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 / RL |
| 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 |
Respiratory syncytial virus bronchiolitis; This 3-month-old female subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 27th July 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 29th September 2018, 64 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed moderate - grade 2 respiratory syncytial virus bronchiolitis. Serious criteria included hospitalization and GSK medically significant. The subject was treated with paracetamol (Tylenol) and 5% dextrose + potassium chloride + 0.9% sodium chloride iv. Bexsero vs Placebo was continued with no change. DTPa-HBV-IPV was continued with no change. Prevnar 13 was continued with no change. Hiberix was continued with no change. Rotarix lyophilized formulation was continued with no change. The outcome of respiratory syncytial virus bronchiolitis was recovered/resolved on 15th October 2018. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Relevant Tests: On 29 Sep 2018, X-ray showed patchy opacity in the right upper to mid lung zone represents atelectasis or consolidation. Diagnostic results (unless otherwise stated, normal values were not provided): On 29th September 2018, Respiratory syncytial virus test result was RSV detected and X-ray result was See text. On 30th September 2018, Electrocardiogram result was normal axis, sinus tachycardia. GSK Receipt Date - 04-OCT-2018 Mother was contacted today 10/4/18 after her missed visit to re-schedule appt. In which she informed us subject was hospitalized for 3 days for RSV. This information was verbally given. Mother does not remember date of admission. Records have been requested and we will follow up when site gets more accurate information. update from hospital records: Patient was admitted 9/29/2018. RVP: RSV+ (confirmed through Respiratory Virus PCR Panel), influenza- and was managed for RSV Bronchiolitis during her stay. She presented on what appears to be day 1 of illness. On admission she appeared to not be in acute respiratory distress although patient was coughing and had labored breathing. On, auscultation, no focal consolidations, no wheezes, although there were bilateral rhonchi in the lower lobes with transmitted upper airway sounds likely from congestion. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchiolitis, 64 days after receiving 1st dose of Bexsero vs Placebo, 1st dose of Prevnar 13, 1st dose of DTPa-HBV-IPV vaccine in pre-filled syringe device injection syringe, 1st dose of Hiberix, 1st dose of Rotarix lyophilized formulation vaccine in oral applicator device co-administered with PCV and routine vaccines in a 3-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering an implausible time to onset and absence of biological plausibility. US-GLAXOSMITHKLINE-US2018181213:
Test Date: 20180930; Test Name: EKG; Result Unstructured Data: (Test Result:normal axis, sinus tachycardia,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180929; Test Name: RSV PANEL; Result Unstructured Data: (Test Result:RSV detected,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180929; Test Name: X-RAY; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Comments: On 29 Sep 2018, X-ray showed patchy opacity in the right upper to mid lung zone represents atelectasis or consolidation.