Received Mar 19, 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 | 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 / RL |
Worsening Acute Viral Bronchiolitis; Worsening Acute Viral Bronchiolitis; 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 08-MAR-2019, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 08-MAR-2019, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, left thigh) on 08-MAR-2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 08-MAR-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. Concurrent medical conditions included acute bronchiolitis (Viral). On 23-APR-2019, 46 days after receiving Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation, the subject developed severe - grade 3 acute bronchiolitis (Verbatim: Worsening Acute Viral Bronchiolitis). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 condition aggravated (Verbatim: Worsening Acute Viral Bronchiolitis) on 23-APR-2019 with serious criteria of hospitalization. The subject was treated with salbutamol (Albuterol) and dexamethasone (Decadron). The action taken with Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation was no change. The outcome of acute bronchiolitis was resolved on 19-MAY-2019. The outcome(s) of the additional event(s) included condition aggravated (resolved on 19-MAY-2019). Relevant Tests: On 25-Apr-2019 Chest X-ray showed, no cardiopulmonary abnormalities.. Diagnostic results (reference ranges are provided in parenthesis if available): Oxygen saturation-In APR-2019 88% on room air percent:In APR-2019 95 percent:In APR-2019 98 percent:In APR-2019 85 percent and in APR-2019 100 percent. The investigator considered that there was no reasonable possibility that the acute bronchiolitis and condition aggravated may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the acute bronchiolitis and condition aggravated may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. Linked case(s) involving the same subject: US2019090498 Subject seen at PCP (primary care physician) office with cough and wheezing that had worsened starting 23-Apr-2019. Decadron IM (intramuscular) and albuterol inh given at PCP. Oxygen placed at 7L via face mask and oxygen sats up to 95 percent. Subject transferred to hospital via EMS (Emergency medical services). At hospital oxygen sats high 80's. Subject was suctioned and thick secretions removed. Chest Xray done-no cardiopulmonary abnormalities shown. Started on vapotherm oxygen at 6L, 30 percent and oxygen sats increased to 98 percent. Temp 99.6. Placed in contact and droplet isolation. IV (intravenous) saline lock placed. No further updates at this time. The subject was admitted on 25-Apr-2019 and was discharged on 28-Apr-2019. The subject was previously seen in the office on 19-Mar-2019, 25-Mar-2019, and 10-Apr-2019 with symptoms of cough, wheezing and mild contractions that had not resolved. The subject was not recovered as of May 10, 2019 and was scheduled to return to the clinic on May 17, 2019. Subject seen by primary care physician on 17-May-2019. Subject presented with cough, wheezing, and 02 sat of 85 percent. Placed on 02 (oxygen) at 2 liters per minute, increased to 100 percent but still wheezing. Subject transferred by EMS to hospital. Subject had tachypnea in the 60s with subcostal retractions, nasal suctioning with improvement in retractions. Admitted for viral bronchiolitis. Subject was discharged home on 19-May-19 after being stable throughout the day and evening. Nasal congestion and wheezing present. Subject was well appearing and breathing comfortable. Case US2019090498 was identified as a duplicate of US2019075981. All correspondence will be added in the case US2019075981. Follow-up information received on 31-JUL-2024 Summary of changes: Treatment drug (Albuterol) and event condition aggravated Updated. Follow-up information received on 11-Feb-2025 Summary of changes: Treatment medication Albuterol (frequency) updated from prn to Q4H. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Bronchiolitis and Condition aggravated, 46 days after receiving Placebo and 1st dose of DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation in a 3-month-old male subject. Placebo case following unblinding, causality assessment non applicable. Report is inconsistent with causal relation to the vaccine products, considering implausible time to onset, absence of biological plausibility and alternative etiology (concurrent medical condition acute bronchiolitis). US-GLAXOSMITHKLINE-US2019090498:
Acute bronchiolitis (Viral)
Test Date: 201904; Test Name: Oxygen saturation; Result Unstructured Data: (Test Result:88% on room air,Unit:percent,Normal Low:,Normal High:); Test Date: 201904; Test Name: Oxygen saturation; Test Result: 95 %; Test Date: 201904; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 201904; Test Name: Oxygen saturation; Test Result: 85 %; Test Date: 201904; Test Name: Oxygen saturation; Test Result: 100 %; Comments: On 25-Apr-2019 Chest X-ray showed, no cardiopulmonary abnormalities.