Report #2832089

Overview

Sex

Male

Age

0.3 yrs

State

—

Recovered

Recovered

Vaccinated

Aug 8, 2022

Onset

Nov 22, 2022

Days to onset

106

Hospital days

3

Symptoms (26)

Symptom narrative

Acute Hypoxic Respiratory Failure; Respiratory Syncytial Virus Bronchiolitis; Disease caused by 2019 Novel Coronavirus; This 7-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 20-OCT-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 20-OCT-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 20-OCT-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 08-AUG-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 22-NOV-2022, 33 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 106 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 respiratory syncytial virus bronchiolitis (Verbatim: Respiratory Syncytial Virus Bronchiolitis). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 coronavirus disease 2019 (Verbatim: Disease caused by 2019 Novel Coronavirus) on 22-NOV-2022 with serious criteria of hospitalization and severe - grade 3 acute hypoxic respiratory failure (Verbatim: Acute Hypoxic Respiratory Failure) on 29-NOV-2022 with serious criteria of hospitalization. The subject was treated with oxygen, remdesivir, sodium chloride (Normal Saline), ibuprofen, lidocaine;prilocaine (Emla), glucose;potassium chloride;sodium chloride (Dextrose;Potassium Chloride;Sodium Chloride), dexamethasone and paracetamol (Acetaminophen). The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation was no change. The outcome of respiratory syncytial virus bronchiolitis was resolved on 05-DEC-2022. The outcome(s) of the additional event(s) included acute hypoxic respiratory failure (resolved on 02-DEC-2022) and coronavirus disease 2019 (resolved on 05-DEC-2022). Relevant Tests: On DEC-2022 Additional Diagnostic Results: Lab Results not previously listed: C02 18 mmol/L, Anion Gap (Na Cl C02) 12 mmol/L, Glucose Level 86 mg/dL, BUN 9mg/dL. Diagnostic results (reference ranges are provided in parenthesis if available): Alanine aminotransferase- 02-DEC-2022 19 unit/litre. Aspartate aminotransferase- 02-DEC-2022 42 unit/litre. Blood albumin- 02-DEC-2022 4.1 g/dL. Blood alkaline phosphatase- 02-DEC-2022 121 unit/litre. Blood bilirubin- 02-DEC-2022 0.3 mg/dL. Blood calcium- 02-DEC-2022 10.5 mg/dL. Blood chloride- 02-DEC-2022 110 mmol/L. Blood creatine- 02-DEC-2022 0.28 mg/dL. Blood potassium- 02-DEC-2022 5.6 mmol/L. Blood sodium- 02-DEC-2022 140 mmol/L. Protein total- 02-DEC-2022 6.7 g/dL. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis, coronavirus disease 2019 and acute hypoxic respiratory failure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis, coronavirus disease 2019 and acute hypoxic respiratory failure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. GSK Receipt date: 25-Jan-2023. Assessment and Plan: Overall 7-month-old male on day 7 of upper respiratory tract infection with RFA positive for RSV and COVID-19 resulting in acute hypoxic respiratory failure weaned to wall nasal cannula. Mild respiratory distress remains. Receiving dexamethasone and remdesivir for COVID-19. Suctioning beneficial. reassuring exam without indication to advanced airway support. Anticipate child to remain hospitalized for continued monitoring and antiviral support until oxygen supplementation improved. Subject was hospitalized from 11/29/22 through 12/02/22. Follow-up information received on 03-APR-2023. Summary of changes: narrative updated. Follow-up information received on 11-APR-2023. Summary of changes: Narrative and type of drug was updated from concomitant to treatment medication. Follow-up information received on 10-MAY-2023. Summary of changes: Narrative and hospitalization dates were updated. Follow-up information received on 31-MAY-2023. Summary of changes: End date of event "Acute Hypoxic Respiratory Failure" were updated. Upon internal review the case was updated on 30-APR-2024. Subject was found COVID-19 Positive on 29/Nov/2022 The COVID-19 test was performed, and result was positive. The subject had not history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset. The subject had not visited any health care facility in the 14 days prior to symptom onset. The subject had taken concomitant medications, including experimental medications, to treat COVID-19. The subject had experienced cough, shortness of breath, fever, loss of appetite. The subject have contact with a confirmed or probable case in the 14 days prior to symptom onset was unknown. The subject had not experienced sore throat, nausea, vomiting, diarrhea, abdominal pain, loss of smell and loss of taste were unknown. The subject was not asymptomatic. The subject was not in home quarantine or isolation. summary of change: COVID-19 details was updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number was updated from 125265 to World-INV for Rotarix lyophilized formulation. Authorization number was updated from World-MKT to World-INV for DTPa-HBV-IPV and Hiberix. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of COVID-19, respiratory syncytial virus bronchiolitis and acute respiratory failure, 33 days after receiving the 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV in DTPa-HBV-IPV and 3rd dose of Hiberix and 106 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 7-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility ans alternative etiology (Viral infection) for Acute respiratory failure event.

Lab data

Test Date: 20221202; Test Name: Alanine Amino Transferase; Result Unstructured Data: (Test Result:19,Unit:unit/litre,Normal Low:,Normal High:); Test Date: 20221202; Test Name: Aspartate Amino Transferase; Result Unstructured Data: (Test Result:42,Unit:unit/litre,Normal Low:,Normal High:); Test Date: 20221202; Test Name: Albumin; Result Unstructured Data: (Test Result:4.1,Unit:g/dL,Normal Low:,Normal High:); Test Date: 20221202; Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:121,Unit:unit/litre,Normal Low:,Normal High:); Test Date: 20221202; Test Name: Bilirubin; Test Result: 0.3 mg/dl; Test Date: 20221202; Test Name: Calcium; Test Result: 10.5 mg/dl; Test Date: 20221202; Test Name: Chloride; Result Unstructured Data: (Test Result:110,Unit:mmol/L,Normal Low:,Normal High:); Test Date: 20221202; Test Name: Creatine; Test Result: 0.28 mg/dl; Test Date: 20221202; Test Name: Potassium; Result Unstructured Data: (Test Result:5.6,Unit:mmol/L,Normal Low:,Normal High:); Test Date: 20221202; Test Name: Sodium; Result Unstructured Data: (Test Result:140,Unit:mmol/L,Normal Low:,Normal High:); Test Date: 20221202; Test Name: Protein total; Result Unstructured Data: (Test Result:6.7,Unit:g/dL,Normal Low:,Normal High:); Comments: On DEC-2022 Additional Diagnostic Results: Lab Results not previously listed: C02 18 mmol/L, Anion Gap (Na Cl C02) 12 mmol/L, Glucose Level 86 mg/dL, BUN 9mg/dL