Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
Respiratory failure with hypoxia; This 3-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-AUG-2022, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 01-AUG-2022, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 01-AUG-2022, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, left thigh) on 01-AUG-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 03-SEP-2022, 33 days after receiving Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV, the subject developed severe - grade 3 hypoxic respiratory failure (Verbatim: Respiratory failure with hypoxia). Serious criteria included hospitalization. The subject was treated with ampicillin;sulbactam, paracetamol (Tylenol), ibuprofen (Motrin), salbutamol (Proventil), oxygen, remdesivir and dexamethasone. The action taken with Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV was no change. The outcome of hypoxic respiratory failure was resolved on 09-SEP-2022. Relevant Tests: On 03Sep2022 Subject seen at PCP (primary care physician) and was diagnosed with COVID 19 and RSV (Respiratory Syncytial Virus). Subject treated with antibiotics and oxygen. On an unknown date in Sep-2022 chest x-ray showed right upper lobe atelectasis versus pneumonia. The ED (emergency department) attendings felt more likely atelectasis so did not start antibiotics.. Diagnostic results (reference ranges are provided in parenthesis if available): Body temperature-In SEP-2022 103. The investigator considered that there was no reasonable possibility that the hypoxic respiratory failure may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV. The company considered that there was no reasonable possibility that the hypoxic respiratory failure may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV. GSK receipt date: 06-SEP-2022 Subject seen at PCP (primary care physician) on 03Sep2022 and was diagnosed with COVID 19 and RSV (Respiratory syncytial virus). Subject's condition declined at home and he was admitted to the hospital on 05Sep2022. He was currently receiving IV (intravenous) antibiotics and oxygen and was still currently hospitalized. Would update when more information was received. On day of admission he developed increased WOB (work of breathing) with tracheal tugging, head bobbing and grunting at home. He had decreased PO intake and decreased UOP (urine output). In ER (emergency room) temp was 103. He had suprasternal retractions and diffuse rhonchi. Cap refill was delayed and his feet appeared mottled. He was suctioned and placed on HFNC (high flow nasal canula) 9L (1.5 L/kg). His Fi)2 required some adjustment due to desats in the ED (emergency department) to the mid 80s and he was captured at 55 percent. He got a NS (normal saline) bolus. ED (emergency department) attendings felt more likely atelectasis so did not start abx (antibiotics). Subject was discharged from the hospital on 09Sep2022 The subject received Dextrose 5 percent and 0.9 percent NaCl with KCl 20 meq from 06-Sep-2022 to 06-Sep-2022 at a dose of 25ml single via intravenous route for the treatment of potassium levels normal. Follow-up information received on 14-SEP-2022. This follow-up was considered significant. Summary of changes: Event date, Outcome of the event and Covid-19 details updated. Follow-up information received on 15-NOV-2022. Summary of changes : Covid-19 details updated, Treatment medication added. Follow-up information received on 07-DEC-2022. Summary of changes : End date for Remdesivir updated Follow-up information received on 13-DEC-2022, 19-DEC-2022. Summary of changes : Lab details updated Follow-up information received on 20-DEC-2022 Summary of changes :Treatment medication updated Follow-up information received on 30-DEC-2022 Summary of change:Investigator text ,Hospitalization stop date updated, AESI statement was removed. Follow-up information received on 20-Feb-2023 Summary of Changes: Treatment drug added. Follow-up information received on 22-Apr-2023 and 27-Apr-2023. Summary of changes: Narrative updated, covid-19 event removed. Follow-up information received on 20-MAY-2023. Summary of changes: Suspect vaccine details and treatment drugs were added. Follow-up information received on 30-MAY-2023. Summary of changes: Event start date updated. Follow-up information received on 08-JUN-2023. Summary of changes: Narrative was updated. Follow-up information received on 28-JUN-2023. Summary of changes: treatment medication updated Upon internal review the case was updated on 07-Feb-2025. Authorization number was updated from World-MKT to World-INV for Hiberix and Rotarix lyophilized formulation. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Dextrose 5 percent and 0.9 percent NaCl with KCl 20 meq details updated in narrative and removed from product tab. Follow-up information received on 11-FEB-2025 Summary of changes: Lab test updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Respiratory failure, 33 days after receiving 1st dose of Bexsero vs Placebo, 1st dose of Rotarix lyophilized formulation, 1st dose of Hiberix , 1st dose of Prevnar 13, 1st dose of DTPa-HBV-IPV, in a 3-months-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 (SARS-CoV-2 test and RSV test positive)
Test Date: 202209; Test Name: Body temperature; Result Unstructured Data: (Test Result:103,Unit:unknown,Normal Low:,Normal High:); Comments: On 03Sep2022 Subject seen at PCP (primary care physician) and was diagnosed with COVID 19 and RSV (Respiratory Syncytial Virus). Subject treated with antibiotics and oxygen. On an unknown date in Sep-2022 chest x-ray showed right upper lobe atelectasis versus pneumonia. The ED (emergency department) attendings felt more likely atelectasis so did not start antibiotics.