and interactive without any respiratory issues or diarrhea, per mom. Follow-up information received on 06-Aug-2024 The subject received biogaria protectis baby at a dosage of 5 drops daily oral from 29-MAR-2019 00:00 to 30-MAR-2019 00:00 for Diarrhoea. The subject received D5 Sodium Chloride 0.9% Potassium Chloride 20 meq/L at a dosage of 5 ml CO intravenously from 29-MAR-2019 to 30-MAR-2019 for maintain IV patency. Later, received at a dosage of 28 ml CO intravenously from 26-MAR-2019 to 29-MAR-2019 for Hydration. Summary of changes: Treatment medication Ceftriaxone details (frequency) updated. Follow-up information received on 30-AUG-2024 Summary of changes: Event Diarrhea deleted, seriousness GSK Medically Significant for event Pneumonia was removed and narrative updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Pneumonia and Viral infection, 68 days after receiving 3rd dose of Bexsero, Hiberix and DTPa-HBV-IPV and 134 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 8-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility and alternative etiology (ParaInfluenza Virus 3 RNA, PCR exam Findings result "Positive").
Test Date: 20190325; Test Name: Band Neutrophil count; Test Result: 16 %; Test Date: 20190327; Test Name: Band Neutrophil count; Test Result: 5 %; Test Date: 20190325; Test Name: Chloride; Test Result: 98 {DF}; Test Date: 20190325; Test Name: Potassium; Test Result: 4.8 {DF}; Test Date: 20190325; Test Name: Sodium; Test Result: 137 {DF}; Test Date: 20190325; Test Name: Blood urea nitrogen; Test Result: 7 mg/dl; Test Date: 20190325; Test Name: Carbone dioxide; Test Result: 27 {DF}; Test Date: 20190325; Test Name: C-reactive protein; Test Result: 15.6 mg/dl; Test Date: 20190327; Test Name: C-reactive protein; Test Result: 7.3 mg/dl; Test Date: 20190325; Test Name: Hematocrit; Result Unstructured Data: (Test Result:10.9,Unit:g/dL,Normal Low:10.50,Normal High:13.50); Test Date: 20190327; Test Name: Hematocrit; Result Unstructured Data: (Test Result:11.5,Unit:g/dL,Normal Low:10.50,Normal High:13.50); Test Date: 20190325; Test Name: Hemoglobin; Test Result: 33 %; Test Date: 20190327; Test Name: Hemoglobin; Test Result: 35 %; Test Date: 20190325; Test Name: Lymphocytes; Test Result: 31 %; Test Date: 20190327; Test Name: Lymphocytes; Test Result: 28 %; Test Date: 20190325; Test Name: Mean corpuscular volume; Test Result: 82 fL; Test Date: 20190327; Test Name: Mean corpuscular volume; Test Result: 83 fL; Test Date: 20190325; Test Name: Monocytes; Test Result: 6 %; Test Date: 20190327; Test Name: Monocytes; Test Result: 9 %; Test Date: 20190325; Test Name: Neutrophils; Test Result: 46 %; Test Date: 20190327; Test Name: Neutrophils; Test Result: 55 %; Test Date: 20190325; Test Name: Platelet count; Result Unstructured Data: (Test Result:502,Unit:K/uL,Normal Low:140.00,Normal High:400.00); Test Date: 20190327; Test Name: Platelet count; Result Unstructured Data: (Test Result:458,Unit:K/uL,Normal Low:140.00,Normal High:400.00); Test Date: 20190325; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:4.03,Unit:M/uL,Normal Low:4.00,Normal High:5.20); Test Date: 20190327; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:4.22,Unit:M/uL,Normal Low:4.00,Normal High:5.20); Test Date: 20190325; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: (Test Result:85,Unit:mm/hr,Normal Low:0.00,Normal High:20.00); Test Date: 20190325; Test Name: Red Cell Distribution Width; Test Result: 13.2 %; Test Date: 20190327; Test Name: Red Cell Distribution Width; Test Result: 13.2 %; Test Date: 20190325; Test Name: White blood cell count; Result Unstructured Data: (Test Result:21.7,Unit:K/uL,Normal Low:6.00,Normal High:17.00); Test Date: 20190327; Test Name: White blood cell count; Result Unstructured Data: (Test Result:18.6,Unit:K/uL,Normal Low:6.00,Normal High:17.00); Comments: On 25-Mar-2019 Myelocytes percent was 1 percent (normal range0-0), PLTS, BLD,QL,MAN was increased, PLTS MORPH was normal, Polychromasia was 1 plus normal range n/a, Dacrocytes, BLD QL, LMICRO was 1 plus normal range n/a, diff Panel MAN DIFF was normal normal range n/a, blood culture result showed no growth (normal range no growth), ANION GAP4 SERPL was 12 normal range 5-16mEq/L, GLUCOSE was 102 normal range 60-159 md/dL, CRATININE was less than 0.20 normal range 0.20-0.40 mg/dL. On 27-Mar-2019 Myelocytes percent was 3 percent (normal range0-0), PLTS, BLD,QL,MAN was confirmed normal range n/a, PLTS MORPH was (normal ranges normal), Hypochromia was 1 plus normal range n/a, Toxic Granuels, Bld QL, Micro was 2 plus normal range n/a, diff Panel MAN DIFF was normal normal range n/a, blood culture result showed no growth (normal range no growth), WBC MANUAL DIFFERENTIAL, REFLUX was abnormal normal range normal, CBC W/AUTOMATED DIFFERENTIAL was abnormal normal range normal. On 25Mar2019 X-Ray chest performed findings showed "right upper lobe consolidation with air brochograms and possible synpneumonic effusion". On 28-Mar-2019 ParaInfluenza Virus 3 RNA, PCR exam Findings result showed, "Positive". normal findings would be negative.